Study On Production Process & Quality Standard Protocol Of Zhepujiuweirunzao Granule

Zhepujiuweirunzao Granule with the main effect enriching blood, eliminating blood stasis, relieving dryness and promoting purgation was used to treat pertinacious aged constipation, which had been from proved recipe with 20-year clinical test of the First Hospital of Lanzhou University. Based on the extraction process, it was the intention to investigate the preparation process, and to build quality standard protocol and quality-controlling methods of production intermediates.Secondly, the spray-drying extraction powder was mixed with different adjuvant as different proportion by high-speed stirring device to granulate.It was the result that extractive powder with 2 folds mixture adjuvant of disosaccaride and starch in proportion as 3:2 was mixed and wetted with 10% MPC-L 80% ethyl alcohol solution. The granulation process was smoothly, and the granules were uniform with low moisture and suitable sweetness.Thirdly, Angelica, rhubarb, safflower and fructus cannabis as the main components in Zhepujiuweirunzao granule were individually identified via thin layer chromatography. Emodin in the drug was extracted via liquid-liquid continuous biphasic extraction, to determine its content by HPLC. The chromatographic condition of HPLC wasindividually Hypersil-OBS C18(200mmx4.6mm, 5//m), methanol-0.1% phosphoric acid(17:3) as mobile phase, 254nm detection wavelength, and l.OmL.min"1 flow rate with external standard ration method used. Emodin concentration presented a good linear range of 17.29~242.06//g.mL"1 (r=0.9999), the average recovery was 99.7%, RSD=1.6%. The chromatographic condition of HPLC for determining the content of ferulic acid in it was individually Hypersil-OBS Ci8(200mmx4.6mm, S^m) , methanol-1% acetic acid (2:3) as mobile phase, 313nm detection wavelength, and l.OmL.min"1 flow rate with external standard ration method used. Ferulic acid concentration presented a good linear range of 17.40~62.40//g.mL'1 (r=0.9995), the average recovery was 99.8%, RSD=1.33%.Finely, to evaluate the determination of Angelica volatile oil in G-CD inclusion compound via liquid-liquid continuous diphase extraction. To compare the assay of Angelica volatile oil in 6-CD inclusion compound via liquid-liquid continuous biphase extraction device designed by oneself with the one via wet distillation method, the assay data was analyzed by paired—samples T test. The content of Angelica volatile oil in 6-CD inclusion compound via liquid-liquid continuous diphase extraction was 13.61%, RSD=2.09%. The one via wet distillation method was 10.11%, RSD=4.97%. Because of P=0.00