CAJ | 학술논문

目的：通过对11批缩泉丸和39批缩泉胶囊进行标准检验及探索性研究，对该品种的质量及标准状况作出总体分析及评价。方法标准检验丸剂按照《卫生部药品标准中药成方制剂第一册》和《中国药典2010年版一部》检验，缩泉胶囊均按照《新药转正标准第43册》检验。探索性研究进行了原药材的质量考察；缩泉胶囊新增加了山药的显微鉴别；缩泉丸中新增加了尿囊素（山药）的含量测定；缩泉丸及缩泉胶囊中新增加了去甲异波尔定（乌药）的含量测定；开展了塑化剂的筛查、重金属及有害元素、二氧化硫残留的考察。结果按现行质量标准检验和探索性研究检验，50批次样品全部合格。结论缩泉丸（胶囊）的总体质量状况评价为“一般”。现行标准基本设置不够完善，部分检测方法不尽合理。探索性研究增加了标准的专属性、可控性及安全性，为修订缩泉丸（胶囊）药品标准、控制药品质量提供参考。
목적：통과대11비축천환화39비축천효낭진행표준검험급탐색성연구，대해품충적질량급표준상황작출총체분석급평개。방법표준검험환제안조《위생부약품표준중약성방제제제일책》화《중국약전2010년판일부》검험，축천효낭균안조《신약전정표준제43책》검험。탐색성연구진행료원약재적질량고찰；축천효낭신증가료산약적현미감별；축천환중신증가료뇨낭소（산약）적함량측정；축천환급축천효낭중신증가료거갑이파이정（오약）적함량측정；개전료소화제적사사、중금속급유해원소、이양화류잔류적고찰。결과안현행질량표준검험화탐색성연구검험，50비차양품전부합격。결론축천환（효낭）적총체질량상황평개위“일반”。현행표준기본설치불구완선，부분검측방법불진합리。탐색성연구증가료표준적전속성、가공성급안전성，위수정축천환（효낭）약품표준、공제약품질량제공삼고。
ABSTRACT:OBJECTIVE To analyze 11 Suoquan Pills and 39 Suoquan Capsules according to the quality stand-ard,and research on the sample ,analyze,and evaluate the global quality control and standard condition of this varie-ty.METHODS Suoquan Pills were analyzed with Drug Specifications Promulgated by the Ministry of Public Health,PR China.Chinese Traditional Patent Formulation .Vol 1 and Chinese Pharmacopoeia 2010 Vol Ⅰ;Suoquan capsules were analyzed in accordance with 43 of the new drug positive standard;The exploratory research inspection was carried out by investigating the quality of raw herbs;increasing the microscopic identification ( Dioscoreae rhizo-ma) of Suoquan capsules;establishing the determination of allantoin ( Dioscoreae rhizoma) in Suoquan Pills;establis-hing the determination of norisoboldine in Suoquan Pills and capsules;plasticizer , heavy metals and harmful ele-ments ,sulfur dioxide residue were investigated .RESULTS According to quality standards inspection and explorato-ry research inspection ,50 samples qualified sample rate was 100.0%.CONCLUSION The overall evaluation of the quality of Suoquan Pills and capsules is “general”.The current quality standard is not perfect ,and some detection methods is not rational .The results of the test indicate that exploratory research could increase the specificity ,control-lability ,and safety of the standard .It would provide the reference for revising the drug standard and controlling the drug quality.