| 张翠莲,王彪,刘芳,王铁树,许婷婷.5种复方丹参口服制剂质量标准对比分析与启示[J].中国药事,2021,35(4):390-396 |
| 5种复方丹参口服制剂质量标准对比分析与启示 |
| Comparative Analysis and Enlightenment of Quality Standards for Five Compound Danshen Oral Preparations |
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| DOI：10.16153/j.1002-7777.2021.04.005 |
| 中文关键词: 复方丹参 中华人民共和国药典 质量标准 日用量 |
| 英文关键词: Compound Danshen Chinese Pharmacopoeia quality standards daily dosage |
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| 中文摘要: |
| 目的：对比5种复方丹参口服制剂质量标准的异同，分析日用量含饮片量与活性组分含量，为临床用药综合评估提供参考。方法：从《中华人民共和国药典》2020年版提取这5种制剂的处方、制法、鉴别、检查及含量测定指标，结合用法用量计算日用量相当于饮片量及活性组分量，分析其异同。结果： 复方丹参滴丸与其他4种制剂组方相似，但处方中君药丹参配比是另4种剂型的1.6倍。滴丸制法对丹参与三七采用水提醇沉工艺，而另4种对丹参均用醇、水分步提取与浓缩后再加三七细粉。5种制剂对三七与冰片的质控均收载TLC鉴别。滴丸有指纹图谱与丹参素定量，而另4种剂型均控制丹参酮ⅡA、丹酚酸B与三七皂苷总量。除滴丸外的4种制剂的日用量均相当于饮片量5.4 g。日用量按活性组分计，滴丸含丹参素不少于3.00 mg，另4种含丹酚酸B与三七皂苷总量低限一致，但颗粒剂含丹参酮ⅡA规定低限值是片、浓缩丸与胶囊的2.17倍(3.9 mg /1.8 mg)。结论：除复方丹参滴丸外4种制剂的处方、制法、质控项目与临床用量基本一致。复方丹参滴丸与另4种剂型的丹参用量、制备工艺与活性组分差异较大，提示临床用药尤应关注滴丸特点，并加强同类制剂安全使用监测。 |
| 英文摘要: |
| Objective: To compare and analyze the amount of decoction pieces and active constituents in daily dosage for five kinds of Compound Danshen oral preparations in order to provide references for the comprehensive assessment of clinic use. Methods: The prescription, preparation, identification, inspection and the content determination indexes of these five preparations were extracted from the Chinese Pharmacopoeia (2020), and the differences and similarities were analyzed by calculating the amount of decoction pieces and chemical constituents in daily dosage. Results: The formula of Compound Danshen Dripping Pills was similar to that of the other four preparations, but the ratio of Salvia in the prescription was 1.6 times higher than that of the other four preparations. The dripping pill preparation method used aqueous alcohol extraction and sedimentation process for Radix et Rhizoma Salviae Miltiorrhizae and Radix et Rhizoma Notoginseng. The other four preparations were made by extracting Radix et Rhizoma Salviae Miltiorrhizae with ethanol and water step by step and concentrating. Then pulverized fine powder of Radix et Rhizoma Notoginseng mixedwith above concentrate and excipient. The quality control of all five preparations for the identification of Notoginsenosides and Borneol was collected by TLC. The chromatography fingerprint and assay of Tanshinol were performed for the Dripping pills, while assay for Tanshinone IIA, Salvianolic acid B, and total amount of notoginsenosides for the other four preparations were controlled. Except the Dripping pills, the quantity of decoction pieces in daily dose was 5.4 g. Tanshinol in daily dosage of the Dripping Pills was not less than 3.00 mg, and there was agreement on the lower limit of Salvianolic acid B and total amount of Notoginsenosides in the other four preparations. However, the quantity of Tanshinone IIA in Compound Danshen Granules was 2.17 times (3.9 mg/1.8 mg) than that of the tablets, concentrated pills and capsules. Conclusion: The prescription, preparation method, quality control items and clinical dosage of the other four oral Compound Danshen preparations are basically the same except for the Compound Danshen Dripping Pills. The differences in dosage, preparation process and active components between Compound Danshen Dripping Pills and the other four dosage forms are significant, suggesting that the characteristics of Dripping Pills should be paid particular attention in clinical use and the monitoring of the safe use of similar preparations should be strengthened. |
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