Research In The Quality Control Of Compound Preparations Of Traditional Chinese And Western Medicine Anchuan Capsule

With the development of the combination between Chinese and western medicine, many new patents of Chinese and western combined have appeared. This is the objective requirement for clinical treatment, and also the inevitable trend of medical development. Compound preparations of traditional Chinese and western medicine is a special preparation of Chinese patent medicines. The theraputical effects are taken by the combined action of Chinese herbal and chemical composition. This preparation has large content differences between the constituents of Chinese and western medicine, coupled with diversity and complexity of Chinese composition. All those have brought great difficulties to the quality control.Anchuan capsule is made from Eupatorii, Semen hyoseyami, Oleum viticis negundo , Periostracum cicada and Clenbuterol and Chlorphenamine, which can be used in treating asthma desease. Problems directed easily abosorbing humidity, low content of active ingredients of Chinese medicine, and bad uniformity, the paper optimized the craft and developed Anchuan capsule. A systematic and comprehensive study on the quality control of Anchuan capsule was carried out.The main contents were as follows:1. Optimize the preparation craft of Anchuan tablet. Establish and optimize the craft and condition of extraction, purification and drying up; Research the quality control standard of the intermediate; Optimize the mixed method of Chinese medicine and chemistry drugs. At last, the new preparation craft of Anchuan capsules is confirmed.2. To research the quality standard of raw materials. Establish the determination of the scopolamine and atropine in Semen hyoseyami by HPLC; Simultaneously determine the three flavonoids hyperoside, quercetin and kaempferol in Eupatorii by HPLC, which can be used in comprehensive quality control; Develop a TLC method of Oleum Viticis Negundo and GC was used to determinate its purity; Establish a method for quality assessment of cicada.3. Establish the quality standard of Anchuan capsules. TLC was used to identify the herba Eupatorii, Semen hyoseyami, Periostracum cicada and Chlorphenamine and HPLC also was used to analysize the content of quercetin and kaempferol in Anchuan capsule; Develop a method for determining the content and uniformity of two chemical medicines, and a content limit of Chlorphenamine was made. All above methods are sensitive, reproducible, exclusive and accurate. 4. Establishment of the fingerprints of Anchuan capsule. The HPLC fingerprints of Anchuan capsule,intermediate and material are established under two UV waves and the similarity assessment is carried out; Study the relevance of fingerprint among medicine materials, intermediates and products and establish the fingerprint quality control system through raw medicinal material by intermediate to products, which can be used in evaluating the react upon Chinese medicine and chemical drugs; Develop the method for determining the lot-to-lot consistency of Anchuan capsules. This proposed multiple HPLC fingerprinting is of significant use in evaluating samples from abnormal production process and the lot-to-lot consistency of Anchuan capsules, so that it is sure that process stable and quality reliable.5. Study on the stability test. The stability of Anchuan capsules was studied at 40℃,RH70%±5% for three months. The results indicated that the factors of characteristics, identification test, content determination and hygienics check remained unchanged. It showed that the quality of Anchuan capsules was stable.