[Objectives]This study was conducted to establish a microbial limit test method for Qingyan Zhisou Powder.[Methods]Applicability tests were carried out according to Microbial Limit Tests of Non-sterile Products,Genera...[Objectives]This study was conducted to establish a microbial limit test method for Qingyan Zhisou Powder.[Methods]Applicability tests were carried out according to Microbial Limit Tests of Non-sterile Products,General Rules 1105-1107 of Part IV of Chinese Pharmacopoeia,2020.[Results]Qingyan Zhisou Powder had a strong bacteriostatic effect on Pseudomonas aeruginosa.After increasing the dilution ratio(1:40),the bacteriostatic effect was obviously eliminated.When the total number of aerobic microbes was determined by the test liquid dilution method(1:40),the recovery values were in the range of 50%-200%;and when using the test liquid(1:10)to determine the total number of mold and yeasts,the recovery ranged from 50%to 200%.Escherichia coli,Salmonella and bile-tolerant Gram-negative bacteria were detected by both the routine method and dilution method in experimental groups.[Conclusions]The microbial limit test of Qingyan Zhisou Powder adopted the test liquid dilution method,and the routine method could be used for the test of Escherichia coli,Salmonella and bile-tolerant Gram-negative bacteria.The applicability test of the method is feasible,with scientific and accurate results,and the method can effectively control the quality of the preparation and is recommended for popularization.展开更多
目的评价止嗽散治疗小儿感冒后咳嗽临床疗效与安全性。方法检索EMBASE、PUBMED、MEDLINE、AMED、CINAHL、Cochrane图书馆、中国知网数据库、重庆维普中文科技期刊数据库、中国生物医学文献数据库、万方数据库和中国中医药期刊文献数据...目的评价止嗽散治疗小儿感冒后咳嗽临床疗效与安全性。方法检索EMBASE、PUBMED、MEDLINE、AMED、CINAHL、Cochrane图书馆、中国知网数据库、重庆维普中文科技期刊数据库、中国生物医学文献数据库、万方数据库和中国中医药期刊文献数据库从建库至2014年12月30日止嗽散治疗小儿感冒后咳嗽随机对照试验研究,筛选合格研究。应用Cochrane评价员手册进行偏倚风险评价,Jadad评分法进行质量评价。应用Rev Man 5.3软件进行Meta分析。结果符合纳入标准的文献共2篇。Meta分析结果显示,止嗽散加减为主方治疗小儿感冒后咳嗽治疗组与对照组相比,临床疗效总有效率比值比(OR)为4.06,95%可信区间(CI)[1.93,8.56],差异有统计学意义(P=0.000 2);临床疗效治愈率OR为3.17,95%CI[1.00,9.99],差异无统计学意义;纳入研究未报道不良反应。结论止嗽散加减治疗小儿感冒后咳嗽临床疗效显著,但由于本系统评价纳入研究的总体质量较低,研究的数量和样本量均较小,尚需要更多高质量、多中心、大样本、严格设计的随机对照试验来进一步验证其疗效与安全性。展开更多
基金Supported by Traditional Chinese Medicine and Ethnic Minority Medicine Technology Research Subject of Guizhou Administrative Bureau(QZYY-2018-095)。
文摘[Objectives]This study was conducted to establish a microbial limit test method for Qingyan Zhisou Powder.[Methods]Applicability tests were carried out according to Microbial Limit Tests of Non-sterile Products,General Rules 1105-1107 of Part IV of Chinese Pharmacopoeia,2020.[Results]Qingyan Zhisou Powder had a strong bacteriostatic effect on Pseudomonas aeruginosa.After increasing the dilution ratio(1:40),the bacteriostatic effect was obviously eliminated.When the total number of aerobic microbes was determined by the test liquid dilution method(1:40),the recovery values were in the range of 50%-200%;and when using the test liquid(1:10)to determine the total number of mold and yeasts,the recovery ranged from 50%to 200%.Escherichia coli,Salmonella and bile-tolerant Gram-negative bacteria were detected by both the routine method and dilution method in experimental groups.[Conclusions]The microbial limit test of Qingyan Zhisou Powder adopted the test liquid dilution method,and the routine method could be used for the test of Escherichia coli,Salmonella and bile-tolerant Gram-negative bacteria.The applicability test of the method is feasible,with scientific and accurate results,and the method can effectively control the quality of the preparation and is recommended for popularization.
文摘目的评价止嗽散治疗小儿感冒后咳嗽临床疗效与安全性。方法检索EMBASE、PUBMED、MEDLINE、AMED、CINAHL、Cochrane图书馆、中国知网数据库、重庆维普中文科技期刊数据库、中国生物医学文献数据库、万方数据库和中国中医药期刊文献数据库从建库至2014年12月30日止嗽散治疗小儿感冒后咳嗽随机对照试验研究,筛选合格研究。应用Cochrane评价员手册进行偏倚风险评价,Jadad评分法进行质量评价。应用Rev Man 5.3软件进行Meta分析。结果符合纳入标准的文献共2篇。Meta分析结果显示,止嗽散加减为主方治疗小儿感冒后咳嗽治疗组与对照组相比,临床疗效总有效率比值比(OR)为4.06,95%可信区间(CI)[1.93,8.56],差异有统计学意义(P=0.000 2);临床疗效治愈率OR为3.17,95%CI[1.00,9.99],差异无统计学意义;纳入研究未报道不良反应。结论止嗽散加减治疗小儿感冒后咳嗽临床疗效显著,但由于本系统评价纳入研究的总体质量较低,研究的数量和样本量均较小,尚需要更多高质量、多中心、大样本、严格设计的随机对照试验来进一步验证其疗效与安全性。
