| Ganoderma spore powder is a dry,mature spore of Ganoderma lucidum(Leyss.ex Fanch)Karst.or Ganoderma sinense Zhao,Xu et Zhang,which rich in a large number of active substances.As the main active ingredient of Ganoderma lucidum,Ganoderma lucidum polysaccharide can reduce blood sugar,blood fat,anti-oxidation and increase immunity.Broken Ganoderma lucidum spore powder is easier to be absorbed and utilized by the body than Ganoderma lucidum sporophore,and its medicinal value can be up to several times.Therefore,the production process,quality control,usage and dosage of Ganoderma lucidum spore powder have become the focus of research.In this study,we mainly researched the production process,quality control,usage and dosage of Ganoderma lucidum spore powder tablets with considering a variety of reasons,and drafted the quality control standard for Ganoderma lucidum spore powder.The main contents are as follows:1、Study on production process of Ganoderma Spore Ultrafine PowderThe raw materials were pulverized by the roller vibratory mill,and the influencing factors in the pulverization process were investigated by the determination of the wall breaking rate,extract and polysaccharide content of the ultrafine powder.The results showed that the optimum conditions can be expressed as pulverization for 90 minutes after the herbs were died for 2 hours.2、Study on quality control of Ganoderma Spore Ultrafine Powder(1)The characteristics,identification(microscopic identification,TLC identification),examination(impurities,moisture,total ash,Broken wall rate,peroxide value)and extract of Ganoderma spore powder pieces prepared in accordance with the relevant methods of Zhejiang province Chinese herbal medicine prepared in 2015 edition were determined.The results showed that the prepared slices of Ganoderma spore powder pieces were yellow-brown to purple-brown powder.The gas is slight and the taste is light;Microscopically,most of the spores were fragmented and brown.In TLC identification,the spots of the sample chromatography were the same as those of the reference chromatography,and the color was also the same,and the blank has no interference.The test of impurities did not detect the presence of mycelium,starch grains and other foreign bodies.Water is divided into 9.0%,The total ash is only 3.0%,The breaking rate must not be lower than 95.0%,The peroxide value is only 0.20;the leachate is not less than 5.0%.(2)The characteristic spectrum of glycerol trioleate of Ganoderma spore powder prepared by HPLC was determined and analyzed.The chromatographic conditions were as follows: Agilent 1100 HPLC system,Welch ultimatexb-c18(4.6?250mm,5μm),acetonitrile-isopropanol(51:49)as mobile phase,1.0 ml/min flow rate,and 1.7ml/min carrier gas flow rate.The detection results showed that there were ten Mark peaks in the characteristic spectrum,one fingerprint region was retained between 13 and 38 min,and the triglycerides were retained for 27.5min.The results showed that the method had good durability and precision.(3)The oil in the Ganoderma Spore Ultrafine Powder were determined by the ether extraction method,and the oil content of the ten batches were 27.5%、27.3%、27.1%、28.0%、27.9%、28.2%、30.8%、31.0%、30.6%、30.6% respectively;The polysaccharide content was determined by UV method.The results showed that the method had the characteristics of specificity,precision,stability(stability within 2 hours)and good repeatability.The linear relationship was A=0.00844X+0.0179,r=0.99919(n=5),and the average recovery was 110.1%.The contents of 10 batches of samples determined by this method were 1.01%,0.98%,0.99%,0.97%,1.00%,0.99%,1.24%,1.25%,1.23% and 1.23% respectively.3、Study on the usage and dosage of Ganoderma Spore Ultrafine PowderThe amount of polysaccharide eluted in the sample was determined by ultraviolets pectrophotometry,and the amount thereof can be obtained.The results showed that the amount of polysaccharides released from Ganoderma lucidum spore powder tablets in pH 4.5 phosphate buffer medium was significantly higher than that of pH 1.2 hydrochloric acid solution and pH 6.8 phosphate buffer solution,we could conclude the taking better after mealst.The boiling water scouring Ganoderma lucidum spore powder pieces and the traditional water decoction Ganoderma lucidum spore powder two preparation methods,the ratio of polysaccharide dissolution measured is 3:1,refer to the "Zhejiang Traditional Chinese Medicine Pieces Processing Specification 2015 Edition" Ganoderma lucidum spore powder to determine the decoction pieces the amount used is 2-4g.The dosage of drugs is related to its effectiveness and safety.However,the investigation found that the amount of broken Ganoderma lucidum spore powder in drug standards and specifications were not uniform.In this topic,we have determined the optimal production process of Ganoderma lucidum spore powder tablets after research,and then used a variety of methods to conduct quality control research,and finally developed a set of certain research basis for future research. |