Apply And Research Of Ultrafine Grinding Technology Used In Praeparatum Craft Of San Jie-zhen Tong Capsules

Sanjie-Zhentong Capsule is an Chinese medicine compound preparations composed of four herbals including Resina Draconis,Panax Notoginseng,Chekiang Fritillary Bulb and Coicis Semen,which can soft lump loosen knot,resolve the hard lumps and relieve the pain.Sanj ie-Zhentong Capsule is used for endometriosis(EMs)and secondary dysmenorrhea,irregular menses,pelvic bag piece and infertility that are cuased by EMs.It got the new drugs certificate at 2004,after about ten years market promoting,because of its exact clinical curative effect,it had became one of the characteristic traditional Chinese drug used for EMs.The mian task of this topic is based on Sanj ie-Zhentong Capsule,connect with its original producing craft,use ultrafine grinding in its process of production.In the experiment,we first made some ultra fine grinding research on the single drug in the prescription of Sanj ie-Zhentong Capsule.Based on the finding,we determine the ultrafine grinding craft for the single drug Prepare Sanj ie-Zhentong Capsules based on ultrafine grinding craft,and compared with the capsules prepare by original craft,we made comparative study on its dissolution in vitro and pharmacodynamics.At last,we establish a quality standard,which is a ground-plan,for Sanj ie-Zhentong Capsules prepared by ultrafine grinding craft.That provide science support for the quality controlling of Sanj ie-Zhentong Capsules prepared by ultrafine grinding craft1.The ultrafine grinding research on the single drug.We made some ultrafine grinding research on the single drug in the prescription of Sanjie-Zhentong Capsules,which including general physical properties,which was including apparent characteristics,bulk density,flowability,extractive,moisture content,hygroscopicity and so on,and dissolution.We discovered that because of the diminution of particle diameter,the general physical properties of the single drug were changed.Along with the diminution of the particle diameter,the powder appeared aggregation gradually and the colour for the powder was shallowed,the grainy was disappeared;the flowability was variation;the content of the extractum and water was increased;the hygroscopicity was strengthen.But the results for the dissolution were different.According to the dissolution and its fitting results,we find that after being ultrafine grinded,the dissolution of the fine powder of Resina Draconis was improved as the diminution of particle diameter,and the dissolution parameter,such as T50,Td and T90 was decreased.It manifested that the use of ultrafine grinding technique was useful for Resina Draconis.However,the results of comparition for dissolution of fine powder and superfine of Panax Notoginseng and Cheking Fritillary Bulb were differert.After use ultrafine grinding technique,the dissolution of the superfine were not improved obviously,and the components in the drugs can get dissolution equilibrium in short time,and the dissolution parameter,such as T50,Td and T90 had small difference.Because of the olein in Coicis Semen,it is inconcinnity to pulverize it alone,so we did not make ultrafine grinding research on Coicis Semen.The results above aolse indicated that the use of ultrafine grinding technique in different drugs should analyze on the basis of extensional conditionAccording to the ultrafine grinding research on the single drug,we determined the ultrafine grinding craft of Sanjie-Zhentong Capsules.In the ultrafine grinding craft,the principal drug,which is Resina Draconis,should be pulverized use ultrafine grinding technique,the drugs last still use the original craft2.The comparison research of Sanjie-Zhentong Capsules prepared by two craftsWe get the Resina Draconis superfine of different particle diameter by using FDA airflow mill to pulverizate the Resina Draconis fine powder for different time.Combine the Resina Draconis superfine of different particle diameter with other drugs in the prescription of Sanjie-Zhentong Capsules;put the combined powder into capsule,we get the Sanjie-Zhentong les prepared with Resina Draconis superfine of different particle diameter.We compared the dissolution of Sanjie-Zhentong Capsules prepared with Resina Draconis superfine of different particle diameter.The results showed that when the particle diameter of Resina Draconis superfine was smaller,the dissolution of the capsules was better.When the dissolution was best,the the particle diameter of Resina Draconis was 13.06 μm.There was no improvment for the dissolution as the diminut of the particle diameter of Resina Draconis superfine.At last,we made the Sanjie-Zhentong Capsules,which prepared with Resina Draconis superfine pulverizated twice and had a particle diameter of 13.06 μm,as the Sanjie-Zhentong Capsules prepared by ultrafine grinding craft.We compared the pharmacodynamics action of the Sanjie-Zhentong Capsules prepared by ultrafine grinding and original craft,which including analgesia and anti-inflammatory action.The results showed that,at the same dosage,the pharmacodynamic action of Sanjie-Zhentong Capsules prepared by ultrafine grinding craft was better than the capsules prepared by original craft.We compared the influence for dysmenorrheal on mice caused by oxytocin of the two preparations that manufactured by different crft,the results showed that the high and medium dose group of preparations manufactured by ultrafine grinding craft had significant difference with preparations manufactured by original craft.In the comparition of tampon granulomatous of Rats for the two preparations,we find that the medium dose group of preparations manufactured by ultrafine grinding craft had significant difference with the other.3.Research on the quality standard for Sanjie-Zhentong Capsules prepared by ultrafine grinding craft.According to the relevant specify of Pharmacopoeia of People’s Republic of China published in 2010 and the Sanjie-Zhentong Capsules quality standard which permited by State Food and Drug Administration,we did research on the quality standard for Sanjie-Zhentong Capsules prepared by ultrafine grinding craft,which was including characteristics,identification,detection,assay,determination for dissolution and so on.In the preparation manufactured by ultrafine grinding craft,there is onle Resina Draconis use ultrafine grinding craft,we detected it in the quality standard.To make Loureirin A and B as the target,we do the determination for the content and dissolution for the preparation.We determinate that the total content of Loureirin A and B must be more than 0.75 mg per pill,and they must dissolve to 90%in 50 and 35 mintunte.The quality standards provide science support for the quality controlling of Sanjie-Zhentong Capsules prepared by ultrafine grinding craft.