Background technology
Infantile eczema (infantileeczema) is a kind of a kind of allergic skin inflammation common, that caused by internal and external factor.Skin lesion has the tendency of oozing out take papulovesicle as main pleomorphism infringement, repeatedly outbreak, and the acute and chronic phase overlaps alternately, accompanies violent pruritus.On its Therapeutic Principle be adopt according to stadium put antipruritic agent on the skin outward, anti-inflammation drugs for oral administration is treated respectively.
Skin pruritus refers to without former breakout, but a kind of dermatosis of pruritus is arranged, and belongs to the neuropsychiatric dermatosis, is a kind of skin neurosis illness.Be mainly in oldaged physically weak, deficiency of qi and blood person.To only have skin pruritus clinically and be referred to as pruritus without the primary cutaneous impairer.Its treatment is also more adopts clearing away heat-damp and promoting diuresis antipruritic agent for oral administration, put the way of itching-relieving tincture on the skin outward.
For the anti-pruritic formulation of putting on the skin outward, the 40-60 age in last century is ointment and medicated wine, and the 60-70 age is antimicrobial ointment or Hormonal ointment; Rise the nineties and somatomedin and biochemical preparation have occurred.
In the Chinese patent database, relate to the application part for the treatment of infantile eczema and senile skin pruritus a lot, used chitosan, namely CN1537557 number " a kind of sterilizing and itch-relieving medicine for external use and preparation method thereof " but only have in 1 the raw material.This medicine for external use has used 8 kinds of Chinese crude drugs, has also used glacial acetic acid and chitosan, and its therapeutic effect is unclear.In medical practice, curing same disease can have different prescriptions, with for different crowds.Therefore excavate herb resource, develop more medicine and be necessary.
Summary of the invention
Purpose of the present invention just is to provide a kind of medicine for external use for the treatment of infantile eczema and senile skin pruritus, directly is infant patients and gerontal patient service, and obtains better therapeutic effect.
Another purpose of the present invention provides the preparation method of the medicine for external use for the treatment of infantile eczema and senile skin pruritus, enables commercial production, is applied to clinical.
The treatment infantile eczema that the inventor provides and the medicine for external use of senile skin pruritus are according to the preparation of raw material of following quality proportioning:
Remaining is purified water.
In the above-mentioned raw materials medicine, carboxymethyl chitosan (Carboxymethyl chitosan) is a kind of important derivatives of chitin, produced with chloroacetate reaction under alkali condition by chitosan and to form, have stable character and antibiotic infection, blood fat reducing and prevent and treat the pharmacological actions such as arteriosclerosis (see Baidupedia: " carboxymethyl chitosan "); Radix Sophorae Flavescentis is the root of leguminous plant Radix Sophorae Flavescentis (Sophora flavescens), hardship, cold, heat clearing and damp drying, the parasite killing diuresis is used for swelling of the vulva pudendal pruritus, eczema, acne, skin pruritus, scabies leprosy (seeing Jiangsu new medical college volume " Chinese medicine voluminous dictionary " P1283) outward; Rhizoma Zingiberis corallini (Rhizoma zingibel) acrid in the mouth is peppery, energy heat-clearing and toxic substances removing, detumescence (seeing 143 pages in " Chinese Plants will " 16 volumes 2 fascicles), and its volatile oil contains terpinene-4 alcohol, can antibiotic, antifungal.
In the above-mentioned adjuvant, twen-80 (Tween 80) is the condensation substance of Span and oxirane, is a class nonionic agent, makes in this product solubilizing agent or emulsifying agent; Buddhist nun's platinum ethyl ester is the white crystals thing, mildly bitter flavor, and the fiber crops of burning are in this product as sterilization antiseptic.
Above-mentioned former/the adjuvant medicine should meet " the regulation in the Chinese pharmacopoeia version in 2010.
The method for making of the medicine for external use for the treatment of infantile eczema of the present invention and senile skin pruritus is:
(1) first by the material preparation of respectively distinguishing the flavor of in the formula proportion;
(2) carboxymethyl chitosan, Radix Sophorae Flavescentis and purified water are placed blender, under heating condition, stir, after its dissolving, continue to mix, make the mixed liquor of homogeneous, for subsequent use;
(3) get Oleum Zingiberis corallini, twen-80 and Buddhist nun's platinum ethyl ester and place vacuum emulsification tank heating emulsification, after the emulsifying evenly, leave standstill, make the volatile oil of homogeneous, for subsequent use;
(4) mixed liquor for subsequent use and volatile oil are placed homogenizer, make its mix homogeneously under high-speed stirred, afterwards, filter, after the assay was approved fill obtains product.
