| 초록 |
Objectives We studied long-term preservation in stability of a mixed preparation of distilled and 70% alcohol extracted Hwangnyunhaedok-tang pharmacopuncture to establish standards for expiration date and quality control. Methods Three lots of consecutively prepared Hwangnyunhaedok-tang pharmacopuncture were each tested in triplicate to a total 5 tests at 3 month intervals over a period of 12 months for analysis of appearance, pH, specific gravity, index component content, endotoxins, microbial sterility, residual organic solvents, heavy metals, and pesticides. Items with no difference by elapsed time were tested at the initial and final timepoints, and data of items with potential difference by elapsed time were analyzed for trends to establish individual quality control standards. Results All tested items were stable over the study period, and therefore the expiration date was set as 12 months. pH quality control standards were set as 3.66~5.69, and that of specific gravity as 0.802~1.203, respectively. In index component content standards, berberine was set at $4.96{ sim}8.98{ mu}g/vial$ , baicalin at $6.47{ sim}10.31{ mu}g/vial$ , and geniposide at $116.03{ sim}189.55{ mu}g/vial$ , respectively. Standards for other items with no difference by elapsed time were set according to general Korean herbal medicine standards in the Korean Pharmacopoeia. Conclusions Manageable expiration date and quality control standards were established through long-term preservation testing of Hwangnyunhaedok-tang pharmacopuncture, furthering standardization of Korean medicine pharmacopuncture. |
