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将复方丹参片生产工艺中的丹参提取物分别在60℃、70℃、80℃、90℃、100℃条件下真空干燥6h,各干燥物用反相HPLC分别测定其丹酚酸B、丹参酮ⅡA的含量,随温度的升高,丹酚酸B含量下降为:70℃时为0.69%,80℃为3.56%,90℃为7.91%,100℃为15.13%,丹参酮ⅡA70℃时为2.68%,80℃为7.45%,90℃为12.36%,100℃为17.20%。此结果提示:在复方丹参片生产过程中,对丹参的提取物的干燥温度应控制在70℃以下,否则会导致片剂中的丹酚酸B与丹参酮ⅡA被破坏,临床疗效降低而不合格。
The Salvia miltiorrhiza extracts of the compound Danshen tablets were respectively dried in vacuum at 60 ℃, 70 ℃, 80 ℃, 90 ℃ and 100 ℃ for 6h. The contents of salvianolic acid B, tanshinone ⅡA With the increase of temperature, the content of salvianolic acid B decreased to 0.69% at 70 ℃, 3.56% at 80 ℃, 7.91% at 90 ℃, 15.13% at 100 ℃, 2.68% at T = 7.45% at 80 ° C, 12.36% at 90 ° C, and 17.20% at 100 ° C. The results suggest that: in the process of compound Danshen tablets, the drying temperature of the extract of Salvia should be controlled below 70 ℃, otherwise it will lead to the tablets of salvianolic acid B and tanshinone Ⅱ A is destroyed, the clinical efficacy of unqualified .