CN104173607B - It is a kind of to treat pharmaceutical composition of chloasma and preparation method thereof - Google Patents
It is a kind of to treat pharmaceutical composition of chloasma and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to a kind of pharmaceutical composition for treating chloasma and preparation method thereof.It is mainly to be prepared from by the fruit of glossy privet, eclipta, the red sage root, Radix Angelicae Sinensis, Chinese cassia tree, rose, grape seed extract.With nourishing liver and kidney, the effect of eliminating blood stasis and removing ecchymoses, it is adaptable to patient with chloasma.Clinical research shows that the present invention can obviously improve patient with chloasma symptom, and overall clinical efficacy rate 91.43% has no toxic side effect；Experimental study shows that the present invention can substantially reduce chloasma Mouse whole blood viscosity number, improves blood viscosity, improves the activity of radicals scavenging enzyme, reduces peroxidatic reaction of lipid, reduces the generation of melanocyte.
Description
First, technical field
The present invention relates to a kind of pharmaceutical composition for treating chloasma and preparation method thereof.
2nd, background technology
Chloasma is a kind of common chromatodermatosis, is mainly in Female in child bearing period, and the state of an illness is obstinate, has a strong impact on
Patient is attractive in appearance, and many worried and pain is brought to its spirit and life.Its incidence of disease of foreign scholar's statistical report 30%~
70%, and the incidence of disease is counted 30% or so in many scholars of China, but as people's rhythm of life is accelerated, social pressures
Increase, the incidence of disease of chloasma is in obvious ascendant trend.
The pathogenesis of chloasma is sufficiently complex, and pathogenic factor is not still fully aware of at present.Modern medicine think mainly with
The factors such as endocrinopathy, gestation, inherent cause, oxygen radical, ultraviolet irradiation are relevant.Western medical treatment chloasma there is no special efficacy
Mainly there are medicinal treatment, physical therapy, chemotherapy etc. in medicine, treatment, its therapeutic effect is undesirable, and there is certain poison is secondary to make
With.The traditional Chinese medical science thinks that chloasma essentially consists in liver,spleen,kidney functional disturbance, liver depression, insufficiency of the spleen, deficiency of the kidney so as to cause functional activity of QI being not smooth, qi and blood
The stasis of blood is stagnant in train of thought, and face is lost foster caused in moistening.Treatment by Chinese herbs chloasma has prominent integrally-regulated, Small side effects, curative effect stable
The advantages of, therefore as effective desirable route for the treatment of chloasma.Since 1990s, China work of Chinese medicine person is in
A large amount of fruitful work have been done in terms of the research of medicine treatment chloasma, it would be highly desirable to develop Innovative TCMs.The present invention is old in name
On the basis of Chinese traditional treatment chloasma proved recipe, with reference to clinical experience for many years, the pure natural medical preparation developed, with nourishing
The effect of liver kidney, eliminating blood stasis and removing ecchymoses, to chloasma determined curative effect.
3rd, the content of the invention
A kind of drug regimen for the treatment of chloasma it is an object of the invention to provide determined curative effect, without obvious toxic-side effects
Thing and preparation method thereof, it is adaptable to patient with chloasma.
Technical scheme：A kind of pharmaceutical composition for treating chloasma, its feature by following raw material compositions and
Weight proportion is prepared from：1~60 part of the fruit of glossy privet, 1~60 part of eclipta, 10~100 parts of the red sage root, 10~100 parts of Radix Angelicae Sinensis, Chinese cassia tree
1~50 part, 1~50 part of rose, 0.1~30 part of grape seed extract.Preferred weight ratio range of the present invention is：The fruit of glossy privet 10
~50 parts, 10~50 parts of eclipta, 20~80 parts of the red sage root, 20~80 parts of Radix Angelicae Sinensis, 5~40 parts of Chinese cassia tree, 5~40 parts of rose, Portugal
0.5~20 part of grape seed extract.Best weight ratio scope of the present invention is：30 parts of the fruit of glossy privet, 30 parts of eclipta, 60 parts of the red sage root,
40 parts of Radix Angelicae Sinensis, 10 parts of Chinese cassia tree, 10 parts of rose, 2 parts of grape seed extract.
Chinese medicine composition as described above, it is characterised in that the source of the raw material can be Chinese medicine either equivalent to
Extract prepared by the use pharmacy conventional method of Chinese medicine crude drug amount, such as glossy privet fruit extract, Yeradetajo extract, the red sage root are carried
Take thing, angelica extract, Flos Rosae Rugosae extract.
Chinese medicine composition as described above, it is characterised in that preparation method is to use pharmaceutically acceptable carrier or figuration
Agent is prepared from by pharmacy common process.
