| Objective:To Develop a Chinese herbal compound preparation "xiang gui soft capsules" for the treatment of dysmenorrheal due to stagnation of qi and blood stasis and study the preparation technology, quality standards, formulation stability, pharmacodynamics. Methods:The prescription of capsule shell,parameters of the extraction of volatile oil and alcohol extract were optimized through orthogonal experiment; the prescription of content and the dosage of antiputrefactive were optimized through parallel experiment. All prescription drugs were identified by TLC;the content of peoniflorin was determined by HPLC.The preliminary formulation stability was investigated and the study of pharmacodynamics were undertaken. Results:Volatile oil was extracted;the gruffs and other herb were extracted with70%alcohol. The soft capsules were made of the extraction combined with volatile oil and adjuvant.The qualitative identification and determination can be carried out according to the quality criteria;the preliminary formulation stability was good.It showed obvious effect of anti-inflammatory, analgesia, activating blood circulation to dissipate blood stasis,et al. Conclusion:Parameters of preparation technology is reasonable, quality and method is reliable, preparations are stable and effective. |
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