Background technology
Body surface wound or breakage are the pains of injury common during people live, and particularly scald, burn etc. is common especially.
The grade of burning such as burn, scald is usually adopted following criteria:
Once burnt: damage is limited to the epidermis shallow-layer.Symptom is that illing skin is rubescent, and pain is inviolent.But normal healing, no cicatrix.
Two degree are burnt, and are divided into:
1. shallow two degree are burnt: damage on epidermis and the corium 1/3, symptom is that the affected part redness is got blister, and can have an intense pain and burning sensation.But normal healing, no cicatrix or slight cicatrix.
2. dark two degree are burnt: damage and be epidermis and corium deep, symptom is that the affected part is rubescent, plays the big blister of white, because teleneuron is partially damaged, more shallow two degree of pain want light.But normal healing can stay cicatrix.
Third-degree burn: whole skin injurys.The affected part is hide-like black eschar or pale, and the flow liquid phenomenon can be arranged.Because most of teleneuron damages, this type of bright the wounded does not often have the affected part pain.
Four degree are burnt: subcutaneous tissue, muscle even skeletal injury are arranged.Can cause amputation.
Five degree are burnt: most of subcutaneous tissue is burnt, and exposes muscular tissue.Sometimes to burn be fatal to five degree.
Six degree are burnt: nearly all meat fiber disappears, and skeleton is burnt.Six degree are burnt normally fatal.
For the damage of rats after severe scald burn burn class, common treatment means no doubt can obtain certain curative effect now, but its curative effect is still not satisfactory, mainly show as: to the serious burn and scald of integumentary musculature, and the patient of severe infections behind the burn and scald, healing time is long, and curative effect is undesirable, leaves cicatrix etc.
Summary of the invention
The pharmaceutical composition that the purpose of this invention is to provide the preferable treatment wound of a kind of curative effect.
Another object of the present invention provides a kind of preparation method of said composition ointment.
The present invention also provides the application of a kind of this pharmaceutical composition in the medicine of the wound of rotting at preparation treatment skin burn, skin scald or skin.
For realizing first goal of the invention, the invention provides a kind of pharmaceutical composition, this pharmaceutical composition is made by the crude drug of following weight ratio example: plucking time at 3 days with the bright leaf 80%~97% of interior Smallfruit Rose Root, Flos Hibisci Mutabilis dry flower 2%~19%, Oleum Camelliae 1%~10%.
Flos Hibisci Mutabilis is the flower of Malvaceae Hibiscus plant Hibisci Mutabilis in the compositions, and another name is named refuses frostwork.Hibisci Mutabilis formal name used at school: Hibiscus mutabilis, English name Cotton rose.Have heat-clearing and toxic substances removing, cooling blood for hemostasis, the medicinal efficacy of detumescence and apocenosis is applicable to diseases such as furuncle, carbuncle sore, acute mastitis and cough due to lung-heat, lung abscess, the metrorrhagia that available again what heat in blood causes.
The fruitlet Rosa is in Rosaceae (Rosaceae) Rosa (RosaL.) plant in the compositions, formal name used at school Rosa cymosa Tratt, another name: Radix Rosae Cymosae, fishing rod, Radix Rosae Cymosae, spend Aesculus chinensis Bunge, seven sisters etc. in vain.But Smallfruit Rose Root leaf removing toxic substances and promoting subsidence of swelling is used to control carbuncle furuncle infections, burn and scald.
Oleum Camelliae is the fatty oil that the mature seed of plant of theaceae oil tea (Camellia oleifera Abel) or lobule oil tea (Camellia meiocarpa Hu.ms.) obtains with milling process in the compositions.Cure mainly: eruptive disease stomachache; Constipation; Ascarid stomachache; Ascaris intestinal obstruction; Scabies; Burn.
In order to obtain better medicinal effects, this pharmaceutical composition formula optimization is that the weight proportion of described crude drug is: plucking time 3 days with the bright leaf 95%~97% of interior Smallfruit Rose Root, water content at the Flos Hibisci Mutabilis dry flower 2%~4% below 10%, Oleum Camelliae 1%~0.3%.
In order to obtain better medicinal effects, this pharmaceutical composition formula optimization is, described Flos Hibisci Mutabilis dry flower be plucking time at 6 months with interior dry flower.
In order to obtain better medicinal effects, to use for the ease of people simultaneously, this medicine composition dosage form is a unguentum.