A kind of preparation method for the pharmaceutical composition for treating chloasma, it is characterised in that finished dosage forms are to use pharmaceutically may be used
Tablet, capsule, granule or pill that the carrier or excipient of receiving are made.Its specific preparation method can be by following several sides
Method is prepared from：
(1) got it filled respectively material by upper described traditional Chinese medicine composite and weight proportion, first by the fruit of glossy privet, eclipta, pellet
Ginseng, Radix Angelicae Sinensis, Chinese cassia tree, rose add extractor, for the first time immersion 30 minutes, plus 10 times of amount decoctings are boiled 2 times, are every time
1.5h, filtration, merging filtrate；70% ethanol is added, precipitates, obtains supernatant, through be concentrated under reduced pressure (70 DEG C, 0.08Mpa), to relative
Density 1.08~1.10 (60 DEG C), reclaims ethanol, obtains medicinal extract, then vacuum dried (70 DEG C, 0.08Mpa), crushes, and crosses 60 mesh
Sieve, get dry extract powder；Grape seed extract and dried cream powder are put in mixer, 30min is mixed, is well mixed, obtains mixed powder A：Press
Pharmacy is routinely added to dressing lactose, microcrystalline cellulose, sodium starch, 1/2 silica and put in mixer, mixes 10min, obtains mixed
Close powder B；By mixed powder A and mixed powder B mixing 30min, to well mixed, total mixed powder is obtained；With 60% ethanol softwood；Will be soft
Material is transferred in oscillating granulator, the granulation of 16 mesh sieves, and 60 DEG C of dryings, 16 mesh sieve whole grains obtain dry particl, standby；It is conventional by pharmacy
Add dressing magnesium stearate, PVPP, 1/2 silica and dry particl to put in mixer, mix 10min, be well mixed,
Obtain total particle；Total particle loads tablet press machine, and 0.7g/ pieces obtain plain piece；Coating powder is made to the coating solution for meeting production requirement, with
Plain piece is together put in seed-coating machine, is coated, is obtained coating tablet.
(2) got it filled respectively material by upper described traditional Chinese medicine composite and weight proportion, the fruit of glossy privet, eclipta, the red sage root, when
Return, Chinese cassia tree, rose, plus 6~12 times of amount decoctings boil 2~3 times, collecting decoction, 50~80% alcohol precipitations, filtration, filtrate is concentrated into
60 DEG C of relative densities 1.15~1.20, add grape seed extract, mix, and pelletize, and dry, plus dressing prepares finished dosage forms.
(3) got it filled respectively material by upper described traditional Chinese medicine composite and weight proportion, rose extracts volatile oil, distillation
The another device of the rear aqueous solution is collected, and the dregs of a decoction and the fruit of glossy privet, eclipta, the red sage root, Radix Angelicae Sinensis, Chinese cassia tree add 6~and 12 times of amount decoctings boil 2~3 times,
Collecting decoction and the above-mentioned aqueous solution, 50~80% alcohol precipitations, filtration, filtrate are concentrated into 60 DEG C of relative densities 1.15~1.20, add
Grape seed extract, is mixed, and is pelletized, and dries, rose flowers volatile oil is uniformly sprayed in particle, is mixed, plus dressing is prepared into
Product formulation.
(4) got it filled respectively material by upper described traditional Chinese medicine composite and weight proportion, 60~80 DEG C of dryings, be ground into 40
~100 mesh fine powders, it is encapsulated；Or water pill processed, in 60~80 DEG C of dryings, packaging is produced.
(5) extract equivalent to Chinese medicine crude drug amount is taken respectively by upper described traditional Chinese medicine composite and weight proportion
Or active component, the finished dosage forms being made using pharmaceutically acceptable carrier or excipient by pharmacy common process.
The advantage of the invention is that prescription is unique, determined curative effect, safety, economy, without obvious toxic-side effects, with nourishing liver
The effect of kidney, eliminating blood stasis and removing ecchymoses, it is adaptable to which patient with chloasma is taken.Clinical research shows that the present invention can obviously improve patient with chloasma
Symptom, overall clinical efficacy rate 91.43%, has no toxic side effect；Experimental study shows that it is small that the present invention can substantially reduce chloasma
Mouse WBV value, improves blood viscosity, improves the activity of radicals scavenging enzyme, reduces peroxidatic reaction of lipid, reduces black
The generation of element.Specific result of study is as follows：
1st, the clinical observation of present invention treatment chloasma
1.1 data and method
1.1.1 diagnostic criteria：Face is filbert to dark brown, the patch of boundary clear, usual symmetry distribution, no inflammation
Performance and the scales of skin that peel off, without obvious subjective symptoms, women is multiple, occurs mainly in after puberty.The state of an illness can have seasonality, Chang Xiachong winters
Gently；Exclude pigmentation caused by other diseases.
