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The Study on Extraction, Preparation and Quality Control of Yinxie Tablets

Author: YangXiaoYu
Tutor: JiaoHaiSheng
School: Lanzhou University
Course: Pharmacy
Keywords: Yinxie tablets Extraction process Preparation process Effervescent granules Dispersible tablets Quality standards colchicines ethosomes soybean phospholipids hydrogenated phosphatidylcholines alcohol isopropyl alcohol
CLC: R286
Type: Master's thesis
Year: 2011
Downloads: 168
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Abstract

Objective:To optimize the extraction and preparation process of Yinxie tablets,formulate the appropriate quality standards of intermediates and preparations, and provide a reliable experimental basis for the subsequent research and industrialization.Methods:(1) The extraction process was optimized by the orthogonal design, using the metastasis rate of the main target components and dry extract as indexes:the volatile oil was obtained from Angelica sinensis and Fineleaf Schizonepeta Herb by steam distillation; Moutan cortex were directly crushed into 1 ittle particles; the others were extracted based on the traditional decoction method.(2) Using single factor experiments and orthogonal design experiments, with the effervescent time or disintegration time as the indexes, to confirm the optimal prescription composition and preparation process, PEG6000 was used at first to encrust NaHCO3, and effervescent granules and dispersible tablets were preparated by wet granulation. All prescription dry extract of Yinxie tablets was used to preparated effervescent granules; the monarch, minister dry extract was used to preparated effervescent granules and dispersible tablets. (3)TLC was established to identify catalpol and astragalosideⅣ, and gradient elution HPLC was developed to determine the content of geniposide, paeonol and ferulic acid.Results:(1) The optimum extraction conditions were as follows:Angelica sinensis and Fineleaf Schizonepeta Herb powders were sieved through 50 meshes and then mixed, the volatile oil was extracted by the method of heating and refluxing for 5h. Except Moutan cortex, the others were extracted based on the traditional decoction method, with the solid-liquid ratio of 1:6,for 3 times, and extraction once for 1h.The extracting solution was mixed and concentrated to its initial density of 1.15+0.02 g/ml (50℃) at 70℃. The concentrate was stirred by the speed of 700 r/min while 95% alcohol was being added into it until its alcoholic concentration is 60%.Then the alcoholic solution was precipitated in a refrigerator for 16h. After the refrigerated, precipitated solution was filtered,the alcohol in it colud be reclaimed, and the final solution was continuously concentrated for the dry extract at 70℃. (2) The optimum conditions of Yinxie effervescent granules preparation process were as follows:using single factor experiments and orthogonal design experiments, with the effervescent time as the main index, to confirm optimal prescription composition and preparation process, and the best proportion could be screened out including 9% sodium bicarbonate,11% citric acid, and 6.4% polyethylene glycol to wrap up the sodium bicarbonate. By wet granulation using 10% PVP ethanol solution, wet granules were sprayed by the volatile oil anhydrous alcohol solution, and keeped airtight for 30 minutes, The critical relative humidity of granules was determined to be less than 50%; The optimum preparation process conditions of Yinxie dispersible tablets were as follows:using single factor experiments and orthogonal design experiments, with disintegration time as the main index, to confirm optimal prescription composition and preparation process, and the best proportion could be screened out including 50% dry extract,23% Moutan cortex powders,14% MCC and 12% PVPP. By wet granulation using 90% ethanol solution, wet granules were sprayed by the volatile oil anhydrous alcohol solution, and. Finally the wet granules were mixed by 1% magnesium stearate, and pressed for tablets. (3) In the dry extract from all Yinxie prescription decoction pieces, the content of geniposide was 11.532mg/g, paeonol was 3.437mg/g and ferulic acid was 0.107mg/g,determined by HPLC gradient elution; In the dry extract from the monarch, and minister decoction pieces, the content of geniposide was 18.912mg/g, paeonol was 5.810mg/g and ferulic acid was 0.177mg/g, determined by gradient elution HPLC as well.Conclusion:The best extraction and preparation of Yinxie tables is suitable for its subsequent industrialization development, and the quality standard draft is reasonable and practicable for the quality control. OBJECTIVE:To compare the difference of characteristics of colchicines ethosomes that made by soybean phospholipids or hydrogenated phosphatidylcholines.METHODS:Colchicines ethosomes were prepared by injection method.the best prescription were screened out by an orthogonal design test. To compare the influence of soybean phospholipids and hydrogenated phosphatidylcholines at morphology,entrapment efficiency,stability. respectively.The difference of transdermal penetration rate were also studied.RESULTS:The ethosomes with spherical or ellipsoidal shape, the particle size of colchicines ethosomes made by soybean phospholipids were 100nm with a narrow range of size distribution.the entrapment efficiency were 58%; the particle size of colchicines ethosomes made by hydrogenated phosphatidylcholines were 50nm with a wide range of size distribution, the entrapment efficiency were 63%;No obvious changes were found in all the indices in the stability test of the ethosomes made by hydrogenated phosphatidylcholines, Better than the ethosomes made by soybean phospholipids. so did in the transdermal penetration test.CONCLUSIONS:By primary study, colchicines ethosomes made by hydrogenated phosphatidylcholines is better than colchicines ethosomes made by soybean phospholipids at entrapment efficiency,stability,transdermal penetration test.

The Study on Extraction, Preparation and Quality Control of Yinxie Tablets

Abstract

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