Study Of Preparation And Quality Standard Of Chuanpu Capsules

Chuanpu capsule was made from chuanxiong rhizome, baikal skullcap root, Fritillaria thunbergii, batryticated silkworm, raw oysters and other 7 Chinese medicines. The decoction of prescription has been using clinically for more than 10 years to treat the symptoms of nasal obstruction, snoring, breath, runny nose, hearing loss and memory decline caused by adenoids hyperplasia. Because of the complex compound of the prescription, the establishment of quality standards for Chinese medicine was significant. Traditional decoction, which had a complex process, was not easy to be accepted by children. Based on the analysis of the prescription we changed the formulation into capsule, which was easily produced, stored and used.Different types of medicine were divided into three types of extraction and preparation process. The powdering rate of batryticated silkworm and Fritillaria thunbergii, which was cleaned and smashed into pharmacy, was used as the test indicator. The extraction of other medcine was optimized by orthogonal test. Among these, chuanxiong and other five medicines were extracted by alcohol, huangqin and other medicines were extracted by water decoction. Finally, we decided the best extraction process of chuanxiong and other medcine as follows: six times 75% alcohol reflux extracted twice, each lasts two hours. The best extraction process of huangqin and other medcine were extracted twice, using ten times water, and each lasts 1.5 hours.The main medicine and stuff used in this paper were identified. Through the standards and regulations of harmacopoeia, we examined Fritillaria thunbergii, batryticated silkworm, chuanxiong, baicalin's TLC, water rate, extraction, ash rate fully to assure the medcine quality. At the same time, we apply the TLC result of negative non- interferenced Fritillaria thunbergii, chuanxiong and baikal skullcap root as the indicators for quality control. We also determine the main content of baicalin through HPLC, and made it as the indicator for chuanpu capsule quality control.ICR mice orally acute toxicity experiments showed that the maximum dosage of chuanpu capsule was 40g per kg and it was a non-toxic level of drug. This capsule was fit for children.