1.1.2 general information：35 patients derive from the outpatient gone to a doctor 1~December in 2012, are women.Age
It is 28~49 years old, average 38.5 years old；Course of disease half a year~10 year, it is average 5.25 years；28 buttferfly-types, 7 are its alloytype；Lost with menstruation
Adjust 22, sleep-disorder 18, dysphoria 23.
1.1.3 treatment method：Test medicine [tablet, by the fruit of glossy privet, eclipta, the red sage root, Radix Angelicae Sinensis, Chinese cassia tree, rose of the present invention
Flower, grape seed extract are prepared from, and are provided by middle clever (Beijing) bio tech ltd of food peptide], 0.5g/ pieces, every time 4
Piece, 3 times a day, and 1 month is 1 course for the treatment of, and curative effect is observed after 3 months.Other drugs are disabled during all patient's treatments, are avoided as far as possible
Exposure to Sunlight.
1.1.4 observational technique observes local skin damaged situation.Skin damaged area and color are recorded weekly.
1.1.5 curative effect determinate standard：
(1) it is basic to cure：Naked eyes regard color spot area regression ＞ 90%, and color disappears substantially；Under point system is calculated after treatment
Index >=0.8 drops；
(2) it is effective：Naked eyes regard color spot area regression ＞ 60%, and color is substantially thin out；Point system, which calculates to decline after treatment, to be referred to
Number >=0.5；
(3) take a turn for the better：Naked eyes regard color spot area regression ＞ 30%, and color is thin out；Point system calculate treatment after decline index >=
0.3；
(4) it is invalid：Naked eyes regard color spot area regression ＜ 30%, and color change is not obvious；Point system is calculated to be declined after treatment
Index≤0.
Methods of marking
| Scoring | Skin damaged area/cm2 | Color |
| 0 | Without skin damaged | Normal skin tone |
| 1 | ＜ 2 | It is filbert |
| 2 | 2~4 | Brown |
| 3 | ＞ 4 | Dark brown |
Decline index calculation method：
Decline total mark before index=(total mark after total mark one is treated before treatment)/treatment
1.1.6 statistical method：Designed using own control, calculate efficient.
1.2 result
Treatment results are basic to cure 8 from table 1, effective 11, take a turn for the better 13, invalid 3, total effective rate
91.43%,.
The clinical observation (example) of the present invention treatment chloasma of table 1
2nd, the experimental study of present invention treatment chloasma
2.1 materials and method
2.1.1 test medicine：Test medicine of the present invention is [by the fruit of glossy privet, eclipta, the red sage root, Radix Angelicae Sinensis, Chinese cassia tree, rose, Portugal
Grape seed extract is prepared from, and is provided by middle clever (Beijing) bio tech ltd of food peptide].VITAMIN C TABLET (the auspicious medicine of Sichuan good fortune
Industry Co., Ltd).
2.1.2 animal：Female KM kind mouse, 28 ± 2g of body weight, by Chinese Academy of Medical Sciences's Animal Experimental Study center
There is provided.
2.1.3 reagent：Progesterone injection：Every 10mg/ml, lot number 20120311, Zhejiang celestial being jade pendant pharmacy share is limited
Company.Superoxide dismutase (SOD) lot number：2012803, MDA (MDA) lot number：20120801, nitric oxide (NO) batch
Number：20120723, Coomassie brilliant blue, lot number：20120736.Kit is that Bioengineering Research Institute is built up in Nanjing.Mouse is anti-human
The super quick kit Kit9710 of monoclonal antibody HM B45 (melanoma melanoma) instant kit MAB-0098, SP, Fujian
Step neoformation technological development Co., Ltd；Concentrated type DAB kits：ZLI-9032, the limited public affairs of Beijing Zhong Shan Golden Bridge biotechnology
Department.
2.1.4 instrument：R-80A type fully automatic blood viscosity apparatus, Olympus-BX50 type light microscopes, MIAS2000 types
Computer digital image analysis.
