Then Plug The Particles Preparation Process And Quality Standards

Bian Se-tong preparation is aimed at treating senile constipation under the instruction of traditional Chinese medicine theory. It derives from the ancient medicine ZhiShu pill(On Spleen and Stomach) and is made from Baishu, Zhishi, Dihuang and Heye. It has an effect on senile constipation caused by deficiency of vital energy and blood, indigestion and congestion of intestines and stomach. Bian Se-tong preparation is worth researching and marketing due to its prominent effect in practice. Making use of modern pharmacy technology, this project studies systematically on the extracting method, quality standard and preliminary stability of Bian Se-tong preparation according to theory of traditional Chinese medicine and regulations of medicine registration.Taking the function of the prescription and qualities of medicine ingredient into consideration, orthogonal test method is adopted into and the most optimal conditions are as follows: distilling Baishu, zhishi with 8 times water for 4 hours to get its volatile oil. Circulating ultrasonically every 1mL volatile oil with 6 times B-cycoldextrin and 72mL water for 30 minutes, and then putting it in refrigerator for 24 hours to get its filtered liquid, Drying it in 40℃for 5 hours . grinding it and sieving it for preparation. Decocting the residue of Baishu and Zhishi after extracating volatile oil and other medicine with 8 times water for two times, each time being 1.5 hour to get its filtered liquid. Combining the filtered liquid with the liquid after extracting volatile oil. Concentrating the mixture to relative density of 1.05(60℃). centrifuging in 12000r/min for 10 minutes. Decompressing and concentrating to relative density of 1.08-1.10(60℃) in 70℃. spraying and drying the concentrated liquid in condition of input temperature 60c, liquid density 1.08-1.10(60℃), input speed 110-120mL/min, temperature of input and output wind 200-210℃, 100-110℃respectively to get the powder. Adding B-cyclodextrin inclusion compound and other stuffs in the powder, making it granule and packing it.Study the quality standards of three samples to chose the best one, including their properties, identification, granule, dissolving ability, pack capacity, content, limitation of microorganism and arsenic salt and heavy metal. Based on the research results above, regulate that Synephrine in each pack should be no less than 10.2mg.Study the samples in aluminum foil pack in 18℃-30℃, relative humidity 50%-80% in 0 month, 1 month, 2 months and 3 months respectively according to the quality standard. The result show that its preliminary stability is good in 3 months in aluminum foil packs.Conclusion: this preparation is scientific, feasible and practical and its quality standards are stable and controllable.