Prescription Optimization and Quality Control of Dispersible Tablets of

ZHAO Yong-heng; ZHOU Yi-sheng; WANG Song; LIN Li-wei

doi:10.11653/syfj2014010035

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Prescription Optimization and Quality Control of Dispersible Tablets of

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- Prescription Optimization and Quality Control of Dispersible Tablets of
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 20, Issue 1, Pages: 35-39(2014)
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- DOI：10.11653/syfj2014010035
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- Published：2014
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ZHAO Yong-heng, ZHOU Yi-sheng, WANG Song, et al. Prescription Optimization and Quality Control of Dispersible Tablets of [J]. Chinese journal of experimental traditional medical formulae, 2014, 20(1): 35-39.
DOI：

ZHAO Yong-heng, ZHOU Yi-sheng, WANG Song, et al. Prescription Optimization and Quality Control of Dispersible Tablets of [J]. Chinese journal of experimental traditional medical formulae, 2014, 20(1): 35-39. DOI： 10.11653/syfj2014010035.

摘要

目的：优化龙须藤分散片的处方工艺并建立其质量控制方法。方法：以崩解时限为指标，采用星点设计-效应面法考察微晶纤维素（MCC）、低取代羟丙基纤维素（L-HPC）及交联聚乙烯吡咯烷酮（PVPP）质量分数对龙须藤分散片处方工艺的影响；采用HPLC测定3’，4’，5’，5，7-五甲氧基黄酮和3’，4’-亚甲二氧基-5’，5，6，7-四甲氧基黄酮含量，流动相乙腈（A）-水（B）洗脱梯度（0~20 min，30%~40%A；20~36 min，40%~48%A），检测波长324 nm，并考察分散片的体外溶出度。结果：最佳处方工艺为MCC，L-HPC，PVPP及硬脂酸镁用量分别为58%，9.2%，9.8%，1.0%；龙须藤分散片崩解时间40 s，30 min内溶出度已达90%。结论：制备的龙须藤分散片具有崩解快、溶出度高的特性，适于临床应用需要。

Abstract

Objective: To optimize formulation process of dispersible tablets of Bauhinia championi and establish its quality control method. Method: Taking disintegration time as index

central composite design and response surface methodology was adopted to optimize preparation process of dispersible tablets with amounts of MCC

L-HPC and PVPP as factors;HPLC was used to determine contents of 3'

7-pentamethoxyflavone and 3'

4'-methylenedioxy-5'

7-tetramethoxyflavone by taking acetonitrile(A)-water(B)(0-20 min

30%-40%A;20-36 min

40%-48%A) as mobile phase

detection wavelength was 324 nm

then in vitro dissolution of dispersible tablets was investigated. Result: Optimal prescription was as following:MCC 58%

L-HPC 9.2%

PVPP 9.8%

magnesium stearate 1.0%;Disintegration time of dispersible tablets was 40 s and its in vitro dissolution was more than 90% within 30 min. Conclusion: These prepared dispersible tablets of B. championi had characteristics of fast disintegrating profile and high dissolution

which was suitable for clinical needs.

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Related Institution

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