CN109771611A - Pharmaceutical composition for treating chloasma as well as preparation method and application thereof - Google Patents
Pharmaceutical composition for treating chloasma as well as preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a pharmaceutical composition for treating chloasma, which is prepared from the following raw material medicines in parts by weight: 3.2 to 4.8 parts of mulberry leaf, 2.4 to 3.6 parts of trichosanthes root and 2.4 to 3.6 parts of zedoary. The invention further discloses a preparation method and application of the pharmaceutical composition. The pharmaceutical composition provided by the invention can obviously reduce facial pigmentation and fade chloasma, has an excellent chloasma removing effect, can treat chloasma, provides a new pharmaceutical choice for clinical treatment, and has a strong practical application value.
Description
Technical field
The present invention relates to drug fields, and in particular to a kind of pharmaceutical composition for treating chloasma and preparation method thereof and uses
On the way.
Background technique
Chloasma is also referred to as chloasma hepaticum, for the yellowish-brown pigmentation of face.Multipair title butterfly is distributed in cheek.It is more common in female
Property, estrogen level height is main cause in blood, is fallen ill related with gestation, Long-term Oral contraceptive, paramenia.The cause of disease is still
It is unclear, it is more common in women, estrogen level height is main cause in blood.It is fallen ill and gestation, Long-term Oral contraceptive, menstruation
Disorder is related.Also the patients such as some female reproductive system illness, tuberculosis, cancer, chronic alcoholism, hepatopathy are seen.Daylight can
Promote to fall ill.Male patient accounts for about 10%, has research to think that male's morbidity is related with heredity.Damage is yellowish-brown or deep brown spot
Piece, is often symmetrically distributed in cheekbone cheek, also can be involved periorbit, forehead, upper lip and nose, and edge is generally more apparent.Without subjective symptom
And general malaise.The color spot depth and season, solarization, endocrine factors are related.Stress is stayed up late, and fatigue can aggravate skin lesion.Mesh
Before there is no satisfied therapy.
Existing clinical main treatment method has: (1) external application tyrosinase inhibitor ointment, such as 5% Hydrochinone Cream, 2-4% are bent
Sour frost and 3% arbutin etc..Painting has different degrees of curative effect after putting on the skin.Such drug is antioxidant, easily in air and daylight
Middle oxidation should be closed, is kept in dark place.In recent years someone's report uses 0.1% Tretinoin Ointment in Treatment chloasma, external application sugar cortical hormone
Element etc. also has certain curative effect.(2) strip off therapy: trichloroacetic acid solution, which locally applies to put on the skin, can make exfoliation, and remove pigmented spots.Liquid
COMBINED CURETTAGE AND CRYOTHERAPY is removed after can making epidermis freezing necrosis, to remove depigmentaton, grinding operation be epidermis is ground off one layer with bistrique, and
Achieve the purpose that except depigmentaton.It is postoperative that suncream etc. is used after wound healing, otherwise it is easy to recur after solarization.(3) facial mask is treated
Method: facial mask therapy includes simple face film agent, face mask cream massage and reverse mould facial mask method.Wherein reverse mould facial mask method is widely used to
The treatment of chloasma, and obtained promising result.Facial mask reverse mould therapy integrates drug, massage, physical therapy, to have a variety of
Therapeutic effect.(4) it laser or intensive pulsed light: has been reported that recently yellow using photorejuvenation and application Q-switch laser therapy
Foxiness some patientss are effective.Surgical effect is obvious on the whole, but somewhat expensive and has side effect.In contrast, Chinese medicine is matched
Square raw material sources are extensive, cheap, and toxic side effect is small, have a clear superiority when preparing eliminate chloasma class drug.
So far, there is not yet by the relevant report of mulberry leaf, radices trichosanthis and curcuma zedoary compatible use treatment chloasma.
Summary of the invention
The purpose of the present invention is to provide a kind of pharmaceutical compositions and its preparation method and application for treating chloasma.
The present invention provides one kind for reducing facial pigmentation, desalinates the pharmaceutical composition of chloasma, it is under
The bulk pharmaceutical chemicals of column weight proportion are prepared: 3.2~4.8 parts of mulberry leaf, 2.4~3.6 parts of smallpox, 2.4~3.6 parts of curcuma zedoary.
Further, foregoing pharmaceutical composition is prepared by the bulk pharmaceutical chemicals of following weight proportion: 4 parts of mulberry leaf, smallpox 3
Part, 3 parts of curcuma zedoary.
