Pharmaceutical Research Of Shujing Fangtong Capsule

Shujing Fangtong capsule is compound preparation,which is composed of 8 traditional Chinese medicines of Radix Paeoniae Alba, radix salviae miltiorrhizae, Radix Angelicae sinensis，Fructus aurantii,Takeba Shibako,licorice root, frankincense and myrrh,which comes from the old traditional Chinese medicine chief physician Yang Jialin’s addition and subtraction of prescription"four inverse scattered and Huoluo Xiaoling Dan", with sparsing and nourishing the liver, promoting blood circulation and relieving pain promoting qi and removing blood stasis effects, mainly used for the treatment of primary liver depression and blood stasis dysmenorrhea. In order to make the patients take medications expediently, this topic is under the guidance of the theories of traditional Chinese medicine, using the modern pharmaceutical technology to study on the preparation process,the quality standard and stability of Shujing Fangtong capsule, to ensure clinical application safely and effectively.1.Preparation technology research(1)Crushing process Radix Paeoniae Alba and radix salviae miltiorrhizae are placed to dry for 3 hour in 80℃ drying oven, cooling in desiccator.According to the proportion of prescriptions,1/3 Radix Paeoniae Alba and Salvia miltiorrhiza Bge were weighed to crush into fine powder, mixed evenly, setted aside.(2)Extraction process According to chemical properties and preliminary test results of main medicinal components of prescription drugs,orthogonal test method and multi-index comprehensive evaluation method were used to extract the process route:in Herba Bupleuri,2/3 Radix Paeoniae Alba, Radix Angelicae sinensis, licorice, citrus aurantium were extracted by water. The extraction content of paeoniflorin and ferulic acid and dry extract yield as the index of comprehensive evaluation,the method of orthogonal experiment is used to investigate three factors:amount of water, decocting time and times, so as to get the optimal water extraction process conditions of Radix Paeoniae Alba and Chinses Angelica:adding 15 times amount of water, extracting for 3 times, each time 1 hour.(3)Purification and concentration process According to the results of preliminary experiments,The liquid was filtered without purification and then concentrated directly.Paeoniflorin used as index to study the effects of water liquid before and after extraction in the change of atmospheric and vacuum concentration, the results show that the content index is relatively large in the atmospheric concentration, small changes of paeoniflorin in concentration vacuum, so the concentration vacuum was used.(4)Drying process The concentrate was pulled into Porcelain plate with mixed powders of 1/3 Radix Paeoniae Alba and Salvia miltiorrhiza Bge.placed to dry completely in 80℃ drying oven,the cried was collected to crush with frozen frankincense and myrrh together, sieved (80 ℃), mixed evenly, mixed powders gotten.(5)Forming process Selecting the optimum accessories category and dosage, at the same time studying the wetting agent,drying time and hygroscopicity, critical relative humidity of product particles.The molding process was:the mixed powder were not added accessories, added wetting agents 95% ethanol granulation directly to Granulating, dried for 1 hour,sorted, mixed evenly, and blended in capsules.2. study on the quality standard and stabilityTo establish TLC methods for the identification of Radix Paeoniae Alba, Radix Angelicae sinensis, frankincense and myrrh, and establish the content determination method of paeoniflorin and tanshinone ⅡA. According to the determination results of samples, making the content limit, make this product every capsule containing of Radix Paeoniae Alba to paeoniflorin, shall not be less than 1.90 mg;Salvia miltiorrhiza Bge to hydroxy-tanshinone ⅡA shall not be less than 0.12 mg.According to the results of stability investigation, this product in the observation, placed at room temperature within 12 months of the indicators are in line with the requirements, the stability is good, the product is valid for 12 months.