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一种市售草药矿物制剂——那伽硫磺的比较物理化学评估

Comparative physicochemical evaluation of a marketed herbomineral formulation: naga bhasma.

作者信息

Garg M, Das S, Singh G

机构信息

Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak-124 001, India.

出版信息

Indian J Pharm Sci. 2012 Nov;74(6):535-40. doi: 10.4103/0250-474X.110598.

Abstract

In the practice of Ayurveda, where herbomineral formulations are said to be made biocompatible through specific processes like Shodhana and Marana, the western medical science on the contrary has raised the safety concerns of these formulations in the recent past. In the present study, comparative physico-chemical analysis of Naga bhasma, a herbo-mineral preparation having a reputation of miraculous drug commonly used to treat several health disorders, was carried out using five marketed formulations through analytical methods like differential scanning calorimetry, X-ray difraction, thermogravimetric analysis, Fourier Transform infrared spectroscopy and also subjected for particle size analysis and estimation of trace and heavy metals to access the safety of these formulation. The results revealed variable observations regarding particle size, metal form and content of lead. The presence of free lead in five different formulations indicated towards the possible risk of severe side effects to the consumer. Present findings certainly put doubt over the safety of this formulation but at the same time, variation in the results with all five formulations also indicated that these formulations were not prepared as per the mentioned Ayurvedic text. Hence, enforcement of strict regulatory guidelines is strongly warranted before launching into the market. Further, a series of biological studies need to be conducted before taking any final verdict on the safety of this formulation.

摘要

在阿育吠陀医学实践中,据说草本矿物配方通过诸如净化和煅烧等特定工艺实现生物相容性,相反,西方医学在最近对这些配方的安全性提出了担忧。在本研究中,使用差示扫描量热法、X射线衍射、热重分析、傅里叶变换红外光谱等分析方法,对五种市售配方的那伽硼砂(一种具有神奇疗效、常用于治疗多种健康疾病的草本矿物制剂)进行了比较理化分析,还对其进行了粒度分析以及痕量和重金属的测定,以评估这些配方的安全性。结果显示,在粒度、金属形态和铅含量方面存在不同的观察结果。五种不同配方中游离铅的存在表明消费者可能面临严重副作用的风险。目前的研究结果确实让人对该配方的安全性产生怀疑,但与此同时,所有五种配方结果的差异也表明这些配方并非按照上述阿育吠陀文献制备。因此,在投放市场之前,强烈需要执行严格的监管指南。此外,在对该配方的安全性做出最终裁决之前,需要进行一系列生物学研究。

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