Contents 1 Overview 2 Common name 3 English name 4 Alias ??of Xinqing Ⅱ 5 Classification 6 Pharmacological effects of Xinqing Ⅱ 7 Pharmacokinetics of Xinqing Ⅱ 8 Adaptations of Xinqing Ⅱ Certificate 9 Contraindications of Xinqing Ⅱ 10 Adverse reactions of Xinqing Ⅱ 11 Precautions 12 Interactions between Xinqing Ⅱ and other drugs 13 Usage and dosage 14 Dosage forms and specifications of Xinqing Ⅱ 15 Xinqing Ⅱ Storage 16 Clinical application of Xinqing Ⅱ 17 Oxacillin poisoning 17.1 Clinical manifestations 17.2 Treatment 18 Oxacillin sodium pharmacopoeia standard 18.1 Product name 18.1.1 Chinese name 18.1.2 Chinese Pinyin 18.1.3 English name 18.2 Structural formula 18.3 Molecular formula and molecular weight 18.4 Source (name), content (potency) 18.5 Properties 18.5.1 Specific rotation 18.6 Identification 18.7 Inspection 18.7.1 Acidity 18.7.2 Clarity and color of solution 18.7.3 Related substances 18.7.4 Oxacillin polymer 18.7. 4.1 Chromatographic conditions and system suitability test 18.7.4.2 Preparation of control solution 18.7.4.3 Determination method 18.7.5 Residual solvent 18.7.5.1 Ethanol, ethyl acetate, n-butanol and butyl acetate 18.7.6 2ethylhexanoic acid 18.7 .7 Moisture 18.7.8 Visible foreign matter 18.7.9 Insoluble particles 18.7.10 Bacterial endotoxin 18.7.11 Sterility 18.8 Content determination 18.8.1 Chromatographic conditions and system suitability test 18.8.2 Determination method 18.9 Category 18.10 Storage 18.11 Preparation 18.12 Attachment : 18.13 Version 19 Pharmacopeial Standard for Oxacillin Sodium for Injection 19.1 Product name 19.1.1 Chinese name 19.1.2 Chinese Pinyin 19.1.3 English name 19.2 Source (name), content (potency) 19.3 Properties 19.4 Identification 19.5 Inspection 19.5.1 Solution Clarity and color 19.5.2 Moisture 19.5.3 Insoluble particles 19.5.4 Acidity, related substances, oxacillin polymers, bacterial endotoxins and sterility 19.5.5 Others 19.6 Assay 19.7 Category 19.8 Specifications 19.9 Storage 19.10 Version 20 References This is a redirect entry sharing content about oxacillin. For the convenience of reading, oxacillin in the following text has been automatically replaced by Xinqing II. You can click here to restore the original appearance, or use notes to display 1 Overview
Xinqing II is a penicillin antibiotic, mainly used For infections caused by penicillin-resistant Staphylococcus aureus, it can also be used for infections such as Streptococcus pyogenes and pneumococci. This drug can penetrate the blood-cerebrospinal fluid barrier. The incidence of adverse reactions is low in clinical application.
Xinqing II is a national essential drug. 2 Common name
Xinqing II No. 3 English name
Oxacillin 4 Alias ??of Xinqing II No.
Andilin; benzisoxazole penicillin; Oxacillin; Oxacillin; Oxacillin; Neopenicillin II; Oxacillinum
5 categories
Antibacterial drugs> β-lactam antibiotics?> Penicillins 6 Pharmacological effects
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Xinqing No. Ⅱ is acid-resistant and penicillinase-resistant penicillin. It has good antibacterial activity against penicillinase-producing staphylococci, but its antibacterial activity against various streptococci and staphylococci that do not produce penicillinase is not as good as penicillin. [1]
1. It is stable against penicillin-resistant β-lactams (penicillinase) produced by Staphylococcus aureus, so it has a powerful bactericidal effect on penicillinase-producing drug-resistant Staphylococcus aureus.