Further, foregoing pharmaceutical composition is that by the medicinal powder of bulk pharmaceutical chemicals of the weight proportion, the water of bulk pharmaceutical chemicals or have
Solvent extract is active constituent, in addition the preparation that pharmaceutically acceptable auxiliary material is prepared.
Further, the preparation is external preparation.
Further, the external preparation be solution, it is powder, tincture, spirit, lotion, finish, emulsion, ointment, hard
Paste, paste, plastics, film, Babu plaster, gelling agent, liniment, aerosol, transdermal patch, bath agent or electro-ionic osmosis
Agent.
The present invention also provides a kind of methods for preparing foregoing pharmaceutical composition, it includes the following steps:
A, the raw material of each weight proportion is weighed；
B, raw material directly beaten to powder, or after adding water or organic solvent to extract, pharmaceutically acceptable auxiliary material or auxiliary is added
Property ingredient is prepared.
Further, when the dosage form of described pharmaceutical composition is powder, it includes the following steps:
A, the bulk pharmaceutical chemicals of each weight proportion are weighed；
B, it crushes, obtains the above coarse powder of 60 mesh.Coarse powder is placed in Baily pulverizing mill and is pulverized, pulverization conditions are as follows:
0~10 DEG C of temperature of crushing, abrasive media filling rate 60~70%, vibration frequency 1000 times/min, oscillation intensity 8g, amplitude 5mm,
Grinding time 60min is to get cell wall-broken micro powder.
Further, the cell wall-broken micro powder, wherein 75 μm of partial size < of powder content 97.1%, cell-wall breaking ratio
98.7%.
Further, described pharmaceutical composition reduces facial pigmentation in preparation, desalinates the use in the drug of chloasma
On the way.
Further, the drug is the drug for treating chloasma.
The present invention is made of mulberry leaf, radices trichosanthis, three herbal medicine of curcuma zedoary.
Mulberry leaf are the dried leaf of moraceae plants mulberry Morus alba L..It is harvested after first frost, removes impurity, dry.It is cold in nature,
It is sweet in flavor, bitter.Return lung, Liver Channel.With dispelling wind and heat from the body, clearing away the lungheat and moisturizing, function of clearing liver and improving vision.For anemopyretic cold, lung-heat type cough, head
Dizzy headache, red eyes and dim-sighted.Radices trichosanthis is cucurbitaceous plant snakegourd Trichosanthes kirilowii Maxim. or bilateral Chinese juniper
The dry root of building Trichosan-thes rosthornii Herms.Autumn, two season of winter excavation, clean, remove crust, dissection or
Vertical profile is dry at valve.Cold nature, sweet in flavor, slight bitter.It attaches to the lung and stomach meridians.With clearing heat and promoting fluid, detumescence and apocenosis function.It is tired for pyreticosis
Yearningly, lung-heat type cough, Heat Diabetes, sore swollen toxin.Curcuma zedoary is zingiberaceous plant zedoary Curcuma phaeocaulis Val., extensively
Western curcuma zedoary Curcuma Kwangsiensis S.G.Lee et C.F.Liang or RADIX CURCUMAE Curcuma wenyujin
The dry rhizome of Y.H.Chen et C.Ling.The latter, which practises, claims " Curcuma wenyujin ".It is excavated after winter cauline leaf is withered, cleans, steam or boil
To the saturating heart, fibrous root and impurity are removed after sun drying or low temperature drying.It is warm-natured, acrid flavour, hardship.Return liver, the spleen channel.There are promoting the circulation of qi blood-breaking, disperse accumulation
The function of analgesic.It is pained for vim and vigour, eating accumulation, abdominal distention, amenorrhea due to stagnation of blood, dysmenorrhea , wei lump in the abdomen lump in the abdomen, traumatic injury.Mulberry
Leaf, radices trichosanthis, curcuma zedoary are synergistic under specific proportion, can produce treatment chloasma effect.
Clinical research shows that pharmaceutical composition provided by the invention can be reduced facial pigmentation, desalinates chloasma, has
Excellent eliminate chloasma effect treats chloasma, and pharmaceutical composition of the present invention is easy to use, provides for clinic a kind of new
Medicament selection, have stronger practical application value.
