Nephritis Four Capsule Preparation Technology And Quality Standards Research

This research focused on formulation improvements from Shenyansiwei Tablet (Standard Number:WS3-B-2345-97) to Shenyansiwei Capsule, clarified the production parameters and developed an improved standard. Shenyansiwei Capsule is manufactured from Astragalus root, Lespedeza aerial parts, Pyrrosia davidii aerial parts and Chinese skullcap root. Comparing to Shenyansiwei Tablet, capsules can cover the bitter taste and bad smell, make the drug look nice and easy to be taken. Shenyansiwei Capsule has a good bioavailability, it has been made without pressure, so can be dissolved rapidly in the stomach, and be absorbed well. Capsules can effectively prevent drug deliquescence, and avoid instability of the drug quality. In addition, Shenyansiwei Capsule can reduce the influence of light, air and water on the drug to protect the drug quality, and have other advantages, such as it is convenient to be carried, transported and taken.Shenyansiwei Capsule production research included extracting water amount research, the concentrated density research and preparation research. We confirmed that the water amount used to extract the three herbs including Astragalus root is A times; the concentrated density of the three herbs including Astragalus root before alcohol precipitation is Bg/cm3,let it sit for D hrs at C℃; the skullcap root production technology is using E times water to soak in a moderate temperature. Preparation technics research included materials selection and formulation research. The final method is adding dextrin which is F%amount of dry extract, and adding H%PVP which is G%amount of the dry extract, drying, granule sorting, embeding into capsules.The quality standards research on Shenyansiwei Capsule established the qualitative and quantitative analysis methods to determine each raw material. We used TLC methods to identify Astragalus root and Chinese Skullcap root and established a HPLC method to determine baicalin content. Comparing to the Shenyansiwei Tablet national standard, we added TLC and HPLC methods to control the quality. The results showed that the established methods are highly specific, good repeatability and negative control without interference. And three batches of samples had good test results in line with specifications.Used the stability test in room temperature, and tested Shenyansiwei Capsule in accordance with quality standards, and results showed:the characteristics, identifications, examinations and content determination were conformed with the specifications. It indicated that the product can keep a basic stable in2years in room temperature.Giving a comprehensive evaluations on safety, efficacy, quality control and other aspects on Shenyansiwei Capsule, we can conclude that the production process for Shenyansiwei Capsule is reasonable, and quality standards is practicable.