2.1.5 method
Female mouse 60, is randomly divided into 6 groups, every group 10.Normal group is used by 2ml/kg body weight intramuscular injection sterile injection
Water；Remaining 5 groups are injected with progesterone injection in mouse hind leg muscle, two legs alternating, and dosage is that 20mg/kg progesterone is (suitable
In 8 times of people's clinical equivalent dosage).6d, continuous 30d are injected weekly.Modeling, which is started simultaneously at, gavages medicine or distilled water
0.2ml/10g, 1 time a day, continuous 30d.The basic, normal, high dosage of the present invention is respectively 12,24,36g/kg is (equivalent to quantity
5th, 10,15 times).Vitamin C doses 0.1g/kg (equivalent to 10 times of people's quantity).After last dose 1h, the small rathole of each group
Socket of the eye blood sampling 1ml is contained in the covered plastic pipe containing heparin (oneself dries), determines WBV value.Put to death each group mouse, back
Unhairing, takes liver, skin histology, and with (4 DEG C) flushings of pre- cold saline, filter paper wipes dry, each 0.5g of skin, liver taken, with 1：9
(W/V) ice physiological saline is added, the homogenate of 10% tissue is made in ice bath, homogenate is centrifuged with 2500rpm, takes supernatant and carry out
The measure of index of correlation.
(1) SOD, MDA, NO Indexs measure：Entered by kit specification method and operation requirement with 722S spectrophotometers
Row is determined.
(2) PATHOMORPHOLOGICAL OBSERVATION OF PULLORUM of dermal melanin cell：Strip one piece of mouse back skin, unhairing, 10% neutrality
Formaldehyde is fixed.Conventional paraffin embedding, continuous 5 μ m-thick section, HE dyeing.Melanin mark uses immunohistochemical method -- chain
Moldin biotin method.Primary antibody selects mouse anti-human monoclonal's antibody HMB45 (melanoma melanoma), DAB colour developings, haematoxylin
Redye.Primary antibody is replaced to do negative control with PBS.Melanin Positive Objects computer image analysis：Each group randomly selects 8 mouse
Skin, be respectively made 1 pathological section, the visual field of 5 non-overlapping copies of every observation is found after Positive Objects, MIAS2000 types
Computer digital image analysis carries out quantitative analysis to target image, draws every 5 visuals field of section and every group of 8 animal black
Average area, average optical density, the integral optical density of plain Positive Objects.
2.2 result
2.2.1 to the influence of mouse skin MDA, SOD, NO content：As seen from Table 2, compared with Normal group, model pair
According to a group mouse skin SOD activity decreases, and MDA, NO content are raised, and wherein MDA contents have obvious difference.With model comparison
Group compares, and the present invention is high, middle dose group SOD activity is significantly raised, and MDA contents are substantially reduced.Vitamin C group and model control group
Compare, MDA contents have obvious reduction.
Influence of the present invention of table 2 to mouse skin MDA, SOD, NO content
Compared * P ＜ 0.05, * * P ＜ 0.01 (similarly hereinafter) with model group
2.2.2 to the influence of mouse liver SOD, MDA, NO content：As seen from Table 3, compared with Normal group, model pair
Decline according to a group mouse liver SOD activity, and MDA, NO content are raised, wherein MDA contents have obvious difference.With model
Control group compares, and high dose group of the present invention and vitamin C group SOD activity are significantly raised, and high dose group MDA contents have obvious drop
It is low.
Influence of the present invention of table 3 to mouse liver MDA, SOD, NO content
2.2.3 the PATHOMORPHOLOGICAL OBSERVATION OF PULLORUM HE dyeing of mouse skin melanocyte：It can not find that melanin is thin under light microscopic
Born of the same parents.HMB45 mark observations：Visible a small amount of melanocyte in Normal group hair follicle, sebaceous glands basal cell.Model control group
Melanocyte cluster is distributed in hair follicle, sebaceous glands basal cell, is also dispersed in epidermal basal cell and stratum spinosum epidermidis point
Cloth.Only sporadically appear melanocyte in 4 medication group basal layer of epidermis and hair follicle basal cell.
2.2.4 to the influence of mouse skin melanocyte：As seen from Table 4, compared with Normal group, model control group
Mouse skin melanocyte Positive Objects area, average optical density, integral optical density value have bright than Normal group mouse
Aobvious rise.Compared with model control group, the present invention is high, middle dose group can obviously reduce mouse skin melanocyte positive cell
Average optical density, integral optical density value.
Influence of the present invention of table 4 to mouse skin melanocyte
2.2.5 to the influence of Mouse whole blood viscosity：As seen from Table 5, compared with Normal group, model control group, dimension life
The different shear rate WBVs of plain C groups mouse are increased significantly than Normal group mouse.Compared with model control group, this hair
Bright high dose group can obviously reduce WBV value, illustrate that the present invention can be obviously improved the hemorheological property of chloasma mouse,
Reduce blood viscosity.