Obviously, above content according to the present invention, according to the ordinary technical knowledge and customary means of relevant art,
Under the premise of not departing from above-mentioned basic fundamental thought of the invention, the modification, replacement or change of other diversified forms can also be made.
The specific embodiment of form by the following examples remakes further specifically above content of the invention
It is bright.But the range that this should not be interpreted as to the above-mentioned theme of the present invention is only limitted to example below.It is all to be based on above content of the present invention
The technology realized all belongs to the scope of the present invention.
Specific embodiment
The preparation of the medicinal composition powders of the present invention of embodiment 1
(1) raw material: mulberry leaf 120g, radices trichosanthis 90g, curcuma zedoary 90g.
(2) bulk pharmaceutical chemicals preparation method: are weighed by above-mentioned weight proportion；Be broken into fine powder, sieve with 100 mesh sieve, mix to get.
The preparation of the Pharmaceutical composition tincture of the present invention of embodiment 2
(1) raw material: mulberry leaf 120g, radices trichosanthis 90g, curcuma zedoary 90g.
(2) bulk pharmaceutical chemicals preparation method: are weighed by above-mentioned weight proportion；It is ground into coarse powder, it is small with 75% alcohol dipping 24
When, it then carries out diacolation, obtains the liquid 450ml that just filters, continue percolate 450ml (being condensed into 50ml), merge 2 percolates to obtain the final product.
The preparation of the drug composition liniment of the present invention of embodiment 3
(1) raw material: mulberry leaf 120g, radices trichosanthis 90g, curcuma zedoary 90g.
(2) bulk pharmaceutical chemicals preparation method: are weighed by above-mentioned weight proportion；It cleans, is dry, chopping, after soaking in water 30 minutes
8 times of water are added to decoct 2 times, every time 60 minutes.It is concentrated into specific gravity 1.02-1.04 (80 DEG C, about 550ml), stands after decoction liquor filtering
Taken after 24 hours supernatant liquid filtering be diluted with water to 600ml (appropriate preservative is added) to get.
The preparation of the pharmaceutical composition ointment of the present invention of embodiment 4
(1) raw material: mulberry leaf 120g, radices trichosanthis 90g, curcuma zedoary 90g.
(2) bulk pharmaceutical chemicals preparation method: are weighed by above-mentioned weight proportion；It cleans, is dry, chopping, 1000ml sesame oil is added to impregnate 3
Day, it is heated to 80 DEG C and is kept for 5 hours, be again heated to 100 DEG C 15 minutes, remove the dregs of a decoction, filtering.It is added in filtered medicine oil
Chinese wax 120g, borneol 10g dissolve at 60 DEG C, mix to obtain the final product.
The preparation of the pharmaceutical composition cell wall-broken micro powder of the present invention of embodiment 5
(1) raw material: mulberry leaf 120g, radices trichosanthis 90g, curcuma zedoary 90g.
(2) bulk pharmaceutical chemicals preparation method: are weighed by above-mentioned weight proportion；Impurity is removed, is cleaned, 60 DEG C of dryings are to aqueous
6% using Universalpulverizer hereinafter, crushed, and obtains the above coarse powder of 60 mesh.By above-mentioned coarse powder into Baily pulverizing mill, by following parameter
Pulverized: crushing temperature is 0~10 DEG C, abrasive media filling rate 60~70%, 1000 times/min of vibration frequency, vibration
Intensity 8g, amplitude 5mm, grinding time 60min, collect Ultramicro-powder to get.
On inspection, it is crushed by upper method, it is average that powder rate 96.8%, the average yield 97.1% that 75 μm of partial size < are put down
Equal cell-wall breaking ratio 98.7%.
Beneficial effects of the present invention are proved below by way of specific clinical test.
The clinical efficacy of the pharmaceutical composition of the present invention of test example 1
1, clinical data
Patient with chloasma 150, wherein male 24, female 126,18~58 years old age (37 ± 3.5 years old), the course of disease 2 months
~20 years (3.2 ± 1.4 years).Sick 55, type mesocuticle type, 49, corium type, mixed type 46.
Subject's face normotopia side position photo is clapped respectively, is recorded in medical record.
1.1 are included in standard
1. all patients meet the diagnostic criteria of chloasma, i.e. chloasma clinical diagnosis and criterion of therapeutical effect (draft), suffer from
This research is participated in the equal informed consent of person, is met ethics requirement as defined in the court and is passed through audit；2. without disease in the blood system；
3. hepatic and renal function is well and without lesion person；4. impassivity systemic disease and mentally disturbed；5. research can be completed with merging alone.
