Study On Preparation Process And Quality Standard Of Compound Lipid-lowering Chewable Tablet

Eucommia ulmoides Oliver,also known as Si Xian,Si Zhong,etc.,is the famous single family of deciduous arbors.It is the "living fossil" behind the second century glacier movement left.So it was widely studied,and by income the "Shen Nong's Materia Medica" among.At present,many countries to energetically promote the development of wood-based oil industry,Eucommia seed kernel is a good quality woody fuel resources and food with the resources,including the protein,the fat and the other physiological active ingredients are very rich.Eucommia can not only be used as a medicine in modern research,but also can be used as health products or functional foods.Eucommia male flowers and Eucommia seed oil has a variety of pharmacological activities,such as protecting liver,reinforcing kidney,strengthen muscles and bones,catharsis,sedative drugs,down three high etc.,and using many of the clinical.It is very valuable research of Chinese herbal medicine.The results of this paper are as follows:1.Investigation on Preparation of ?-Cyclodextrin from Eucommia Seed OilIn this paper,the inclusion rate and yield of Eucommia seed oil were standard.The single factor experiment was used to select and optimize the inclusion process of Eucommia seed oil.The effects of saturated aqueous solution method and grinding method on the inclusion rate and yield of ?-cyclodextrin inclusion compound Eucommia seed oil were compared.The ?-cyclodextrin inclusion complex was disassembled by Soxhlet Extraction.The phase was identified by infrared spectroscopy,differential scanning calorimetry and differential scanning thermogravimetric analysis.The results show that ?-cyclodextrin has been completely formed after the addition of Eucommia seed oil,and the inclusion complex has been successfully applied.2.The choice of adhesives,lubricants,flavoring,respectivelyThe optimum formulation was as follows: 80% syrup as binder,milk powder as flavoring agent,stearin Magnesium as a lubricant by single factor experiment.3.Study on quality standard of compound lipid-lowering chewable tabletsIn this paper,according to the requirements of 2015 edition of "Chinese Pharmacopoeia",the compound lipid-lowering chewable tablets were tested for heavy metals,arsenic salts,moisture,tablet weight,hardness and microbiological limits.The inspection results were in accordance with the relevant regulations.The content of geniposide,chlorogenic acid,aucubin,geniposide and carbohydrate were determined by high performance liquid chromatography(HPLC).The results were analyzed by gas chromatography(GC)-linolenic acid content,and the methodological validation,the two methods of linearity,repeatability,stability,precision,sample recovery rate test are more consistent with the relevant provisions.According to the measured content of compound lipid-lowering chewable tablets,the compound of Euphorbia triterpenoids(chlorophyll,geniposide,aucubin,geniposide),chlorogenic acid,?-linolenic acid content limit: each containing iridoid terpenoids(with aucubin,geniposide,geniposide,asperuloside),a total of less than 2.0 mg,Each piece of chlorogenic acid,not less than 0.16 mg,each containing Eucommia seed oil to ?-linolenic acid,not less than 28.0 mg.4.Study on the stability of compound lipid-lowering chewable tabletsIn this paper,the accelerated stability test(40?±2?,RH75%±5%)was carried out in oral solid medicinal high density polyethylene bottle(50 pieces / bottle,1g each).At 0,1,2,3 months fixed time sampling,inspection of the quality of the provisions of the main content.The results showed that water content,tablet weight difference and content of the three batches.The results of accelerated stability test showed that the content of ?-linolenic acid in Eucommia oil was not significantly decreased.Long-term stability testing remains to be studied.