Influence of the present invention of table 5 to Mouse whole blood viscosity
Chloasma is the pigmented dermatosis caused by a kind of multifactor, multisystem, too many levels, and pathogenesis is complicated, really
Pathogenic factor at present it is still not fully aware of.It increases dermatoses as a kind of pigment, and melanogenesis is excessively that it is basic former
Cause, melanocyte synthesis melanocyte is an extremely complex process, affected by various factors.There is blood flow in patient with chloasma
Dynamics index is abnormal, it is believed that hemorheology changes in close relations with chloasma.With qi depression to blood stasis, venation block in traditional Chinese medicine
It is consistent, therefore blood stasis is one of cause of disease of chloasma.In recent years many studies have shown that the formation of oxygen radical and dermal melanin
And pigmentation is relevant.MDA can cause protein molecule to crosslink, and form the pigment of fluorescent chromophore one.SOD decapacitation is effectively clear
In addition to free radical, also with the activity for suppressing tyrosinase, pigmented effect is reduced.Great mass of data shows that chloasma is suffered from
SOD and catalase (CAT) activity are significantly reduced in person's blood, LPO and MDA contents substantially increase.Research prompting above, oxidation
With it is anti-oxidant it is unbalance be probably produce chloasma key factor.In all multi signal mediated pathways of influence melanocyte function
In, NO is considered as a kind of particularly important signaling molecule and played a role.NO can stimulate the activity of tyrosinase, improve new close
Into the amount of melanocyte.This experimental studies results shows that the present invention has effect promoting blood circulation and removing blood stasis, can substantially reduce chloasma mouse
WBV value, improves blood viscosity, in addition, the SOD activity in chloasma model control group mouse liver and skin histology
Substantially reduced compared with Normal group, and MDA, NO are higher than normal group, and MDA content and increased SOD can be significantly reduced after administration
Activity, point out the present invention may be by improve radicals scavenging enzyme activity, reduce peroxidatic reaction of lipid, reduce melanocyte
Generation.
4th, embodiment
The present invention is elaborated with specific embodiment below：
Embodiment 1：
Raw material is weighed according to following proportioning：50 parts of the fruit of glossy privet, 50 parts of eclipta, 80 parts of the red sage root, 70 parts of Radix Angelicae Sinensis, Chinese cassia tree 15
Part, 15 parts of rose, 5 parts of grape seed extract.
Preparation method：Got it filled respectively material by upper described traditional Chinese medicine composite and weight proportion, first by the fruit of glossy privet, ink drought
Lotus, the red sage root, Radix Angelicae Sinensis, Chinese cassia tree, rose add extractor, for the first time immersion 30 minutes, plus 10 times of amount decoctings are boiled 2 times, every time
For 1.5h, filtration, merging filtrate；70% ethanol is added, precipitates, supernatant is obtained, through be concentrated under reduced pressure (70 DEG C, 0.08Mpa), to phase
To density 1.08~1.10 (60 DEG C), ethanol is reclaimed, medicinal extract, then vacuum dried (70 DEG C, 0.08Mpa) are obtained, crushed, cross 60 mesh
Sieve, get dry extract powder；Grape seed extract and dried cream powder are put in mixer, 30min is mixed, is well mixed, obtains mixed powder A；Press
Pharmacy is routinely added to dressing lactose, microcrystalline cellulose, sodium starch, 1/2 silica and put in mixer, mixes 10min, obtains mixed
Close powder B：By mixed powder A and mixed powder B mixing 30min, to well mixed, total mixed powder is obtained；With 60% ethanol softwood；Will be soft
Material is transferred in oscillating granulator, the granulation of 16 mesh sieves, and 60 DEG C of dryings, 16 mesh sieve whole grains obtain dry particl, standby；It is conventional by pharmacy
Add dressing magnesium stearate, PVPP, 1/2 silica and dry particl to put in mixer, mix 10min, be well mixed,
Obtain total particle；Total particle loads tablet press machine, and 0.7g/ pieces obtain plain piece；Coating powder is made to the coating solution for meeting production requirement, with
Plain piece is together put in seed-coating machine, is coated, is obtained coating tablet.
Embodiment 2：
Raw material is weighed according to following proportioning：10 parts of the fruit of glossy privet, 10 parts of eclipta, 30 parts of the red sage root, 20 parts of Radix Angelicae Sinensis, 5 parts of Chinese cassia tree,
5 parts of rose, 0.1 part of grape seed extract.
