| Objective:To develop a national new drug used for chemotherapy Phlebitis which has the effect of invigorate the circulation of blood,cleaning heat and expelling damp,dredging the channel and relieving pains,swelling and raw muscle.This study was on the preclinical prescription screening、preparation process test,and expected to develop a transdermal drug preparation of traditional Chinese Medicine for chemotherapy patients that convenient to use and Safe and efficient。Methods:Under the guidance of TCM theory,turn TCM oncologist Wang-Xixing ’s Clinical experience prescription for chemotherapy Phlebitis into topical formulation.Compound prescription cane zhi paste contains toxic medicinal material—Tenghuang,In clinical application,shuangxiang cane zhi paste is as good as compound prescription cane zhi paste.This topic was on the preclinical prescription screening、preparation process test,and it aimed to further compare the two prescriptions curative effect of chemotherapy phlebitis and discuss the influence of Tenghuang on compound prescription cane zhi paste.1 Shuangxiang cane zhi paste prescription screening: NVB chemotherapy-induced rat tail vein phlebitis of the animal model;Compare the roles for chemotherapy phlebitis of the three--Shuangxiang cane zhi paste 、 compound prescription cane zhi paste 、 compound prescription cane zhi paste removed Tenghuang.0.2ml NVB was injected into mouse tail vein and different groups treated with respective drugs from the root to the tail.The drugs for five consecutive days and twice a day,it will keep 4 hours,6 hours apart.Mice in each group to observe the classification of phlebitis,combined with the pathological tissue HE staining,analysis of different prescription on the therapeutical effect of phlebitis.2 The process route of Shuangxiang cane zhi paste to determine: According to the physicochemical properties of the prescription,combined with the preliminary clinical application,we preliminarily confirmed that Raw rhubarb,frankincense,myrrh,borneol and menthol were used powder into medicine.We should explore the process route of leftover herbs.We preliminarily drawed up 4 routesas follows: The first rout is the powder of the rhubarb,frankincense,myrrh,borneol,menthol and fritillaria thunbergii and big blood cane,angelica,golden cypress and radices saussureae were handled with alcohol extraction and water decocting.The second rout is the powder of the rhubarb,frankincense,myrrh,borneol,menthol and fritillaria thunbergii and big blood cane,angelica,golden cypress and radices saussureae were handled with water decocting.The third rout is the powder of the rhubarb,frankincense,myrrh,borneol and menthol and big blood cane,angelica,fritillaria thunbergii,golden cypress and radices saussureae were handled with alcohol extraction and water decocting.The fourth rout is the powder of the all the medicinal materials.Mice in each group to observe the classification of chemotherapeutic phlebitis,combined with the pathological tissue HE staining,analysis of different process rout on the therapeutical effect of phlebitis.The HPLC fingerprint method is used to establish the fingerprints of different processes routes,and associated with the principal component analysis method.The process route was finally determined.3 Optimization of process parameters for preparation of Shuangxiang cane zhi paste and investigation of forming process: Compared independent comminution and mixed comminution.Investigated different modes of comminution of frankincense,myrrh,borneol and menthol----water fly,grind,deep-frozen and ordinary comminution.The mode of comminution and granularity would be determined ultimately.In accordance with patch dosage forms,supplementary material and clinical characteristics of chemotherapy phlebitis,in combination with production practice and literature research.We screening species and proportion of the stroma to maximize the load.Results:1 The incidence of chemotherapy phlebitis of shuangxiang cane zhi paste group 、compound prescription cane zhi paste group and compound prescription cane zhi paste removed Tenghuang group were70%、90%、100% respectivezly.Model control group is significant higher than normal control group(P<0.001),shuangxiang cane zhi paste group is significant lower than model control group(P<0.05);The classification of chemotherapeutic phlebitis of model control group is significant higher than normal control group(P<0.001),Model control group is significant lower than shuangxiang cane zhi paste group and compound prescription cane zhi paste group(P<0.001,P<0.01).In the histopathological observation of caudal vein,shuangxiang cane zhi paste group and compound prescription cane zhi paste group play the same role in anti-inflammatory,but compound prescription cane zhi paste removed Tenghuang group is the worst.It indicates that shuangxiang cane zhi paste,s effect on chemotherapy phlebitis of anti-inflammatory is the best.The prescription of Shuangxiang cane zhi paste contains :big blood cane,angelica,Raw rhubarb,fritillaria thunbergii,radices saussureae,golden cypress,frankincense,myrrh,borneol and menthol.2 In the four process routes,the incidence of chemotherapy phlebitis were100%、90%、90%、70%.Respectivezly.Model control group is significant higher than normal control group(P<0.001),route 4 group is significant lower than model control group(P<0.05);The classification of chemotherapeutic phlebitis of model control group is significant higher than normal control group(P<0.001),route 4 group is significant lower than model control group(P<0.01),There was a significant difference between the route 4group and the rest(P<0.05)..In the histopathological observation of caudal vein,the effect of route4 on chemotherapy phlebitis of anti-inflammatory is better than route 3,The inflammatory response of route 1 and 2 are obvious and the effect on anti-inflammatory is worse.It indicates that the process route 4 has the best effect on chemotherapy phlebitis of anti-inflammatory.Combined with production cost,we selected process routes 4 as the best.All the medicinal materials were medicated with powder.3 In the prescription,big blood cane,angelica,Raw rhubarb,fritillaria thunbergii,radices saussureae,golden cypress adopted mix crushing and the remaining four herbs were adopted frozen crushing because of they would be melt when they got hot.Medium powder,fine powder and finest powder all have a good feel,but fine powder has better compatibility with stroma.According to clinical application and the literature research,we choose yellow vaseline,lanolin,glycerin and liquid paraffin as the stroma of Shuangxiang cane zhi paste.The proportion is powde: yellow vaseline: lanolin:glycerin=4:2:1:2.Conclusion:Screening prescription of shuangxiang cane zhi paste and determining the process route of all the medicinal materials were medicated with powder.Choicing patch dosage forms and optimizing the modes of comminution----some Chinese medicinal materials were handled with mixed comminution and the remaining were adopted frozen crushing.We investigated the molding process and confirmed the type and the proportion of stroma.The preparation process of Shuangxiang cane zhi paste is feasible and reasonable.It has some anti-inflammatory effects on the chemotherapy-induced rat tail vein phlebitis in mice.It can provide a reference for the treatment of chemotherapy phlebitis by Chinese Medicine tumor,and it provides an experimental basis for further development of Chinese medicine external application patch. |
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