| ObjectiveTaking Ruyijinhuangsan as the research object, Based on studying of the pharmaceutical technology, characteristic, TLC, Pharmacodynamics, and Transdermal Absorption in vitro about the ultra fine and ordinary powder with Ruyijinhuangsan, In order to explore the advantages of ultra-fine powder about the Extracting of Effective Components and Pharmacodynamics in compound. To offer Scientific information for dose conversion about the ultra fine and ordinary powder. Optimizing the best formula of hydrophilic cataplasm, in order to establish a set of Cataplasm Techniques with the advantages of general practicality.Methods1Ruyijinhuangsan ultrafine and its choice of powder:application of superfine powder technology, Selectting Pieces of the prescription for the raw of various ingredients materials. Using hydrochloric berberine, curcumin dissolution of curcumin in vitro transdermal absorption rate as an indicator, this paper wish to compare its ultrafine and ordinary powder and Prefere the particle size of its.1.1Dissolution test:reference "Chinese Pharmacopoeia2010edition two appendix XC dissolution determination method, berberine, curcumin as indicators, using the paddle method, the detection of two different particle size powders dissolution investigated two kinds of powderdissolution characteristics of the body, preferably suitable for the powder of particle size.1.2Transdermal absorption test:Using Curcumin as an indicator to study the impact of the different particle size wishful golden powder of the active ingredient in transdermal rate.Exploring the active ingredient curcumin accumulated through the amount of powder particle size.1.3Comparison of the microscopic character about ultra fine and ordinary powder, Adopting chloral hydrate method and using microscope.1.4studying on the TLC of Rhubarb, Angelica and Turmeric, Comparison of the TLC about the ultra fine and ordinary powder in ruyijinhuangsan, by the premise of consistent with the sampling amount and method.2Ruyijinhuangsan powder preparation process2.1Comparing Crushed separately,mixed vibration crushed and the air smash,Used it to determine the Ruyijinhuangsan powder ultrafine grinding process.2.2Using Berberine hydrochloride dissolution as the indicators, to choice the appropriate of crushed particle size.2.3single factor test, Using the ground water, particle size, medium fill rate, inputs into the mill, grinding process parameters as indicators, To determine the best technical parameters of Advanced Micro Devices, Ruyijinhuang powder.3Quality control indicators and methods3.1Select traits, powder characterization, surface area, bulk density, angle of repose and particle size as the external quality evaluation of Supermicro ruyijinhuangsan.3.2Using water, dissolution, physicochemical properties, TLC, and determination as its intrinsic quality evaluation.3.3Establishing Supermicro Ruyijinhuangsan powder quality standards.4Preparation of ultra-fine Ruyijinhuang powder Cataplasm Transdermal.4.1Adopted carbomer sodium polyacrylate, CMC-Na, Glycerol, tartaric acid and dihydroxyaluminum aminoacetate as indicators, using L16(45) orthogonal design in order to Optimizing cataplasma matrix.4.2Through pilot production, process validation to study the stability of the production process. 5The main pharmacodynamic study5.1Analgesic effect:With using Kunming mouse(SPF) as the experimental animal, in order to study on the Influence of jasminoidin on inflammation of pinnae in mice,and also the different of effects on Pharmacodynamics.5.2Anti-inflammatory effects:With using Kunming mouse(SPF) as the experimental animal, in order to study on the Influence of acetic acid torsion reaction in mice.660patients with Acute soft tissue injury were divided into two groups randomly:theraphy group (ultra Ruyijinhuang Cataplasm Transdermal), contrasted group (Injury wet cured pain cream). With pain, swelling, tenderness, ecchymosis, dysfunction, dry mouth, constipation, tongue, pulse other grading score and disappear recovery time as factors to calculate the efficacy of change.Results1The choice of Ruyijinhuangsan superfine and ordinary powder.1.1Dissolution testing:Superfine powder and its berberine hydrochloride in dissolution of the ordinary powder were0.0971g and0.0926g.1.2The HPLC method is stable and reliable, The ultra fine powder and ordinary powder of Ruyijinhuansan contained curcumin transdermal increased through the extension of the amount of time, and has a good linear relationship between amount of time; The amount iontophoretic flux reached25.22μg/cm2,while Ruyijinhuansan ultra fine powder on the administration of the first3h in rabbit, but the ordinary powder of Ruyijinhuansan only17.37μg/cm2.1.3Ordinary