In above-mentioned the 2nd step, heating-up temperature is 30 ℃ in blender, and mixing time is 15 minutes.
In above-mentioned the 3rd step, heating-up temperature is 30 ℃ in emulsion tank, and time of repose is 24 hours.
In above-mentioned the 4th step, mixing time is 15 minutes in homogenizer.
Product should meet " the requirement in one one of the Chinese pharmacopoeia version in 2010.
The medicine for external use usage for the treatment of infantile eczema of the present invention and senile skin pruritus is external: be applied to the affected part or evenly be sprayed on the skin lesion surface apart from skin lesion 3cm place, every day 3~5 times.
Result in clinical application shows, this medicine is evident in efficacy to infantile eczema and senile skin pruritus.
Hospital Attached to Guiyang Medical College's department of dermatologry uses this medicine to carry out out-patient treatment 68 routine eczema infants in February, 2009-2010 a year August, wherein: boy's 38 examples, girl's 30 examples; 6 months to 16 years old age; The course of disease 2 thoughtful 3 years, person's 16 examples in ill January, 1-6 month person 41 examples, person's 11 examples more than 7 months.Therapeutic Method is this medicine of external, and 2 times/days, 2 weeks of continuous use were 1 course for the treatment of.This 68 routine infant is through 1~3 course for the treatment of, and 30 examples of fully recovering account for 40%; Effective 24 examples account for 38.4%; Invalid 12 examples account for 17.6%, get rid of 2 examples.Total effective rate is 82.4%.
Hospital Attached to Guiyang Medical College's department of dermatologry carries out out-patient treatment 100 routine senile skin pruritus patients in February, 2009-2010 year August, is divided into two groups, and one group is treatment group, and another group is matched group.Wherein, treatment group man 27 examples, women 23 examples, 51~82 years old age, average 67 years old, the course of disease 3 months~5 years, average 1.9 years.Two groups of patients' difference not statistically significant, P>0.05 has comparability.This medicine for the treatment of group external treatment, 2 times/days, levocetirizine capsule for oral administration, every day 1 time, 1 time 1; Matched group is levocetirizine capsule for oral administration only, every day 1 time, 1 time 1.Treat after 1 month and to observe, treatment group 12 examples of fully recovering account for 24%, and 31 examples that take a turn for the better account for 62%, and invalid 7 examples account for 14%, and total effective rate is 86%; Matched group 8 examples of fully recovering account for 16%, and 25 examples that take a turn for the better account for 50%, and invalid 17 examples account for 34%, and total effective rate is 66%.The treatment group total effective rate is higher than matched group, and difference has statistical significance, P<0.01.
The medicine for external use for the treatment of infantile eczema of the present invention and senile skin pruritus has improved patient's cure rate, can improve Quality of Life and health status, and prescription is simple, and method for making is easy, and stable processing technique, production environment safety are pollution-free.It is one of substitute species of existing antipruritic agent.
The specific embodiment
Embodiment gets carboxymethyl chitosan 200g, Radix Sophorae Flavescentis 100g, Oleum Zingiberis corallini 50g, twen-80 50g, Buddhist nun's platinum ethyl ester 10g by formula proportion first, gets the raw materials ready.
Carboxymethyl chitosan, Radix Sophorae Flavescentis and 96kg purified water are placed blender, stirred 10 minutes being heated under 30 ℃ of conditions, after its dissolving, continue to stir 15 minutes mix homogeneously, make the mixed liquor of homogeneous, for subsequent use;
Get again Oleum Zingiberis corallini, twen-80 and Buddhist nun's platinum ethyl ester and place the vacuum emulsification tank to be heated to 30 ℃ of emulsifyings, after the emulsifying evenly, left standstill 24 hours, make the volatile oil of homogeneous, for subsequent use;
At last, mixed liquor for subsequent use and volatile oil are placed homogenizer, make under high-speed stirred after its mix homogeneously 15 minutes, filter, after the assay was approved fill obtains product.
Product dispatches from the factory according to per 1 bottle of 100ml fill.