Preparation method：Got it filled respectively material by upper described traditional Chinese medicine composite and weight proportion, first by the fruit of glossy privet, ink drought
Lotus, the red sage root, Radix Angelicae Sinensis, Chinese cassia tree, rose add extractor, for the first time immersion 30 minutes, plus 10 times of amount decoctings are boiled 2 times, every time
For 1.5h, filtration, merging filtrate；70% ethanol is added, precipitates, supernatant is obtained, through be concentrated under reduced pressure (70 DEG C, 0.08Mpa), to phase
To density 1.08~1.10 (60 DEG C), ethanol is reclaimed, medicinal extract, then vacuum dried (70 DEG C, 0.08Mpa) are obtained, crushed, cross 60 mesh
Sieve, get dry extract powder；Grape seed extract and dried cream powder are put in mixer, 30min is mixed, is well mixed, obtains mixed powder A；Press
Pharmacy is routinely added to dressing lactose, microcrystalline cellulose, sodium starch, 1/2 silica and put in mixer, mixes 10min, obtains mixed
Close powder B；By mixed powder A and mixed powder B mixing 30min, to well mixed, total mixed powder is obtained；With 60% ethanol softwood；Will be soft
Material is transferred in oscillating granulator, the granulation of 16 mesh sieves, and 60 DEG C of dryings, 16 mesh sieve whole grains obtain dry particl, standby；It is conventional by pharmacy
Add dressing magnesium stearate, PVPP, 1/2 silica and dry particl to put in mixer, mix 10min, be well mixed,
Obtain total particle；Total particle loads tablet press machine, and 0.7g/ pieces obtain plain piece；Coating powder is made to the coating solution for meeting production requirement, with
Plain piece is together put in seed-coating machine, is coated, is obtained coating tablet.
Embodiment 3：
Raw material is weighed according to following proportioning：30 parts of the fruit of glossy privet, 30 parts of eclipta, 60 parts of the red sage root, 40 parts of Radix Angelicae Sinensis, Chinese cassia tree 10
Part, 10 parts of rose, 2 parts of grape seed extract.
Preparation method：Got it filled respectively material by upper described traditional Chinese medicine composite and weight proportion, first by the fruit of glossy privet, ink drought
Lotus, the red sage root, Radix Angelicae Sinensis, Chinese cassia tree, rose add extractor, for the first time immersion 30 minutes, plus 10 times of amount decoctings are boiled 2 times, every time
For 1.5h, filtration, merging filtrate；70% ethanol is added, precipitates, supernatant is obtained, through be concentrated under reduced pressure (70 DEG C, 0.08Mpa), to phase
To density 1.08~1.10 (60 DEG C), ethanol is reclaimed, medicinal extract, then vacuum dried (70 DEG C, 0.08Mpa) are obtained, crushed, cross 60 mesh
Sieve, get dry extract powder；Grape seed extract and dried cream powder are put in mixer, 30min is mixed, is well mixed, obtains mixed powder A；Press
Pharmacy is routinely added to dressing lactose, microcrystalline cellulose, sodium starch, 1/2 silica and put in mixer, mixes 10min, obtains mixed
Close powder B；By mixed powder A and mixed powder B mixing 30min, to well mixed, total mixed powder is obtained；With 60% ethanol softwood；Will be soft
Material is transferred in oscillating granulator, the granulation of 16 mesh sieves, and 60 DEG C of dryings, 16 mesh sieve whole grains obtain dry particl, standby；It is conventional by pharmacy
Add dressing magnesium stearate, PVPP, 1/2 silica and dry particl to put in mixer, mix 10min, be well mixed,
Obtain total particle；Total particle loads tablet press machine, and 0.7g/ pieces obtain plain piece；Coating powder is made to the coating solution for meeting production requirement, with
Plain piece is together put in seed-coating machine, is coated, is obtained coating tablet.
Embodiment 4：
Raw material is weighed according to following proportioning：30 parts of the fruit of glossy privet, 30 parts of eclipta, 60 parts of the red sage root, 40 parts of Radix Angelicae Sinensis, Chinese cassia tree 10
Part, 10 parts of rose, 2 parts of grape seed extract.
Preparation method：Got it filled respectively the material fruit of glossy privet, eclipta, pellet by upper described traditional Chinese medicine composite and weight proportion
Ginseng, Radix Angelicae Sinensis, Chinese cassia tree, rose, plus 6~12 times of amount decoctings boil 2~3 times, collecting decoction, 50~80% alcohol precipitations, filtration, and filtrate is dense
60 DEG C of relative densities 1.15~1.20 are reduced to, grape seed extract is added, mixed, are pelletized, are dried, plus dressing prepares finished product agent
Type；Its finished dosage forms is tablet, capsule, granule or the pill being made of pharmaceutically acceptable carrier or excipient.
Embodiment 5：
Raw material is weighed according to following proportioning：30 parts of the fruit of glossy privet, 30 parts of eclipta, 60 parts of the red sage root, 40 parts of Radix Angelicae Sinensis, Chinese cassia tree 10
Part, 10 parts of rose, 2 parts of grape seed extract.
