中国药师
中國藥師
중국약사
China Pharmacist
2015年
11期
1864-1869,1870
,共7页
排孜也提排孜拉%程雪梅%滕亮%王长虹%马桂芝
排孜也提排孜拉%程雪梅%滕亮%王長虹%馬桂芝
배자야제배자랍%정설매%등량%왕장홍%마계지
骆驼蓬生物碱乳膏剂%质量标准%去氢骆驼蓬碱%骆驼蓬碱%鸭嘴花碱
駱駝蓬生物堿乳膏劑%質量標準%去氫駱駝蓬堿%駱駝蓬堿%鴨嘴花堿
락타봉생물감유고제%질량표준%거경락타봉감%락타봉감%압취화감
Peganum harmala alkaloid cream%Quality standard%Harmine%Harmaline%Vasicine
目的：：初步建立骆驼蓬生物碱乳膏剂的质量控制方法。方法：按照《中国药典》2010年版一部附录有关制剂通则要求，对制剂进行一般质量检查。以去氢骆驼蓬碱和骆驼蓬碱为指标，采用薄层色谱法对乳膏剂进行薄层色谱鉴别。以去氢骆驼蓬碱、骆驼蓬碱、鸭嘴花碱为指标，采用高效液相色谱法对制剂进行含量测定。结果：检查项目均符合《中国药典》要求。薄层色谱中供试品在与对照品相同位置上显相同颜色斑点。去氢骆驼蓬碱、骆驼蓬碱和鸭嘴花碱分别在3.440~110.000μg· ml-1、3.340~107.000μg·ml-1和1.380~22.000μg·ml-1浓度范围内线性关系良好，平均回收率分别为98.1%(RSD=1.75%， n=6)、99.8%(RSD=1.78%， n=6)和99.3%(RSD=1.95%， n=6)。结论：所建立的质量控制方法符合方法学要求，为最终制定骆驼蓬生物碱乳膏剂质量标准奠定了试验基础。
目的：：初步建立駱駝蓬生物堿乳膏劑的質量控製方法。方法：按照《中國藥典》2010年版一部附錄有關製劑通則要求，對製劑進行一般質量檢查。以去氫駱駝蓬堿和駱駝蓬堿為指標，採用薄層色譜法對乳膏劑進行薄層色譜鑒彆。以去氫駱駝蓬堿、駱駝蓬堿、鴨嘴花堿為指標，採用高效液相色譜法對製劑進行含量測定。結果：檢查項目均符閤《中國藥典》要求。薄層色譜中供試品在與對照品相同位置上顯相同顏色斑點。去氫駱駝蓬堿、駱駝蓬堿和鴨嘴花堿分彆在3.440~110.000μg· ml-1、3.340~107.000μg·ml-1和1.380~22.000μg·ml-1濃度範圍內線性關繫良好，平均迴收率分彆為98.1%(RSD=1.75%， n=6)、99.8%(RSD=1.78%， n=6)和99.3%(RSD=1.95%， n=6)。結論：所建立的質量控製方法符閤方法學要求，為最終製定駱駝蓬生物堿乳膏劑質量標準奠定瞭試驗基礎。
목적：：초보건립락타봉생물감유고제적질량공제방법。방법：안조《중국약전》2010년판일부부록유관제제통칙요구，대제제진행일반질량검사。이거경락타봉감화락타봉감위지표，채용박층색보법대유고제진행박층색보감별。이거경락타봉감、락타봉감、압취화감위지표，채용고효액상색보법대제제진행함량측정。결과：검사항목균부합《중국약전》요구。박층색보중공시품재여대조품상동위치상현상동안색반점。거경락타봉감、락타봉감화압취화감분별재3.440~110.000μg· ml-1、3.340~107.000μg·ml-1화1.380~22.000μg·ml-1농도범위내선성관계량호，평균회수솔분별위98.1%(RSD=1.75%， n=6)、99.8%(RSD=1.78%， n=6)화99.3%(RSD=1.95%， n=6)。결론：소건립적질량공제방법부합방법학요구，위최종제정락타봉생물감유고제질량표준전정료시험기출。
Objective:To establish the quality standard for peganum harmala alkaloids cream ( CAPH) . Methods: The general quality of CAPH was inspected according to the general notices described in Chinese Pharmacopoeia volumeⅠ2010 edition. The qual-itative identification was carried out by TLC with harmine and harmaline as the index ingredients. The content determination was carried out by HPLC methods with harmine, harmaline and vasicine as the index ingredients. Results:The inspection items were all met the requirements. The experimental samples and the reference substances in TLC showed the identical spots with the same color and shape at the same position. The calibration curve of harmaline, harmine and vasicine was linear within the concentration range of 3. 440-110. 000 μg·ml-1 , 3. 340-107. 000 μg·ml-1 and 1. 380-22. 000 μg·ml-1 , respectively. The recovery was 98. 1%, 99. 8% and 99. 3% with RSD of 1. 75%, 1. 78% and 1. 95%, respectively (n=6). Conclusion: The established quality control methods meet the requirements of methodology, and the results lay foundation for the quality standard for CAPH.
