Kailas Jeevan(一种阿育吠陀专利配方)的加速稳定性研究

IF 0.1 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
Giridhar Vedantam, Veena B. Kupati, Gundakalle M B, Ajit Lingayat, Divya Khare, Vedhas M Kolhatkar
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引用次数: 0

摘要

背景:稳定性研究是评估阿育吠陀成药保质期的试验。印度政府规定,中成药的许可和许可续期必须进行强制性测试。加速稳定性研究的测试间隔为 0、3 和 6 个月。 Kailas Jeevan 是一种专有的半固体剂型,由通过 GMP 认证的 Ayurveda Sumshodanalaya (P) Pvt.Pvt.适用于便秘、脚跟干裂、伤口、丘疹、烧伤等。目的和目标通过加速稳定性研究评估 Kailas Jeevan 的保质期。材料与方法配方在通过 GMP 认证的药房配制。在特定温度(40±2°C)和相对湿度(75±5%)下的稳定室中保存后,通过评估理化、微生物和定量特征的变化来评估产品的保质期。每隔 0、1、3、6、9、12、18 和 24 个月进行一次分析。根据《印度阿育吠陀药典》(Ayurvedic Pharmacopoea of India, Part I Vol ix)指南,计算出平均 25% 的降解时间,从而得出保质期。结果和结论在对 Kailas Jeevan 进行的加速研究中,所评估的各项参数在 24 个月内均未达到限值。根据乘法系数,Kailas Jeevan 的保质期为 7.02 年。关键字稳定性、保质期、Kailas Jeevan、加速稳定性研究
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Accelerated Stability Study of Kailas Jeevan – A Proprietary Ayurvedic formulation
Background: Stability studies are the test to assess the shelf life of the Ayurvedic proprietary medicines. Govt. of India made mandatary test for licencing and renewal of licencing of the proprietary medicine. Accelerated stability studies, testing interval of 0,3 and 6 months.  Kailas Jeevan is a proprietary semisolid dosage form prepared in GMP approved Ayurveda Sumshodanalaya (P) Pvt. Ltd. Dhayri, Pune. It is indicated in Constipation, Cracked heels, Wounds, Pimples, Burns etc. Aims and Objectives: To evaluate the shelf life of Kailas Jeevan through accelerated stability study. Materials and Methods: The formulation was prepared in the GMP approved pharmacy. Shelf life of product was evaluated by assessing in changes in physicochemical, Microbial and quantification profiles, after keeping it in stability chamber at specific temperature (40±2°C) and relative humidity (75±5%). Analysis was carried out at the intervals of 0, 1, 3, 6, 9,12, 18 and 24 months. Average 25% degradation time was calculated to find the shelf life as per the Ayurvedic Pharmacopoea of India, Part I Vol ix guidelines. Results and Conclusion: The parameters assessed in accelerated study of Kailas Jeevan, was shown under limits till 24 months. Based on multiplication factor shelf life of Kailas Jeevan is 7.02 year. Key Words: Stability, Shelf life, Kailas Jeevan, Accelerated stability study  
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来源期刊
International Journal of Ayurvedic Medicine
International Journal of Ayurvedic Medicine MEDICINE, RESEARCH & EXPERIMENTAL-
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