| The standardized research in quality of Chinese traditional medicine preparation is the essence to ensure the quality, it is also the only way to achieve modernization of Chinese traditional medicine. In the course of developing new drug, only by using advanced technique method, launching the study of quality standard systematic,comprehensively and objectively, can our knowledge be improved and developed during experiments. OBJECTIVE To establish an eligible qualitative and quantitative analysis system of Yili Zhitong Capsules for better quality control; to carry out an experiment on preliminary stability for making sure the validity of the product and carrying on the quantity evaluation. METHOD Uses the thin-layer chromatography to carry on the qualitative distinction of five medicinal materials in the preparation. Radix Veratri: a silica gel G plate was adopted with developing solvent consisted of Chloroform and methanol (15: 5), inspected at 365nm. Rhizoma Paridis: a silica gel G plate was adopted with developing solvent consisted of the lower layer of the mixture of Chloroform, methanol and water (15: 5: 1), an alcobolic solution of sulfuric acid(10%) was used as colouring agent, inspected at sunlight or at 365nm. Olibanum and Myrrha: a silica gel G plate was adopted with developing solvent consisted of cyclohexane and ethyl acetate (11:1), Vanillin sulfuric acid solution (5%) was used as colouring agent. Radix Psammosileis: a silica gel G plate was adopted with developing solvent consisted of Chloroform, ethyl acetate and methanol (8: 5: 1), an alcobolic solution of sulfuric acid(10%) was used as colouring agent. Taking veratroylzygadenine as the target, A reversed-phase high performance liquid chromatogrophy method was developed to determine Radix Veratri in the preparation. An Agilent ZORBAX SB-C18 column (4.6×250mm , 5μm) was used. The mobile phase was consisted of acetonitrile, acetic acid and water (20: 80: 0.3), detected at 215nm, the velocity of flow was 1.0ml·min-1, temperature of the column was 35 ℃. Carries on the quantitative analysis according to the external standard method by the peak area of veratric acid, which was the hydrolysate of veratroylzygadenine, while by coefficient 3.6082 to be converted into the content of veratroylzygadenine. Three batches of Radix Veratri and ten batches of Yili Zhitong Capsules were determined and limitations of contents were established. According to "Chinese Pharmacopoeia" (2000), requirements for capsules, limit tests for heavy Metals and Arsenic were examined. According to the quality standard (draft) and "Stability test requests for the new Chinese traditional medicine", inspect on preliminary stability of preparation was also carried out. RESULTS In the identification, the sample displayed the same spots or fluorescence spots as the reference substance did in the Chromatography, while the negative sample did not. In the assay, the linear ranges of Veratric acid was 0.0432~0.2592μg, linear regression equation was Y= 4863628.3X+ 3767.4,r=0.9999. The RSD of precision was 0.19%, of repeatability was 0.19%. The recovery was 98.4%. The sample solution was stable within 12 hours(RSD=0.61%). Veratroylzygadenine in Radix Veratri was no less than 0.07%, and in eachof Yili Zhitong Capsule was no less than 5mg. The examining result show that Water<9.0%, Uniformity of content<±10.0%, Disintegration<30min, Heavy Metals<5ppm and Arsenic <2ppm. Through inspection on preliminary stability of this product for 3 months, the character, identification, disintegration limit, content determination all are in accordance with the stipulations. There is no great change to detect the data and no other abnormal quality changes have been observed. CONCLUSION The TLC methods for identification and HPLC method for assay have been developed and validated. The methods are simple, rapid, specific, sensitive and accurate. The quality standard of Yili Zhitong Capsules was estalished firstly. The inspection results on preliminary stability of samples showed that thi...
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