The Pharmaceutical Research Of Ganxinping Granules

Coronary artery Heart Disease is a form of Myocardial Ischemia (insufficient blood supply to the heart muscle) caused by a decreased capacity of the coronary vessels. Angina is the most common clinical manifestation of Coronary artery Heart Disease and may accompany by arrhythmia. Severe Coronary artery Heart Disease may cause heart-failure, myocardial infarction and sudden cardiac arrest. During the treatment, the long-term using of chemicals tends to cause adverse reactions and tolerance, and there also many contraindications to these chemicals, so chemical medication have limitations.The prescription of Guanxin-ping granule was a proved effective recipe that has been used for many years in the treatment of Coronary artery Heart Disease by the famous doctor of Traditional Chinese Medicine——Li Qi-yi.The recipe was made up of Rhizoma Polygonati Praeparata, Radix Et Rhizoma Notoginseng, Radix Angelicae Sinensis, Pericarpium Trichosanthis, Radix Et Rhizoma Nardostachyos. This project is to study preparation technology, quality standard and stability of Guanxin-ping granule according to the demands of new preparations for Traditional Chinese Medicine.Preparation Section:According to the theory of Traditional Chinese Medicine and the physicochemical property of the active ingredient, preparation process has been designed.1. The extracting technology of Rhizoma Polygonati Praeparata has been evaluated by pharmacodynamic method. Using the extraction ratio of polysaccharides and the yield of n-butanol extaction as indexes, extracting method of Rhizoma Polygonati Praeparata has been optimized. The results show that the pharmacological effects of the extraction are declined after refined by alcohol precipitation. So Rhizoma Polygonati Praeparata is unfit to refine by alcohol precipitation after extracted by water. The optimized extraction technology is:extracting 3 times, using 8-fold volume of water for 0.5 hour each time.2. The distilled oil of Radix Angelicae Sinensis and Radix Et Rhizoma Nardostachyos have been extracted by steam distillation method. Using the volume of distilled oil and ferulic acid content in the extraction as indexes, the extraction time has been made certain; Distilled oil have been included by P-cyclodextrin. Using the inclusion percentage as the index, possible factors affecting the inclusion procedure have been investigated by single factor experiments, and then the technology has been optimized using orthogonal design. The result is:1mL distilled oil being resolved in 4 times alcohol then dropping it into 10gβ-cyclodextrin's saturated water solution and stirring for 3 hours. The volume of solvent which used to resolve the distilled oil has significant influence on inclusion effect.3. Using the content of the ferulic acid as the index, extracting method of Pericarpium Trichosanthis, Radix Angelicae Sinensis and Radix Et Rhizoma Nardostachyos has been optimized. The result is:extracting 2 times, using 9-fold volume of water for 0.5 hour each time. 4. Using the extraction ratio of Notoginsenoside R1, ginsenoside Rg1 and ginsenoside Rb1 as indexes, extracting method of Radix Et Rhizoma Notoginseng has been optimized using uniform design method. The result is:extracting 1 time with 70% and 80% alcohol respectively, using 8-fold volume of 70% alcohol and 10-fold volume of 80% alcohol for 1 hour each time.5. Using the transfer percent of the ferulic acid and the dose of ethanol as indexes, the alcohol precipitation process of Pericarpium Trichosanthis, Radix Angelicae Sinensis and Radix Et Rhizoma Nardostachyos'water extracts has been studied. The result is:the temperature is 70℃, the vacuum is 0.08～0.09MPa, the relative density of the extrction is 1.10(determined under 60℃), adding alcohol to the extraction and making it a 60% alcohol solution, then letting it stand for 12 hours.6. Preparation process for the granule has been optimized.7. Pilot-scale experiments have been carried out using the stuied preparation process.Quality Standard Section:1. According to the Chinese Pharmacopoeia (edition2005), herbs used for preparation has been checked and identified.2. The identification methods of the herbs in the preparation have been established using TLC.3. The Determination methods of ferulic acid, Notoginsenoside R1, ginsenoside Rg1 and ginsenoside Rb1 have been established using HPLC.4. According to the general principles for granule, the preparation has been checked and the results met the requirement of Chinese Pharmacopoeia.Stability Section:The preliminary stability of the preparation has been studied.