For realizing second goal of the invention, the invention provides a kind of preparation method of using the aforementioned proportion medicine as the ointment of raw material, may further comprise the steps:
A. prepare raw material: prepare crude drug by following proportioning: plucking time at 3 days with the bright leaf 80%~97% of interior Smallfruit Rose Root, Flos Hibisci Mutabilis dry flower 2%~19%, Oleum Camelliae 1%~10%;
B. make medicine mud: bright leaf of Smallfruit Rose Root leaf and the Flos Hibisci Mutabilis dry flower prepared among the step a are made medicine mud;
C. call in Oleum Camelliae: in the medicine mud that step b obtains, add Oleum Camelliae and mixing, make ointment.
Optimization method as above-mentioned ointment preparation method, each proportion of raw materials adopts: plucking time 3 days with the bright leaf 95%~97% of interior Smallfruit Rose Root, water content at the Flos Hibisci Mutabilis dry flower 2%~4% below 10%, Oleum Camelliae 1%~0.3%, the medicine effect that such crude drug ratio is prepared is better.
As the preferred version of technology, the present invention is further comprising the steps of:
D. cold preservation is carried out cold preservation to ointment after promptly making ointment, and to obtain better preservation effect, best refrigerated storage temperature is 3 ℃~-25 ℃, and this condition can be obtained best preservation effect.
For realizing the 3rd goal of the invention, the invention provides the application of a kind of this pharmaceutical composition in the medicine of the wound of rotting at preparation treatment skin burn, skin scald or skin.
This composite medicine preparation method is simple, and is with low cost and have a notable therapeutic effect; The ointment that makes according to crude drug prescription of the present invention and ointment production technology is through clinical verification, and internal energy pain relieving of short time has the cell regeneration effect to skin trauma.Be used for the treatment of skin injurys such as empyrosis, can cure in 1~2 day most of 1 degree fire victim, can cure in 3~5 days most of 2 degree fire victims, to most of 3 above burn and scald of degree or the septic patient of skin height is can cure in 7~15 days, and preventing from scar, be that application compress are restored in a kind of ideal skin cell regeneration.
Trial edition invention ointment in somewhere is scalded the patient to serious burn and is treated, and its result adds up as follows: burn, scald patient 7 people, and wherein 3 spend patient 6 people that burn, and 4 spend patient 1 people that burns; Male 4 people among the patient, women 3 people; Age is not waited from 7 years old by 32 years old.Use ointment of the present invention by 1 to 3 drug of topical application every day, therapeutic outcome is as follows: 10 have 4 people with interior cured person, and cured person has 3 people in 10~15 days, cure rate 100%, and the prognosis preventing from scar does not have apparent side effect.
The specific embodiment
Embodiment 1
Get the Smallfruit Rose Root leaf 470g that won the same day, pluck 3 months Hibisci Mutabilis dry flower 25g, water content 8% in the dry flower, mixes and smashes into the mud shape, and the medicine mud that makes is added 5g Oleum Camelliae (Oleum Camelliae is that the Semen Camelliae squeezing get), is in harmonious proportion evenly, makes ointment.The ointment of the present invention that makes placed 0 ℃ environment preservation.
Embodiment 2
Pick 2 days Smallfruit Rose Root leaf 485g, pluck 4 months Hibisci Mutabilis dry flower 10g, water content 6% in the dry flower, mixes and smashes into the mud shape, and the medicine mud that makes is added 5g Oleum Camelliae (Oleum Camelliae get for the squeezing of lobule Semen Camelliae), is in harmonious proportion evenly, makes ointment.The ointment of the present invention that makes placed-25 ℃ to 3 ℃ environment preservation.
Embodiment 3
Pick 3 days Smallfruit Rose Root leaf 450g, pluck 6 months Hibisci Mutabilis dry flower 40g, water content 15% in the dry flower, mixes and smashes into the mud shape, and the medicine mud that makes is added 10g Oleum Camelliae (Oleum Camelliae is that the Semen Camelliae squeezing get), is in harmonious proportion evenly, makes ointment.The ointment of the present invention that makes placed-25 ℃ to 3 ℃ environment preservation.
Embodiment 4
Pick 3 days Smallfruit Rose Root leaf 400g, pluck 6 months Hibisci Mutabilis dry flower 95g, water content 20% in the dry flower, mixes and smashes into the mud shape, and the medicine mud that makes is added 5g Oleum Camelliae (Oleum Camelliae is that the Semen Camelliae squeezing get), is in harmonious proportion evenly, makes ointment.The ointment of the present invention that makes placed-25 ℃ to 3 ℃ environment preservation.
