XIA Zhong-yu, HE Qing, SUN Guo-bing. Preparation and Dissolution Determination of Belladonnae Herba Dispersible Tablets[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(13): 29-31.
DOI:
XIA Zhong-yu, HE Qing, SUN Guo-bing. Preparation and Dissolution Determination of Belladonnae Herba Dispersible Tablets[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(13): 29-31. DOI: 10.13422/j.cnki.syfjx.2014130029.
Preparation and Dissolution Determination of Belladonnae Herba Dispersible Tablets
Objective: To prepare Belladonnae Herba dispersible tablets and establish a method for determination of its dissolution. Method: Taking cross-linked polyvinylpyrrolidone(PPVP)+sodium carboxymethyl starch(CMS-Na) inside and outside addition as disintegrating agents
calcium hydrogen phosphate
sucrose and CMS-Na as fillers
60% ethanol solution containing 5% hydroxypropyl methyl cellulose(HPMC) as adhesives
microcrystalline cellulose as glidants
talcum powder as lubricants
HPLC was adopted to determine dissolution of Belladonnae Herba dispersible tablets with mobile phase of acetonitrile-methanol-0.01 mol·L-1 phosphate solution containing 0.005 mol·L-1 sodium heptanesulfonate(potassium dihydrogen phosphate-dibasic potassium phosphate 1:1)(25:10:65) and detection wavelength at 211 nm. Result: Atropine sulfate showed a linear relationship in the range of 0.003 38-0.026 624 μg
RSD of precision was 1.29%
average recovery was 99.76% with RSD of 0.86%.Dissolutions of Belladonnae Herba dispersible tablets in 2
5
10
15
30 and 45 min were 0%
15.29%
25.74%
40.40%
67.42% and 73.30%
respectively.Dissolution of ordinary Belladonnae Herba tablets was 23.22% within 45 min. Conclusion: These prepared Belladonnae Herba dispersible tablets had good uniformity.This determination was simple
accurate and suitable for quality control of this product.
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