Study On The Quality Standard Of Xiaoliu Capsule, Tongguan Teng And Xiao Bai

1、Xiaoliu Powder is a folk recipe consisting of twenty ingredients. It has been used to treat hysteromyoma and ovarian dropsy in Yunnan Province of China. The results of pharmacological tests showed that the aqueous extract of the recipe significantly inhibited the uterine proliferation induced by diethylstilbestrol. Therefore, we intended to develop a preparation for hysteromyoma, Xiaoliu Capsule, from the recipe.Deng and Shen had optimized the preparation process and the prescription of Xiaoliu Capsule, and established the quality control methods of the Xiaoliu Capsule. In this thesis, three batches of Xiaoliu Capsules were prepared with intermediates, then their qualities were evaluated by pharmaceutics exams, TLC methods and the contents of emodin, tanshinol and tenacissoside H.Besides, a six-month preliminary stability and an twelve-month long-term stability were also investigated. The results showed that the three batches of Xiaoliu Capsule were stable.2、Caulis Radix Folium Marsdeniae Tenacissima is the dried stem of Marsdneia tenacissima. This herbal medicine has been used as a remedy for cancer, pneumonia, trachitis, asthma, rheumatism, fracture and so on. It was recorded in Chinese Pharmacopoeia 1977.The moisture and total ash of 11 samples were determined according to the methods in Chinese Pharmacopoeia 2005. The contents of moisture and total ash were 4.129%～9.210% and 4.162%～6.983%, respectively. It is proposed to contain less than 10.0% of moisture and 8.0% of total ash calculated to the dried drug.We established a colorimetric method to determine the total C₂₁ steoidal glycosides of Marsdenia tenacissima for quality evaluation. Methanol was used as the extraction solvent and the samples were purified by macroporous resin D-101. Colorimetric method was used with tenacissoside H as the reference substance. A mixture of sulfuric acid-methanol （4:1） was used as color-producing reagent. The absorbance was measured at 325 nm. There was a good linearity （r = 0. 9998） within the range of 8.4～100.8μg. The average recovery of tenacissoside H was 98.87% with a RSD value of 2.20% （n=6）. The contents of total C₂₁ steoidal glycosides were 3.722%～7.407%. It is proposed to contain not less than 3.5% of C₂₁ steoidal glycosides calculated with reference to the dried drug.3、To establish a colorimetric method to determine the total saponins of Asparagus filicinus root for quality evaluation. Methanol was used as the extraction solvent and the samples were purified by macroporous resin ADS-7. Colorimetric method was used with aspafilioside B as the reference substance. A mixture of sulfuric acid-methanol （7:3） was used as color-producing reagent. The absorbance was measured at 320 nm. There was a good linearity （r = 0.9997） within the range of 10.6～127.2μg. The average recovery of aspafilioside B was 98.36% with a RSD value of 2.38%. The contents of total saponins were 5.946%～7.977%. It is proposed to contain not less than 6.0% of total saponins calculated with reference to the dried drug.Besides, the moisture, total ash and acid-insoluble ash were determined according to the methods in Chinese Pharmacopoeia 2005. And the contents of moisture, total ash and acid-insoluble ash were 6.285%～9.496%, 3.222%～4.387% and 0.110%～0.510%, respectively. It is proposed to contain less than 10.0% of moisture, 5.0% of total ash and 1.0% of acid-insoluble ash calculated to the dried drug.