Research On The Safety And Quality Of Chinese Herbal Medicinal Oral Liquid Of BCNE

The oral liquid BCNE used for the treatment of DVH is composed of flavonoids of baicalin,chrysanthemum,notoginseng and epimedium,which are the main effective ingredients of these traditional Chinese herbs.In order to certify the BCNE could treat the DVH without toxic reaction,we did the research on safety and quality of BCNE as follows:1.The safety of compound Chinese herbal oral liquid of BCNEThe safety researchof compound Chinese herbal oral solution of BCNE includes the acute toxicity test,the long-term toxicity test and the target animal safety test.In the acute toxicity test,the preliminary experiment failed to detect the LD50 of BCNE.Therefore we conducted the test of maximum administration dosage.The result showed that maximum administration dosage of BCNE is 8000 mg/kg(calculated with net content).In the long-term toxicity test,the ICR mice in the treatment groups were respectively given BCNE according the different dosages by gavage.The mice's spirit,activity,ingestion,drinking water,morbidity and mortality were sequentially observed.In order to measure the blood routine,biochemical criterions of hepatic and renal function,blood was collected from eyeballs.The weights of heart,livers,spleen,lung and kidney were recorded and the pathology changes were observed.The results displayed that the clinic indication,mental state of the mice were normal.Blood routine indexes and blood biochemical indexes of each group were within the scope of normal values after administration with BCNE.The pathological changes of visceral organ were not found by naked eye.The sections of liver and kidney showed no changes compared with that of the control.These results indicated that the BCNE had no obviously long-term toxicity.Duckings served as target animal safety test were divided into four groups at different dosages of BCNE.The blood serum hepatic and renal function biochemical criterions and the viscera index were determinated.The results showed that the clinic indications,mental state and blood biochemical index in each group were normal,which indicated the safety of BCNE for ducking.2.Qualitative and quantitative analysis in Chinese herbal medicinal oral liquid of BCNE In order to control the quality of the BCNE,the qualitative and quantitative determination method of main ingredients in BCNE were studied by the high-performance liquid chromatography(HPLC)and the thin-layer chromatography.The total flavonoids content of BCNE was determined by rutin method.The wave length,sample recovery rate,instrument precision,repeatability etc.were preferentially investigated.The results exhibited that the interference of determination of sample is minimal when the wave length is 510 nm.The total flavonoid contentsof the three batches samples rangedat 7.496?7.781 mg/mL.The sample preparation,mobile phase,column temperature condition,and injection volume were optimized in the experiment of the quantitive analysis of icariin and baicalin by HPLC.Three batches samples were measured and the contents of icariin,baicalinwere 0.283?0.290 mg/mL and 1.501?1.674 mg/mL,respectively.In the experiment of identification of the epimedium,baicalin,Notoginseng,Chrysanthemum flower by TLC,the conditions such as injection volume,developing solvent,developing temperature,chromogenic temperature were optimized and the main effective ingredients of the three batches samples were coloured perfectly.3.Preliminary investigationon thestability of Chinese herbal medicinal oral liquid of BCNEExamine the character,redispersibility,sediment volume ratio,pH value,total flavonoids content,and the content soficariin and baicalin of the oral liquid to confirm the stabilization of the effective constituent of BCNE.The light acceleration test with the illumination intensity of 45001x ± 5001x was served to observe the changes of the above indexes in BCNE at 0 d,6 d,12 d.As a result,the character,redispersibility,sediment volume ratio,pH value kept stabile.The contents of icariin and baicalin showed little decrease which suggested that the BCNE should be preserved BCNE in the low light level or shadow.Temperature and humid accelerated stability test with the conditions at 37 ? ±2 ? and the humid of 60%± 5%was used to observe 3 batches samples.All thesefore said indicators,as a result,showed no change.The result suggests that BCNE can be kept stable within 3 months.