2. The antibacterial effect on penicillin-sensitive Staphylococcus aureus and various streptococci is worse than that of penicillin.
7 Pharmacokinetics
Xinqing No. Ⅱ is stable to acid. After oral administration of 1g on an empty stomach, the peak plasma concentration of 11.7μg/ml is reached in 0.5 to 1 hour; after intramuscular injection of 0.5g, the peak concentration is reached half an hour later. The peak plasma concentration is 16.7μg/ml. The plasma protein binding rate is 90% to 94%. It is widely distributed in the liver, kidney, intestine, spleen, pleural effusion and joint cavity fluid, and can reach effective therapeutic concentrations. It is difficult to penetrate the normal meninges, but can penetrate the placental barrier and be secreted into breast milk in small amounts. The elimination half-life is 0.4 to 0.7 hours. About 49% of the drug is metabolized by the liver and excreted in the urine. About 10% of the drug is excreted in bile. [1]
Xinqing Ⅱ is stable to acid and is well absorbed after oral administration, with 30% to 33% being absorbed in the intestines. Take 1g orally on an empty stomach, and the peak plasma concentration is reached in 0.5 to 1 hour, which is approximately 11.7 μg/ml. After intramuscular injection of 0.5g, the plasma concentration reaches the peak value at about 16.7 μg/ml 0.5 hours later. Doubling the dose will also double the plasma concentration. 250 mg was infused intravenously within 3 hours. The average blood concentration at the end of the infusion was 9.7 μg/ml and 0.16 μg/ml 2 hours later. After intramuscular injection of 20 mg/kg in neonates, the peak plasma concentrations (average) of neonates aged 8 to 15 and 20 to 21 days were 51.5 μg/ml and 47.0 μg/ml, respectively. After drug absorption, effective therapeutic concentrations can be reached in the liver, kidneys, intestines, spleen, pleural effusion and joint cavity fluid. The concentration of the drug in peritoneal fluid is low, and the concentration in sputum is 0.3 to 14.5 μg/ml (average 2.1 μg/ml). Xinqing II is difficult to penetrate the normal blood-cerebrospinal fluid barrier. The protein binding rate of Xinqing II is very high (90%-94%). The half-life of normal healthy adults is 0.4-0.7h. The half-life of neonates aged 8-15 days and 20-21 days is 1.6 days and 1.2 days respectively. About 49% of Xinqing II is metabolized by the liver and excreted in the urine through glomerular filtration and tubular secretion. The urinary excretion of intramuscular injection and oral administration is 40% and 23% to 30% respectively. Some drugs can be excreted through bile, and the amount of bile excretion is higher than other penicillinase-resistant penicillins. Hemodialysis and peritoneal dialysis cannot effectively remove Xinqing II. 8 Indications
Xinqing II is mainly used for various infections caused by penicillinase-producing Staphylococcus aureus and Staphylococcus epidermidis, such as sepsis, endocarditis, pneumonia, skin and soft tissue infections etc., it can also be used for mixed infections caused by Streptococcus pyogenes or pneumococci and penicillin-resistant Staphylococcus aureus. Not applicable to central infection. [1] 9 Contraindications
People allergic to Xinqing II or other penicillins [1]. 10 Adverse reactions of Xinqing Ⅱ
Allergic reactions to Xinqing Ⅱ include drug rash, drug fever and anaphylactic shock. Nervous system reactions such as convulsions, spasms, confusion, and headaches may occur after large doses. Occasionally, neutropenia may occur, which may cause bleeding tendency in people with specific constitutions. Some individuals have elevated aminotransferase levels. Phlebitis may occur with intravenous administration. A small number of people may develop secondary infection with Candida albicans. [1]
1. More common. Various allergic reactions caused by penicillin can occur after taking the drug.
2. Neurotoxicity: Large-dose (up to 18g per day) intravenous injection can cause neurotoxic reactions such as headache, convulsions, and convulsions, which is especially common in patients with reduced renal function.
