Ayurvedic Drug Testing and Standardization Laboratory, Bharatiya Sanskriti Darshan Trust's Integrated Cancer Treatment and Research Centre, Wagholi, India.
Bhasma Section, Atharva Nature Healthcare Pvt Ltd, Wagholi, India.
Drug Dev Ind Pharm. 2024 Aug;50(8):721-734. doi: 10.1080/03639045.2024.2396902. Epub 2024 Aug 29.
Ayurvedic marine drugs derived from mollusc shells and coral are regularly used by Ayurvedic physicians to treat several disease conditions like acid peptic disease, irritable bowel syndrome, osteoporosis, etc. However, standard operating procedures for manufacturing these drugs and their complete characterization have not been published in the Ayurvedic Formulary and Ayurvedic Pharmacopeia of India to date.
Present study describes the traditional manufacturing process and thorough characterization using classical and advanced analytical tools. The raw materials characters, in-process parameters, and finished product specifications have been elaborated to develop monographs. Especially, the identity and purity of raw coral and pearl were checked by Raman Spectroscopy and Energy Dispersive X-ray Fluorescence analysis.
In the finished product analysis, the X-Ray Diffraction study revealed that incineration after trituration with leaf pulp or rose water converted the aragonite phase of calcium carbonate into calcite phase in mother pearl, cowry, and pearl while the calcite form of raw coral was retained. The prominent bands around 1390, 870, and 712 cm detected by Fourier Transform-Infrared Spectroscopy and mass loss between 39-44% (w/w) revealed by thermogravimetric analysis confirmed the carbonate form of these calcium-based drugs. The finished products were very fine grayish-white powders constituted by irregularly shaped nano-micro particulate calcium carbonate exhibiting particle size between 600 nm (D10 value) to 1.2 µm (D90 value).
The quality control and assurance achieved in this study may be further utilized by the pharmaceutical industries to manufacture quality marine drugs and conduct efficacy studies.
阿育吠陀医学中使用的来源于贝类贝壳和珊瑚的海洋药物,常被阿育吠陀医师用于治疗多种疾病,如胃酸过多、肠易激综合征、骨质疏松症等。然而,迄今为止,这些药物的制造标准操作规程及其完整特性尚未在印度的《阿育吠陀方剂》和《阿育吠陀药典》中公布。
本研究描述了传统的制造工艺,并使用经典和先进的分析工具进行了全面的特性描述。详细阐述了原材料特性、中间过程参数和成品规格,以制定专论。特别是,通过拉曼光谱和能量色散 X 射线荧光分析检查了原始珊瑚和珍珠的身份和纯度。
在成品分析中,X 射线衍射研究表明,在与叶浆或玫瑰水一起研磨后进行焚烧,将母珍珠、宝贝和珍珠中碳酸钙的方解石相转变为方解石相,而原始珊瑚的方解石形式则保留下来。傅里叶变换红外光谱检测到的约 1390、870 和 712 cm 处的特征带以及热重分析中 39-44%(w/w)的质量损失表明这些基于钙的药物为碳酸盐形式。成品为非常细的灰白色粉末,由不规则形状的纳米微颗粒碳酸钙组成,粒径在 600nm(D10 值)至 1.2μm(D90 值)之间。
本研究中实现的质量控制和保证,可进一步被制药行业用于制造高质量的海洋药物并进行功效研究。