Reverse engineering method for speculating source of medicament manufacturer
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A manufacturer and pharmaceutical technology, applied in the field of drug analysis, can solve problems such as the effect of drug efficacy, and achieve the effect of eliminating errors
Pending Publication Date: 2021-12-14
江苏集萃新型药物制剂技术研究所有限公司
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Therefore, excipients from different sources may have a more significant impact on the efficacy of the drug
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Embodiment 1
[0066] A method for measuring the content of medium-chain fatty acid glycerides in pharmaceutical preparations, comprising the steps of:
[0067] 1. Preparation of pharmaceutical preparations for the test solution: Weigh about 0.5 g of the preparation to be tested that needs to be reverse engineered respectively, put it in a 100 mL reflux bottle, add 40 mL of methanol for proper ultrasonic dispersion, add 25 mg / mL methyl nonanoate solution ( Internal standard) 2.0mL, 6% sodium hydroxide methanol solution 0.5mL, reflux in water bath for 30min, take out, cool to room temperature, transfer to a separatory funnel, wash the reflux bottle with 20mL of n-hexane three times, and put the lotion into the separatory funnel Add water 40mL, shake vigorously to extract, stand to separate layers; extract the water layer twice with 20mL of n-hexane, and combine the n-hexane layer; wash with water twice, 20mL each time, take the n-hexane layer; Dry over sodium sulfate, filter, and take the fil...
Embodiment 2
[0090] A method for determining the source and content of medium-chain fatty acid glycerides in pharmaceutical preparations, comprising the following steps:
[0091] 1. Preparation of pharmaceutical preparations for the test solution: Weigh about 1.0 g of the preparation to be tested that needs to be reverse engineered respectively, put it in a 100 mL reflux bottle, add 40 mL of methanol for proper ultrasonic dispersion, add 25 mg / mL methyl nonanoate solution ( Internal standard) 2.0mL, 6% sodium hydroxide methanol solution 0.5mL, reflux in water bath for 40min, take out, cool to room temperature, transfer to a separatory funnel, wash the reflux bottle with 20mL of n-hexane three times, and put the lotion into the separatory funnel Add water 40mL, shake vigorously to extract, stand to separate layers; extract the water layer twice with 20mL of n-hexane, and combine the n-hexane layer; wash with water twice, 20mL each time, take the n-hexane layer; Dry over sodium sulfate, filt...
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Abstract
The invention relates to the field of pharmaceutical analysis, in particular to a reverse engineering method for speculating the source of a medicament manufacturer, which comprises the following steps: (1) obtaining a medicament test solution to be reversed; (2) obtaining a mixed reference substance solution; (3) obtaining a manufacturer test solution; (4) detecting by using a gas chromatograph; (5) performing first calculation: calculating the amount of methyl caprylate and the amount of methyl caprate; performing second calculation: calculating the ratio of the amount of methyl caprylate to the amount of methyl caprate according to the caprylate-caprate ratio; and performing third evaluation: comparing thecaprylate-caprate ratios of the medicament test solution to be reversed and the manufacturer test solution of a plurality of target manufacturers, and speculating the manufacturer source. According to the method disclosed by the invention, the manufacturer source of the medium-chain fatty glyceride in the preparation needing reverse engineering can be relatively accurately speculated, and the content of the medium-chain fatty glyceride can be relatively accurately calculated; and the method provides an effective research means for reverse engineering in drug research and development.
Description
technical field [0001] The invention relates to the field of drug analysis, in particular to a reverse engineering method for inferring the source of pharmaceutical manufacturers. Background technique [0002] After the patent protection of original drugs expired, generic drugs appeared one after another, and these generic drugs also made important contributions to the medical system. But generic drugs have mixed efficacy. In recent years, the differences between generic drugs and brand-name drugs have been attracting attention. The reason for this difference is not only the production equipment and process, but also the quality and composition of excipients to a large extent. [0003] In July 2018, the National Center for Drug Evaluation issued the "Technical Evaluation Requirements for Newly Registered and Classified Generic Drugs for External Use on the Skin (Draft for Comment)", which requires generic drug applicants to review reference drug instructions, patents, liter...
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