Embodiment 5
Pick 3 days Smallfruit Rose Root leaf 485g, pluck 6 months Hibisci Mutabilis dry flower 10g, water content 5% in the dry flower, mixes and smashes into the mud shape, and the medicine mud that makes is added 5g Oleum Camelliae (Oleum Camelliae get for the squeezing of lobule Semen Camelliae), is in harmonious proportion evenly, makes ointment.The ointment of the present invention that makes placed-25 ℃ to 3 ℃ environment preservation.
Embodiment 6
Pick 3 days Smallfruit Rose Root leaf 400g, pluck 6 months Hibisci Mutabilis dry flower 50g, water content 10% in the dry flower, mixes and smashes into the mud shape, and the medicine mud that makes is added 50g Oleum Camelliae (Oleum Camelliae get for the squeezing of lobule Semen Camelliae), is in harmonious proportion evenly, makes ointment.The ointment of the present invention that makes placed-25 ℃ to 3 ℃ environment preservation.
Embodiment 7
Pick 3 days Smallfruit Rose Root leaf 475g, pluck 6 months Hibisci Mutabilis dry flower 20g, water content 5% in the dry flower, mixes and smashes into the mud shape, and the medicine mud that makes is added 5g Oleum Camelliae (Oleum Camelliae is that the Semen Camelliae squeezing get), is in harmonious proportion evenly, makes ointment.The ointment of the present invention that makes placed-25 ℃ to 3 ℃ environment preservation.
Embodiment 8
Pick 3 days Smallfruit Rose Root leaf 485g, pluck 6 months Hibisci Mutabilis dry flower 13.5g, water content 5% in the dry flower, mixes and smashes into the mud shape, and the medicine mud that makes is added 1.5g Oleum Camelliae (Oleum Camelliae is that the Semen Camelliae squeezing get), is in harmonious proportion evenly, makes ointment.The ointment of the present invention that makes placed-25 ℃ to 3 ℃ environment preservation.
Embodiment 9
Pick 3 days Smallfruit Rose Root leaf 480g, pluck 6 months Hibisci Mutabilis dry flower 17g, water content 5% in the dry flower, mixes and smashes into the mud shape, and the medicine mud that makes is added 3g Oleum Camelliae (Oleum Camelliae is that the Semen Camelliae squeezing get), is in harmonious proportion evenly, makes ointment.The ointment of the present invention that makes placed-25 ℃ to 3 ℃ environment preservation.
, form the antimicrobial protection film if but this drug main Smallfruit Rose Root leaf endogenetic fungus human activin cell regeneration vigor kills the body inner virus.Thereby play therapeutic effect.Flos Hibisci Mutabilis, Oleum Camelliae have heat-clearing and toxic substances removing, invigorating blood circulation what, fresh-keeping the preserving moisture of medicine are had good result human body, Oleum Camelliae can guarantee the survival of Smallfruit Rose Root leaf endogenetic fungus, can guarantee that fungus can play a role, Oleum Camelliae can promote the growth and breeding of Smallfruit Rose Root leaf endogenetic fungus simultaneously, makes it bring into play therapeutical effect better.
This drug main will show and can efficiently kill virus, toxin expelling, effectively removes the muscular death part, does not stay residue, and removing the protecting film that downright bad muscle surface generates covering automatically, prevents superinfection.This medicine can activate the skin growth factor on the other hand, quickens skin and duplicates, and quickens to promote muscle cell regeneration to duplicate with human body skin.So this formulation product can play good therapeutic effect, treatment time is short, and can form effective protecting film, prevents superinfection.
Embodiment 10
Use embodiment 1,2,3 described ointment respectively with the bright leaf of Smallfruit Rose Root, Oleum Camelliae, Flos Hibisci Mutabilis dry flower are used for the treatment of rat scalds, and divides six groups to carry out, every group is used 20 of rat, specific as follows:
Experiment bark fetching skin not damaged healthy white rat, with rat spinal column both sides metastomium skin with the depilation of depilatory sodium sulfide, the about 3cm * 4cm of area, (account for body surface 10%).Use the warm water cleaning depilatory, return cage to observe about 24 hours, see abnormal phenomenas such as skin zero damage, redness, erythra.To window in the middle of 6cm * 6cm medical proof fabric, area 3cm * 4cm, make the big cotton pad of 3cm * 4cm again, to eat about rusting heat to 140 ℃, the big cotton pad of adhesional wetting takes out and is affixed on immediately on the depilation skin, take off after 30 seconds, making and scalding the position is that dark two degree are scalded, and observes and sees after 24 hours that wound surface has tangible inflammatory reaction to change, as purplish red hyperemia, edema etc.The area and the degree of depth that the rat of each group is scalded are similar, the wound surface area of record rat.After animal model made, each component cage was raised, and gave following medicine: embodiment 1 described ointment, embodiment 2 described ointment, embodiment 3 described ointment, the bright leaf of Smallfruit Rose Root leaf, Flos Hibisci Mutabilis dry flower, Oleum Camelliae respectively.The administration process is directly coating, once a day.Carry out 2 experiments altogether, once for scalding administration in back 10 minutes, once for scalding administration in back 24 hours, 6 groups of different pharmaceutical are all carried out in each experiment, and every group is used 20 rat.
