| Research backgroundBefore the reform and opening-up,the pharmaceutical level fell behind and the drug supply was limited in China.At that time,in-hospital preparations was effective supplements for commercially available drugs,the in-hospital preparations of traditional Chinese medicine which could well embody the characteristics and advantages of traditional Chinese medicine was effective supplements for commercially available drugs too.As the in-hospital preparations that have been used in Beijing Hospital of Traditional Chinese Medicine for decades,Furong ointment was developed according to proved recipes of Zhao Bingnan,a prestigious traditional Chinese doctor in this hospital,which has been widely used in clinic with exact efficacy.It can be used in sores and abscess with the efficacy of clearing heat,removing toxins,removing swelling,relieving pain.In recent years,relevant policies on the management of in-hospital preparations have become stricter and stricter,it is necessary to conduct systematic and normative research on such in-hospital preparations of traditional Chinese medicine with long-term clinical application and deeply-recognized efficacy but without basic research data as Furong ointment,including the research from composition theory to pharmacodynamics,security and the research of clinical efficacy,so as to provide basis for its safe and effective application in clinic,which is not only the inheritance and promotion to traditional Chinese medicine preparations,but also meets disciplinary research direction of clinical traditional Chinese pharmacology.Research ObjectivesTo provide basis for its safe and effective application of Furong ointment in clinic by analyzing the composition theory of its in-hospital preparations and studying the pharmacology,safety and clinical efficacy.In order to form a systematic and complete basic research data on the preparation,so as to carry out a further medicinal mechanism study.Research Methodsl.The statistical analysis for external treatment prescription with "Furong" as the name:Firstly,search the ancient literature,including the information of "Furong ointment","Furong powder",etc.on searching engines of ancient traditional Chinese medicine books such as www.tcm 100.com,www.yaozh.com and www.zysj.cn.After inquiry and check with original texts based on original literature,screen and summarize the results,and then conduct statistics and analysis on classification of the drugs,application frequency,etc.Secondly,conduct full-text search for modern literature,including the information of "Furong ointment","Furong powder "etc.on yaoZH,CNKI,VIP and WANGFANG DATA,summarize and research the prescription composition and preparation standard of Furong ointment,screen and summarize other drugs named "Furong" in the results,and then conduct statistics and analysis on classification of the drugs,application frequency and effect,etc2.Phannacodynamic research:Through two classical anti-inflammatory pharmacological tests:ear swelling of the mouse and cotton-ball granulomatous hyperplasia of the rat,to observe the anti-inflammatory and repercussive effects of Furong ointment.Through simulated sores test of the rat,to observe the effect of Furong ointment in promoting wound healing and treating Yang sore symptoms of redness and heat pain.Among them,voltaren ointment(diclofenac diethylamine cream)is treated as the control drug in the ear swelling test,and the male ICR mice are divided into 5 groups in random,10 mice in each group:model control group(yellow Vaseline matrix),control group of positive drugs(Voltaren:7.50g/kg),high-dosage group of Furong ointment(2.80g crude drug/kg group),medium-dosage group of Furong ointment(1.40g crude drug/kg group)and low-dosage group of Furong ointment(0.70g crude drug/kg group).While Voltaren ointment(diclofenac diethylamine cream)is treated as the control drug in the granulomatous hyperplasia test,and SD rats are divided into 5 groups in random,10 rats in each group:model control group(yellow Vaseline matrix),control group of positive drugs(Voltaren:5.00g/kg),high-dosage group of Furong ointment(1.12g crude drug/kg group),medium-dosage group of Furong ointment(0.56g crude drug/kg group)and low-dosage group of Furong ointment(0.28g crude drug/kg group).In the test of simulated rat sores,male SD rats are divided into 4groups in random,10 rats in each group:blank group,model group,mupirocin ointment group of 5.00g/kg,Furong ointment group of 0.70g crude drug/kg.Except for the blank group,the rats in other groups are scratched a cross incision in hair-removal area on the back with a blade,so that infection with positive sores symptoms of swelling,fever and pain appeared on such area.Finally,the physiological and behavior features,wound forms and death situation of rats are observed and recorded,specifically including weight,feeding situations,hair color,activity situation,tissue state at the wound position,healing rate of the wound,healing time,shell temperature,and the blood routine tests of rats shall be conducted at the fourth and seventh day before and after administration.3.Safety test:Firstly,Furong ointment(3g,2g,and 1g)and excipient(vaseline)are applied to complete skin and damaged skin of rabbit respectively,and the stimulus reaction of drugs to the skin is observed.Secondly,drugs are applied to guinea pigs that have been removed the hair with 2,4-dinitrochlorophenone solution as positive control,and then the anaphylactic reaction of drugs to the skin is observed.Thirdly,Furong ointment extract is applied to the complete skin of rabbits that have been removed the hair,twice a day,and the accumulated administration dosages to high and low dosage groups of Furong ointment extract respectively are 8g/kg,4g/kg,that is,1.6g crude drug/kg,0.8g crude drug/kg,which are respectively equivalent to 96 times and 48 times of proposed clinical dosage(0.0166g crude druge/kg).Finally,the toxic reaction within short time after the administration on the animal should be observed for 14d.4.0 bservation of clinical effect:The concept of sore in Chinese traditional medicine is broad.In the research,choose only one kind of sore disease called Jie,correspond as epifolliculitis in Western medicine.60 cases of patients clearly diagnosed with epifolliculitis are divided into the control group and treatment group in random according to the random digits generated with Excel and RAND function.Among them,patients in the treatment group are treated with the Furong ointment,while patients in the control group are treated with the mupirocin ointment.Then,the treatment results in both