Preparation method：Got it filled respectively material by upper described traditional Chinese medicine composite and weight proportion, rose extracts volatilization
Oil, the another device of the aqueous solution after distillation is collected, the dregs of a decoction and the fruit of glossy privet, eclipta, the red sage root, Radix Angelicae Sinensis, Chinese cassia tree add 6~12 times measure decoctings and boil
2~3 times, collecting decoction and the above-mentioned aqueous solution, 50~80% alcohol precipitations, filtration, filtrate be concentrated into 60 DEG C of relative densities 1.15~
1.20, grape seed extract is added, is mixed, is pelletized, dries, rose flowers volatile oil is uniformly sprayed in particle, is mixed, plus is applied
Material prepares finished dosage forms；Its finished dosage forms be made of pharmaceutically acceptable carrier or excipient tablet, capsule,
Granula or pill.
Embodiment 6：
Raw material is weighed according to following proportioning：30 parts of the fruit of glossy privet, 30 parts of eclipta, 60 parts of the red sage root, 40 parts of Radix Angelicae Sinensis, Chinese cassia tree 10
Part, 10 parts of rose, 2 parts of grape seed extract.
Preparation method：Got it filled respectively material, 60~80 DEG C of dryings, powder by upper described traditional Chinese medicine composite and weight proportion
40~100 mesh fine powders are broken into, it is encapsulated；Or water pill processed, in 60~80 DEG C of dryings, packaging is produced.
Embodiment 7：
Raw material is weighed according to following proportioning：30 parts of the fruit of glossy privet, 30 parts of eclipta, 60 parts of the red sage root, 40 parts of Radix Angelicae Sinensis, Chinese cassia tree 10
Part, 10 parts of rose, 2 parts of grape seed extract.
Preparation method：Taken respectively equivalent to Chinese medicine crude drug amount by upper described traditional Chinese medicine composite and weight proportion
Extract or active component, the finished product agent being made using pharmaceutically acceptable carrier or excipient by pharmacy common process
Type.
Claims (7)
1. a kind of pharmaceutical composition for treating chloasma, it is characterised in that the medicament that the raw material matched by following weight is made：Female
Loyal 1~60 part of son, 1~60 part of eclipta, 10~100 parts of the red sage root, 10~100 parts of Radix Angelicae Sinensis, 1~50 part of Chinese cassia tree, rose 1~50
Part, 0.1~30 part of grape seed extract.
2. a kind of pharmaceutical composition for treating chloasma as claimed in claim 1, its raw material and weight proportion are：The fruit of glossy privet 10
~50 parts, 10~50 parts of eclipta, 20~80 parts of the red sage root, 20~80 parts of Radix Angelicae Sinensis, 5~40 parts of Chinese cassia tree, 5~40 parts of rose, Portugal
0.5~20 part of grape seed extract.
3. a kind of pharmaceutical composition for treating chloasma as claimed in claim 1 or 2, its raw material and weight proportion are：Glossy privet
30 parts of son, 30 parts of eclipta, 60 parts of the red sage root, 40 parts of Radix Angelicae Sinensis, 10 parts of Chinese cassia tree, 10 parts of rose, 2 parts of grape seed extract.
4. a kind of pharmaceutical composition for treating chloasma as claimed in claim 1, it is characterised in that the source of the raw material is
The extract that Chinese medicine is either prepared equivalent to the use pharmacy conventional method of Chinese medicine crude drug amount, such as glossy privet fruit extract,
Yeradetajo extract, Salvia root P.E, angelica extract, Flos Rosae Rugosae extract.
5. a kind of pharmaceutical composition for treating chloasma as claimed in claim 1, it is characterised in that preparation method is to use medicine
Acceptable carrier or excipient are prepared from by pharmacy common process on.
