补骨脂乳膏剂的制备及其质量控制(1)
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[摘要] 目的:制备补骨脂乳膏并建立其质量标准。方法:加热回流法提取补骨脂中主要成分补骨脂素和异补骨脂素,浓缩至浸膏。取处方对应量的主药、乳化剂水相和油相制得乳膏剂,采用高效液相法测定乳膏中补骨脂素和异补骨脂素的含量,并考察制剂稳定性。结果:补骨脂素检测浓度在0.014 5～0.362 0 μg范围内线性关系良好(r=0.999 9),平均回收率为98.20%(RSD=1.79%,n=6);异补骨脂素检测浓度在0.018 8～0.47 0 μg范围内线性关系良好(r=0.999 9),平均回收率为98.87%,RSD=1.58%,且制备的补骨脂乳膏均匀细腻,易于涂布,质量稳定。结论:补骨脂乳膏的处方及制备工艺合理,质量可控,值得推广,质量控制方法简便﹑准确﹑重现性好,适用于该制剂的质量控制。
[关键词] 补骨脂;乳膏;制备;质量控制
[中图分类号] R943[文献标识码]A [文章编号]1673-7210(2010)06(a)-071-03
The preparation of Fructus Psoraleae Cream and its quality control
WANG Chuanke
(Yueyang Vocational Technical College, Yueyang 414000, China)
[Abstract] Objective: To prepare Fructus Psoraleae Cream and establish its standard of quality control. Methods: Extracted psoralen and isopsoralen by using heating reflux method and condense to a certain volume. The oil phase and water phase were prepared according to prescription and merged to make Fructus Psoraleae Cream. The HPLC method was used to determined the content of psoralen and isopsoralen. Results: The linear range of psoralen was in the range of 0.014 5-0.362 0 μg (r=0.999 9). The average recovery was 98.20% with a RSD of 1.79% (n=6). The linear range of isopsoralen was in the range of 0.018 8-0.470 0 μg (r=0.999 9). The average recovery was 98.87% with a RSD of 1.58% (n=6). The prepared Cream was even, fine stable and easy to spread. Conclusion: The prescription and preparation of Fructus Psoraleae Cream are reasonable and controllable, worth popularizing. The method for determinetion is simple, accurate and reproducible, applicable to the quality control of the preparation.
[Key Words] Fructus Psoraleae; Cream; Preparation; Quality control
白癜风是一种常见的后天性表皮色素脱失性皮肤病,中医称为“白癜”、“白驳风”,好发于皮肤皱褶及暴露部位,在临床中属于慢性、难治的疾病,临床表现为皮肤上出现大小不等的圆形或椭圆形的白斑,边界清晰,边缘色素较深。该病可发生于任何年龄、性别,多发于40岁以前,我国白癜风发病率为1%～2%,有逐年上升的趋势[1]。因其病因复杂,治疗比较困难,其治疗的主要目的是增加皮损中黑色素细胞的数量,中药补骨脂别名黑故子,为豆科植物补骨脂(Psoralea corylifolia L.)的干燥成熟果实,性味辛、苦、温,归肾、脾经,为中医传统补肾助阳中药,有温肾助阳、纳气、止泻的功效,且有祛白斑增色的作用,常用于治疗白癜风等皮肤顽疾[2-5],临床应用的有口服片剂、胶囊、针剂、酊剂等传统剂型,均可因吸收入血而导致全身不良反应(视网膜毒性、肝毒性)等[6],而外用制剂避免了这些不良反应,成为了补骨脂制剂的主要研究开发方向,为了开发更安全有效的外用制剂,本试验从补骨脂中提取分离获得其中主要有效成分补骨脂素和异补骨脂素[7-9],通过处方的选择,制备了补骨脂乳膏。
1 仪器与试药
高效液相色谱仪(Agilent 1200LC),UV检测器;补骨脂素对照品(中国药品生物制品检定所,批号:110739-200814),异补骨脂素对照品(中国药品生物制品检定所,批号:110738-200309),乙醇、甲醇均为色谱纯,双重蒸馏水,其他试剂均为分析纯 ......
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