The Preparation And Clinical Research Of The New Pain Plaster

Objective Optimizing the extraction process,the ratio of matrix for the new pain plaster,to develop it into a safe, effective, small side-effects,easily transdermal,easy to save, clean and new pain plaster.And study its clinical curative effect, to further standardize the new pain plaster in treatment of cancer pain to provide clinical basis,rich cancer pain treatment.Method The Preparation of The New Pain Plaster:①With the resulting dry paste and Asarinin as observation indexes,with solidliquid ratio,extraction time and extraction times as examine factors,selectting the best ethanol reflux extraction process of Asarum,Radix Aconiti Preparata,Rhizoma Paridis,by L9(34) orthogonal design.With the extract and octyl acetate content as the indexes,with extraction pressure,extraction temperature and extraction time as examine factors,selectting the best supercritical CO2 extraction process of Frankincense,Myrrh,Zedoary, by L9(34) orthogonal design.Toad venom, Dragon’s blood,Borneol,Menthol powder,pass through 100 mesh sieve,medicine directly.②With the melt resistance under 40 ℃ condition,evenness,hardness,viscosity as indexes,weighted score,selectting the best ratio of matrix for the new pain plaster,by L18(37)orthogonal design.③With Asarinin as detection index to measure the new pain plaster of in vitro percutaneous absorption rate.The Clinical Research of The New Pain Plaster:80 patients observed with lung cancer pain,were randomly divided into treatment group(The new pain plaster group)and control group(The placebo group),40 cases in each group.Both groups were based on the three-step analgesic therapy recommended by WHO. Added the new pain plaster in the treatment group,the control group was given placebo.Compared the two groups’ differences of the degree of pain relief,tumor marker,three ladder drug decrement,KPS score,quality of life,weight changes,the adverse reaction,and found out that there was or no statistical significance.Result The preparation of the new pain plaster ①The best ethanol reflux extraction process of Asarum,Radix Aconiti Preparata,Rhizoma Paridis was 6 times 70% ethanol,extract 3 times,each time 2 h.The best supercritical CO2 extraction process of Frankincense,Myrrh,Zedoary was 20 Mpa extraction pressure, 50℃,each time 4 h.②The best ratio of matrix for the new pain plaster was 0.60 g glycerin,0.60 g lanolin,0.15 g triethanolamine,0.05 g sodium dodecyl sulfate,1.20 g paraffin wax,1.80 g stearic acid,0.9g monostearin.③The new pain plaster had good transdermal absorption rate.Asarinin transdermal rate was 26.01% in vitro in 24 h.The clinical research results of the new pain plaster ①The pain remission rate of two groups have statistically significant,the new pain plaster group was better than control group.②The difference of carcino-embryonic antigen(CEA) reduction between the two groups had statistically significance,the new pain plaster might have the efficacy of reducing CEA in lung cancer patients;And cancer antigen 125(CA125),Neuron-specific enolase(NSE) showed no significant difference between the two groups.③The opioid analgesics decrement of two groups had obvious difference,the former was superior than the latter.④The KPS scores of the new pain plaster was obviously higher than that of control group.⑤No obvious difference was found between two groups in weight change.⑥The new pain plaster can improve the symptoms of constipation caused by oxycontin.It could significantly improve the patients’ life quality.⑦The new pain plaster for external use was safe and effective,and had no obvious side-effects.Conclusion The new pain plaster had the advantages of simple preparation,highly transdermal rate,safe,effective,small sideeffects.Can obviously increase the degree of pain relief,reduce the three ladder drug utilization,improve KPS score,reduce the adverse reactions of three-steps analgesic.And it might have anti-tumor effect.Could be accepted by most of patients,and worth batch production and promotion in the clinical.