1.2 exclusion criteria
1. using oral drugs, Chemical peeling agent or decolorising agent etc. in 3 months, all influenced the treatment of metabolism of pigment process
Patient；2. Pregnant and lactant women；Blood coagulation tendency person is shown 3. treating preceding laboratory and checking；4. once thering is thrombus, the heart to twist
Bitterly, myocardial infarction, cerebral ischemia medical history person；The patient of ⑤You gynaecology and hepatitis history；6. other are such as to the excessively high person of the desired value of curative effect.
2, test medication preparation
Nti-freckle powder: taking mulberry leaf 400g, radices trichosanthis 300g, curcuma zedoary 300g, removes impurity, cleans, and 60 DEG C of dryings are to aqueous
For 6% hereinafter, being crushed using Universalpulverizer, sieve with 100 mesh sieve.
Mulberry leaf powder: taking mulberry leaf 1000g, and ibid prepared by method.
Smallpox pulvis: taking radices trichosanthis 1000g, and ibid prepared by method.
Curcuma zedoary powder: taking curcuma zedoary 1000g, and ibid prepared by method.
Dress medicinal powder solution: 2:3:1 is mixed by volume for 95% alcohol, 25% acetic acid solution, glycerol, is stirred evenly.
All patients are divided into nti-freckle side's group, mulberry leaf group, radices trichosanthis group, curcuma zedoary group and control group according to random digits table
Each 30.The general information comparing difference such as every group of patient age, gender, the course of disease, parting is not statistically significant (P > 0.05), tool
There is comparativity.
3, therapeutic scheme
Control group: putting 3% Hydrochinone Cream on the skin outside, (manufacturer: Guangdong Renren Kang Pharmaceutical Co., Ltd, authentication code: traditional Chinese medicines are quasi-
Word H20040088) it at skin lesion and softly massages, each 1 time sooner or later.Other groups are tuned into paste with 10-15 grams of solubilizer of traditional Chinese medicine powder
It is applied with one time a day, 2 hours every time.3 months as a treatment course.
4, observation of curative effect
4.1 criterion of therapeutical effect
The treatment of two groups of patients is observed and compared after treating 3 months referring to chloasma clinical diagnosis and criterion of therapeutical effect (draft)
Effect, chloasma scoring and satisfaction evaluation.
Recovery from illness: pigmented spots color disappears, and area reduces >=90%；
Effective: pigmented spots color is thin out, and area reduces 60%~89%；
Improve: pigmented spots color is thin out, and area reduces 30%~59%；
Invalid: pigmented spots color reduces < 30% without significant change, area.
Efficient=(recovery from illness number of cases+effective number of cases)/total number of cases × 100%.
Chloasma standards of grading: it is divided into 0~3 point, 0 point: the colour of skin is normal；1 point: filbert；2 points: brown；3 points: deep brown
Color.
4.2 statistical method
Statistical procedures are for statistical analysis to clinical data using SPSSl8.0 statistics software, and enumeration data uses
Pearson Chi-square Test, measurement data are examined using t.Level of significance α=0.05.
5, treatment results
5.1 clinical efficacy
The comparative example (%) of the 1 pretherapy and post-treatment clinical efficacy of each group patient of table
The effective percentage of control group patient is 66.67%, and nti-freckle side's group, mulberry leaf group, radices trichosanthis group, curcuma zedoary group are respectively
83.33%, 56.67%, 53.33% and 63.33%.Nti-freckle side's group there were significant differences compared with the control group (x2=1.841, P <
0.05), three groups of mulberry leaf group, radices trichosanthis group, curcuma zedoary group control groups compare no significant difference (x2=1.841, P >
0.05)。
The scoring of 3.2 chloasma
The scoring of the area and chloasma of the 2 pretherapy and post-treatment chloasma of each group patient of table is compared
Note: * P < 0.05
Area of chloasma, chloasma integral contrast before each group patient treatment, no significant difference (t=0.013,
0.282；P > 0.05)；After nti-freckle side's group and control group group patient treatment before the area of chloasma, the integral of chloasma and treatment
Comparing there were significant differences, (area of control group chloasma is pretherapy and post-treatment: t=13.951, P < 0.05；Control group chloasma integral
It is pretherapy and post-treatment: t=14.205, P < 0.05；The area of nti-freckle side's group chloasma is pretherapy and post-treatment: t=7.405, P < 0.05；Nti-freckle
Side's group chloasma integral is pretherapy and post-treatment: t=6.798, P < 0.05).The area of chloasma, chloasma after other group of patient's treatment
Integral with treatment before compared with without significant difference.
