Pharmaceutical Research Of Sanqi Dieda Sunshang Unguentum

Sanqidiedasunshang unguentum is found in the long-term treatment of fractures orthopaedic hospital for the treatment of acute soft tissue contusion with good effect.Clinical use for many years,the party made of plaster for acute soft tissue contusion cure rate is high,this is the prescription ointments made in-depth study has laid a solid clinical basis.Sanqidiedasunshang unguentum is composed of Notoginseng Radix et Rhizoma,Draconis Sanguis and other traditional Chinese medicine.Its efficacy is dredge blood vessels,remove blood stasis,eliminating swelling and pain,mainly use it to treat soft tissue injuries,illness characterized by tissue damage,blisters and sore.Guided by the theory of TCM and relied on modern pharmaceutical technology,This research has carried on the reform to the preparation technology,such as the prescription dosage forms,extraction process selection,preparation molding process,the scale-up production,quality standards,etc.Aimed at to develop it into a safe,effective,stable and controllable unguentum.Based on the clinical curative effect and combined with pharmacological test,this research determined with water as the extraction solvent.With the extraction capacity of notoginsecoside R₁,ginsenoside Rg₁,asperosaponin?,ginsenoside Rb₁and ratio of extraction as comprehensive evaluation index,the weighting coefficient in five synthetic evaluation indexes was determined by mixed weighted AHP-CRITIC.And extracting process was optimized by orthogonal test.Ultimately determine the extract of powder preparation process as follows:Prescription medicines added 8times the amount of water for soaking 2 h,extracting 1 h,then extracted 2 times with6 times the amount of water,1 h each time.Collection of filtrate,and concentration to a relative density of 1.08¹.09?50??of the extractum.Preparations molding process in the study,unguentum with appearance,thermal stability,cold stability and centrifugal stability as a evaluation index.In combination with prescription of drugs features and screen the suitable matrix formulation from three kinds of matrix formulation as a basis for the optimization.By the method of single factor test to sift out the prescription of drugs to add order,emulsifying time and emulsifying temperature,the dosage of preservatives and the range of matrix consumption.Then using the Box-Behnken method to optimize the best prescription,Determine the quantity of promoting the permeability agent menthol by the vitro transdermal experiments.Finally determine the unguentum preparation process as:Put superfine Draconis Sanguis?37.5g?and Pyritum?5g?in the 80?water bath melt of PEG-6000,stir well,at the same temperature put in the extractum;Weighing the prescribed amount of stearyl alcohol?161g?,vaseline?145g?and lanolin?16g?,water bath to 80?to melt,stir well,as the oil phase;Another propylene glycol?60g?,sodium dodecyl sulfate?10g?and water,putting in the same temperature to dissolve it,stir well,as the water phase;at the same temperature,adding the water phase to oil phase slowly,constantly stiring.The next to join ointment in ointments substrate,stiring.When the temperature was below 50?,adding ethylparaben?1g?,Borneolum Syntheticum?2.5g?,menthol?30g?which was dissolved by ethanol,and mixed them.Study on the Pilot test:Expand the preparation dosage,with the best technology condition,continuous produce 3 batches of samples,its preparation is stable and practical,Three batches of samples conform to the relevant provisions of the unguentum,and cater to the requirements of industrial production.In the quality specification study,TLC identification methods of Notoginseng Radix et Rhizoma,Draconis Sanguis,Dipsaci Radix,Cibotii Rhizoma,Myrrha and the rules of preparation for unguentum had been checked.In addition,content determination methods of ginsenoside Rg₁,asperosaponin?,ginsenoside Rb₁,dracorhodin were established,achieving a multi index HPLC method content determination.