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The compound silymarin Pill preparation process and quality standards

Author: ZhengWeiRan
Tutor: WuLiJun
School: Shenyang Pharmaceutical University
Course: Natural Medicinal Chemistry
Keywords: Silymarin The Schisandra alcohol mentioning cream Solid dispersion Dropping Pills
CLC: TQ461
Type: Master's thesis
Year: 2006
Downloads: 47
Quote: 0
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Abstract


Compound Yiganling film is developed on the basis of the unilateral Yiganling piece from pure Chinese medicine, its main ingredient is milk thistle extract and Schisandra extract complementary to the role of the two extracts, which played a stabilize liver cell membrane, enhanced the hepatocyte microsomal enzymes, rapid and lasting decrease transaminase, an overall improvement in the role of liver function, significant clinical effect of the preparation, by the majority of pharmaceutical industry colleagues praise and trust of patients and favor. But the film's view of the compound silymarin silymarin (milk thistle extract one of the active ingredients) can not easily be absorbed by the body, the lower its bioavailability. In order to improve its bioavailability, we will be made into formulations bioavailability - Compound Yiganling Pill, to improve its absorption in the human body. Dripping pills in recent years, there is a greater development of new solid dosage forms, has a quick release, bioavailability advantages, and the production process is simple, process, short period. However, the current development of Chinese medicine water-soluble compound drop pills by the matrix and the limitations of the cooling agent, less variety, for which we study their craft, carrier, and quality standards. First, the orthogonal experiment investigated the impact of different conditions on milk thistle extract as an indicator of total flavonoids thus preferable extract, the purification process, clear its optimum extraction conditions, also examines the different spray drying The conditions Schisandra extract content schizandrol provide a scientific basis for the industrial production. This paper examines the impact of the different carriers the compound silymarin Pill dissolution, the final selection of PEG6000 as carrier material, demonstrated through IR scanning experiments drugs exist in an amorphous form of dispersion effects of different proportions of drug and carrier dissolution. 9 (3 4 ) orthogonal design test filter out the best formula was based on the study of solid dispersion, the application of L . Research of quality standards, using thin-layer chromatography the Qualitative Identification the compound silymarin Pill index components, the method to reproduce a good, strong specificity, chromatographic spots were clear, separation, can be used as preparation The main basis of the identification of the index components; HPLC method was adopted compound silymarin Pill, indicators ingredient content of the studies, the best chromatographic conditions, silymarin index components Silybum index components silibinin and Schisandra of schizandrol able to obtain good peaks, and this method is good reproducibility, high recovery, precision and good, and has laid a good foundation for the accurate determination of the indicators of the ingredients in the compound silymarin Pill. Commercial ordinary film-coated tablets for the control, in vitro dissolution experimental results show that the compound Yiganling Pill: at the same time, the release of the silibinin significantly higher than film-coated tablets release of silibinin degrees, indicating that the the Diwan bioavailability higher than the original tablet. The subject of study for the development and industrial production of the compound Yiganling Pill has laid a good foundation, especially the determination of the new technology, the establishment of quality standards as well as the investigation of the dissolution, to improve the efficacy of the compound Yiganling improve biological provide a scientific basis for utilization has practical significance and application value.

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CLC: > Industrial Technology > Chemical Industry > Pharmaceutical chemical industry > The Chinese herbal medicine preparations of the production
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