参白润肤膏的制备及质量评定(1)
【摘 要】 目的:研究参白润肤膏的处方和制备工艺,并通过稳定性留样评价对其工艺进行进一步优化。方法:将不同处方的样品通过耐热、耐寒实验、长期稳定性实验进行质量对比评定,优选出最佳的工艺,并在临床进行志愿患者试用调查。结果:优选出参白润肤膏的最佳处方为中药浸膏16 g,卡波姆2 g,山梨酸0.05%、乙醇3 g,甘油30 g,纯化水115 g,硬脂酸10 g,十八醇10 g,司班-60 3 g,白凡士林15 g,山茶油10 g,羟苯乙酯0.1%、当归挥发油0.5 g,三乙醇胺10g。按照该处方制备的乳膏工艺稳定、成型性较好。结论:优选的参白润肤膏处方质量稳定、可控,临床应用效果较好,可进一步深入研究临床疗效和中试规模生产。
【关键词】 参白润肤;乳膏;制备工艺;质量评定
【中图分类号】R285 【文献标志码】 A 【文章编号】1007-8517(2020)20-0050-04
Preparation and Quality Evaluation of Shenbai Moisturizing Cream
PAN Xu WANG Mengyu GONG Kaimin LIU Jun* HE Qirui
Yinchuan Hospital of Traditional Chinese Medicine, Yinchuan 750001,China
Abstract:Objective To study the prescription and preparation process of Shenbai moisturizing cream, and to further optimize its process through the evaluation of stability retention.Methods Samples of different prescriptions were compared and evaluated for quality through heat resistance, cold resistance experiments, and long-term stability experiments, the best process was selected, and a trial investigation of volunteer patients was conducted in the clinic.Result The best prescription for choosing Shenbai moisturizing cream is traditional Chinese medicine extract 16 g, carbomer 2 g, sorbic acid 0.05%,ethanol 3 g, glycerin 30 g,purified water 115 g,stearic acid 10 g,Stearyl alcohol 10 g, Span-60 3 g,white vaseline 15 g,camellia oil 10 g,ethyl paraben 0.1%,angelica essential oil 0.5 g and triethanolamine 10 g.The cream paraben 0.22 g,angelica essential oil 0.5 g and triethanolamine 10 g.The cream prepared according to this prescription has a stable process and good in formability.Conclusion The optimal prescription of Shenbai moisturizing cream is stable and controllable, and its clinical application effect is good. It can further study the clinical efficacy and pilot scale production.
Keywords:Shenbai Moisturizing Skin; Cream; Preparation Process; Quality Assessment
參白润肤膏中所含浸膏的中药处方来源于银川市中医医院皮肤科胡艳君主任的经验方,组方有人参、当归、川芎、玫瑰花等药,具有活血化瘀、美白淡斑等功效,临床应用十余年,疗效确切,受到众多患者肯定,但也存在着使用不便的问题。为方便患者使用,拟将其研究制备成乳膏剂,增强透皮吸收后起到滋润、保湿、加强疗效的作用。中药处方成分复杂,易与乳膏基质发生作用,如何平衡中药乳膏剂载药量和质量稳定,是需要深入研究的,故本实验将研究参白润肤膏的制备工艺并通过稳定性留样观察对其工艺进行进一步优化和评价。
1 实验仪器与试药
1.1 实验仪器 YP4002电子天平(上海越平科学仪器有限公司);HH·S21-Ni6B/C电热恒温水浴锅(北京长源实验设备厂);KQ-500DA超声波清洗器(昆山市超声仪器有限公司);WD-A型药品稳定性试验箱(天津药典标准仪器厂);冰箱(苏州三星电子有限公司)。
