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Study on Long-Term Preservation of Hwangnyunhaedok-Tang Pharmacopuncture

  • Journal of Korean Medicine Rehabilitation
  • Abbr : JKMR
  • 2016, 26(2), pp.51-59
  • Publisher : The Korean Academy Of Oriental Rehabilitation Medicine
  • Research Area : Medicine and Pharmacy > Korean Medicine

이진호 1 하인혁 1 Mi-Riong Kim 1 정화진 1 이재웅 1 김민정 1 김은지 1 Lee In Hee 1

1자생의료재단

Accredited

ABSTRACT

ObjectivesWe studied long-term preservation in stability of a mixed preparation of dis-tilled and 70% alcohol extracted Hwangnyunhaedok-tang pharmacopuncture to establish standards for expiration date and quality control.MethodsThree lots of consecutively prepared Hwangnyunhaedok-tang pharmaco-puncture 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, en-dotoxins, 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 in-dividual quality control standards.ResultsAll 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∼8.98 μg/vial, baicalin at 6.47∼10.31 μg/vial, and geniposide at 116.03∼189.55 μg/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. ConclusionsManageable expiration date and quality control standards were established through long-term preservation testing of Hwangnyunhaedok-tang pharmacopuncture, fur-thering standardization of Korean medicine pharmacopuncture. (J Korean Med Rehab 2016;26(2):51-59)

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