Establishment Of Production Process And Quality Standard Of Sanghuang Granules

Inonotus hispidus（Bull.）P.Karst.is a fungal medicinal material of Hymenochaetaceae,Inonotus,which is considered as the main source of traditional Chinese medicine’Sanghuang’in China.It contains a variety of active ingredients and has more pharmacological activities.Although Sanghuang has a long history of treating diseases in China,but its market development speed is relatively slow,the main reasons are the insufficient depth of research on its material basis and the singleness of product reserach and development.In the paper,first the progress of pharmacological activity of Sanghuang and granulation technology of traditional Chinese medicine was reviewed by consulting literature.Then the experimental part includes the determination of the best preparation process of Sanghuang granules,the formulation of quality standards,acute toxicology and immune activity experiments.The determination of the best production process of Sanghuang granules The best production process of Sanghuang granules was determined by using the fruiting bodies of Inonodus hispitus as the main raw material.The research and development of pharmaceutical preparations and the determination of quality standards of preparations were in line with the needs of the current development of Sanghuang industry.The determination of the best production process of Sanghuang granules,With Sanghuang as the raw material,xylitol as the excipient,the ratio of raw materials（A）,ethanol concentration（B）and ethanol dosage（C）as the investigation factors,the number of molding particles was determined by orthogonal test,and the variance analysis was carried out.The results showed that the optimum production process conditions were as follows,the ratio of raw materials was 8:5,the volume fraction of ethanol was75%,and the amount of ethanol was 40 m L.The molding process of Sanghuang granules was optimized,and three batches were produced at the same time.The process was verified,and the production process was stable and reliable.The establishment of quality standards for Sanghuang granules The Sanghuang granules were identified by thin layer chromatography.Sanghuang granules and standard substances showed the same spots at the same position.The contents of polysaccharides,triterpenes,sterols and polyphenols were measured by standard curve method,which were not less than 42.69μg/mg,15.85μg/mg and 12.73μg/mg,respectively.Other inspection items such as moisture,particle size and loading difference all met the relevant provisions under the general rule 0104 granules of the2020 edition of Chinese Pharmacopoeia,and the quality standard of Sanghuang granules was formulated.Acute toxicity experiment of Sanghuang granules 32 Kunming mice were selected,half male and half female,were divided into blank group and Sanghuang granules group.The mice were given intragastric administration for 15 days,and the changes of body weight,food intake and water intake were recorded,and the organ indexes of heart,liver,spleen,lung,kidney and thymus were calculated.The results showed that the mice in the administration group of Sanghuang granules were in good condition,and the food intake and water intake were normal.It was observed that there were no abnormalities and lesions in the organs of the mice in the blank group and the administration group,and the mice did not die.The LD₅₀ could not be measured,indicating that Sanghuang granules were non-toxic,indicating that they were safe and had the potential to be developed and utilized as raw materials for drugs and functional products.Immune activity experiment of Sanghuang granules 72 female KM mice were divided into 9 groups,8 in each group.The feeding temperature was（22±2）°C,the relative humidity of the environment was 50%-60%,and the diet was normal.After 3 days of adaptation to the environment,the mice were random Ly divided into blank group（normal group）,model group（cyclophosphamide）,positive group（levamisole hydrochloride,40mg/kg）,sample group（Sanghuang granules,sanghuang ultrafine powder and Sanghuang 80 mesh powder high dose,low dose group）.Except for the blank group,the other groups used cyclophosphamide to replicate the immunodeficiency mouse model.From the day of intragastric administration of cyclophosphamide,the model group was not administered,the positive group was intragastrically administered with 40 mg/kg levamisole hydrochloride every day,and the high and low dose groups of Sanghuang granules,Sanghuang ultrafine powder and Sanghuang powder（80 mesh）were intragastrically administered daily.The doses were3198 mg/kg and 799.5 mg/kg,respectively.After 18 days of continuous administration,all the rats were sacrificed on the 19th day.The blood was taken from the inner canthus,dissected,and the spleen,thymus and liver were weighed and recorded.The spleen index,thymus index and liver index were calculated.At the same time,the levels of serum immune factors IL-2,IL-4,Ig A and IFN-γwere detected.The results showed that Sanghuang granules,Sanghuang ultrafine powder and Sanghuang powder（80 mesh）could enhance the immune function of mice.Anti-inflammatory activity experiment 42 mice were divided into 7 groups.6mice in each group were used for ear swelling experiment.The right ear of each mouse was coated with 100μL xylene,and the left ear was used as control.One hour later,the cervical vertebra was dislocated and sacrificed.Two ears were cut off along the baseline of the auricle,and round ear slices were laid at the same site with an 8mm diameter puncher and weighed accurately.The weight difference between the two ears was used as the swelling index,and the swelling inhibition rate was calculated.The results showed that Sanghuang products had an inhibitory effect on ear swelling caused by xylene,and the inhibitory effect was proportional to the dose.In a word,Sanghuang granules with Sanghuang as the main raw material were developed for the first time.The acute toxicology and immune activity experiments were carried out,and the quality standard of Sanghuang granules was established,which provided a basis for the subsequent pilot test and expanded production of Sanghuang granules.