CAJ | 학술논문

目的：建立药物固体制剂中原料药晶型的定性鉴别方法。方法采用粉末X射线衍射技术，依托尼莫地平、罗红霉素，通过定量检测，采用物相扣除技术获得固体制剂中原料药晶型存在状态的粉末衍射图谱，并与晶型原料药的标准图谱比对实现晶型定性鉴别。结果利用建立的固体制剂中晶型原料药鉴别方法，通过对尼莫地平、罗红霉素11个不同厂家生产的27批次固体制剂进行分析研究，获得不同厂家生产固体制剂中原料药的晶型粉末X射线衍射图谱，通过与晶型标准图谱比对，成功实现了对固体制剂中原料药晶型状态的定性鉴别。结论所建立的基于粉末X射线衍射技术的固体制剂中晶型原料药的鉴别方法具有良好的普适性，方法准确性高，可实现药物固体制剂中的原料药晶型鉴别，可作为固体制剂晶型质量控制的定性鉴别通用方法。
목적：건립약물고체제제중원료약정형적정성감별방법。방법채용분말X사선연사기술，의탁니막지평、라홍매소，통과정량검측，채용물상구제기술획득고체제제중원료약정형존재상태적분말연사도보，병여정형원료약적표준도보비대실현정형정성감별。결과이용건립적고체제제중정형원료약감별방법，통과대니막지평、라홍매소11개불동엄가생산적27비차고체제제진행분석연구，획득불동엄가생산고체제제중원료약적정형분말X사선연사도보，통과여정형표준도보비대，성공실현료대고체제제중원료약정형상태적정성감별。결론소건립적기우분말X사선연사기술적고체제제중정형원료약적감별방법구유량호적보괄성，방법준학성고，가실현약물고체제제중적원료약정형감별，가작위고체제제정형질량공제적정성감별통용방법。
Objective To establish a method for qualitative identification of polymorphs in pharmaceutical solid preparations of active pharmaceutical ingredients ( API ) . Methods We obtained the powder diffraction patterns of the polymorphic drug substance like nimodipine and roxithromycin in solid preparation material and completed quantitative identification for polymorphs by the quantitative detection and using PXRD technology, deduction calculation through the powder X-ray diffraction and comparing with standard diagram. Results Through the analysis of nimodipine and roxithromycin which came from 27 batches of solid preparations from 11 different manufacturers, and comparing to the standard patterns of pure polymorphs, the quantitative identification of different crystalline states of API in pharmaceutical preparations had been established. Conclusion The qualitative detection method for polymorphs of API in pharmaceutical preparations by powder X-ray diffraction has wide applicability and high accuracy, which can be used to identify the polymorphism of API in solid preparation,and also used to control the quality of solid preparations commonly as a qualitative analysis method.