维血宁合剂中抑菌剂使用现状分析及抑菌效力研究

Use of bacteriostatic agents and bacteriostatic efficacy in Weixuening mixture

目的考察不同企业维血宁合剂中抑菌剂使用情况和不同抑菌剂浓度下维血宁合剂的抑菌效力,探索维血宁合剂中抑菌剂的最佳添加量。方法采用高效液相色谱法测定不同企业维血宁合剂中抑菌剂含量,结合生产工艺阶段各样品的抑菌剂测定结果,对各生产企业样品中抑菌剂种类和含量进行分析;对添加0.026%、0.25%苯甲酸钠的维血宁合剂,进行抑菌效力检查。结果21批维血宁合剂中均未检出山梨酸,对羟基苯甲酸甲酯和对羟基苯甲酸乙酯含量极低,可能来自于原料药材,苯甲酸钠含量介于0.0197%~0.2659%,不同企业样品间含量差异显著;维血宁合剂中苯甲酸钠浓度为0.026%、0.25%时,均对金黄色葡萄球菌和大肠埃希菌达到杀菌效果,14 d后无菌生长,对鲁氏酵母和白念珠菌达到口服制剂抑菌要求。结论维血宁合剂各生产企业均以苯甲酸钠作为抑菌剂,样品中苯甲酸钠含量差别较大,说明各企业并未严格按照药典处方进行投料,存在较大的随意性;维血宁合剂中抑菌剂的使用浓度应结合产品本身的灭菌工艺、初始微生物负载、有效期、包装规格来综合考虑。

Objective To determine the use of bacteriostatic agents in Weixuening mixture from different enterprises and the bacteriostatic efficacy of Weixuening mixture under different concentrations of bacteriostatic agents,and determine the best dosage of bacteriostatic agents for Weixuening mixture.Methods The content of bacteriostatic agents in Weixuening mixture from different enterprises was determined by high performance liquid phase method.Based on the results of bacteriostatic agents in the samples of different stages of production process,the types and content of bacteriostatic agents in the samples of each enterprise were analyzed.The bacteriostatic efficacy of Weixuening mixture with 0.026%and 0.25%sodium benzoate was examined respectively.Results No sorbic acid was detected in the 21 batches of Weixuening mixture,and the content of methyl p-hydroxybenzoate and ethyl p-hydroxybenzoate was very low,possibly from the raw materials.The content of sodium benzoate ranged 0.0197%~0.2659%,with much difference among samples from various enterprises.The bactericidal effect was achieved for Staphylococcus aureus and Escherichia coli and no bacterial growth was found after 14 days,with the concentration of sodium benzoate of 0.026%or 0.25%in Weixuening mixture.The bacteriostatic effecacy on Saccharomycesroux-ⅡBoutroux and Candida albicans was also achieved.Conclusion Sodium benzoate is commonly in Weixuening mixture by all manufacturers as bacteriostatic agent and its content difference among samples vary,indicating that the enterprises do not strictly follow the pharmacopoeia prescriptions,but rather randomly add bacteriostatic agents.The sterilization process of the product itself,initial microbial load,expiration date and packaging specifications should all be taken into account as to the concentration of bacteriostatic agents in Weixuening mixture.