Study On Preparation Process And Quality Standards Of Gouqi Granules

Objective: To study the literatures of Gouqi granules，preparation process andquality standards, according to the relevant provisions of “Measures for the Administrationof Drug Registration” and the technical guidelines on the study of Chinese medicinenatural medicines, and modern pharmacetic techniques are also applied into thisresearch.Due to the different physicochemical properties of effective ingredients, optimumselection is adopted and a safe, effective, stable, controllable, easy to carry the moderntraditional Chinese medicine preparations were developed.Methods:1. To study the achievement of the chemical composition of lycium grain,extract process and the pharmacological by the methods of Literature search Summary.2. The Study on Preparation process: Use of alcohol extraction and water extractionprocess of the application of industrial production to different polarity of medicinalingredients, selection of optimum by orthogonal design.3. To established the TLC identification of Cycii Fructus、Ligustri Lucidi Fructus、Astragali Radix、Ginseng Radix Rhizoma Rubra、Asinine Corii Colla、Crataegi Fructus.4. Completed the Preliminary investigation of lycium grain, investigated the quality ofmedicines on theunder of plastic composite membrane packaging materials.Results:1.Select the evaluation of astragaloside and dry extract yield,optimizedextraction conditions of Ligustri Lucidi Fructus、Astragali Radix、Ginseng Radix RhizomaRubra by Orthogonal design. Plus six times the amount of60%ethanol extrsct, the firstthree hours,the second is two hours, Optimized for2times to6times the amount of waterevery two hours. The extract obtained liquid was concentrated to the relative density of1.08to1.10(60℃), spray drying, granulation by the evaluation of astragaloside and dryextract yield. Try the system in three batches of samples investigated, Confirmed by the preparation process is safe, reliable, and good reproducibility.2. Toestablished the TLC identification of Cycii Fructus、Ligustri Lucidi Fructus、Astragali Radix、Ginseng Radix Rhizoma Rubra、Asinine Corii Colla、Crataegi Fructus.Theresults show that test products for chromatography with the same color spotscorresponding to the location of the herbs and standard control chromatography，andnegative control solution chromatogram corresponding spots in the corresponding position,the experiments confirmed that this method is simple, sensitive, specific, and thereproducibility is very good, can be used for the identification of Chinese herbalmedicines in this preparation.3. Datermination of the Astragaloside the content by HPLC method.4. Made a preliminary stability test to the product, The results show that this product isstable quality, packaging and plastic composite membrane without an adverse impact onthe quality and stability of the product.Conclusion:By the study of technology research, quality standards, stability testingof lycium grain, show that the process is reasonable and feasible quality standards, stabilityof the prepared samples,quality control.