3. Hepatotoxicity: A few patients may develop specific hepatitis after taking the drug, manifesting as fever, nausea, vomiting and elevated aspartate aminotransferase, which can return to normal after stopping the drug.
4. Nephrotoxicity: Acute interstitial nephritis accompanied by renal failure has occasionally been reported; hematuria, proteinuria and uremia have been reported in infants after taking large doses of the drug.
5. Blood system: Intravenous administration may occasionally cause neutropenia or agranulocytosis, which can cause bleeding tendencies in people with specific constitutions, but can return to normal after discontinuation of the drug.
6. Gastrointestinal reactions: Gastrointestinal symptoms such as nausea, vomiting, bloating, diarrhea, loss of appetite, and occasionally pseudomembranous colitis may occur after oral administration.
7. Others: A few patients may still experience secondary infection by Candida albicans, phlebitis, etc. after taking the drug. 11 Precautions
(1) Use with caution in newborns, those with severe liver and kidney function impairment, and those with a history of allergic diseases [1].
(2) Patients with mild or moderate renal impairment do not need to adjust the dose. Patients with severe renal impairment should avoid using large doses to prevent central nervous system toxic reactions [1].
(3) If overdose occurs and adverse reactions occur in the central nervous system, the drug should be stopped promptly and symptomatic and supportive treatment should be given [1].
Others are the same as penicillin [1]:
(1) First, ask about the allergic history in detail. People with a history of allergies are generally not suitable for skin tests [2].
(2) Before using the drug, a skin test must be carried out according to the prescribed method (concentration: 500 units/ml, intradermal injection of 0.05~0.1ml) [2].
(3) Once symptoms of anaphylactic shock occur, 0.1% epinephrine 0.5-1ml should be injected intramuscularly immediately. If the clinical symptoms do not improve, repeat the injection after half an hour, and cooperate with other symptomatic treatments [ 2].
(4) Penicillin is not suitable for intrathecal injection and can be administered intramuscularly or intravenously. When the daily dose for adults exceeds 5 million units, intravenous administration is appropriate. During intravenous administration, the speed should not exceed 500,000 units per minute, and it should be infused quickly in batches, usually once every 6 hours, to avoid central nervous system reactions [2].
(5) People with a history of asthma, eczema, hay fever, urticaria and other allergic diseases should use it with caution. People with severe renal impairment should adjust the dosage or extend the dosing interval [2].
(6) When administering large doses, the introduction of sodium ions or potassium ions should be taken into consideration, which may cause hypernatremia or hyperkalemia. One million units of penicillin sodium contains 1.7mmol (39mg) of sodium ions; 1 million units of penicillin G potassium contains 1.5mmol (65mg) of potassium ions [2].
(7) Penicillin aqueous solution is unstable and easy to hydrolyze, so the injection should be prepared freshly. If it must be stored, it should be refrigerated and used within 24 hours [2]. 12 Drug interactions
(1) Probenecid blocks the excretion of this product and increases the plasma concentration, allowing the effect to be maintained for a longer period of time [1].
(2) Combined use with sisomicin or netilmicin can enhance its anti-Staphylococcus aureus effect [1].
(3) Combined use with gentamicin or ampicillin can mutually enhance the antibacterial effect against enterococci [1].
