复方红景天胶囊制剂工艺与质量控制方法研究

【作者】 傅欣彤；

【导师】 石任兵；

【作者基本信息】 北京中医药大学 ， 中药化学， 2007， 硕士

【摘要】 复方红景天胶囊由红景天、刺五加、丹参、延胡索、银杏叶提取物等五味药组成,具有益气活血,通脉止痛之功效。用于胸痹气虚血瘀症。症见胸闷,胸中刺痛或隐痛,心悸不寐,神疲乏力,气短懒言等,以及冠心病、心绞痛见上述症状者。论文对复方红景天胶囊的药学部分进行了研究,共分为三大部分:第一部分文献综述研究对近10年来有关冠心病心绞痛中医药治疗近况进行综述;对近10年来有关复方红景天胶囊组成各单味药的化学成分、质量控制和药理学研究进展进行综述,共引文献137篇。第二部分实验研究1.制剂工艺的研究:通过正交试验法优选了红景天与刺五加、丹参、延胡索合并乙醇提取的工艺条件,固定提取时间为2小时,选择乙醇浓度、乙醇用量、提取次数为影响提取的主要因素,各取3个水平,进行L9(34)正交试验,重复操作三次,选择君药红景天中红景天苷的含量作为评价指标,采用高效液相色谱法(HPLC法)进行测定。最佳工艺条件为:加5倍量85%乙醇,回流提取3次,每次2小时;此外,确定了胶囊剂最佳成型的工艺条件。2.质量控制的研究:为控制复方红景天胶囊的生产质量,进行了有关复方红景天胶囊质量标准的研究,建立了本制剂质量标准与控制方法。采用薄层色谱法对处方药味红景天中的红景天苷、刺五加中的紫丁香苷、丹参中的丹参酮ⅡA、延胡索中的延胡索乙素进行了定性鉴别,色谱斑点清晰,重现性好,专属性强,空白无干扰;采用HPLC法测定了制剂中红景天苷、紫丁香苷、丹参酮IIA的含量。红景天苷标准曲线为Y =1233240.46X +21634.86,r = 0.9999(n=5),表明红景天苷在0.115～0.920μg范围内呈良好的线性关系,精密度RSD为0.19%,重复性RSD为1.20%,加样回收率为98.53%,RSD为1.08%;紫丁香苷标准曲线为Y =2581530.89X -12670.48,r = 0.9999(n=5),表明紫丁香苷在0.06432～0.51456μg范围内呈良好的线性关系,精密度RSD为0.82%,重复性RSD为0.78%,加样回收率为99.06%,RSD为0.74%;丹参酮IIA标准曲线为Y =5635543.97 X +2667.89,r = 0.9999(n=5),表明丹参酮IIA在0.06541～0.3270μg范围内呈良好的线性关系,精密度RSD为0.10%,重复性RSD为1.29%,加样回收率为99.09%,RSD为1.07%。3.初步稳定性研究:按照新药稳定性研究的技术要求和本制剂的质量标准,采用室温存放的方式,即室温条件下,放置三个月,观察3批样品,结果制剂稳定。第三部分总结与讨论论文所建立的制剂工艺合理、稳定、可行;所建立的质量标准与控制方法,能从定性到定量多指标多方位有效地控制制剂质量。更多还原

【Abstract】 Compound Prescription Hong-Jing-Tian capsule consists of five medicines which are Radix Et Rhizoma Rhodiolae Crenulatae, Radix Et RhizomaSeu Caulis Acanthopanacis Senticosi, Radix Et Rhizoma Salviae Miltiorrhizae, Rhizoma Corydalis and Extractum Ginkgo Siccus. It has the benefit of supplementing Qi and activating blood circulation, removing obstruction in the channels to relieve pain. The indications include the obstruction of Qi in the chest, deficiency of Qi and blood stasis with symptoms of chest tightness, sharp or dull pain, heart palpitation, insomnia, lack of vitality and exertion.Shortness of breath and lazy to talk. Physical & Lab examinations revealed coronary heart disease or angina pectoris.This thesis includes three parts:Part one: Literatures and summarizationsDocuments about the present research situation in treatment of Coronary heart disease angina pectoris with traditional Chinese medicine which are studied as a whole and the research progresses in the chemical constituents and pharmacological activities of medicines which belong to Compound Prescription Hong-Jing-Tian capsule, 137 references are cited.Part two:1. Investigation of manufacture procedure: Optimizingthe ethanol-extracting procedure for Radix Et Rhizoma Rhodiolae Crenulatae combined with Radix Et RhizomaSeu Caulis Acanthopanacis Senticosi, Radix Et Rhizoma Salviae Miltiorrhizae, Rhizoma Corydalis. The optimum technology of extraction was studied by orthogonal test. Fix the extraction time with 2 hours, the factors of the orthogonal testable L9(34) were ethanolconcentration (A), extracting degrees(B), the ratio of material to liquid(C). The content of salidroside was determined by HPLC. The optimum parameters were: A3B2C2. It was 85%ethanol of 5-times volume, extracting for three times and 2 hour for each. The optimum technology of capsule forming had been studied.2. Investigation of quality control: Inorder to control the quality of Compound Prescription Hong-Jing-Tian capsule, we had investigated the quality standard for Compound Prescription Hong-Jing-Tian capsule. Salidroside in Radix et Rhizoma Rhodiolae Crenulatae,isofraxidin in Radix et RhizomaSeu Caulis Acanthopanacis Senticosi,tanshinoneⅡA in Radix Et Rhizoma Salviae Miltiorrhizae and tetrahydropalmatine in Rhizoma Corydalis were qualitatively identified by TLC. The concentration of salidroside, syringin and tanshinoneⅡA was qualitatively analyzed by HPLC.The linear range of salidroside is from 0.115 to 0.920μg, the correlation cosfficients is 0.9999. The average recoveries are 98.53% (RSD 1.08%, n=5). The linear range of syringin is from 0.06432 to 0.51456μg, the correlation cosfficients is 0.9999. The average recoveries are 99.06% (RSD 0.74%, n=5). The linear range of tanshinoneⅡA is from 0.06541 to 0.3270μg, the correlation cosfficients is 0.9999. The average recoveries are 99.09% (RSD 1.07%, n=5).3. Investigation of stability: The stability of the cream was investigated by sample-keeping observation method. It could maintain stable in room temperature for 3 months.Part three: Analysis and discussion of experiments.The established manufacture procedure of Compound Prescription Hong-Jing-Tian capsule is reasonable and feasible. The established quality standard and control methods can control the quality of preparation effectively in many sides.更多还原