军队医院制剂养胃颗粒质量检查项目的验证  

Verification of Quality Inspection Items for Hospital-prepared Yangwei Granules

作　　者：杨阳 葛媛 赵娜娜 陈晴 李娜 庄子赫 朱斌 YANG Yang;GE Yuan;ZHAO Na-na;CHEN Qing;LI Na;ZHUANG Zi-he;ZHU Bin(The 71st Group Army Hospital of CPLA Army/the Affiliated Huaihai Hospital of Xuzhou Medical University,Xuzhou 221004,China)

机构地区：[1]陆军第71集团军医院/徐州医科大学附属淮海医院,江苏徐州221004

出　　处：《解放军药学学报》2024年第4期304-307,共4页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：陆军科技英才培养工程资助项目,No.ZG2019-174;陆军第七十一集团军医院院内科研课题,No.YNMS-2022016。

摘　　要：目的对军队医院制剂养胃颗粒质量检查项目进行验证。方法依据处方组成及工艺制备3个批次养胃颗粒,进行性状和理化鉴别,粒度、溶化性、装量差异、水分、干燥失重、微生物限度等项目的检查。结果3个批次养胃颗粒的粒度检查中,不能通过一号筛与能通过五号筛的总和为(7.40±1.13)%;溶化性检查中,溶液均呈轻微浑浊,未见异物及焦屑;装量差异中,超出装量差异限度(±5%)的每个批次均未超过2袋,且未有1袋超出装量差异限度1倍;水分检查中,水分为(4.22±0.33)%;干燥失重检查中,减失质量为(1.60±0.38)%。3个批次养胃颗粒中金黄色葡萄球菌、枯草芽孢杆菌、铜绿假单胞菌、白色念珠菌、黑曲霉菌的回收比值均在0.5~2.0范围内;试验组大肠埃希菌正常检出,阴性对照组未检出。结论3个批次养胃颗粒的粒度、溶化性、装量差异、水分、干燥失重、微生物限度项目检查结果均符合《中国药典》(2020年版)四部要求。平皿法适用于养胃颗粒中需氧菌总数、霉菌和酵母菌总数计数,常规法适用于大肠埃希菌的测定。Objective To verify the quality inspection items for Yangwei granules prepared by a military hospital.Methods Three batches of Yangwei granules were prepared according to the prescribed composition and process.The properties and physicochemical characteristics were identified.Such items for inspection as particle size,solubility,packing mass differences,moisture content,loss mass on drying,and microbial limits were studied.Results During the inspection of particle size of three batches of Yangwei granules,the sum percentage of substances that failed to pass No.1 sieve and substances that passed No.5 sieve was(7.40±1.13)%.In the solubility inspection,the solutions were slightly turbid,but no foreign bodies or scorched debris were found.In the inspection of packing mass differences,no more than two bags of each batch exceeded the packing mass difference limit(±5%),and no bag exceeded the packing mass difference limit by 200%.In the moisture content inspection,the moisture was(4.22±0.33)%.In the loss mass on drying inspection,the reduced mass was(1.60±0.38)%.The recovery ratios of Staphylococcus aureus,Bacillus subtilis,Pseudomonas aeruginosa,Candida albicans,and Aspergillus niger of three batches of Yangwei granules ranged from 0.5 to 2.0.Escherichia coli was detected in the test group rather than in the negative control group.Conclusion The test results for particle size,solubility,packing mass differences,moisture content,loss mass on drying,and microbial limits for the three batches of Yangwei granules all met the requirements stipulated in Chinese Pharmacopoeia(2020 Edition,Part 4).The plate method is applicable to the determination of the total count of aerobic bacteria,molds and yeasts in Yangwei granules,while the conventional method is preferable for the determination of E.coli in Yangwei granules.

关 键 词：养胃颗粒 质量检查 方法验证 

分 类 号：R927.1[医药卫生—药学]