Preparation And Identification Of Wuweiwentong Chubi Capsule

Objective: Prescription composition of Wuweiwentong Chubi Capsule are as follows: Cassia twig, Rhizoma Wenyujin Concisum, Radix Scutellariae, Epimedium and Poria cocos.The function is warming yang and invigorate pulse,relieving cold and relieving pain. It is mainly used for the treatment of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis.This article has made an experimental study on extraction process, drying process and optimization of molding process. To determine the best preparation technology of Wuweiwentong Chubi Capsule.Through the thin layer identification, content determination and stability investigation, further improve the quality control methods of Wuweiwentong Chubi Capsule, to ensure the quality of the preparation.Methods:1. Using L9(34) orthogonal test method, the volume and extraction rate of volatile oil were selected as evaluation indexes, and the three factors of soaking time, distillation time and water addition were investigated. The optimum extraction process of volatile oil was optimized.2. Using L9(34) orthogonal table arranged the test scheme and icariin extraction rate, extraction rate as the evaluation index of comprehensive evaluation, the effect of main factors with the amount of water, extraction time, extraction times,to optimum water extraction process.3. Study of microwave drying and vacuum low temperature drying two drying methods from the dry extract characters and yield of extract, moisture absorption property, icariin, baicalin content, and to choose the best drying method.4. The three kinds of materials such as dextrin, starch and lactose were studied from the aspects of the characters, the forming rate and the moisture absorption property of the particles. Using L9(34) orthogonal test method, investigating the proportion of powdered extract and excipients,ethanol concentration and drying temperature,moisture absorption and fluidity as the evaluation index, omprehensive evaluation, to optimize the shaping process.5. Using TLC to identify qualitatively in Ramulus Cinnamomi, turmeric, tuckahoe, epimedium, Radix Scutellariae; Using UPLC method for the simultaneous determination of the content of icariin, baicalin and cinnamic aldehyde.6. According to the contents of the capsule in the 2010 edition of Chinese Pharmacopoeia, the moisture content, disintegration time limit, loading capacity and microbial limit of three batches of samples were examined, and the stability was studied.Results:1. The best volatile oil extraction technology was as follows: immersing 1h, adding 8 times volume of water and distilling 10 h.2. The optimal water extraction technology was as follows:adding 10 times volume of water and extracting 3 times with 1 h for each time.3.The best drying method is microwave drying.4.The best excipients is cornstarch,and the best granulation process was as follows: the proportion of powdered extract and excipients is 1:1, ethanol concentration is 80%,and the drying temperature is 70?.5. TLC chromatographic spots were clear,the method was simple,accurate,without interference and easy to be recognized.And establish the method of simultaneous determination of icariin, baicalin and cinnamic aldehyde by UPLC method.The method was sufficiently simple,sensitive,specificity and reproducible.6. All the tests were in accordance with the requirements of the "Chinese Pharmacopoeia" 2010 Edition capsules, the stability of the test, the three batch of samples were no significant differences in the results.Conclusion: The preparation process of Wuweiwentong Chubi Capsule is stable and reliable; quality control method is simple, accurate and stable, operability, used to control the quality of this preparation; stability study showed that, the stability of three batches of samples.