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Design and development of a stable polyherbal formulation based on the results of compatibility studies

机译：根据相容性研究结果设计和开发稳定的多草药配方

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Introduction:Ayurvedic and herbal medicinal products contain a combination of botanicals; each of these contains a number of chemical compounds that may give the anticipated activity in combination. Therefore, it is very important to analyze and evaluate the compatibility of various active constituents and markers from different medicinal plants for their possible chemical interactions with various excipients at different storage conditions during the development of a stable polyherbal formulation.Objective:To study chemical stability of kalmegh (Andrographis paniculata) and kutki (Picrorhiza kurroa) extract for their active markers andrographolide, kutkoside and picroside-I and to develop stable polyherbal formulation based on the incompatibility studies.Materials and Methods:The compatibility study was carried out on individual ethanolic extracts of these two plants along with the commonly used excipients in the ratio of 1:1 at 40 ± 2°C and 75 ± 5% relative humidity and at a refrigeration temperature of 5 ± 1°C for initial, 7-, 15- and 30-day intervals. The analysis was carried out using the validated reverse phase–high-performance liquid chromatography methods. A stable tablet dosage form was developed based on the results of these studies.Result:The study suggested that the active markers of kutki (kutkoside and picroside-I) were found to be degraded in the presence of the kalmegh extract. However, the active marker of the kalmegh extract (andrographolide) was found to be stable. Both the extracts showed excellent compatibility with all the excipients used in making this formulation. No significant decrease in the kutkoside and picroside-I content from the formulation was observed.Conclusion:By separate granulation process the exposure of both the extracts can be minimized thus avoiding the degradation of active markers.
机译：简介：阿育吠陀和草药产品均含有植物药;这些化合物中的每一个都包含许多化合物，这些化合物可能结合在一起提供预期的活性。因此，在稳定的多草药配方开发过程中，分析和评估不同药用植物中各种活性成分和标记物与各种赋形剂在不同储存条件下可能发生的化学相互作用的相容性非常重要。 kalmegh（Andrographis paniculata）和kutki（Picrorhiza kurroa）提取物具有活性标记穿心莲内酯，kutkoside和picroside-I，并在不相容性研究的基础上开发出稳定的多草药配方。这两种植物以及常用的赋形剂在40±2°C和75±5％相对湿度下的比例为1：1，初始，7、15、30和30的冷藏温度为5±1°C天间隔。使用经过验证的反相高效液相色谱方法进行了分析。根据这些研究的结果，开发了一种稳定的片剂剂型。结果：研究表明，发现存在kalmegh提取物时，库特基的活性标记（kutkoside和picroside-I）被降解了。但是，发现卡尔梅提取物（穿心莲内酯）的活性标记是稳定的。两种提取物均与制备该制剂中使用的所有赋形剂均具有优异的相容性。结论：通过单独的制粒工艺，可以将两种提取物的暴露量降至最低，从而避免了活性标记的降解。

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