6. a kind of preparation method for the pharmaceutical composition for treating chloasma as claimed in claim 5, it is characterised in that preparation side
Method can be prepared from by one of following several method：
(1) got it filled respectively material by upper described traditional Chinese medicine composite and weight proportion, first by the fruit of glossy privet, eclipta, the red sage root, when
Return, Chinese cassia tree, rose add extractor, for the first time immersion 30 minutes, plus 10 times amount decoctings boil 2 times, be 1.5h every time, filter
Cross, merging filtrate；70% ethanol is added, precipitates, supernatant is obtained, through 70 DEG C, 0.08Mpa is concentrated under reduced pressure, to 60 DEG C of relative densities
1.08~1.10, ethanol is reclaimed, medicinal extract is obtained, then through 70 DEG C, 0.08Mpa vacuum drying is crushed, crosses 60 mesh sieves, get dry extract powder；Will
Grape seed extract is put in mixer with dried cream powder, mixes 30min, is well mixed, is obtained mixed powder A；It is routinely added to by pharmacy
Auxiliary material lactose, microcrystalline cellulose, sodium starch, 1/2 silica are put in mixer, are mixed 10min, are obtained mixed powder B；By mixed powder
A and mixed powder B mixing 30min, to well mixed, obtains total mixed powder；With 60% ethanol softwood；Softwood is transferred to swing
In grain machine, the granulation of 16 mesh sieves, 60 DEG C of dryings, 16 mesh sieve whole grains obtain dry particl, standby；Auxiliary material stearic acid is routinely added to by pharmacy
Magnesium, PVPP, 1/2 silica and dry particl are put in mixer, mix 10min, are well mixed, are obtained total particle；Total
Grain loading tablet press machine, 0.7g/ pieces obtain plain piece；Coating powder is made to the coating solution for meeting production requirement, coating is together put with plain piece
In machine, it is coated, obtains coating tablet；
(2) got it filled respectively the material fruit of glossy privet, eclipta, the red sage root, Radix Angelicae Sinensis, meat by upper described traditional Chinese medicine composite and weight proportion
Osmanthus, rose, plus 6~12 times of amount decoctings boil 2~3 times, collecting decoction, 50~80% alcohol precipitations, filtration, and filtrate is concentrated into 60 DEG C of phases
To density 1.15~1.20, grape seed extract is added, is mixed, is pelletized, is dried, plus auxiliary material prepares finished dosage forms；
(3) got it filled respectively material by upper described traditional Chinese medicine composite and weight proportion, rose extracts volatile oil, after distillation
The another device of the aqueous solution is collected, and the dregs of a decoction and the fruit of glossy privet, eclipta, the red sage root, Radix Angelicae Sinensis, Chinese cassia tree add 6~and 12 times of amount decoctings boil 2~3 times, merge
Decocting liquid and the above-mentioned aqueous solution, 50~80% alcohol precipitations, filtration, filtrate are concentrated into 60 DEG C of relative densities 1.15~1.20, add grape
Seed extract, is mixed, and is pelletized, and dries, rose flowers volatile oil is uniformly sprayed in particle, is mixed, plus auxiliary material prepares finished product agent
Type；
(4) got it filled respectively material by upper described traditional Chinese medicine composite and weight proportion, 60~80 DEG C of dryings, be ground into 40~
100 mesh fine powders, it is encapsulated；Or water pill processed, in 60~80 DEG C of dryings, packaging is produced；
(5) by upper described traditional Chinese medicine composite and weight proportion take respectively equivalent to Chinese medicine crude drug amount extract or have
Imitate position, the finished dosage forms being made using pharmaceutically acceptable carrier or excipient by pharmacy common process.
7. a kind of preparation method for the pharmaceutical composition for treating chloasma as claimed in claim 6, it is characterised in that finished product agent
Type is tablet, capsule, granule or the pill being made of pharmaceutically acceptable carrier or excipient.
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| CN201310201337.4A CN104173607B (en) | 2013-05-28 | 2013-05-28 | It is a kind of to treat pharmaceutical composition of chloasma and preparation method thereof |
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| CN104706836B (en) * | 2015-02-13 | 2018-03-23 | 江苏康缘药业股份有限公司 | A kind of Chinese medicine composition of eliminating chloasma and its application and preparation method |
| CN104784577A (en) * | 2015-05-05 | 2015-07-22 | 淄博齐鼎立专利信息咨询有限公司 | Traditional Chinese medicine formula granule for treating chloasma |
| CN105233040A (en) * | 2015-10-28 | 2016-01-13 | 陆莎 | Chinese herbal medicine composition for removing chloasma, eliminating toxins and beautifying skin |
| CN108310139A (en) * | 2017-01-16 | 2018-07-24 | 王海焱 | A kind of Tibetan medicinal composition and preparation method thereof for treating chloasma |
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| CN102205007A (en) * | 2011-05-25 | 2011-10-05 | 遵义陆圣康源科技开发有限责任公司 | Pharmaceutical composition with function of removing chloasma |
| CN102657745A (en) * | 2012-05-17 | 2012-09-12 | 双飞人制药（中国）有限公司 | Medicinal composition with effect of removing chloasma |
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| CN102205007A (en) * | 2011-05-25 | 2011-10-05 | 遵义陆圣康源科技开发有限责任公司 | Pharmaceutical composition with function of removing chloasma |
| CN102657745A (en) * | 2012-05-17 | 2012-09-12 | 双飞人制药（中国）有限公司 | Medicinal composition with effect of removing chloasma |
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