| According to the theory of traditional Chinese medicine, we use heat-clearing and detoxifying herbal compound ZhiLou XunXiJi to observe the clinical efficacy on reducing post operative mixed hemorrhoids pain, edema, and accelerating wound healing. And carries on the formulation of reform, according to the Chinese medicine" preparation pharmaceutical researchn technical requirements" for preclinical studies, prepared with carbomer (Carbomer, Carbopol, CP) as a matrix of water soluble matrix ointment-ZhiLou gel. Completion of main pharmacodynamics, safety experimental research, and compare the advantages of the current market popular hemorrhoids medicine,ultimately determine wehether the new formulations have clinical use basis, the best dosage forms, drug dose.Clinical results show,50patients with mixed hemorrhoids dued to downward flow of damp-heat after using ZhiLou XunXiJi, he pain disappeared time, wound healing time was better than the pifuKang group (P﹤0.05or0.01). Conclusion Treating mixed hemorrhoid dued to downward flow of damp-heat with ZhiLou XunXiJi has curative clinical effect.Extraction process using emodin as index, takeing the single factor and orthogonal test method to study and determine the alcohol extracting technology condition about the rhubarb, Polygonum cuspidatum, results, the emodin content in the extract of is original" ZhiLou XunXiJi "10times; Using gallic acid as the index, orthogonal test was adopted to study and determine the litchi chinensis grass, cordate houttuynia,and gallnut water extract conditions.The three batch verifying test results shou that the main medicine extraction technology is reasonable, stable. Molding process using carbomer (1.5%CP-940) and polyethylene glycol (PEG400)5%as mixed matrix, glycerol as humectant,propylene glycol as solvent. Molding process using carbomer (1.5%CP-940) and polyethylene glycol (PEG400)5%as mixed matrix, glycerol as humectant,propylene glycol as solvent, Ethyl hydroxybenzoate as preservatives, azone as transdermal enhancer, triethanolamine as pH regulator, after three batch of prescription verification test for gel viscosity fit, its colloidal stability, a pH in the range of6.3-6.4, conformed to topical ointment provisions.Pharmacodynamic experimental results show, hemorrhoid lotion and its improved form-hemorrhoids gel can reduce the xylene induced mouse peritoneal capillary permeability, reduces carrageenan-induced paw edema in rats, significantly reduce the swelling paw inflammatory tissue in the PGE2content; inhibition of acetic acid-induced writhing reaction in mice, improve thermal pain response latencies, and with the increase of loading effect, pharmacodynamic change strong, comprehensive curative effect is better than that of hemorrhoids lotion and the same period in the market on the other hemorrhoids liquid lotion. Conclusion:hemorrhoids and fistula lotion gel has good anti-inflammatory, analgesic, improve local microcirculation function, can be used as hemorrhoids postoperative medication of choice.Safety experiment shows zhilou Gel with CP-940as matrix didnt’ cause any irritation reaction ion New Zealand rabbits with intact skin and damaged skin, has no allergic reaction on guinea pig skin. Useing safely,has no obviouse toxic and side reaction.Conclusion the original forms-ZhiLou XunXiJi can significantly ease the damp-heat mixed hemorrhoid postoperative anal local pain, eliminate local edema, promote the patient recover quickly; New dosage forms of water soluble matrix ointment (zhilou gel) extraction technology is reasonable, stable, good stability, in line with the Pharmacopoeia topical ointment provisions.The pharmacodynamics experiment, safety experiments strongly support zhilou gel can be used as hemorrhoids postoperative medication of choice. |
PDF Full Text Request