Study On Preparation Process And Quality Standard Of Zengkangning Buccal Tablets

Zengkangning prescription was derived from Zengkangning tablets in the tenth volume of the Drug Standard of Ministry of Public Health of Traditional Chinese Medicine Prescription.Its ingredients are Radix Paeonia Alba,Astragalus,Fructus Ziziphi Jujubae and Stevia rebaudiana.It has the function of replenishing qi to invigorate the spleen,nourishing yin and promoting fluid production,improving the immune function of organism.This study will change the dosage form into buccal tablet and establish the fessible scientefic prepraration process,applying modern pharmaceutical technology and scientific analysis method,under the guidance of TCM theory.The quality standard is discussed and established in this paper which can ensure effective drug safety,stable and reliable quality.1.Study on the preparation technology of Zeng’kangning buccal tabletsThe water extraction process: With the dry extract yield as the evaluation index,this subject respectively study the medicinal water absorption rate,boiling water added,decocting time,decocting times on the extraction effect of water.The best water extraction precess was:covered with 12 times amount of water for the first time,boiling 2 hours,filtering;adding 10 times amount of water for the second time,boiling 2 hours,filtering.The alcohol precipitation process: This subject selected the yield of dry extract and content of Paeoniflorin as the evaluation indexes,inspected the clear paste ’ s concentration degree,using the comparative experimental method.The result for the alcohol precipitation conditions was to concentrate the water extract to a relative density of 1.15±0.01(60℃)of clear paste.Preparation process of finished product:Taking the granule situation as the evaluation indexes,the subject inspected the suitable thinner,wetting agent and taste modifying agent.Results: take mannitol 660 g,citric acid 10 g,Hydroxypropyl cellulose 50g(through 80 mesh sieve),mixing with the dry extract power which is extracted from one prescription.Adding alcohol as wetting agent,sieving with 18 mesh,preliminary preparation of particles,adding magnesium stearate which accounting for 0.8% of the total granule and menthol which accounting for 0.1% of the total granule,full mixing,pressing into pieces,that end product was.2.Study on quanlity standardStudy on TLC qualitative: identify the 2 species of crud drug Astragalus and Stevia rebaudiana in the preparation by TLC.Experimental results of the TLC chromatogram show that,in the corresponding position control of Astragalus there are the same color spots,and without the interference of negative control in the corresponding position.After repeated experiments,the reproducibility is good;and in the corresponding position control of Stevia rebaudiana there are the same color spots,and without the interference of negative control in the corresponding position.After many times experiments,the repeatability is good.Study on content assay method of HPLC:The subject developed HPLC for the content of paeoniflorin.The determination of parameters are: taking 18 alkyl silane bonding silica gel as the filling agent;taking acetonitrile-water(containing 0.1% phosphoric acid)(15:85)as mobile phase;Injection rate 1.0 ml/min;25℃ is optim column temperature;230nm is the detected wavelength.The methodology was validated in this subject.Test results showed that the method has good linear relationship with the content of paeoniflorin in the range of 0.1024~1.0240 ug,r=0.99995;precision test,CV=1.55%;stability test,CV= 0.23%;repeatability test,CV=2.23%;recovery test,the average recovery rate =97.55%.Results show that the method is reasonable and feasible.It has good stability.This method is suitable For the quality assurance of Zengkangning Buccal tablets.The determination of paeoniflorin is not less than 2.2mg in each tablet.