健儿消食口服液中抑菌剂及抑菌效力研究

Study on the Antimicrobial and Antimicrobial Effectiveness of Jianer Xiaoshi Oral Liquids

关键词:  健儿消食口服液  pH  抑菌剂  山梨酸钾  抑菌效力

Key words:  Jianer Xiaoshi oral liquids  pH  antimicrobial  potassium sorbate  antimicrobial effectiveness

摘要:

目的 考察全国评价性抽验的35家企业220批市售健儿消食口服液中抑菌剂的使用情况，探索抑菌剂种类、浓度、货架期、pH值等不同因素对抑菌剂抑菌效力的影响。方法 采用酸度计对全国抽验的220批健儿消食口服液的pH值进行检测；采用HPLC-UV对220批健儿消食口服液中山梨酸钾的含量进行测定，色谱条件：以乙腈-0.02 mol·L^-1乙酸铵(5∶95)为流动相；检测波长为254 nm，流速1 mL·min^-1。参照中国药典2010年版一部附录ⅩⅧD抑菌剂效力检查法指导原则和中国药典2015年版四部通则1121抑菌效力检查法进行抑菌效力测定。结果 35家企业220批健儿消食口服液的pH值均为3.5~4.7。91.43%(32/35)的企业使用的抑菌剂种类与标准一致，2.86%(1/35)的企业更改抑菌剂种类，5.71%(2/35)的企业添加其他种类抑菌剂。17.14%(6/35)的企业使用的山梨酸钾含量为0.6~0.7 mg·mL^-1，42.86%(15/35)使用的山梨酸钾含量为0.5～0.6 mg·mL^-1，8.57%(3/35)使用的山梨酸钾含量<0.3 mg·mL^-1，其中2.86%(1/35)未使用山梨酸钾，14.28%(5/35)使用的山梨酸钾含量>0.7 mg·mL^-1，其中2.86%(1/35)使用的山梨酸钾含量高达2.3 mg·mL^-1。抑菌剂浓度和pH值2个因素对抑菌效力的影响较大，而货架期对抑菌效力的影响不大。结论 健儿消食口服液中抑菌剂的使用种类和浓度存在违规现象，使该产品安全性存在一定风险。抑菌剂浓度一定时，pH值越低，抑菌效力越强；pH值一定时，抑菌剂浓度越高，抑菌效力越强，且抑菌效力对pH值的依赖性强于对一定范围内抑菌剂浓度的依赖性。

Abstract:

OBJECTIVE To investigate the employment state of antimicrobial in 220 batchs of Jianer Xiaoshi oral liquids from 35 enterprises and to explore the effect on antimicrobial effectiveness of antimicrobial variety, concentration, shelf-life, pH and other factors. METHODS Acid estimation apparatus was used to detect the the pH of 220 batchs of Jianer Xiaoshi oral liquids from nationwide. The method of HPLC-UV was applied with mobile phase of acetonitrile-0.02 mol·L^-1 ammonium acetate(5∶95); detection wavelength of 254 nm; flow rate of 1.0 ml·min^-1. And to carry out the determin of antimicrobial effectiveness, according to the requirements described in guiding principle in subdivision appendix ⅩⅧD of Chinese Pharmacopeia (2010 Edition) and the examination methods of antimicrobial effectiveness in tetrodivision general information 1121 of Chinese Pharmacopeia (2015 Edition). RESULTS The pH were all among 3.5~4.7 of 220 batchs of Jianer Xiaoshi oral liquids from 35 selected enterprises. There were 91.43%(32/35) enterprises reached quality standards in antimicrobial variety, however, 2.86%(1/35) enterprises had changed their antimicrobial variety, 5.71%(2/35) enterprises had added other antimicrobial. The content of potassium sorbate was 0.6-0.7 mg·mL^-1 in Jianer Xiaoshi oral liquids from 17.14%(6/35) enterprises, while it was 0.5-0.6, <0.3 and >0.7 mg·mL^-1 from 42.86%(15/35), 8.57%(3/35) and 14.28%(5/35) enterprises, respectively. Additionally, the content of potassium sorbate was 0 mg·mL^-1 and >2.3 mg·mL^-1 from 2.86%(1/35) and 2.86%(1/35) enterprises. Antimicrobial concentration and pH had greater influence on antimicrobial effectiveness than shelf-life. CONCLUSION The violation of variety and content of antimicrobial result in quality risk of Jianer xiaoshi oral liquids. With the same pH, more antimicrobial, stronger antimicrobial effectiveness; with the same content antimicrobial, lower pH, stronger antimicrobial effectiveness. moreover, the dependence on pH more than on given antimicrobial content to antimicrobial effectiveness.