Several Kinds Of Traditional Chinese Medicine Quality Standards

The objective of this paper is to study the quality control formula of Weikangling capsule, Tongbianling capsule and Pudilanxiaoyan tablet. Through these studies, we established three scientific,reasonable and feasible quality control formula of traditional Chinese medicine. Now the following is the content of research on every compound preparation.The study on Weikangling capsule: 1. The general study situation of Weikangling capsule and raw materials were summarized; 2.The improvement of preparation technique of Weikangling capsule was studied; 3. The quality criterion of Weikangling capsule was established. Radix Paeoniae Alba, Radix Glycyrrizae, Radix Notoginseng and Poria in Weikangling capsule were identified by TLC with clear and reproducible spots. Determination of the amount of Paeoniflorin and glycyrrhetinic acid in Weikangling capsule was done by HPLC. They had good linearity within the range of 24μg～120μg/ml (r=0.99999) and 27μg～135μg/ml ( r=0.9996 ) respectively. The average recoveries were 99.07%(RSD=1.17%) and 98.11% (RSD=0.81%) separately; 4.The quality criterion of raw materials was established. Based on China Pharmacopoeia , we revised the initial quality criterion of partial raw materials and established the new quality criterion of other raw materials in the study; 5.The stability test of Weikangling capsule was carried out.The study on Tongbianling capsule: l.The general study situation of Tongbianling capsule and raw materials were summarized; 2. The quality criterion of Tongbianling capsule was established. Folium Sennae and Radix Angelicae Sinensis in Tongbianling capsule were identified by TLC with clear and reproducible spots. The total anthraquinones and anthrones in Tongbianling capsule were determined with spectrophotometer. TLC and spectrophotometry provided qualitative and quantitative basis for Tongbianling capsule; 3.The quality criterion of raw materials was established. Based on China Pharmacopoeia , we revised the initial quality criterion of raw materials and established the new quality criterion of other raw materials in the study; 5.The stability test of Tongbianling capsule was carried out.The study on Pudilanxiaoyan tablet: l.The general study situation of Pudilanxiaoyan tablet and raw materials were summarized; 2.The quality criterion of Pudilanxiaoyan tablet was established. Radix Scutellarlae and Herba Corydalis Bungeanae in Pudilanxiaoyan tablet were identified by TLC with clear and reproducible spots. Determination of the amount of Baicalin in Pudilanxiaoyan tablet was done by HPLC. It had good linearity within the range of 17μg～85μg/ml(r=0.99999).. The average recovery was 98.77%(RSD=1.73%); 3.The stability test of Pudilanxiaoyan tablet was carried out.