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引用本文:宋旭莹,陆纪宏,厉英光,应晓鸯,王小兰,金庆平.积雪苷口腔崩解片的研制及质量控制[J].中国现代应用药学,2011,28(11):1018-1020.
SONG Xuying, LU Jihong, LI Yingguang, YING Xiaoyang, WANG Xiaolan, JIN Qingping.Preparation and Quality Control of Asiaticoside Orally Disintegrating Tablets[J].Chin J Mod Appl Pharm(中国现代应用药学),2011,28(11):1018-1020.
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积雪苷口腔崩解片的研制及质量控制
宋旭莹,陆纪宏,厉英光,应晓鸯,王小兰,金庆平
浙江金华康恩贝生物制药有限公司,浙江 金华 321016
摘要:
目的 研制积雪苷口腔崩解片。方法 以积雪苷为主药,内加淀粉为崩解剂,建立性状、崩解时限、含量测定等质控方法。结果 制备的口腔崩解片符合工艺要求。以高效液相色谱法测定积雪苷口腔崩解片中积雪草苷的含量,平均回收率为100.7%,RSD=1.01%(n=9)。结论 该制剂制备工艺可行,测定方法简便、准确。
关键词:  口腔崩解片  制剂工艺  积雪苷
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基金项目:
Preparation and Quality Control of Asiaticoside Orally Disintegrating Tablets
SONG Xuying, LU Jihong, LI Yingguang, YING Xiaoyang, WANG Xiaolan, JIN Qingping
Zhejiang Jinhua Conba Bio-pharm.Co., Ltd., Jinhua 321016, China
Abstract:
OBJECTIVE Preparation and formulation investigation of asiaticoside orally disintegrating tablets. METHODS Prepare the tablets by using asiaticoside as principal drug and starch as disintegrating agent; establish the quality control method including character, disintegration, assay etc. RESULTS The asiaticoside orally disintegrating tablets prepared met technology requirements. The assay of asiaticoside was determined by HPLC, average recovery rate and RSD were 100.7% and 1.01% (n=9) respectively. CONCLUSION The preparation technology is feasible and testing method is convenient and accurate.
Key words:  orally disintegrating tablets  preparation procedure  asiaticoside
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