Pharmacy And Pharmacodynamic Research Of Fukang Gel

Purpose:This experiment was mainly to study the preparation process,quality standard and pharmacodynamics(antibacterial test)of Fukang Gel,provided a theoretical basis for the clinical use of Fukang Gel,and brong the gospel to patients with skin diseases such as dermatitis and eczema.Material and Method:1.Study on Preparation Technology of Fukang GelTaked the appearance,transparency,fineness,spreadability and drug consistency of the Fukang Gel as the indicators,the relationship between the matrix selection and dosage of the gel,the amount of water added to the matrix and the swelling time,and the choice of neutralizing agent were investigated.And the dosage,the selection and dosage of the humectant,the choice of preservatives,etc.The preparation process of the Fukang Gel was preferred.2.Study on the quality standard of Fukang GelTLC was used to identify the extracts of Astragalus membranaceus,matrine and paeonol.The identification of chlorhexidine acetate was carried out by physical and chemical identification method.The extract of Astragalus membranaceus,matrine and Dan was determined by HPLC.Determination of the content of phenol and chlorhexidine acetate;examination of the properties of the Fukang Gel according to the pharmacopoeia.3.Pharmacodynamic Study of Fukang Gel(Antibacterial Test)Through the detection of the total number of bacterial colonies,the total number of fungal colonies,Escherichia coli,Pseudomonas aeruginosa,Staphylococcus aureus,and hemolytic streptococcus colonies;stability test of drug bacteriostasis;investigation of antibacterial properties of dissolution bacteriostatic products to determine the antibacterial effect of Fukang Gel.4.Skin irritation testShaved the hair on both sides of the back spine of the rabbit and did not damage the skin.On the next day,0.5 g of the sample was applied to the intact skin of one side of the hair,andthen covered with a layer of non-irritating plastic film,and the other side of the skin was used as a blank control(equal sterilization of normal saline)Results:1.The best preparation process of the Fukang Gel by experiment was as follows:carbomer-940 was used as the gel matrix,triethanolamine was used as the neutralizing agent,glycerin was the moisturizing agent,and hydroxyethyl ester was the preservative.2.The results of TLC showed that the Fukang test gel could display the same color spots in the same position as the control,and the negative control had no spots.The results of physical and chemical identification showed that the Fukang test gel showed the same color change as the control,while the negative test sample did not.The results of the content determination showed that the linearity of baicalin injection in the range of 0.0528~1.056?g was good,r=0.9999.The precision,stability and repeatability of the determination method were good,the recovery rate was 99.6%,RSD=1.19%;the amount of matrine injection in the range of 0.1028~2.570?g was good,r=0.9999,the precision,stability and repeatability of the content determination method were good,the recovery rate was 99.2%,RSD=1.45%;The linear relationship of the phenolol injection in the range of 0.1067~1.067?g was good,r=0.9999.The precision,stability and repeatability of the content determination method were good,the recovery was 100.0%,and the RSD was 0.08%.The linearity of chlorhexidine acetate injection in the range of 0.817~1.067?g was good,r=0.9997.The precision,stability and repeatability of the content determination method were good,the recovery rate was 99.9%,RSD=0.03%.3.Pharmacodynamic experiments showed that: the microbial index meet the requirements of GB 15979-2002;the sample had strong antibacterial effect on the tested strain;the sample had a minimum of two years at room temperature for the antibacterial effect of the tested strain;The skin irritation index of the sample on white rabbits was 0,and the skin irritation intensity was not irritating.4.Skin irritation test: After several complete skin irritation experiments,the edema and erythema scores of each group were 0 within 14 days,and the scores of both the control group and the experimental group were 0.Conclusion:1.Developed the best preparation process of Fukang Gel2.Established the TLC identification,chemical identification and content determination of Fukang Gel.The quality standard of Fukang Gel and the properties and examination of Fukang Gel were established.Finally,the draft quality standard of Fukang Gel was established.3.The experimental research showed that the Fukang Gel has antibacterial effect and good stability,which provided a theoretical basis for the treatment of fungal and bacterial skin diseases by Fukang Gel.4.The sample has a skin irritation index of 0 for rabbits,and the skin irritation intensity was non-irritating.