当归丹参滴丸的成型、滴制工艺及质量标准
摘 要
冠脉供血不足，心肌出现急性或短暂的缺血和缺氧，会导致患者出现一种症状，称为冠心病心绞痛。当归丹参滴丸是湖北医学院二院长期临床运用的一种有效方法，它是由当归和丹参配伍而成，经过多年的临床实践证明，它在治疗冠状动脉粥样硬化时起效快，效果可靠，但是它的口服给药方法很不便利，因此，我们将它开发为一种新型的“中药滴丸”，它不仅可以快速起效，而且还可以起到快速的治疗效果，而且还可以增加它的稳定性。
本文对该制剂的提取、成型工艺进行了优选，并制备了当归丹参滴丸，考察了滴丸的稳定性，制定了滴丸的质量标准，最后进行了相关的毒理药理研究。研究结果表明，当归丹参滴丸在治疗冠心病心绞痛方面疗效确切，便于服用，有极好的应用开发前景。
关键词：当归丹参滴丸；成型工艺；滴制工艺；质量标准
Abstract
Inadequate coronary blood supply and acute or transient myocardial ischemia and hypoxia can lead to a symptom called coronary heart disease and angina. Danggui Danshen Dropping Pill is an effective method for long-term clinical use in the Second Hospital of Hubei Medical College. It is a combination of Danggui and Danshen. After years of clinical practice, it has proved that it has a fast and reliable effect in the treatment of coronary atherosclerosis, but its oral administration method is very inconvenient. Therefore, we have developed it into a new type of "traditional Chinese medicine dropping pill", which can not only take effect quickly, And it can also have a rapid therapeutic effect, and can also increase its stability.
In this paper, the extraction and molding process of the preparation were optimized, and Danggui Danshen dropping pills were prepared. The stability of the dropping pills was investigated, and the quality standards for the dropping pills were established. Finally, relevant toxicological and pharmacological studies were conducted. The research results show that Danggui Danshen Dropping Pill has a definite therapeutic effect in treating coronary heart disease and angina pectoris, which is easy to take, and has an excellent application and development prospect.
Key words: Danggui Danshen Dropping Pills; Forming process; Dropping process; quality standard
目 录
摘 要 I
Abstract II
目 录 III
引 言 1
第1章、当归丹参滴丸的成型工艺研究 2
1.1、 成型工艺因素的筛选 2
1.1.1药液的配制 2
1.1.2基质的选择 2
1.1.3冷凝剂的选择 2
1.1.4料温的选择 2
1.1.5冷凝柱管口温度的选择 2
1.2、成型工艺的选择 2
第2章、 当归丹参滴丸的滴制工艺研究 6
1.1、滴制工艺因素的筛选 6
1.1.1冷凝液温度的选择 6
1.1.2滴头口径的选择 6
1.1.3滴距的选择 6
1.1.4滴速的选择 6
1.2、滴制工艺的选择 6
第3章、当归丹参滴丸的质量标准 8
1.1、性状 8
1.2、色谱鉴别 8
1.2.1当归鉴别 8
1.2.2丹参鉴别 8
1.3、检查 8
1.4、功能与主治 9
1.5、用法与用量 9
1.6、规格 9
1.7、贮藏 9
结 论 10
参考文献 11
摘 要
冠脉供血不足，心肌出现急性或短暂的缺血和缺氧，会导致患者出现一种症状，称为冠心病心绞痛。当归丹参滴丸是湖北医学院二院长期临床运用的一种有效方法，它是由当归和丹参配伍而成，经过多年的临床实践证明，它在治疗冠状动脉粥样硬化时起效快，效果可靠，但是它的口服给药方法很不便利，因此，我们将它开发为一种新型的“中药滴丸”，它不仅可以快速起效，而且还可以起到快速的治疗效果，而且还可以增加它的稳定性。
本文对该制剂的提取、成型工艺进行了优选，并制备了当归丹参滴丸，考察了滴丸的稳定性，制定了滴丸的质量标准，最后进行了相关的毒理药理研究。研究结果表明，当归丹参滴丸在治疗冠心病心绞痛方面疗效确切，便于服用，有极好的应用开发前景。
关键词：当归丹参滴丸；成型工艺；滴制工艺；质量标准
Abstract
Inadequate coronary blood supply and acute or transient myocardial ischemia and hypoxia can lead to a symptom called coronary heart disease and angina. Danggui Danshen Dropping Pill is an effective method for long-term clinical use in the Second Hospital of Hubei Medical College. It is a combination of Danggui and Danshen. After years of clinical practice, it has proved that it has a fast and reliable effect in the treatment of coronary atherosclerosis, but its oral administration method is very inconvenient. Therefore, we have developed it into a new type of "traditional Chinese medicine dropping pill", which can not only take effect quickly, And it can also have a rapid therapeutic effect, and can also increase its stability.
In this paper, the extraction and molding process of the preparation were optimized, and Danggui Danshen dropping pills were prepared. The stability of the dropping pills was investigated, and the quality standards for the dropping pills were established. Finally, relevant toxicological and pharmacological studies were conducted. The research results show that Danggui Danshen Dropping Pill has a definite therapeutic effect in treating coronary heart disease and angina pectoris, which is easy to take, and has an excellent application and development prospect.
Key words: Danggui Danshen Dropping Pills; Forming process; Dropping process; quality standard
目 录
摘 要 I
Abstract II
目 录 III
引 言 1
第1章、当归丹参滴丸的成型工艺研究 2
1.1、 成型工艺因素的筛选 2
1.1.1药液的配制 2
1.1.2基质的选择 2
1.1.3冷凝剂的选择 2
1.1.4料温的选择 2
1.1.5冷凝柱管口温度的选择 2
1.2、成型工艺的选择 2
第2章、 当归丹参滴丸的滴制工艺研究 6
1.1、滴制工艺因素的筛选 6
1.1.1冷凝液温度的选择 6
1.1.2滴头口径的选择 6
1.1.3滴距的选择 6
1.1.4滴速的选择 6
1.2、滴制工艺的选择 6
第3章、当归丹参滴丸的质量标准 8
1.1、性状 8
1.2、色谱鉴别 8
1.2.1当归鉴别 8
1.2.2丹参鉴别 8
1.3、检查 8
1.4、功能与主治 9
1.5、用法与用量 9
1.6、规格 9
1.7、贮藏 9
结 论 10
参考文献 11
