| Geriatric constipation is a kind of disease that happen on old people easily,choosing to contain anthraquinone kind of traditional Chinese medicine is a strategy,but it has various side effects such as larger,liver toxicity,renal toxicity,enterotoxicity and carcinogenicity,even to aggravating constipation symptoms.Astragalus membranaceus laxative compound tablets consists of Astragalus membranaceus,Hemp kernels,Angelica sinensis,and Dried tangerine could have effect on constipation.It is extracted and refined by modern technology and prepared with appropriate excipients.It possessed the functions of moistening dryness for relaxing bowels,invigorating spleen,replenishing qi,replenishing blood,replenishing blood and so on.It has been used for qi deficiency,loss of spleen and stomach taht caused by gastrointestinal motility and constipation.Objective:To study the water extraction and refining process,drying process and preparation molding process of Astragalus membranaceus laxative compound tablets,and to study its quality control,developed a product for the treatment of senile constipation.Methods:?1?Astragalus membranaceus as the sovereign drug of this prescription,the single factor level was determined by the comprehensive score of transfer rate and extract yield of Astragaloside IV,the index component.The box-behnken response surface method was used to optimize the water extraction process parameters of Astragalus membranaceus laxative compound tablets.In order to reduce the solid content,increase the drug load,and achieve the purpose of reducing the dosage of tablets,orthogonal test design was used to optimize the optimal alcohol precipitation process parameters.?2?Single factor method was used to study the effect of different excipients on the adhesion of Astragalus membranaceus compound extract.The"OD value"of the overall evaluation of powder yield and water content of spray drying was used as the evaluation index,and the key process parameters were screened and predicted by Plackeet-Burmann factor screening test design?PBD?and Central-Composite center Composite test design?CCD?,and finally verified.?3?Single factor test was conducted to screen the types and doses of common excipients with the following factor,such as particle yield,water content,appearance and disintegration time as the index parameters,and to determine the preparation process parameters of Astragalus membranaceus laxative compound tablets.?4?According to the ChP in 2015,the quality control study of Astragalus membranaceus laxative compound tablets was studied to establish the content determination method of Astragaloside IV in Astragalus membranaceus laxative compound tablets,and to establish the identification method of Hemp kernels,Angelica sinensis and Dried tangerine.?5?Refer to Technical Standard for Health Food Inspection and Evaluation,2003,the pharmacological experiment of Astragalus membranaceus laxative compound tablets proved that it has the function of relieving bowels.Results:?1?The best extraction,refining process for extractions 3 times with 10 folds the amount of water,80 minutes for each time,and consolidation solution,the extracts were combined and concentrated to 1.1g·mL-1?60??with the concentration of alcohol precipitation70%,and kept in cold storage for 12h,sharply lower solid content,easy to forming the preparation technology of late tablet.?2?Spray drying add?-cyclodextrin wall sticking prevention effect is the most ideal,The optimal spray process is 1.10g·mL-11 liquid density,30 liquid temperature,150 air inlet temperature,20 r·min-1 feeding speed,0.5Mpa atomizing pressure,and 17%additive excipients ratio,under the optimal process parameters,the powder yield is the highest and not easy to stick wall.?3?The preparation molding process of Astragalus membranaceus laxative compound tablets was determined.The tablet weight was 0.6g/tablet,the dosage was 3 times/day and 4 times/time,the dosage was drastically reduced.?4?To establish the method for the determination of Astragaloside IV in Astragalus membranaceus laxative compound tablet,the TLC identification method of Hemp kernels,Angelica sinensis,and Dried tangerine were established.?5?Through the experiment of small intestine movement in mice,the test results of defecation time,fecal particle number and total fecal weight have significant influence,indicating that Astragalus membranaceus laxative compound tablets has the function of defecation in animals.Conclusion:The water extraction,alcohol precipitation process,spray drying process of Astragalus membranaceus laxative compound tablets are accurate and feasible.The tablets obtained by the preparation process are smooth,beautiful and stable in quality.The quality evaluation method is stable and reliable,which provides scientific theoretical basis for industrial production and later research.Pharmacological experiments show that Astragalus membranaceus laxative compound tablets has the function of relieving constipation in animals. |
PDF Full Text Request