The Preparation And Study On Quality Standard Of Xianglian Suppository

ObjectiveThe purpose in this dissertation was to prepare the Xianglian Suppository and establish its quality standard, and study its preliminary stability research.Methods1. we prepared the Xianglian Suppository by fusion method. The preparation process were performed by using odd factor design method, including the varieties of bases, the precipitated temperature and the quantity of Tween-80, ect. And then, the optimal formula was seleeted by using orthogonal design. Finally, we studied the dissolution experiment of Xiangliam Suppository by paddle method and determined the total alkaloids in the xianglian suppository by UV.2. About the study of quality standard, we indentified four Chinese herbs in Xianglian Suppository by TLC and determined the contents of the allylguaiacol and berberine hydrochloride in Xianglian Suppository by HPLC.3. In the preliminary stability research, we investigated the effect of influencing factor test and accelerated test of Xianglian Suppository. The influencing factor included illumination and humidness and accelerated test was kept on 3 months under the conditions of temperature (30±2)℃and relative humidity (65%±5%).Result1. The optimal formula of xianglian Suppository was the following:the ratio between extractum and base was 1:3, the ratio between semi-synthetic fatty acid glyceride and the sum of beeswax and S-40 was 16:1, the ratio between beeswax and S-40 was 2:3. And then, the analytic method for researching the dissolution and determination of total alkaloids of Xianglian Suppository was established, in which the regression equation was A=93.2234C-0.0034, with r=0.9998. It revealed that the absorbance and the concentration reflected good linear relations.2. we have indentified four Chinese herbs which were caryophyllus, coptidis rhizome, agastache rugosa and radix gentianae in xianglian suppository by TLC. And then we established the standard curves of allylguaiacol and berberine hydrochloride by HPLC, which the regression equations were Y= 1262482.39X-11937.34 and Y= 1719899.01X-18794.53 respectively. They reflected good linear relations in 0.03～1.09μg and 0.024～0.960 u g respectively.3. Under the high huminity (90%±5%), the weight of Xianglian Suppositories were out of regulation and Under the high huminity(75%±5%), the contents of allylguaiacol and berberine hydrochloride in the Xianglian Suppository were decreased about17%and 10% respectively. Under the illumination(4500500) LX, the contents of allylguaiacol and berberine hydrochloride were decreased about 18% and 10% respectively. In the accelerated test, the contents of allylguaiacol and berberine hydrochloride were decreased about 10% and 5% in the first month,15% and 8% in the second month and 30% and 12% in the third month respectively.Conclusion1. The preparation technology of Xianglian Suppository was reasonable and available. Meanwhile, the optimal formula was proof to be stable and reliable and the preparade Xianglian Soppository had uniform color, modicus hardness and smooth appearance.2. The identification of TLC of four Chinese herbs had clear spots and the reproducibility was nice, so it can be used to set up quality standard. At the same time, the determination of contents of allylguaiacol and berberine hydrochloride in the Xianglian Soppository by HPLC had accurate result, high sensitivity and nice reproducibility, and it also can be used to set up quality standard. Finally, according to determining results of batches of samples, we tentatively defined that the contents of allylguaiacol and berberine hydrochloride in the Xianglian Soppository were not less than 7.6mg and 3.5mg respectively in each granule (1.6g).3. Under the condition of illumination(4500±500)LX and humidity (90%±5%), the xianglian suppository was instability. So it should be conserved in the cryodrying.The result of accelerated test has indicate that the allylguaiacol and berberine hydrochloride were instability under the conditions of temperature (30±2)℃and relative humidity(65%±5%) and we should study its stability by Long-term stability test...