Preparation Of Panax Notoginseng Saponin Enteric-coated Pellets Saponin Enteric-coated Pellets

Panax notoginseng saponins（PNS）has a significant effect in the treatment of severe chronic cardiovascular and cerebrovascular diseases[1-2].At present,in China,it has been found that preparations given by a variety of oral drugs are susceptible to damage by the gastric acid environment,leading to human bioavailability.The degree is low,and the frequency of medication is frequent,and the preparations administered by injection make the patient’s compliance poor when taking the medication,and it is easy to cause the phenomenon of drug allergic reaction[3-4].The results of pharmacological studies show that PNS has good digestion and absorption in the small intestine[5].Compared with the release characteristics of ordinary capsules,microcapsules have the characteristics of dose dispersion,stable performance during release,prevention of sudden release of doses,drug release,etc.,which can effectively reduce individual differences in drugs,improve the bioavailability and stability of drugs In this study,it is planned to make panax notoginseng saponins into enteric-coated pellets,so that panax notoginseng saponins can exert their medicinal effects in the small intestine,avoid destruction in the environment of gastric juice,and improve the bioavailability of drugs.The main contents of this paper include the following parts:1.Study on the preparation of panax notoginseng saponin pellets by extrusion spheronizationIn this experiment,the single factor test was used to select the roundness,yield and comprehensive score as the inspection indicators,and the sieve plate aperture,the prescription drug load,and the auxiliary materials were investigated.The preparation process parameters were initially selected,and it was finally determined to use0.6mm.The sieve plate with an aperture has a drug loading capacity of25%and is supplemented with microcrystalline cellulose and lactose.Based on a single factor,orthogonal process experiments were used to optimize the preparation process parameters.The optimal process parameters for extrusion spheronization were determined as:extrusion speed 54r·min^-1,spheronization speed 900r·min^-1,and spheronization time 4min.2.Study on preparation of panax notoginseng enteric-coated pellets by fluidized bed methodThe above drug rates for this topic are research indicators.The types of pellet cores,the concentration of binders,the amount of talcum powder,and the amount of glyceryl monostearate were studied.The barrier layer and Weight gain of the enteric layer.The results determined that the type of pellet core was microcrystalline cellulose pellet core,the amount of binder was 2%,the amount of talc was 40%relative to HPMC,the amount of glyceryl monostearate was 5%,and the weight of the barrier layer was increased by 5%.It is appropriate that the enteric layer gains 20%.3.Study on process parameters of fluidized bedIn this project,single-factor experimental method was used to screen the process parameters of the fluidized bed preparation of pellets.Based on the yield index,the inlet air volume was determined to be 11～12m³/h,the material temperature was 40～45℃,and the atomizing pressure It is 0.8 bar.At the same time,the drying time of the pellets was screened and the drying time was determined to be 2h.4.Study on Physicochemical Properties of Raw Materials of Panax Notoginseng SaponinsThe subject studied the physical and chemical properties of the extract of Panax notoginseng saponins,including p H,solubility,and solubility.The results showed that the aqueous solution was weakly acidic and its solubility was 238.53 mg in a p H 7.4 buffer ml^-1.The solubility in methanol is 227.01 mg·ml^-1.5.Study on the quality of enteric-coated pelletsIn this project,a method for the determination of 5 active ingredients in panax notoginseng saponins was established by UPLC.The method only required 11 minutes to complete the determination,and the measurement time was significantly shorter than that required by a method in the 2015 edition of the Chinese Pharmacopoeia.The analysis and detection efficiency is improved,and the method is simple,accurate,and repeatable.It can be used for the determination of five saponin components in Panax notoginseng saponins pellets.In this project,a thin-layer chromatography identification method for panax notoginsenoside R1,ginsenoside R1,ginsenoside Re,ginsenoside Rb1,ginsenoside Rd1,and panax notoginsenoside R1,ginseng was established The content determination method of saponin R1,ginsenoside Re,ginsenoside Rb1,and ginsenoside Rd1 was carried out,and the methodological investigation was carried out.At the same time,the properties and loading differences of this preparation were checked.The results show that the standard is simple and easy to implement,and control the quality of the preparation effectively.