CAJ | 학술논문

目的:对我院所制的中药制剂进行质量的稳定性检测,同时验证中药制剂的有效期.方法:选取比较常见的并且具有代表性的6种中药制剂进行监测,这些中药制剂主要是洗剂,片剂,软膏剂和口服液,其中有内服也有外用的,为保证药剂的质量,通常还要对药剂进行稳定性检查,即在为期12到24个月的有效期内对药剂质量进行检测,一般检查的主要方面包括崩解时限,化学酸碱性PH值,药剂的相对密度和药剂内的微生物限度等,在考察期内,6种中药制剂经过检查都是符合国家的有关标准的.结果:根据相应的崩解时限检查法对三种片剂进行检查,3种片剂在有效期内各自的崩解时限都符合相应标准的指定值.结论:对于我院配制的这6种常用的中药制剂在有效期内均具有稳定的质量,有效期的设定也是合理的.
목적:대아원소제적중약제제진행질량적은정성검측,동시험증중약제제적유효기.방법:선취비교상견적병차구유대표성적6충중약제제진행감측,저사중약제제주요시세제,편제,연고제화구복액,기중유내복야유외용적,위보증약제적질량,통상환요대약제진행은정성검사,즉재위기12도24개월적유효기내대약제질량진행검측,일반검사적주요방면포괄붕해시한,화학산감성PH치,약제적상대밀도화약제내적미생물한도등,재고찰기내,6충중약제제경과검사도시부합국가적유관표준적.결과:근거상응적붕해시한검사법대삼충편제진행검사,3충편제재유효기내각자적붕해시한도부합상응표준적지정치.결론:대우아원배제적저6충상용적중약제제재유효기내균구유은정적질량,유효기적설정야시합리적.
@@@@Objective:In our hospital for Chinese medicine preparation quality of stability testing, and verification of the validity of traditional Chinese medicine preparations.Methods:To select the most commonly used at the same time a representative sample of 6 kinds of preparation of traditional Chinese medicine, the preparation of traditional Chinese medicine is mainly lotion, tablet, ointment and oral liquid, wherein the medicine also has external, in order to ensure the quality of drugs, usually of a pharmaceutical stability check, namely in the period of 12 to 24 months of effective the period for pharmaceutical quality testing, general examination includes major aspects of disintegration, chemical pH pH value, relative density and chemical agents within the microbial limit, during this period, 6 kinds of traditional Chinese medicine after inspection are in line with national standards.Results:Disintegration time according to the test method to check the three tablets, 3 tablets in the disintegration time of each period are in line with the specified value of the corresponding standards. Conclusion:The prepared in our hospital this 6 kinds of commonly used traditional Chinese medicine preparation in period of validity has stable quality, the period of validity of the setting is reasonable.