中国药师
中國藥師
중국약사
CHINA PHARMACIST
2015年
4期
671-673
,共3页
平胃分散片%制备%苍术素%高效液相色谱法%含量测定
平胃分散片%製備%蒼術素%高效液相色譜法%含量測定
평위분산편%제비%창술소%고효액상색보법%함량측정
Pingwei dispersible tablets%Preparation%Atractylodin%HPLC%Content determination
目的：制备平胃分散片并建立以高效液相色谱法测定其苍术素含量的方法。方法：以 Kromasil C18（250 mm ×4.6 mm，5μm）为色谱柱，流动相为甲醇-水（75：25），检测波长为340 nm，流速为1.0 ml·min-1，柱温为30℃，进样量是10μl。结果：处方中内崩解剂微晶纤维素、外崩解剂羧甲基纤维钠、羟丙甲纤维素的浓度分别是40%、9%、2%，以2%的羟丙甲纤维素的70%乙醇溶液作为黏合剂，以1.5%的硬脂酸镁作为润滑剂后压片。苍术素在0.1006~0.5030μg范围内进样量与峰面积呈良好的线性关系（r=0.9999），平均回收率为99.3%（RSD=0.9%，n=6）。结论：平胃分散片制备工艺合理，定量方法简便、准确、专属性强，可用于该制剂的含量测定。
目的：製備平胃分散片併建立以高效液相色譜法測定其蒼術素含量的方法。方法：以 Kromasil C18（250 mm ×4.6 mm，5μm）為色譜柱，流動相為甲醇-水（75：25），檢測波長為340 nm，流速為1.0 ml·min-1，柱溫為30℃，進樣量是10μl。結果：處方中內崩解劑微晶纖維素、外崩解劑羧甲基纖維鈉、羥丙甲纖維素的濃度分彆是40%、9%、2%，以2%的羥丙甲纖維素的70%乙醇溶液作為黏閤劑，以1.5%的硬脂痠鎂作為潤滑劑後壓片。蒼術素在0.1006~0.5030μg範圍內進樣量與峰麵積呈良好的線性關繫（r=0.9999），平均迴收率為99.3%（RSD=0.9%，n=6）。結論：平胃分散片製備工藝閤理，定量方法簡便、準確、專屬性彊，可用于該製劑的含量測定。
목적：제비평위분산편병건립이고효액상색보법측정기창술소함량적방법。방법：이 Kromasil C18（250 mm ×4.6 mm，5μm）위색보주，류동상위갑순-수（75：25），검측파장위340 nm，류속위1.0 ml·min-1，주온위30℃，진양량시10μl。결과：처방중내붕해제미정섬유소、외붕해제최갑기섬유납、간병갑섬유소적농도분별시40%、9%、2%，이2%적간병갑섬유소적70%을순용액작위점합제，이1.5%적경지산미작위윤활제후압편。창술소재0.1006~0.5030μg범위내진양량여봉면적정량호적선성관계（r=0.9999），평균회수솔위99.3%（RSD=0.9%，n=6）。결론：평위분산편제비공예합리，정량방법간편、준학、전속성강，가용우해제제적함량측정。
Objective:To prepare Pingwei dispersible tablets and establish a method for the determination of atractylodin. Meth-ods:HPLC was performed on a Kromasil C18 column(250 mm × 4. 6 mm,5 μm)using methanol-water(75:25)as the mobile phase at a flow rate of 1 ml·min-1 . The detection wavelength was at 340nm. The column temperature was 30℃ and the injection volume was 10 μl. Results:The optimized formula of the tablets was as follows:the proportion of inner disintegrant microcrystalline cellulose,out-side disintegrant carboxymethyl cellulose sodium and HPMC was 40%,9% and 2%,respectively. The adhesive was 2% HPMC in 70% ethanol,and 1. 5% magnesium stearate was used as the lubricant. The linear range of atractylodin was 0. 100 6-0. 503 0 μg(r=0. 999 9),and the average recovery was 99. 3%(RSD=0. 9%,n=6). Conclusion:The formula and the preparation process of the tablets are reasonable and the content determination method is simple,accurate and specific,which can be used in the quality control of Pingwei dispersible tablets.