(4) Aspirin and sulfa drugs can inhibit the binding of Xinqing II to plasma proteins in vitro, and sulfa drugs can reduce the absorption of Xinqing II in the gastrointestinal tract. 13 Usage and dosage
(1) Intravenous drip: ① Adults, 0.5 to 1.0g once, once every 4 to 6 hours. For serious infections, the dose may be increased. In case of bloodstream infection and meningitis, daily The dose can be increased to 12g. ②Children, those weighing less than 40kg should take 12.5-25mg/kg every 6 hours, and those weighing more than 40kg should take the adult dose. For newborns weighing less than 2kg, the dosage is 25mg/kg every 12 hours for those 1 to 14 days old, and 25mg/kg every 8 hours for those 15 to 30 days old; for those weighing more than 2kg, the dosage is 25mg/kg every 12 hours for those 1 to 14 days old. For those aged 15 to 30 days, take 25 mg/kg of body weight every 8 hours, and for those 15 to 30 days old, take 25 mg/kg of body weight every 6 hours. [1]
(2) Intramuscular injection: 0.5 to 1g once, 3 to 4 times a day. [1]
(3) Oral administration: Adults, 0.5~1g once. 4 times a day. [1] 14 Dosage forms and specifications
(1) Tablets and capsules: 0.25g. [1]
(2) Sterile powder for injection: ①0.5g; ②1.0g. [1] 15 Storage of Xinqing II
Store in a closed and dry place [1]. 16 Clinical application of Xinqing II
Xinqing II has strong antibacterial activity against Staphylococcus aureus, Streptococcus pyogenes, hemolytic Streptococcus, pneumococcus, and Bacillus anthracis. It is not as effective as penicillin against Staphylococcus aureus that does not produce enzymes. According to domestic reports, 88 cases of infections caused by Staphylococcus aureus, hemolytic Streptococcus or mixed infections were treated with Xinqing II, 18 of which were systemic infections, lung infections, intestinal infections and soft tissue infections. After application, 15 cases were cured, 2 cases had basic infection control, and 1 case was ineffective. Another 60 cases were impetigo. After application, 57 cases were cured, 1 case was effective, and 2 cases were ineffective. The total effective rate was 96.6%. 17 Xinqing II poisoning
Xinqing II (oxacillin, neopenicillin II) is mainly used for infections caused by penicillin-resistant Staphylococcus aureus, and can also be used for infections such as Streptococcus pyogenes and pneumococci. . This drug can penetrate the blood-cerebrospinal fluid barrier. The protein binding rate is 93%, and the half-life is 0.5~0.7h. Common dosage: oral administration: 2 to 6 g/d, divided into 4 to 6 times; intramuscular injection: 4 to 6 g/d, divided into 4 times; intravenous infusion: 4 to 12 g/d, divided into 2 to 4 times. The incidence of adverse reactions is low in clinical application. [3] 17.1 Clinical manifestations
[3]
1. After oral administration, about 15% of patients will experience gastrointestinal reactions, with upper abdominal discomfort, abdominal distension, and loss of appetite being common. etc., nausea, vomiting, abdominal pain, and diarrhea may occur in some cases.
2. Fever, nausea and vomiting, and increased serum aminotransferase may occasionally occur after intravenous injection, which may disappear after stopping the drug. It may be an allergic reaction. Neutropenia or agranulocytosis is occasionally seen.
3. Large-dose intravenous injection can cause neurotoxic reactions such as convulsions and confusion, especially in patients with reduced renal function.
4. Acute interstitial nephritis accompanied by renal failure has been reported. Hematuria, proteinuria, and uremia have been reported in infants after large doses. 17.2 Treatment
The key points in the treatment of Xinqing II poisoning are [3]:
1. For patients with severe renal impairment, avoid using large doses to prevent nervous system toxic reactions. occur.
2. Hemodialysis and peritoneal dialysis cannot remove this product from the blood.
3. Symptomatic treatment.
18 Xinqing Ⅱ Sodium Pharmacopoeia Standard 18.1 Product name 18.1.1 Chinese name
Xinqing Ⅱ Sodium 18.1.2 Chinese Pinyin
Benzuoxilinna 18.1.3 English name
< p> Oxacillin Sodium 18.2 Structural formula 18.3 Molecular formula and molecular weightC19H18N3NaO5S·H2O? 441.44 18.4 Source (name), content (potency)
This product is (2S, 5R, 6R) 3,3 dimethyl 6 (5 methyl 3 phenyl 4 isoxazole carboxamido) 7 oxo 4 thia 1 azabicyclo [3.2.0] heptane 2 carboxylic acid sodium salt - hydrate. Calculated as anhydrous, the content of Xinqing II (C19H19N3O5S) shall not be less than 90.0%. 18.5 Properties
This product is white powder or crystalline powder; odorless or slightly odorless.
