Study On Technology And Quality Control Of Compound Antiviral Particles

Antiviral granules are derived from Radix Isatidis and chemical agents lamivudine.This combination with Chinese and Western medicine compound preparation,have played the effect of active ingredients of traditional Chinese medicine and Western medicine chemical synergistic in the treatment effect.Although the treatment of chemical drugs are significant,there are obvious side effects.However,the addition of traditional Chinese medicine can reduce its side effects,and improve the drug safety.With the further development of medical technology,the using of Chinese and Western medicine in clinical practice has become a common phenomenon,so a large number of Chinese and Western medicine compound preparations,has become the inevitable trend of the development of medicine.In this study,the the lamivudine in anti-virus particles,is the world's first treatment for hepatitis B virus infection nucleoside analogues,the efficacy of significant resistance to the existence of the problem.And Banlangen is recognized as a good antiviral effect of one of the traditional Chinese medicine,combined with lamivudine can effectively reduce the resistance and reduce the incidence of adverse reactions.A good combination of Chinese and Western medicine preparations,not only to good efficacy,high security,but also to achieve quality control.The preliminary pharmacodynamics,toxicology studies have shown that the main component of this product lamivudine,Banlangen optimal ratio of 1:10.By screening the prescription,the final composition and ratio of the prescription were: lamivudine 3g,Banlangen 30.0g,corn starch 66.9g,magnesium stearate 0.1g,water 45.6g.By analyzing the physical and chemical properties and characteristics of lamivudine,the dissolution and isomerization of the corresponding test method,and determine the content of the product determination method.The dissolution of this product according to the dissolution and release degree of determination to 0.1mol / L of HCL 900 mL for the dissolution medium,the speed of 50 r / min,30 min,take the solution 10 mL,plus the dissolution medium to 6?g / mL,and then Detection.Determination of content based on high performance liquid chromatography(Chinese Pharmacopoeia 2015 Edition General 0512),the use of C18 column,the preparation of 0.025 M CH3COONH4 solution(pH 3.8)for the water phase A,CH3 OH for the organic phase B,mobile phase A: B = 95 : 5(v / v);detection wavelength: 277 nm;flow rate: 1.0 mL · min-1;column temperature: 35 ° C.The mobile phase A: B = 95: 5(v / v)was prepared by high performance liquid chromatography with ?-cyclodextrin column,0.1mol / L CH3COONH4 as water phase A,CH3 OH as organic phase B,;Detection wavelength: 270 nm;flow rate: 1.0 mL · min-1;column temperature: 15 ~ 30 ?.Through the analysis of Banlangen,the qualitative test of thin layer chromatography was carried out according to the Chinese Pharmacopoeia 2015 edition,and the quality of Radix Isatidis was controlled.According to the requirements of the guiding principle of drug stability test,influencing factor test(5000 lx light,60 high temperature and RH? 92.5% high humidity),and accelerated test(temperature 42 ?± 2 ?,RH75% ± 5%)were investigated.The results showed that the indexes did not change significantly during the above test,and the stability of the preparation was proved to be good.