Toxicology And Pharmacodynamics Studies On Compound Kujin Cream

OBJECTIVE:To estimate the safety and effect of CKJC, Weobserved the acute and the chronic toxicity of CKJC in rats and rabbitsand evaluated the main treatment effect of CKJC bypharmacodynamic experiment. METHODS: According to the principle of toxicity experimentof skin before clinic, we did the following experiments. The acute toxicity test: CKJC 10.0g in forty percent and eightypercent were used twice on the wounded and normal skin of rabbitswithin 24 hours. The drug should be washed after 24 hours. Weobserved and wrote down the daily activity, body weight, skin lusterand death of the rabbits in 7 days, comparing these indexes with thenegative control group;CKJC 1.0g in eighty percent was appliedtwice on the back of rats within 18 hours, We observed the sameindexes as the last test in 7 days. The chronic toxicity: three groups of rats (in high, medium andlow dosage of CKJC)were applied cream on the back skin respectivelyfor 28 days. Body weight,hematological and hematobiochemicalparameters, coefficient and histomorphological figure of organs (theheart, liver, spleen, lung, kidney, adrenal, testis, prostate, ovary, uterus)would be examined in 28 days and 14 days after the cessation ofCKJC, compared the above indexes with the negative control group. The skin stimulation test :CKJC in forty percent and eightypercent were used on the wounded and normal skin of rabbits. Thedrug should be washed after 24 hours. We observed erythema andedema on the local skin and compared with the negative control group.The drug should be daubed 7 days, then we observed the reaction ofthe local skin and markd by the graded standard.The skin allergy test: CKJC in forty percent, excipient and thepositive sensitization drug were used on the left back skin of guineapig repeatedly. The drug should be used 0.1g on the right back skinafter 14 days and washed 6 hours later. All changes, for exampleerythema and edema on the local skin were observed immediately, 24hours later, 48 hours later, 72 hours later and compared with thenegative control group (excipient). We markd by the graded standardaccording to the reaction of the local skin.According to the standard pharmacology experiment methods,We established the acute allergic inflammation animal models andskin itch model. The models included the tests of the mice earswelling induced by xylene, the foot swelling induced by egg white inrats, the hind paw edema induced by one percent carrageenan in rats,the penetrability of capillary vessel induced by histamine in rats andthe skin itch created by histamine. All anti-inflammation andantipruritic experiments were conducted respectively by CKJC in tenpercent, twenty percent and forty percent.RESULTS: The acute toxicity test showed that there was noacute toxicity effect to the rabbits and rats;The chronic toxicityshowed that the datas of hematobiochemical, pathological andcoefficient of organ compared with the negative control group werenot significant difference in 28 days and 14 days after the cessation ofCKJC;The skin stimulation test showed that there was no stimulationto the wounded and normal skin of rabbits;The skin allergy testshowed that no sensitization of contacting to the skin of guinea pigwas found. CKJC in twenty percent and forty percent couldsignificantly inhibit the ear swelling induced by xylene in mice, itcould significantly inhibit the foot swelling induced by egg white inrats, it could significantly inhibit the hind paw edema induced by onepercent carrageenan in rats and it could significantly inhibit theincreasing of penetrability of capillary vessel induced by histamine inrats. CKJC in ten percent,twenty percent and forty percent has betterantipruritic effect than the positive control group of Miconzole Nitratecream.CONCLUSION: The toxicity and safty test showed CKJC haslittle side effect without stimulation and sensitization. It is safe to useCKJC on the local skin. CKJC in twenty percent and forty percenthave better anti-inflammation and antipruritic effect than those of thepositive control group of Miconzole Nitrate cream. The experimentprovides the basis for treating cutaneous superficial fungus with CKJCin clinic.According to the newest research results on cutaneous superficialfungus of China and abroad, This study has the following new ideas:1,According to the ten-year literatures in Chinese traditionalmedicine institute library of Jilin Province, reports on treatingcutaneous superficial fungus with Traditional Chinese Medicine couldbe founded, but only on clinical observation and treatment. No reporton pharmacodynamics and toxicology could be found.2 , To date, cutaneous superficial fungus treatment mainlydepends on western drugs,such as Miconzole Nitrate cream et al.butthese drugs with great adverse effect are expensive, and the disease isapt to relapse when the drugs were stopped. However, by clinicalobservation and inhibiting bacteria test, CKJC was confimed safer andmore effective compared with Miconzole Nitrate cream, and apparenttoxic effect wasn't seen. Moreover, the drug is abundant and cheap.3,Pharmacodynamics test: CKJC has striking anti-inflammationand antipruritic effects,and its effects are superior to MiconzoleNitrate cream.4,Toxicity test:The acute and chronic toxicity tests showed thatCKJC has no apparent toxic effect, no local stimulation and allergyeffect, and its clinical dosage is safe.5,The research results of this study have been identified.Identification specialists all think that this study is new, and its resultsare in lead in China.In summary, CKJC which is safe has apparent anti-inflammationand antipruritic effect,so it's an ideal drug in treating cutaneoussuperficial fungus. This study demonstrates the scientific and reliablecharacteristics of CKJC, which supplies scientific support for clinicalusing pure Traditional Chinese Medicine to treat cutaneous superficialfungus.