The medicine mud that the bright leaf of the Smallfruit Rose Root leaf that uses in the present embodiment is smash for the Smallfruit Rose Root leaf of plucking 1 day;
The Flos Hibisci Mutabilis dry flower that uses in the present embodiment is that moisture about 8% Flos Hibisci Mutabilis dry flower is smash patent medicine mud with deionized water;
The Oleum Camelliae that uses in the present embodiment gets as the Semen Camelliae squeezing, directly spreads upon the affected part during use.
(1) burn medication in back 10 minutes:
|
Embodiment 1 described ointment group |
Embodiment 2 described ointment groups |
Embodiment 3 described ointment groups |
The bright leaf group of Smallfruit Rose Root leaf |
Flos Hibisci Mutabilis dry flower group |
The Oleum Camelliae group |
Cure in 3 days |
??18 |
??19 |
??17 |
??0 |
??0 |
??0 |
Cured in 3~5 days |
??2 |
??1 |
??3 |
??10 |
??0 |
??0 |
Cured in 5~10 days |
??0 |
??0 |
??0 |
??10 |
??9 |
??8 |
Do not cure |
??0 |
??0 |
??0 |
??0 |
??11 |
??12 |
Total effective rate |
??100% |
??100% |
??100% |
??100% |
??45% |
??40% |
(2) burn medication in back 24 hours:
|
Embodiment 1 described ointment group |
Embodiment 2 described ointment groups |
Embodiment 3 described ointment groups |
The bright leaf group of Smallfruit Rose Root leaf |
Flos Hibisci Mutabilis dry flower group |
The Oleum Camelliae group |
Cure in 3 days |
??0 |
??0 |
??0 |
??0 |
??0 |
??0 |
Cured in 3~5 days |
??1 |
??2 |
??0 |
??0 |
??0 |
??0 |
Cured in 5~10 days |
??16 |
??17 |
??17 |
??1 |
??0 |
??0 |
Cured in 10~15 days |
??3 |
??1 |
??3 |
??19 |
??2 |
??2 |
Do not cure |
??0 |
??0 |
??0 |
??0 |
??18 |
??18 |
Total effective rate |
??100% |
??100% |
??100% |
??100% |
??10% |
??10% |
Embodiment 11
Patient Liu, the woman, 7 years old, both feet were by the boiled water rats after severe scald burn, a few hours are sent treatment to hospital after hindering, the attending doctor was once advising amputation, adopted external application of ointment treatment of the present invention in back 11 days in wound, used the back wound to feel comfortable, apply 3 times every day later on, the wound symptom is clearly better after a few days, uses after 15 days, scalds wound and returns to one's perfect health.
Embodiment 12
Patient Zeng, the woman, 39 years old, boiled water was scalded, and left lower extremity 2 degree are burnt, and area reaches 20%, and epidermis festers, frowziness.Use external application of ointment treatment of the present invention; cooperate the penicillin intravenous drip to protect from infection; treat and do not have obvious phenomenon in first day; found suppurating sore place desiccation in second day; and white antimicrobial protection film appears; begin to occur the thigh heel after the 3rd day and grow 1 cun fresh epidermis in the left and right sides, ulcer surface disappears, and begins healing.Change to restore external application of ointment every day,, scald and suffer from limb and restore, do not find ill symptoms after stopping using ointment through a wheat harvesting period through treatment in seven days.After the patient suffers from the limb recovery from illness, preventing from scar, epidermis is the same with normal skin, and the non-pigment calmness does not influence and suffers from the limb function, observes having no side effect at present.
Embodiment 13
The patient relies certain, the man, and 22 years old, boiled water was scalded, and left lower extremity 1 degree is burnt, area reaches 6.5%, and the surface is red and swollen, and scorching hot pain is used external application of ointment treatment of the present invention to scald skin of lower extremity after 3 days and begun to close up, cure after 5~6 days, no cicatrix is residual, does not influence to suffer from the limb function, observes having no side effect at present.
Embodiment 14
Patient Liao, the woman, 34 years old, suffered from paronychia 3 years, conventional treatments is invalid, repeatedly recurrence.Use ointment of the present invention to smear once every day, smeared continuously 3 days, week back recovery from illness.