This product is easily soluble in water, very slightly soluble in acetone or butanol, and almost insoluble in ethyl acetate or petroleum ether. 18.5.1 Specific rotation
Take this product, weigh it accurately, add water to dissolve it and quantitatively dilute it to make a solution containing about 10mg per 1ml, and measure it according to the law (2010 Pharmacopoeia Part 2 Appendix VI E). Specific rotation is +195° to +214°. 18.6 Identification
(1) In the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
(2) The infrared light absorption spectrum of this product should be consistent with the control spectrum (Figure 239 of "Drug Infrared Spectrum Collection").
(3) This product shows sodium salt identification reaction (1) (2010 edition of Pharmacopoeia, Part II, Appendix III). 18.7 Inspection 18.7.1 Acidity
Take this product, add water to make a solution containing 20mg per 1ml, and measure according to the law (2010 edition of Pharmacopoeia, Appendix VI H), the pH value should be 5.0 to 7.0. 18.7.2 Clarity and color of the solution
Take 5 portions of this product, each 0.6g, add 5ml of water to dissolve respectively, the solution should be clear and colorless (2010 edition of the Pharmacopoeia, Appendix IX A, Method 1) ; If it is obviously turbid, it shall not be more concentrated than the No. 1 turbidity standard solution (Appendix IX B of Pharmacopoeia, Part 2, 2010 Edition). 18.7.3 Related substances
Take an appropriate amount of this product, weigh it accurately, add mobile phase to dissolve and dilute it to make a solution containing 1 mg of Xinqing II No. per 1 ml, as the test solution; measure it accurately 1ml, put it in a 100ml measuring flask, add mobile phase to dilute to the mark, shake well, and use it as a control solution. According to the chromatographic conditions under the content determination item, take 20 μl of the control solution and inject it into the liquid chromatograph. Adjust the detection sensitivity so that the peak height of the main component chromatographic peak is approximately 25% of the full scale. Then accurately measure the test solution and the control solution. 20 μl of each was injected into the liquid chromatograph, and the chromatogram was recorded to 7 times the retention time of the main component peak. If there is an impurity peak in the chromatogram of the test solution, the sum of the peak areas of impurity B1 and impurity B2 shall not be greater than 1.5 times (1.5%) of the main peak area of ??the control solution; the peak area of ??impurity D shall not be greater than 0.5 times (0.5%) of the main peak area of ??the control solution. %); the peak area of ??cloxacillin shall not be greater than the main peak area of ??the control solution (1.0%); the peak area of ??other individual impurities shall not be greater than 0.5 times the main peak area of ??the control solution (0.5%); the sum of the peak areas of each impurity shall not be greater than the main peak area of ??the control solution 3 times (3.0%). 18.7.4 Xinqing No. Ⅱ Polymer
Determination according to size exclusion chromatography (Appendix V H of Pharmacopoeia Part 2, 2010 Edition). 18.7.4.1 Chromatographic conditions and system suitability test
Use Sephadex G10 (40~120μm) as the filler, the inner diameter of the glass column is 1.0~1.4cm, and the column length is 30~40cm. Mobile phase A is 0.01mol/L phosphate buffer with pH 7.0 [0.01mol/L disodium hydrogen phosphate solution-0.1mol/L sodium dihydrogen phosphate solution (61:39)][4], and mobile phase B is water. ;The detection wavelength is 254nm. Take 100-200 μl of 0.1mg/ml blue dextran 2000 solution, inject it into the liquid chromatograph, and measure with mobile phases A and B respectively. The number of theoretical plates is calculated based on the blue dextran 2000 peak, and is not less than 400 , the tailing factors should all be less than 2.0. The ratio of the retention times of the blue dextran 2000 peak in the two mobile phase systems should be between 0.93 and 1.07. The main peak of the control solution and the polymer peak in the test solution and the blue dextran 2000 peak in the corresponding chromatographic system should be between 0.93 and 1.07. The ratio of peak retention times should be between 0.93 and 1.07. Weigh about 0.2g of Xinqing No. Ⅱ sodium, place it in a 10ml measuring bottle, dissolve and dilute to the mark with 0.4mg/ml blue dextran 2000 solution, and shake well.
