| Uterine rectification is clinic ordinary disease. Many causes lead to the disease. So it is important to select drugs to help parturient recover. The purpose of this project is to research a safety,effective medicament that can prevent and cure the disease.Chanfukang keli is made up of Radix Astragali, HerbaLeonuri, Angelica sinensis, Radix Rehmanniae, Herba Agrimoniae, and Fructus Aurantii etc. It has the actions of nourishing qi, enriching the blood and activating blood circulation to dissipate blood stasis. The Granules ofresearch was based on the clinical soup dosage. This project mainly deals with the preparation procedure,quality standard and stability of the prepration.Angelica sinensis and Rhizoma chuanxiong has the same content ferulic acid and Ligustilide which is unstable. The effective content of Herba Agrimoniae has good solubility in ethanol. We extract them with ethanol. The optimum extraction process of Angelica sinensis, Herba Agrimoniae, Rhizoma chuanxiong was investigated by L9(34) orthogonal experimental design as the ferulic acid content index. The concentration ethanol, amount of ethanol, extraction time and extraction times was the four factors in experiment. The optimum extraction process was as follows: was extracted with 70% ethanol for 2 times, with the solvent volume 8 times amount and extraction time 2h each time.The optimum extraction process of Radix Astragali, Herba Leonuri, Radix Rehmanniae, Fructus Aurantii was selected with the L9(34) orthogonal experimental design as the astragaloside IV and sugar content index. The final process was as follows: 10 times amount of water for 3 times, and extracting for 2 hours each time.We investigate the effect of chitosan on the content of astragaloside IV and sugar in the process of clarifying water decoction and do the L9(34) orthogonal experimental. The optimum clarifying condition was as follows: the concentration of chitosan was 5%, density 1. 07g .ml-1 and PH 4. 5.The method of fluid bed granulation can simplify the procedure and reduce the damage of drugs and shorten the work time. To select the best conditions for fluid bed granulation, orthogonal experimental design L9(34) was done. The results of the study were that the blast temperature and the aeration temperature were notable effect. The optimum process: the rate of spraying was 30g/min, the spraying press was 2.1kg, the blast temperature was 100±2℃ and the aeration temperature was 40±2 ℃.To improve the process, the other three batches drugs were done .The result showed that the batches were good and showed that the process was feasible.In the quality control study, TLC was used for identification of Herba Leonuri, Herba Agrimoniae,and Fructus Aurantii. These methods of TLC were simple, rapid and with a good reappearance, and available for quality control of the preparation. The content of astragaloside Ⅳ was determined by HPLC-ELSD. The linear range of astragaloside Ⅳwas 0.336-2. 016μg, γ=0.9994.The average recovery was 95.90% and RSD was 1.2%. It was limited that the content of astragaloside Ⅳ wasn't lower than 0. 57mg per bag. The method is simple and accurate. It can be used for quality control of Chanfukang Keli.Finally the stability of the preparation was investigated. The result showed that these drugs were stable. |
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