A Pharmaceutical Investigation On Treating Of Hyperplasia Of Mammary Glands By Xuandan Cataplasm

This article select title of "An pharmaceutical investigation on treating ofhyperplasia of mammary glands by new drug Xuandan cataplasm"—which isreferenced by the review and applied in the clinic practice for many years. Asthe related specialists demonstrating, the drug is affirmed sufficiently andevaluated highly. It is our aim to develop a new drug which is possessedadvanced dosage form, reasonable technological process, precise therapeuticeffect and practicable quality standard.1. Studies on the technological process According to the feature of clinicmedication, we choose the cataplasm as the dosage form of the new drug.According to the physicochemical properties of the each medicine and adoptingthe different extracting method, technological process was optimized by theresult of the orthogonal experiment. The optimal formulation ofcataplasmwas obtained by using uniform design to study the different influence of eachmatrix by cohesion test, content test in the vitro release etc, meanwhile, thepreparing technology was optimized by the result of the orthogonal experiment.2. Studies on the permeation of herb and prescription A series of basicstudies on the Rhizoma Radix Salviae Miltiorrhiae extraction and prescriptionwas performed by the means of transdermal experiment and advanceddetective measures. In order to know the transdermal characters of theingredient, The effect of skin model, media, rat skin of different storage time,matrix and enhancer on the transdermal absorption of drugs has beeninvestigated to find out a better method to enhance the transdermal absorptionamount.3. Studies on the quality standard The formulation of a standard for thequality control of Xuandan cataplasm was studied. Notoginsenoside R₁,Ginsenoside Rg₁, Icarrine and Salvianolic acid B were chosen to quantitativedetermination in the standard. Precision, reproducibility, stability and averagerecovery etc. conformed to related measure in studies of methodological inspect.Epimedium brevicornum, Maxim, Radix Notoginseng, CaulisSpatholobi, Rhizoma Radix Salviae Miltiorrhiae and corydalis were identifiedby TLC. We defined TLC identification method and defined the qualitystandard with the different area's corydalis by HPLC fingerprinting, meanwhile,HPLC fingerprinting technique was made a deep studies in identification ofcorydalis and its confused species—Rhizoma Corydalis Decumbentis.4. Studies on the pharmacodynamics Guided by the modern TCM theoryand designing Xuandan cataplasm with therapeutic principles of activatingblood circulation and dissipating the stasis, relieving pain and resolving massesand regulating meridians, The model of HMG was induced by benzoate estradiol intramuscular injection female rabbits and female rats of cut-ovary for15 times respectively. Compared with the normal group, the proliferation wasobvious in mammary glands tissue and the serum levels of E₂ remarkablyincreased in model group. The results show that Xuandan cataplasms couldinhibit HMG model evidently.the serum levels of E₂ were lower than that ofmodel group. At the same time, The mouse abdominal cavity painful modelwas induced by acetic acid; The rat painful model was induced by electricstimulus, and the Xuandan cataplasm inhibitory action of the rat chronicgranuloma formation and the mouse acutely inflamed ear was induced bydimethyl benzene. The results show that Xuandan cataplasms have theefficency of anti-inflammation and analgesia. Moreover, promoting blood—flowing experiment has been made by measuring the hemorrheologyindex, blood viscosity, reduced viscosity and erythrocyte electrophoretic time.The results show that Xuandan cataplasms could promote blood circulation.5. Studies on sensitivity and stimulus Daub repeatedly the topical skin andinjured skin of rabbits with Xuandan cataplasm to test whether it may inducestimulus, such as: red swelling, hyperemia, degeneration and necrosis, daubrepeatedly the topical skin and injured skin of guinea pigs with theaforementioned cataplasm and excipients to test whether it may result in skinhypersusceptibility such as erythema, hydroncus allergic response. It will bepredict the potential skin stimulus and anaphylaxis of the cataplasm and directthe clinic application. The cataplasm can beget no skin stimulus, nor can itcause skin hypersusceptibility.6. Studies on acute toxicity In order to evaluate the safety of cataplasm onaffected area in clinical practice, acute toxicity test on the intact and damagedskin of the rabbits was observed. The results show that xuandan cataplasmmight be safe if it is used as dermal dosage.In short, it was good for preparation and transdermal absorption toabstract effective ingredients from TCM. In the course of developingCataplasm, we should choose reasonable prescription, suitable matrix andscientific preparation technology to improve its quantity. Based on theexperimental studies of permeation of herb and prescription, technologicalprocess, quality standard, pharmacodynamics, sensitivity, stimulus and acutetoxicity, it would lay the foundation for the development of new drug.