Study On Preparation Process And Quality Standard Of Huoxuexiaoying Tablet

Huoxuexiaoying tablet is a new compound preparation of pure Traditional Chinese Medicine, which consists of Semen Persicae, Rhizoma Curcumae and other six herbs. It has the function of promoting blood circulation, removing obstruction in collaterals and eliminating goiter, for the treatment of nodular goiter. This subject is guided by Traditional Chinese Medicine theory, application of modern technology and methods for the preparation process and quality standards, to ensure scientific and rational preparation, pharmaceutical is safe and effective quality control.1. Study on preparation processThe extracting process of volatile oil:with volatile oil extraction volume as evaluation indexes, inspected the amount of water, soaking time, extracting time on the effects of volatile oil extraction, using the orthogonal experimental method is used to extract technology conditions. The optimum extracting conditions were:with 8 times amount of water soaking 3 hours and using steam distillation extraction 6 hours.The inclusion process of volatile oil:with volatile oil inclusion rate as evaluation indexes, first we adopt single factor experiment, inspected theβ-CD:volatile oil (g:mL), temperature, time on the effects of volatile oil inclusion, determines the level of each factor value, reoccupy effect surface method optimization inclusion process conditions. The optimum inclusion conditions were:β-CD:volatile oil (g:mL)=6.8:1, inclusion temperature 47℃, inclusion time 2.2 hours. The water extraction process of plant medicine:with content of Amygdalin and extract yield as the evaluation indexes, inspected the amount of water, extracting time, extraction times, soaking time on the effects of water extraction, using the orthogonal experimental method is used to water extraction process conditions. The optimum water extraction conditions were: with 8 times amount of water soaking 0.5 hours, extracting 3 times, each time 1.5 hours.The purification process of water extraction liquid:with content of Amygdalin and extract yield as the evaluation indexes, inspected the ethanol precipitation and chitosan clarification of purification process, the effect of technology, and finally determined that liquid water extraction by chitosan clarify technical. The optimum purification conditions were:the total water extract as crude drug:water extraction liquid= 1:8, at 60℃water bath, according to 1.2 mL/g join 0.5% chitosan solution, mixing, make its dispersed homogeneously, keep warm by 5-10min and placed 12hours, then leach the supernatant of it.The drying process of water extraction fluid:with dry conditions in material as the evaluation index, inspected the excipients addition amount, relative density and richness into fluid speed, into wind temperature, out of air temperature, the influence of spray drying effect by single factor experiment method is used to spray drying process conditions. The optimum spray drying process conditions were:the relative density for 1.15～1.18 (60℃), add 10% dextrin, into liquid temperature 60～65℃, into fluid speed 45～55mL·min-1, into wind temperature for 160～170℃, out air temperature for 70～80℃, under the condition of 45HZ frequency atomizer spray drying.The ethanol extraction process of animal medicine:with extract yield and total nitrogen content as evaluation indexes, inspects ethanol concentration, extraction times, extraction time, add alcohol content on animal medicine alcohol extraction process, using the orthogonal experimental method influence selection ethanol-extraction process conditions. The optimum ethanol extraction conditions were:with 6 times the amount of 60% ethanol refluxing extraction two times, each time 1.5 hours.The molding process of preparations:The contrast experiment inspected the different thinners and dosage, wetting agents and dosage, lubricants and dosage of granulating and presser situation influence. The optimum ethanol extraction conditions were:the proportion of Raw materials:accessories= 6:1, with 20% of the total amount materials of 90% ethanol as wetting agents, soft material, granulating,60℃dry, pelletized, add 0.5% particles amount of magnesium stearate, blending, and presser, granule-coating.2. Study on quality standardStudy on TLC qualitative:identify the 4 species of crud drug Persicae, Rhizoma Curcumae, Radix Bupleuri and Semen Vaccariae in the preparation by TLC. Experimental results show that the product in reference substance chromatography corresponding control medicinal materials or position, all show the same color spots, and the negative control in the corresponding position is no interference. And after repeated experiments, the reproducibility is good.Study on content of HPLC determination:the preparations were determined by HPLC method of Amygdalin content, with 18 alkyl silane bonding silica gel as the filling agent; Mobile phase:methanol-0.1% phosphoric acid (80:20); Velocity 1.0 mL·min-1; Column temperature 30℃; detected wavelength 210nm. And the methodology, the results show that this investigation is rational and feasible, and good reproducibility, and can be used for the quality control of Huoxuexiaoying tablet.The content of Amygdalin is not less than 3.14 mg in each tablet.