powder can be clearly observed to a colorless mass tilting, fiber single scattered, mostly in groups of stone cells, there are also single scattered from the shape and sizes. Small calcium oxalate crystals scattered in ray cells, oil cells can be seen everywhere; and ultra fine powder characteristics of the microstructure is not obvious, although it can be observed to the stone cells, but the vast majority of damaged fiber cell debris, and it is no complete oil cells to see.1.4When the same conditions as sample volume, sample handling, The ultra fine powder show spots more clear, ultrafinedarker and obvious than ordinary powder of Rhubarb, Angelica and Turmeric, on TLC.2Ultrafine grinding process2.1Selectting Separately,mixed grinding vibration crushed and air jet mill, to determine the RuYiJinHuangSan mixing crushed, and the vibration crush is better than air jet mill.2.2The dissolution of active ingredients show that Ruyijinhuangsan powder suitable for crushed particle size D9036μm.2.3Using Single factor test to determine the process parameters Ruyijinhuangsan powder:Billy machine grinding, the amplitude of5.5mm, smash a temperature of0-5℃into the grinding material water for3to6%into the grinding particle size for the mealmedium fill rate of60to70percent, the feeding amount of250g, vibration time of30min.3Advanced Micro Devices, Ruyijinhuangsan powder quality standard:Describe the three batches of ultrafine powder samples, using powder characterization, specific surface area, bulk density, angle of repose and particle size detection, and prepared external quality evaluation of Advanced Micro Devices, Ruyijinhuangsan powder, according to the moisture of the three batches of ultrafine powder samples, dissolution, physicochemical properties, TLC identification, assay, developed its intrinsic quality evaluation to establish the quality standards of Advanced Micro Devices, Ruyijinhuangsan powder.4Preparation of ultra-fine Ruyijinhuang powder Cataplasm Transdermal.4.1Optimized cataplasma:the indicators formulation are matrix carbomer sodium polyacrylate, CMC-Na, Glycerol, tartaric acid and dihydroxyaluminum aminoacetate:30:1:0.8:7:100:80.4.2it was verified for three batch of the pilot test, so this technology is feasible and stable product quality.5The main pharmacodynamic study5.1Analgesic effect:With using Kunming mouse(SPF) as the experimental animal, in order to study on the Influence of jasminoidin on inflammation of pinnae in mice,and also the different of effects on Pharmacodynamics.5.2Anti-inflammatory effects:With using Kunming mouse(SPF) as the experimental animal, in order to study on the Influence of acetic acid torsion reaction in mice,and also the different of effects on Pharmacodynamics.6The treatment of acute soft tissue injury markedly effective rate in the Supermicro Ruyijinhuangsan Papua paste was80%, the total efficiency of90.00%, in the control group were23.33%and53.33%. It is total markedly effective rate was86.67%, the over all efficiency of96.67%in the control group were23.33%and53.33%. Disease, card between the efficacy of group differences were statistically significant, the treatment group was significantly better than the control group.Conclusion1Using modern ultrafine grinding technology to the Ruyijinhuansan powder to be the average particle size of0.1～75μm, The microscopic characteristics of after ultrafine herbs powder is significantly reduced, uniform in size, and the oil cells to be broken, the active ingredients of essential oils can be better exposed, rather than through the transparent wall (membrane) to release, So the medicinal efficacy can release faster from herbs.2Using curcumin as an indicator of in vitro percutaneous absorption test, the transdermal rate of curcumin in Supermicro Ruyijinhuansan powder faster than ordinary power, suggesting that the ultrafine powder formulations have certain advantages, and has prospects for the development and application.3The ultra fine powder show spots more clear, obvious than ordinary powder of Rhubarb, Angelica and Turmeric, on TLC, That preparations made of ultrafine active ingredients more stripping, providing a reference for the improvement of the dosage form and dosage.4The Supermicro Ruyijinhuangsan powder cataplasm matrix formula conducive to molding, the quality of finished product is stability, and mainly pharmacodynamic exact.5In this thesis, the results provide new agents for Supermicro Ruyijinhuang powder cataplasm and it will bringing larger social and economic benefits.6Clinical observation of the treatment about acute soft tissue injury with Ultra-fine Ruyijinhuangsan Cataplasm, it provides a clinical basis for the development of new formulation.
|
PDF Full Text Request