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Study on Mediament Technology and Quality and Quantiity Standard of Ganlening Capsule

Author: LiuJunKai
Tutor: AnLianYing
School: Chengdu University of Technology
Course: Analytical Chemistry
Keywords: Ganlening capsule preparation quality standard
CLC: TQ461
Type: Master's thesis
Year: 2007
Downloads: 88
Quote: 0
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Abstract


Ganlening capsule is based on the Chengdu University of Traditional Chinese Medicine Professor Zhang for the clinical experience to develop into a modern Chinese proprietary, including Curcuma Louga L., Artemisia capillariea Thunb. and Atractylodes macrocephala koiz, mainly for the treatment of high incidence of fatty liver crowd. In this study, prescription drugs and the chemical constituents of nature and based on the pharmacological effects, the capsule Ganlening Preparation and major quality-control, identified Ganlening capsules preparation line, and the main technology index components, optimized conditions of preparation, which included refluxing extraction, water decocting extraction, purification, steam distillation, packing procedure, condensing and drying process, granulation by the numbers, study for the development of the exact efficacy of the treatment of fatty liver medicine six new drugs lay the groundwork study。Guided by the content of curcumin and paste rate, screening tests, identified Curcuma Louga L. the extraction and purification technology line. Curcuma Louga L. curcumin optimize the extraction conditions is 60 % ethanol, 80℃,15 times of materials, time of extraction is an hour, single extraction, curcumin extraction to1.119mg/g pharmacognostic. Using resin purification Curcuma Louga L. extract liquor, guided by the content of curcumin and paste rate, find that resin S-8 is better. The optimal conditions for the resin purification: the pH of liquid is 6, velocity of flow is 2 BV/h and at room temperature, adsorption rate is 97.12%. Resin analytic process conditions: pH=6, 80 % ethanol solution eluant, control flow rate of 3 BV/h, extrication rate is 95.55 %. Under these conditions, column purification process of curcumin retention rate of over 90 %. the percentage of the extract reduced to 7.85 % from 2.47 %, the purity of product reached 4.48 %. Dry extract purified curcumin content from 1.42% up to 4.48%.Guided by 6,7-dimethoxycoumarin(DEM), volatile oil content and the rate of dry extract, the optimum conditions of steam distillation extraction volatile oil from Artemisia capillariea Thunb. and Atractylodes macrocephala koiz is: 12 times water, soak for 12 hours distillation every six hours, on average for the extraction of volatile oil is 0.79 ml/250 g pharmacognostic; through the use of 75 % ethanol edulcoration the distillation of the water decoction, dry extract to reduce the rate from 15.7 % to 2.1%. The proportion of volatile oil andβ-cyclodextrin was 1:10, the proportion ofβ-cyclodextrin and water was 1:10, inclusion time was 2.5 h, inclusion rate was 81.6%.Concentrated in the drying process, using low-temperature rotary vacuum evaporator to concentrate purified extract of Curcuma Louga L. and purification of Artemisia capillariea Thunb. and Atractylodes macrocephala koiz decoction, DEM content and the content of curcumin loss rate of 3.7 % and 5.5 %, using freeze-drying dessicate DEM and curcumin content and the loss rate of 1.4 % and 3.7 %.In molding process optimization of the main conditions: extract soluble starch powder and the ratio of 8:2, 95 % ethanol concentration of wetting, dosage of the extract powder 40 ml/100 g creat extract. Forming particles passing rate of not less than 80%.In the optimum preparation, the transfer rate of curcumin, DEM and volatile oil reached 81.8 %, 78.6 %, 72.5 %, respectively, and RSD≤3.56 % (n=3) in their reduplicate experiments.Pharmacopoeia reference to experimental medicines and the capsule system of TLC and HPLC, dual wavelength determination, In Curcuma Louga L., Artemisia capillariea Thunb. and Atractylodes macrocephala koiz ingredients of TLC, medicines for the control sample and the corresponding position is the same color spots, and the color clear, no negative interference; use dual-wavelength scanning method to detect the effects of curcumin and DEM content, the curcumin and DEM content in the granuleis 1.846 mg/g granule, 7.944 mg/g granule.

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