ABSTRACT
Objective To optimize the preparation process of Tangzu Granula. Methods With the paste-forming rate and total content of paeoniflorin as the indexes, the optimal water-extraction condition was screened by orthogonal design. With hydroscopicity, fluidity and formability as the indexes, the appropriate ratio of the excipient and the formula were selected. Results The optimum water-extraction condition was as follows: 10-fold water, decoction for 2 times and 1.5 hour for each time. The optimal ratio of the excipient and the formula for preparation of Tangzu granules were two proportions of the extract and three proportions of the excipient which consisted of lactose and dextrin(2 : 1, w/ w). Conclusion The technology is effec-tive, scientific, reasonable, and practical.
ABSTRACT
OBJECTIVE: To establish a bacterial endotoxin test method for fluorescein sodium injection.METHODS: Based on the bacterial endotoxin test method stated in Chinese Pharmacopoeia 2005 edition(second part),an interference test was conduced on different batches of fluorescein sodium samples using tachypleus amebocyte lysate from different companies.RESULTS: At a concentration of no more than 0.75 mg?mL-1,fluorescein sodium showed no interfere with the bacterial endotoxin test.CONCLUSION: It is feasible for bacterial endotoxin test of fluorescein sodium injection be conducted in a limit value of 0.15 EU?mL-1.
ABSTRACT
Objective To establish a method for the determination of berberine hydrochloride in Huanglian Jiangtang Pill. Methods The sample was extracted with hydrochloric acid-methanol(1 ∶ 100). The chromatographic conditions were as follows:Diamonsil C18 chromatographic column(250 mm? 4.6 mm,5 ? m)with a mobile phase of acetonitrile-0.05 mol/L potassium dihydrogen phosphate(28 ∶ 72),the detection wavelength at 350 nm and the flow rate being 1.0 mL? min-1. Results A good linearity was obtained from 0.244 ? g to 2.928 ? g of berberine hydrochloride in Huanglian Jiangtang Pill(r=0.999 9,n=7).The average recovery was 99.07 % and RSD=1.30 %(n=6). Conclusion This method is simple,sensitive,specific and accurate for determination of berberine hydrochloride in Huanglian Jiangtang Pill.
ABSTRACT
Objective To study the feasibility of applying extrusion-puffing technique to the preparation of Qingyin Teabag.Methods Extrusion-puffing techique and water decoction were used to prepare the Qingyin Teabag,and thecorresponding products were compared by pharmacodynamic tests .Meanwhile,a dissolution test was carried out for the monarch drug Radix Glycyrrhizae in the teabag before and after pressurizing-expansion,thus to explore the influence of extrusion-puffing technique on the dissolution speed of ammonium glycyrrhetate from Radix Glycyrrhizae.Results With ammonium glycyrrhetate as the index,T50 and Td of Radix Glycyrrhizae before extrusion puffing extraction were 20.25 min and 56.20 min,while were 7.975 min and 18.975 min respectively after extrusion puffing extraction,the difference being very significant.Pharmacodynamic tests showed effects of the products processed by extrusion-puffing technique were slightly superior to those by water decoction.Conclusion It is feasible to adopt extrusion-puffing technique to the preparation of Qingyin Teabag.