海峡药学
海峽藥學
해협약학
Strait Pharmaceutical Journal
2015年
9期
47-49
,共3页
咳喘宁制剂%评价检验%质量分析
咳喘寧製劑%評價檢驗%質量分析
해천저제제%평개검험%질량분석
Kechuanning Preparation%Evaluation of sampling%Quality analysis
目的：评价咳喘宁制剂的产品质量和现行质量标准的可行性。方法按照咳喘宁制剂的现行标准检验，探索性研究采用 HPLC法测定咳喘宁口服液中盐酸麻黄碱的含量。结果按现行法定标准检验咳喘宁制剂100批次，合格率100％；通过探索性研究检验，可更加科学合理的控制咳喘宁口服液的产品质量。结论咳喘宁（片）现行标准有待提升和统一，咳喘宁口服液现行标准基本可行，有的项目可进一步修订提高。
目的：評價咳喘寧製劑的產品質量和現行質量標準的可行性。方法按照咳喘寧製劑的現行標準檢驗，探索性研究採用 HPLC法測定咳喘寧口服液中鹽痠痳黃堿的含量。結果按現行法定標準檢驗咳喘寧製劑100批次，閤格率100％；通過探索性研究檢驗，可更加科學閤理的控製咳喘寧口服液的產品質量。結論咳喘寧（片）現行標準有待提升和統一，咳喘寧口服液現行標準基本可行，有的項目可進一步脩訂提高。
목적：평개해천저제제적산품질량화현행질량표준적가행성。방법안조해천저제제적현행표준검험，탐색성연구채용 HPLC법측정해천저구복액중염산마황감적함량。결과안현행법정표준검험해천저제제100비차，합격솔100％；통과탐색성연구검험，가경가과학합리적공제해천저구복액적산품질량。결론해천저（편）현행표준유대제승화통일，해천저구복액현행표준기본가행，유적항목가진일보수정제고。
ABSTRACT:OBJECTIVE To evaluate the quality of Kechuanning Prepration and feasibility of current stand-ards.METHODS Inspection in accordance with the current standard for Kechuanning preparation , exploring the content of ephedrine hydrochloride by HPLC method for determination of Kechuanning oral liquid.RESULTS 100 batches of Kechuanning Preparation were tested ,the qualified rate of current standards test were 100%;The explora-tory testing can be more scientific and reasonable control asthma Ning oral liquid on the quality of the prod -ucts.CONCLUSION The current standard of Kechuanning ( tablet) needs to be improved and unified ,the current standard for Kechuanning oral liquid is basically feasible ,some projects may be further amended to improve.
