The Study On The Preparation Technology And Quality Standard Of Guantong Capsule

Objective: Guantong capsule is a kind of traditional Chinese medicine compound preparations to prevent the restenosis after PTCA coronary heart disease.It composed of 8 traditional Chinese medicines,such as:panax notoginseng,Salvia miltiorrhiza,Ginseng,Dried tangerine peel,Trichosanthes fructus,Radix Ophiopogon,Earthworm,Gynostemma pentaphyllum.With a effect of promoting blood circulation and removing blood stasis,regulating qi and resolving phlegm,activating qi and other,it is expected to reduce the postoperative restenosis and improve the clinical symptoms,improve the quality of life.To facilitate patients to take and improve the bioavailability of drugs,the subject of Guantong capsule of preparation technology and quality standard were studied and established stable and controllable Guantong capsule preparation process and quality standards.Methods: This topic research to Guantong Decoction reliable effect in the clinic as well as the premise,to the theory of traditional Chinese medicine as a guide,and combined with the prescription drug nature of effective ingredients,the application of modern science and technology of Guantong capsule of preparation technology and quality standard system was studied.1.Research method of preparation technologyExtraction process: Radix notoginseng powder used as a medicine.The extraction experiment for Salvia miltiorrhiza and Ginseng was used with ethanol: to the transfer of Tanshinone?A and the extract yield as evaluationindex,using the single factor and L₉?3⁴?orthogonal experimental design,to study on ethanol concentration,extraction time,adding alcohol amount of times and extraction frequency.Ultimately we determine the optimal extraction technology of alcohol extraction.Other components of the prescription were extracted by water extraction and alcohol precipitation method: to the transfer of Hesperidin and the extract yield as evaluation index,using the single factor and L₉?3⁴?orthogonal experimental design,to inspect soaking time,extraction frequency,adding water amount of times and extraction time.Finally,the optimal extraction process of water extraction was choosed.To the reduction rate of extractum as evaluation index,using the single factor and L₉?3⁴?orthogonal experimental design,to observe and study the liquid ratio before alcohol precipitation,alcohol concentration of drug and time of repose,and the optimal extraction process of alcohol precipitation was choiced in the end.Preparation forming process: Using comprehensive score method and with forming rate,moisture absorption rate and angle of repose as the index,to inspect the effects of different excipients on the granulation and select the most appropriate.At the same time we studied different concentration of wetting agent,the dosage of wetting agent,the drying temperature of particles and critical relative humidity of particles.The forming process of Guantong capsules was selected at last.2.Research method of quality standardThe study examined the extraction and chromatographic conditions of Notoginsenoside R1,and the thin layer chromatography?TLC?was used for the qualitative identification of four kinds of medicines of Guantong capsule in Panax notoginseng,radix salviae miltiorrhizae,radix ginseng,dried tangerine peel.Used high performance liquid chromatography?HPLC?to determine thecontent of Notoginsenoside R1.And to examination the moisture in the preparation,the difference of filling quantity and disintegration time limit of Guantong capsule.Results:1.Results of preparation process research: The optimum extraction process of Salvia miltiorrhiza and Panax ginseng is that with the concentration of 90%ethanol for 1 time,with the solvent volume11 times amount and extraction time 1 hour each time,and use rotating apparatus to Concentrate to recycle ethanol.The best water extraction process is with water for 2 times,with the solvent volume 16 times,soaking 30 minutes and extraction time 2 hours each time.The optimal alcohol precipitation process was that concentrated to a liquid ratio of 1.1g/ml,liquid alcohol content of80%,enzymatic hydrolysis time 6h.The recovery of ethanol,to concentrate right amount,and use vacuum dryer to dry.Mixed Panax notoginseng Powder and extract powder,and added suitable amount of dextrin and micro silica gel,over sieve,then splashed 95% ethanol,pelletized by 24 mesh sieve,dry,encapsulate.2.Results of quality standard researchThe method of TLC was established for the qualitative identification of Panax notoginseng,radix salviae miltiorrhizae,radix ginseng,dried tangerine peel.With reference to the method for the determination of Notoginsenoside R1,the method of HPLC was established to test the contents of Notoginsenoside R1.And the results of the moisture in the preparation,the difference of filling quantity and disintegration time limit were in accordance with the requirements of the general rule of the Pharmacopoeia of the capsules.Conclusion: After a test screening,we determined the optimal preparation technology of Guantong capsule,developed the Guantong capsule qualitystandards,and established the Guantong capsule effective ingredients of TLC identification and content determination methods.