Improvement Of The Quality Standard Of Methionine Vitamin B₁ Injections

1 ObjectiveMethionine B₁ injection includes methionine B₁ for injection and methionine B₁injection.It is self-developed producted in China and is not included in domestic and foreign pharmacopoeias.The number of manufacturers and approval numbers of the variety is large,the current standards are numerous,and the quality standards are mostly single-line standards of the National Bureau,which leads to different quality control standards and It is comprehensively and effectively difficult to control the quality of drugs.At the same time,the preparation process of the injection is complicated,the quality requirement is high,and the cost is so high,which is a clinical high-risk variety.The adverse reactions identified in the drug instructions are mainly headache,nausea and so on.It is clinically reported that there are many adverse reactions.In order to ensure the safety of Drug-using,the quality standard of drugs should be raisedd to improve the safety and effectiveness of drugs.2 MethodsThis study was based on the problems found in routine testing of 100 batches of samples and conducted exploratory studies.The following aspects are mainly carried out:the establishment of related substances HPLC detection method,based on the initial results of stability inspection,the relevant substances are controlled,the impurities are traced and the impurity spectrum analysis;the establishment of HPLC method to determine the content of two groups simultaneously;the establishment of bacteria The endotoxin test controls the biosafety;for the particularity of the injection,the effect of sterilization conditions on the quality of the drug,the influence of excipients and additives on the quality of the drug are examined.3 ResultsAccording to the results of exploratory research,a more comprehensive quality standard was drafted to provide a basis for better control of drug quality.To establish a method for the content determination and the related substances and find that the difference between the results of the determination and the original standard method was quite different.A bacterial endotoxin test was established to control biosafety.The sterilizing conditions of the injection were investigated.It was found that the injection sterilization and the auxiliary heating time increased,the temperature increased,the related substances increased,the sterilization conditions were closely related to the sample quality,and some companies used high-temperature sterilization,which was unreasonable.The prescription and production process need to be further optimized;a batch of methionine for injection B₁ has a high cytotoxicity due to high content of tannic acid,and the content of methionine B₁ mannitol for 6 injections is inconsistent with the prescription;The content of antioxidants in the batch injection is lower than the prescribed amount,which may be related to the degradation of the antioxidant and the main drug.4 ConclusionTo discuss the quality standard of the variety.Through analyzing the current quality standard of Methionine B₁ injection,combined with the quality standard of the variety stated in foreign pharmacopeia and re-lated literatures.Some aspects of“detection”and“content determination”need to be improved and were open to question.The suggestions provide usefulreference for complete evaluation and the improvement of the quality standard.