groups are observed and statistics analysis is conducted on the data observed by SPSS.Research Results1.Statistics analysis of medication rule,indications and efficacy to the external treatment prescription named "Furong":From ancient times to the present day,there are many external treatment prescriptions named with "Furong",and most of them contain components of hibiscus mutabilis.The main medicinal parts of hibiscus mutabilis are leaves,which is consistent with the leaves of hibiscus mutabilis used in Furong ointment in this research.The external treatment prescriptions of other "Furong ointment(powder)" in ancient literature are completely different from the prescription of Furong ointment in this research.Moreover,in the external treatment prescriptions of other "Furong ointment(powder)" recorded in modern literature,the components of Furong ointment in this research such as hibiscus mutabilis,rheum officinale,borneol,golden cypress,scutellaria baicalensis Georgi,coptis chinensis and herba lycopi are used more frequently,ranking the top six(among them,two components are tied for the sixth place).When counting all effects of of other "Furong ointment(powder)" in modern literature,it is found that the frequency of "clearing heat","stopping pain"(one prescription is for relieving pain),"detumescence"(one prescription is for detumescence)and "detoxification" is high,ranking the top 4,which is consistent with the effects of Furong ointment in this research,that is "clearing heat and detoxification".In terms of indications of the prescription,it is also basically consistent with the indications of Furong ointment in this research,that is"heat-toxin syndrome of swelling sores".2.Pharmacodynamic research resultsAfter applying xylene to the left ear of mice in the model group,the ear is obviously swollen.Compared with the model control group,the swelling degree of ear in Voltaren group is significantly reduced(P<0.05),and the swelling degree of ear in the groups of Furong ointment 0.70g crude drug/kg and Furong ointment 1.40g crude drug/kg is significantly reduced(P<0.05).After implanting drug-sensitive penicillin G tablet into rates for 7d,the weight of granulation tissue is increased.Compared with the model control group,the weight of granulation of rats in the Voltaren group is significantly reduced(P<0.05),and the swelling of granulation of rats in the group of Furong ointment 0.56g crude drug/kg is significantly reduced(P<0.05).In the test of simulating rat sores,the temperature of rats in various groups are significantly raised compared with the blank group,and the food-intake of rats in the Furong ointment group is increased,which meets the syndromic characteristic of Yang sores in traditional Chinese medicine.Compared with the model group,the scores of rats' sores are significantly reduced after administration for 3-7d in groups of Furong ointment and mupirocin ointmen,and the quantity of healed animals in the two groups are significantly larger than that of the model group.Correspondingly,the healing rate of sore surface is also increased.In terms of haematological index analysis,the WBC and MCH in the mupirocin ointment group and Furong ointment group are significantly reduced after administration compared with the model group,while the Hgb in the Furong ointment group is significantly increased.3.Safety test results:After applying drugs to the complete skin of rabbits in various dosage groups of Furong ointment and excipient group for many times and removing drugs and excipient for 1h,24h,48h and 72h,the stimulus intensity to skin shows no irritation,while applying drugs to the damaged skin of rabbits in various dosage groups of Furong ointment and excipient group for many times,removing drugs for 1h and 24h in the high-dosage and medium-dosage groups of Furong ointment,and removing drugs for 1h in the low-dosage group,the stimulus intensity to skin shows mild irritation.When removing drugs for 48h and 72h in the high-dosage and middle-dosage groups of Furong ointment,and removing drugs for 24h,48h and 72h in the low-dosage group,the stimulus intensity to skin shows no irritation.Meanwhile,the stimulus intensity to skin shows no irritation after removing the excipient for 1h,24h,48h and 72h.When applying Furong ointment to guinea pigs for many times,it will cause mild sensitization to them.After administration of complete skin in rabbits,all of them survive with normal diet and increased weight,their appearance,behavior,secreta and excreta are normal,hairs and eyes remain unchanged,the administrated areas show no edema and the administration group shows no evident dermal toxicity reaction.4.Observation for clinical efficacy:in this research,5patients are cured in the mupirocin ointment(15.2%),11 patients have significant efficacy(33.3%),16 patients have efficacy(48.5%)and 1 patient has no efficacy(3.0%),while in the Furong ointment group,7 patients are cured(25.9%),11 patients have significant efficacy(40.7%),7 patients have efficacy(25.9%)and 2 patients have no efficacy(7.4%).There is statistics difference in efficacy score before and after treatment(P<0.05).There is no statistics difference for efficacy distribution of the two groups(P>0.05),which shows that the efficacy of two drugs has no difference in treating epifolliculitis.Conclusion1.The preparations or prescriptions with leaves of hibiscus mutabilis as the main components have been widely used for external treatment of traditional Chinese medicine.The Furong ointment in this research isn't evolved from ancient prescription,but has strong common features with most of modern prescription medicines named "Furong",and the composition of Furong ointment in this research is reasonable with clear efficacy and indications.2.The Furong ointment has the function of anti-inflammatory detumescence and promoting healing.3.The Furong ointment has no irritation to complete skin,and it has mild irritation to damaged skin,which shows that Furong ointment is more suitable for positive swollen sores.Therefore,the patients with local skin damage shall use such drug under guidance of the physician.4.When applying Furong ointment for many times,it may cause mild sensitization,which shows that the patient allergic to this product and with allergic constitution shall use such drug carefully.5.The Furong ointment will not cause evident dermal toxicity reaction after applying to complete skin.6.The Furong ointment has reliable efficacy when it is externally used for treating epifolliculitis,which reflects the effect of external treatment of traditional Chinese medicine. |
PDF Full Text Request