腊肠的制备及标准化

Shilpa Patel, Nikunj Patadiya, Pooja Makvana, Rikin Patel
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摘要

本文主要研究了腊肠的制备和标准化。市场剂型(MF1和MF2)和实验室剂型(LF)的各项参数均在药典规定范围内。其平均重量和重量变化分别为2057 mg和0.2±0.1%,崩解时间为8±2 min,硬度为4.6±0.2 Kg/cm2,脆度为0.9722±0.2%,灰分值分别为2.4%(酸不溶性灰分)和2.15%(水溶性灰分),提取率分别为5.6%(酸不溶性灰分)和7.25%(水溶性灰分)。为了保证最终产品的质量和稳定性,从混合物中分离出一些重要的化学标记物,并选择高效薄层色谱进行定性和定量分析。标准化参数的结果在三者之间存在显著差异,这与市场配方的真实性有关。甚至HPTLC指纹图谱也显示出市场配方中存在掺假或质量低劣的成分。hplc指纹图谱测定方法准确、准确地定量了水杨桃苷(0.84%)、胡椒碱(0.92%)、姜黄烯(0.71%)3种化学标记物,并通过IR、NMR、质谱对其进行了表征。
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PREPARATION AND STANDARDIZATION OF CHITRAKADI VATI
The present work deals with the preparation and standardization of chitrakadi vati. All the parameters of both market formulation (MF1 & MF2) and Laboratory formulation (LF) were found to be within the limit prescribed in pharmacopoeia. Average weight and weigh variation of LF was 2057 mg and 0.2±0.1 %, disintegration time was 8±2 min, hardness was 4.6±0.2 Kg/cm2 , friability was 0.9722±0.2 %, ash values were 2.4 % (acid insoluble ash) and 2.15 % (water soluble ash), extractive values were 5.6 % (acid insoluble extractive) and 7.25 % (water soluble extractive). In order to ensure quality and stability of final product, some of the important chemical markers has been separated from the mixture and for analysis by high performance thin layer chromatography was selected for qualitative and quantitative purpose. The results of standardization parameters showed marked difference among three, which fingers to authenticity of market formulations. Even HPTLC fingerprinting showed some ingredients in market formulations were taken adulterated or inferior in quality. The HPTLC method for fingerprinting was found to be precise and accurate to quantify three chemical markers plumbagin (0.84%), piperine (0.92%), zingiberene (0.71%), and it further characterized by IR, NMR, Mass spectra.
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