中国药物警戒
中國藥物警戒
중국약물경계
CHINESE JOURNAL OF PHARMACOVIGILANCE
2015年
8期
467-470
,共4页
跌打丸%评价性抽验%质量评价
跌打汍%評價性抽驗%質量評價
질타환%평개성추험%질량평개
Dieda pills%evaluative testing%quality evaluation
目的:评价跌打丸的质量现状及存在问题。方法按现行标准结合探索性研究进行样品检验,统计分析检验结果对跌打丸的质量现状进行评价。结果检测显示34批样品的重量差异、水分、溶散时限、微生物限度和含量测定均符合规定。结论该品种质量状况总体评价良好,现行检验标准可行,但探索性研究显示现行质量标准还需进一步完善。
目的:評價跌打汍的質量現狀及存在問題。方法按現行標準結閤探索性研究進行樣品檢驗,統計分析檢驗結果對跌打汍的質量現狀進行評價。結果檢測顯示34批樣品的重量差異、水分、溶散時限、微生物限度和含量測定均符閤規定。結論該品種質量狀況總體評價良好,現行檢驗標準可行,但探索性研究顯示現行質量標準還需進一步完善。
목적:평개질타환적질량현상급존재문제。방법안현행표준결합탐색성연구진행양품검험,통계분석검험결과대질타환적질량현상진행평개。결과검측현시34비양품적중량차이、수분、용산시한、미생물한도화함량측정균부합규정。결론해품충질량상황총체평개량호,현행검험표준가행,단탐색성연구현시현행질량표준환수진일보완선。
Objective To evaluate the quality status and exsisting problems of Dieda pills. Methods Using statutory testing methods combined with the exploratory research to examine samples, the quality status of Dieda pills was evaluated by statistical analysis of the results. Results In 34 batches of samples, the quality of all products can meet the current standards(100%) in terms of weight variation, disintegration time, water content, microbial limit and determination of content. Conclusion At present, the preparation quality is generally good, but exploratory research shows that current standards are defective.