Inject 100 to 200 μl into the liquid chromatograph, measure with mobile phase A, and record the chromatogram. The ratio of the peak height of the polymer to the valley height between the monomer and the polymer should be greater than 2.0. In addition, use mobile phase B as the mobile phase, accurately measure 100 to 200 μl of the control solution, and inject the sample 5 times continuously. The relative standard deviation of the peak area should not be greater than 5.0%. 18.7.4.2 Preparation of control solution
Take about 25 mg of Xinqing No. Ⅱ reference substance, weigh it accurately, add water to dissolve it and quantitatively dilute it to make a solution containing about 50 μg per 1 ml. 18.7.4.3 Determination method
Take about 0.2g of this product, weigh it accurately, put it in a 10ml measuring bottle, add water to dissolve and dilute to the mark, shake well, and immediately and accurately measure 100~200μl and inject it into the liquid chromatograph In the instrument, use mobile phase A as the mobile phase for measurement and record the chromatogram. In addition, accurately measure 100 to 200 μl of the control solution and inject it into the liquid chromatograph. Use mobile phase B as the mobile phase and measure in the same way. Calculate the peak area according to the external standard method. Polymers containing Xinqing No. Ⅱ are calculated as Xinqing Ⅱ. , shall not exceed 0.10%. 18.7.5 Residual solvents 18.7.5.1 Ethanol, ethyl acetate, n-butanol and butyl acetate
Take about 1g of this product, place it in a 10ml measuring bottle, add water to dissolve and dilute to the mark, shake well, As the test product stock solution, accurately measure 1 ml and place it in a headspace bottle, then add 1 ml of water accurately, shake well, and seal to use as the test product solution; accurately weigh approximately 1 ml each of ethanol, ethyl acetate, n-butanol and butyl acetate. 0.25g, put it in a 50ml measuring flask, dilute it with water to the mark, shake well, accurately measure 10ml, put it in a 100ml measuring flask, dilute it with water to the mark, shake it well, and use it as the reference substance stock solution; accurately measure 1ml of the reference substance stock solution. Place it in the headspace bottle, then add 1ml of water accurately, shake well, seal, and use it as the system suitability test solution; accurately measure 1ml of the reference substance stock solution and place it in the headspace bottle, add 1ml of the test sample stock solution accurately, shake well, and seal it, as the system suitability test solution. Reference solution. Determine according to the residual solvent determination method (2010 version of the Pharmacopoeia, Appendix VIII P, second method), using a capillary column with 100% dimethylpolysiloxane (or similar polarity) as the stationary liquid as the chromatographic column; the starting temperature is 40℃, maintain for 8 minutes, then increase to 100℃ at a rate of 30℃ per minute, maintain for 5 minutes; the inlet temperature is 200℃; the detector temperature is 250℃; the headspace bottle equilibrium temperature is 70℃, equilibrium time for 30 minutes; take a headspace sample of the system suitability test solution and record the chromatogram. The order of the peaks is: ethanol, ethyl acetate, n-butanol and butyl acetate. The separation between each chromatographic peak should meet the requirements. . Take a headspace injection of the reference solution and calculate the results of several injections. The relative standard deviation shall not exceed 5.0%. Take headspace injections of the test solution and the reference solution respectively, record the chromatograms, and calculate the peak area using the standard addition method, all of which should comply with the regulations. 18.7.6 2 Ethylhexanoic acid
Take this product and check it according to the law (2010 edition of Pharmacopoeia, Part II, Appendix VII L), it should not exceed 0.8%. 18.7.7 Moisture