1.2 实验试药 中药浸膏包括人参、当归、川芎、玫瑰花等中药饮片(均购于宁夏明德中药饮片有限公司,经我院药检室鉴定后,均符合规定);当归挥发油(中药饮片购于宁夏明德中药饮片有限公司,经我院药检室鉴定后,符合规定,并委托其他研究机构超临界萃取制得);其他基质三乙醇胺为分析纯(购于天津市科密欧化学试剂有限公司);司班-60为化学纯(购于天津市科密欧化学试剂有限公司);吐温-80和乙醇(购于四川金山制药有限公司)和山梨酸(湖南华日制药有限公司)及白凡士林、卡波姆、十八醇、硬脂酸、甘油、羟苯乙酯(均购于湖南尔康制药股份有限公司)为药用级;山茶油为食品级(购于浙江久晟油茶科技股份有限公司),纯化水(自制)。, 百拇医药(潘旭 王梦昱 宫凯敏 刘军 何其睿)
【关键词】 参白润肤;乳膏;制备工艺;质量评定
【中图分类号】R285 【文献标志码】 A 【文章编号】1007-8517(2020)20-0050-04
Preparation and Quality Evaluation of Shenbai Moisturizing Cream
PAN Xu WANG Mengyu GONG Kaimin LIU Jun* HE Qirui
Yinchuan Hospital of Traditional Chinese Medicine, Yinchuan 750001,China
Abstract:Objective To study the prescription and preparation process of Shenbai moisturizing cream, and to further optimize its process through the evaluation of stability retention.Methods Samples of different prescriptions were compared and evaluated for quality through heat resistance, cold resistance experiments, and long-term stability experiments, the best process was selected, and a trial investigation of volunteer patients was conducted in the clinic.Result The best prescription for choosing Shenbai moisturizing cream is traditional Chinese medicine extract 16 g, carbomer 2 g, sorbic acid 0.05%,ethanol 3 g, glycerin 30 g,purified water 115 g,stearic acid 10 g,Stearyl alcohol 10 g, Span-60 3 g,white vaseline 15 g,camellia oil 10 g,ethyl paraben 0.1%,angelica essential oil 0.5 g and triethanolamine 10 g.The cream paraben 0.22 g,angelica essential oil 0.5 g and triethanolamine 10 g.The cream prepared according to this prescription has a stable process and good in formability.Conclusion The optimal prescription of Shenbai moisturizing cream is stable and controllable, and its clinical application effect is good. It can further study the clinical efficacy and pilot scale production.
Keywords:Shenbai Moisturizing Skin; Cream; Preparation Process; Quality Assessment
參白润肤膏中所含浸膏的中药处方来源于银川市中医医院皮肤科胡艳君主任的经验方,组方有人参、当归、川芎、玫瑰花等药,具有活血化瘀、美白淡斑等功效,临床应用十余年,疗效确切,受到众多患者肯定,但也存在着使用不便的问题。为方便患者使用,拟将其研究制备成乳膏剂,增强透皮吸收后起到滋润、保湿、加强疗效的作用。中药处方成分复杂,易与乳膏基质发生作用,如何平衡中药乳膏剂载药量和质量稳定,是需要深入研究的,故本实验将研究参白润肤膏的制备工艺并通过稳定性留样观察对其工艺进行进一步优化和评价。
1 实验仪器与试药
1.1 实验仪器 YP4002电子天平(上海越平科学仪器有限公司);HH·S21-Ni6B/C电热恒温水浴锅(北京长源实验设备厂);KQ-500DA超声波清洗器(昆山市超声仪器有限公司);WD-A型药品稳定性试验箱(天津药典标准仪器厂);冰箱(苏州三星电子有限公司)。
1.2 实验试药 中药浸膏包括人参、当归、川芎、玫瑰花等中药饮片(均购于宁夏明德中药饮片有限公司,经我院药检室鉴定后,均符合规定);当归挥发油(中药饮片购于宁夏明德中药饮片有限公司,经我院药检室鉴定后,符合规定,并委托其他研究机构超临界萃取制得);其他基质三乙醇胺为分析纯(购于天津市科密欧化学试剂有限公司);司班-60为化学纯(购于天津市科密欧化学试剂有限公司);吐温-80和乙醇(购于四川金山制药有限公司)和山梨酸(湖南华日制药有限公司)及白凡士林、卡波姆、十八醇、硬脂酸、甘油、羟苯乙酯(均购于湖南尔康制药股份有限公司)为药用级;山茶油为食品级(购于浙江久晟油茶科技股份有限公司),纯化水(自制)。, 百拇医药(潘旭 王梦昱 宫凯敏 刘军 何其睿)