Study On Preparation Technology And Quality Control Of Compound Cistanche Granules

Objective:Prescription of compound Cistanche granules from the book of the Song Dynasty,"Family of Retirement and Friendship,"and the former Pharmacist is made up of Cistanche,Bacillus and other drugs.Most of them are powdered in medicine and they are inconvenient to carry and take.They are difficult to sanitize.Up to standard,low bioavailability of drugs;However,the granules can overcome the defects of inconvenient carrying and low bioavailability,and can retain the comprehensive curative effect of various components in the original medicinal materials,and conform to the characteristics of comprehensive Chinese medicines.In view of this,this study intends to change traditional pills into granules through modern extraction techniques and quality control techniques to better exert the advantages of traditional Chinese medicine.Methods:On the basis of single-factor experiments,the L₉?3⁴?orthogonal table design test was used to evaluate the content of total polysaccharides,total flavonoids,and extract yield of the compound,and then the optimum extraction process conditions were selected.By examining the physical properties of the extracts under different concentration and drying methods,the optimum concentration and drying conditions were determined.The mathematical model was used to evaluate the hygroscopicity of the particles prepared from the different excipients.The appropriate excipients were selected.Combined with the amount of excipients and the amount of wetting agent used,the optimum conditions of the molding process were selected based on the particle yield,molding rate,and hygroscopicity percentage.Comparing the antioxidation activities of compound Fuling granules and Qirongwan in vitro,the dissolution rate of total flavonoids in the same temperature and the same pH environment were investigated.To establish a method for the qualitative identification of Cistanche and Morinda officinalis in compound Bengrong granules,and to establish a quantitative identification method for the index components of the two herbs in the compound Bengrong granules by high performance liquid chromatography.Control Method.Results:1)The extraction process of the compound Cistanche granules was determined as follows:25 times volume of 5%ethanol solution,soaking for 40 min,reflux extraction three times,extracting for 120 min;the obtained extracts were combined and suction filtered;The preferred concentration and drying processes are as follows:a vacuum degree of 0.083 MPa,a rotation speed of 60 r/min,and a concentration of approximately 1.34 for extracting at a temperature of 70°C,and drying in a vacuum drying oven at a vacuum of 0.075 MPa at 60°C.That is,a dry extract of the compound extract.2)The best molding process for the compounded Cistanche granules was as follows:microcrystalline cellulose and dextrin were mixed at a ratio of 1:1 for particle diluent,drug-assisted ratio was 1:1,wetting agent 80%ethanol solution,and wetting dose For the drug-assisted total amount of 0.67 times,in this condition,the compound Zhu Rong particles molding rate of 94.15%,48 h moisture absorption rate of 5.62%,the relative critical humidity of 67%.3)Comparing the antioxidant activity of the compound Cistanche granules and Citrus grandis in vitro,the results showed that the compound Ruanrong granules with the same concentration?calculated according to the crude drug dosage?had higher DPPH free radical and hydroxyl free radical scavenging rate than Cistanche Pills.The iron-purification and potassium reduction power of Citrus reticulata granules is also higher than that of Citrus grandis pill;In the same temperature and pH environment,the dissolution rate of flavonoids in compound Cistanche granules with the same dose?calculated according to the crude drug dosage?in the same time period is much higher than that of flavones in Citrus pilosa.4)The TLC method was used to establish the identification method for Cistanche deserticola and Babatian thin layer in the compound Bengrong granules.The chromatographic conditions were as follows:Cistanche:Using acetic acid-methanol-water?1:2:7?as a developing agent,spread on a polyamide film,air dry,and examine at 365 nm;Morinda Officinalis:Toluene-ethyl acetate-formic acid?8:2:0.1?was used as developing solvent,developed on GF 254 silica gel plate,dried and observed at 365 nm.This test establishes a method for the determination of echinacoside and nifesi sugar in Fufang Rongrong granules.The chromatographic conditions are as follows:Echinacoside:The column was an Agilent ZORBAX SB-C18 column?250 mm×4.6 mm,5?m?with a mobile phase of methanol-1%acetic acid-acetonitrile?15:75:10?and a column temperature of 30°C.The volumetric flow rate was 0.6 m L/min and the measurement wavelength was 334 nm;Nextrose:The column was an Agilent ZORBAX SB-C18 column?150 mm×4.6 mm,5?m?,the mobile phase was methanol-water?3:97?,the column temperature was 25°C,and the volume flow rate was 0.8m L/min.ELSD parameters Drift tube temperature is 80°C,atomization temperature is 50°C,and gain is 1.0.Conclusion:The extraction process of the compound Cistanche granules screened in this experiment is stable and reliable.The optimized molding process can provide the theoretical basis for the preparation of the compound Cistanche granules.To study the antioxidative activity in vitro of compound Fuling granules and Qirongwan can be concluded:The anti-oxidation activity of compound Cistanche granules at the same concentration?calculated according to the crude drug dosage?is much greater than the anti-oxidation activity of Citrus grandis in vitro.Under the same circumstances,the dissolution rate of flavonoids in compound Cistanche granules is much higher at the same time.The dissolution rate of flavonoids in Yurongrong Pills is related to the antioxidative activity in vitro of Citrus grandis granules.The above experimental data provide a theoretical basis for the research group to study the efficacy of the compound Bengrong granules;the qualitative and quantitative identification methods initially established in this experiment can scientifically and effectively control the quality of the compound Bengrong granules,and further establish the quality standard for the follow-up.Provide theoretical basis.