Take this product and measure it according to the moisture determination method (Appendix VIII M, Method 1, 2010 edition of the Pharmacopoeia). The moisture content should not exceed 5.0%. 18.7.8 Visible foreign matter
Take 5 portions of this product, each portion is 1g, add fine particles and dissolve in water for inspection. Check according to the law (2010 edition of Pharmacopoeia, Part 2, Appendix IX H), and it should comply with the regulations. 18.7.9 Insoluble particles
Take 3 portions of this product, add particles for inspection and make a solution containing 50 mg per 1ml with water for inspection. Check according to the law (Appendix IX C of Part II of the 2010 edition of the Pharmacopoeia). For every 1g of sample, The number of particles containing more than 10 μm must not exceed 6,000 particles, and the number of particles containing more than 25 μm must not exceed 600 particles. Human body surface area calculator BMI index calculation and evaluation Female safe period calculator Pregnancy date calculator Normal weight gain during pregnancy Safety classification of medication during pregnancy (FDA) Five elements and eight characters Adult blood pressure evaluation Body temperature level evaluation Diabetes diet recommendations Common clinical biochemistry units Conversion to basal metabolic rate Calculate sodium supplementation calculator Iron supplementation calculator Commonly used Latin abbreviations for prescription Quick check Common symbols for pharmacokinetics Quick check Effective plasma osmolarity calculator Ethanol intake calculator
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Take this product and check it according to the law (2010 edition of Pharmacopoeia, Part II, Appendix XI E). The amount of endotoxin contained in 1 mg of Xinqing II should be less than 0.10 EU. 18.7.11 Sterility
Take this product, dissolve it with an appropriate amount of solvent, transfer it to no less than 500ml of 0.9% sterile sodium chloride solution, treat it with membrane filtration, and inspect it in accordance with the law (2010 edition Pharmacopoeia Part II, Appendix XI H), should comply with the regulations. 18.8 Content determination
Determine according to high performance liquid chromatography (Appendix V D of Pharmacopoeia Part 2, 2010 Edition).
18.8.1 Chromatographic conditions and system suitability test
Use octadecylsilane bonded silica gel as the filler, and potassium dihydrogen phosphate solution [take 2.7g of potassium dihydrogen phosphate, add 1000ml of water to dissolve, Adjust the pH value to 5.0)-acetonitrile (75:25)] as the mobile phase; the detection wavelength is 225nm. Take 25 mg of this product and place it in a 100 ml measuring flask. Add 1 ml of 0.05 mol/L sodium hydroxide solution to dissolve it. After leaving it for 3 minutes, dilute it to the mark with mobile phase and shake it well. Each 1 ml of the product contains about 0.25 mg of cinnamon. Mix solution (1) of No. Ⅱ and its degraded impurities, and take an appropriate amount of cloxacillin reference substance, add mixed solution (1) to dissolve and dilute to make a mixed solution (2) containing 0.1 mg of cloxacillin per 1 ml, as a system Take 20 μl of the suitability test solution and inject it into the liquid chromatograph, and record the chromatogram; the relative retention times of the peaks of impurities B1, B2, D, and cloxacillin are 0.4, 0.5, 0.9, and 1.45 respectively. The peak of impurity D is identical to that of Xinqing II No. The resolution of peaks should be greater than 1.5, and the resolution of Xinqing Ⅱ peak and cloxacillin peak should be greater than 2.5. 18.8.2 Determination method