The above result shows that pharmaceutical composition of the present invention has the function of significantly treating chloasma, and drug effect is better than single
With mulberry leaf, radices trichosanthis or curcuma zedoary, it was demonstrated that three taste bulk pharmaceutical chemicals complement each other in formula, have played synergistic function.
In conclusion pharmaceutical composition provided by the invention can substantially reduce facial pigmentation, desalinates chloasma, have
Excellent eliminate chloasma effect treats chloasma, provides a kind of new medicament selection for clinic, there is stronger reality to answer
With value.
Claims (10)
1. a kind of pharmaceutical composition for treating chloasma, it is characterised in that: it be by following weight proportion bulk pharmaceutical chemicals preparation and
At: 3.2~4.8 parts of mulberry leaf, 2.4~3.6 parts of radices trichosanthis, 2.4~3.6 parts of curcuma zedoary.
2. pharmaceutical composition according to claim 1, it is characterised in that: it is the bulk pharmaceutical chemicals preparation by following weight proportion
It forms: 4 parts of mulberry leaf, 3 parts of radices trichosanthis, 3 parts of curcuma zedoary.
3. pharmaceutical composition according to claim 1 or 2, it is characterised in that: it is by the bulk pharmaceutical chemicals of the weight proportion
Medicinal powder, bulk pharmaceutical chemicals water or extractive with organic solvent be active constituent, in addition what pharmaceutically acceptable auxiliary material was prepared
Preparation.
4. pharmaceutical composition according to claim 3, it is characterised in that: the preparation is external preparation.
5. pharmaceutical composition according to claim 4, it is characterised in that: the external preparation is solution, powder, tincture
Agent, spirit, lotion, finish, emulsion, ointment, emplastrum, paste, plastics, film, Babu plaster, gelling agent, liniment, gas
Mist agent, transdermal patch, bath agent or electro-ionic osmosis agent.
6. a kind of method for preparing Claims 1 to 5 any one described pharmaceutical composition, it is characterised in that: it includes as follows
Step:
A, the raw material of each weight proportion is weighed；
B, raw material directly beaten to powder, or after adding water or organic solvent to extract, be added pharmaceutically acceptable auxiliary material or it is complementary at
Divide and is prepared.
7. according to the method described in claim 6, it is characterized by: it includes when the dosage form of described pharmaceutical composition is powder
Following steps:
A, the bulk pharmaceutical chemicals of each weight proportion are weighed；
B, it crushes, obtains coarse powder, pulverize, obtain cell wall-broken micro powder.
8. according to the method described in claim 7, it is characterized by: the cell wall-broken micro powder, wherein 75 μm of partial size <
Powder content 97.1%, cell-wall breaking ratio 98.7%.
9. claim 1~8 any one described pharmaceutical composition reduces facial pigmentation in preparation or desalinates chloasma
Purposes in drug.
10. purposes according to claim 9, it is characterised in that: the drug is the drug for treating chloasma.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104208411A (en) * | 2014-08-08 | 2014-12-17 | 兰州古驰生物科技有限公司 | Traditional Chinese medicine preparation for removing yellow spot |
| CN104398431A (en) * | 2014-11-21 | 2015-03-11 | 贵州神奇药物研究院 | Traditional Chinese medicine extract product for treating chloasma and preparation method for traditional Chinese medicine extract product |
| CN106421462A (en) * | 2016-10-11 | 2017-02-22 | 江苏省中医药研究院 | Traditional Chinese medicine composition with face beautifying function |
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2019
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| CN104208411A (en) * | 2014-08-08 | 2014-12-17 | 兰州古驰生物科技有限公司 | Traditional Chinese medicine preparation for removing yellow spot |
| CN104398431A (en) * | 2014-11-21 | 2015-03-11 | 贵州神奇药物研究院 | Traditional Chinese medicine extract product for treating chloasma and preparation method for traditional Chinese medicine extract product |
| CN106421462A (en) * | 2016-10-11 | 2017-02-22 | 江苏省中医药研究院 | Traditional Chinese medicine composition with face beautifying function |
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