伤科解毒颗粒微生物限度检查方法适用性试验的研究  

Verification Experiment of Microbial Limit Test for Shangke Jiedu Granules

作　　者：韦玉燕 何科[1] 吴勇梅 王小新 庞云娟 WEI Yu-yan;HE Ke;WU Yong-mei;WANG Xiao-xin;PANG Yun-juan(Hospital Pharmacy Department of Integrated Traditional Chinese and Western Medicine,Guangxi Yulin 537000;Yulin Center for Food and Drug Control,Guangxi Yulin 537000,China)

机构地区：[1]玉林市中西医结合骨科医院,广西玉林537000 [2]玉林市食品药品检验检测中心,广西玉林537000

出　　处：《广州化工》2020年第19期89-91,共3页GuangZhou Chemical Industry

基　　金：广西科技计划项目(桂科AA18126004)。

摘　　要：伤科解毒颗粒是我院院内制剂,主要用于预防和治疗骨折术后伤口感染、红肿热痛、下肢静脉血栓等。伤科解毒颗粒为不含药材原粉的口服固体制剂,根据其给药途径及处方,按照《中国药典2015》版要求,需要对其需氧菌总数、霉菌和酵母菌总数及大肠埃希菌进行检查,本文对其微生物限度检查法进行适用性试验研究,建立伤科解毒颗粒微生物限度检查方法。Shangke Jiedu Granule is an in-hospital preparation in our hospital.It is mainly used for preventing and treating wound infection,red swelling and pain,lower limb venous thrombosis,etc.after fracture operation.Shangke Jiedu Granules is an oral solid preparation that does not contain crude powder of medicinal materials.According to its route of administration and prescription,and according to the requirements of the Chinese Pharmacopoeia 2015 edition,it is necessary to inspect the total number of aerobic bacteria,the total number of mold and yeast,and the total number of Escherichia coli.The applicability of the microbial limit test method for Shangke Jiedu Granules was studied,and the microbial limit test method for Shangke Jiedu Granules was established.

关 键 词：伤科解毒颗粒 微生物 限度检查 适用性试验 

分 类 号：R927.11[医药卫生—药学]