Take an appropriate amount of this product, weigh it accurately, add mobile phase to dissolve and quantitatively dilute it to make a solution containing approximately 0.1mg per 1ml, accurately measure 10μl and inject it into the liquid chromatograph. Record the chromatogram; take an appropriate amount of Xinqing No. Ⅱ reference substance and measure in the same way. Calculate the C19H19N3O5S content in the test sample based on the peak area according to the external standard method. 18.9 Category
Beta-lactam antibiotics, penicillins. 18.10 Storage
Seal tightly and store in a dry place. 18.11 Preparations
Xinqing No. Ⅱ Sodium 18.12 for Injection Attached:
Impurities B1, B2: RCO2H: (4S) 2[carboxy[[5methyl3phenylisoxazol4yl]carbonyl]amino]methyl]5 ,5dimethylthiazolidine4carboxylic acid
Chinese name: (4S) 2[carboxy[[5methyl3phenylisoxazole 4yl]formyl]amino]methyl]5,5 dimethylthiazolidine 4 Carboxylic acid
Impurity D: RH: (2RS,4S)5,5dimethyl2[[[(5methyl3phenylisoxazol4yl)carbonyl] amino]methyl]thiazolidine4carboxlic acid
Chinese name: (2RS,4S ) 5,5 dimethyl 2[[[(5methyl3phenylisoxazole4yl)formyl]amino]methyl]thiazolidine4carboxylic acid version 18.13
"People's Republic of China* **Japanese Pharmacopoeia 2010 Edition 19 Pharmacopoeia Standard 19.1 Xinqing Sodium II for Injection Product Name 19.1.1 Chinese Name
Xinqing II Sodium for Injection 19.1.2 Chinese Pinyin
Zhusheyong Benzuoxilinna 19.1.3 English name
Oxacillin Sodium for Injection 19.2 Source (name), content (potency)
This product is a sterile powder of Xinqing No. Ⅱ sodium. Calculated based on anhydrous content, the content of Xinqing No. Ⅱ (C19H19N3O5S) should not be less than 90.0%; calculated based on the average loading volume, the content of Xinqing No. Ⅱ (C19H19N3O5S) should be 95.0% to 105.0% of the labeled amount. 19.3 Properties
This product is white powder or crystalline powder. 19.4 Identification
Take this product and perform the identification (1) and (3) tests under Xinqing No. Ⅱ sodium, and the same results are shown. 19.5 Check the clarity and color of 19.5.1 solution
Take 5 bottles of this product and add water according to the labeled amount to make a solution containing 0.1g per 1ml. The solution should be clear and colorless (2010 Pharmacopoeia II) Method 1 of Appendix IX A of Part II); if it is turbid, it shall not be more concentrated than the No. 1 turbidity standard solution (Appendix IX B of Part II of the Pharmacopoeia 2010 edition). 19.5.2 Moisture
Take this product and measure it according to the moisture determination method (Appendix VIII M, Method 1, 2010 edition of the Pharmacopoeia). The moisture content should not exceed 5.5%.
19.5.3 Insoluble particles
Take this product, add particles for inspection according to the labeled amount, and make a solution containing 50 mg per 1ml. Check according to the law (2010 edition of Pharmacopoeia, Part II, Appendix IX C). The labeled amount is 1.0 The conversion below g is that every 1.0g sample must contain no more than 6,000 particles of 10 μm or more, and no more than 600 particles of 25 μm or more. The labeled amount is 1.0g or more (including 1.0g). Each test sample container must contain 10 μm. The number of particles above 25 μm must not exceed 6,000 particles, and the number of particles containing above 25 μm must not exceed 600 particles. 19.5.4 Acidity, related substances, Xinqing No. Ⅱ polymer, bacterial endotoxin and sterility
Inspect according to the method under Xinqing Ⅱ sodium and all shall comply with the regulations. 19.5.5 Others
In addition to the difference limit of loading volume not exceeding ±7.0%, all relevant regulations under injections should be complied with (2010 edition of Pharmacopoeia, Part II, Appendix I B). 19.6 Content determination
Take the contents under the item of difference in loading volume and measure according to the method under the item of Xinqing No. Ⅱ sodium. 19.7 Category
Beta-lactam antibiotics, penicillins. 19.8 Specifications
Calculated according to C19H19N3O5S? (1) 0.5g? (2) 1.0g 19.9 Storage
Sealed and stored in a dry place.
Version 19.10