CN1209162C - Medicinal composition for treating acne and chloasma - Google Patents
Medicinal composition for treating acne and chloasma Download PDFInfo
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- CN1209162C CN1209162C CN200410034160.4A CN200410034160A CN1209162C CN 1209162 C CN1209162 C CN 1209162C CN 200410034160 A CN200410034160 A CN 200410034160A CN 1209162 C CN1209162 C CN 1209162C
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Landscapes
- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to a medicinal composition using pure natural vegetable medicine as main medicinal components with the effects for resolving toxin, eliminating acne and removing speckles. The medicinal composition is a preparation prepared from the raw materials of 40 to 1000 portions by weight of dandelion, 50 to 1100 portions by weight of climbing groundsel, 50 to 1100 portions by weight of arborvitae leaf, 50 to 1100 portions by weight of sargentgloryvine, 50 to 1100 portions by weight of bupleurum root, 40 to 1000 portions by weight of Armand clematis stem, 50 to 1100 portions by weight of dahurian angelica and 10 to 360 portions by weight of honeylocust thorn. The medicinal composition has the main functions and the main indications for expelling wind, clearing heat, resolving toxin and eliminating acne and is used for acne and chloasma caused by wind-heat counterflow ascension. The medicinal composition has the obvious effects for resisting bacteria, clearing heat, removing toxicity, eliminating pox, moistening the skin, moistening the intestines, relaxing the bowel, resisting inflammation and reducing swelling. The clinical trial results also indicate that the medicinal composition has certain curative effects on an abnormal tongue image and abnormal pulse manifestation. The medicinal composition can be applied to patients with idiopathic and secondary chloasma of traditional Chinese medicine syndrome differentiation of liver-kidney yin vacuity, blood stagnation and blood stasis, and comedo patients with first-degree acne and second-degree acne which is mainly represented by comedo, papule and pustule who belongs to traditional Chinese medicine syndrome differentiation of lung channel wind-heat, gastrointestinal damp-heat.
Description
Technical field
The present invention relates to a kind of with the pure natural plant medical material be main medicinal ingredient have a disappear pharmaceutical composition of Cuo, spot-removal function of detoxifcation.
Technical background
Chloasma is the common pigmented dermatosis of department of dermatologry, and " Yizong Jinjian surgery heart method knack " thinks its " former depressed in being worried, not magnificent a little less than the blood, fiery dryness accumulated in the stomach and intestine stagnates and is born on the face, and the women has it more ".The hepatic and renal YIN deficiency, hyperactivity of fire caused by deficiency of YIN, qi depression to blood stasis are the main etiology and pathogenesis of chloasma.Acne is skin commonly encountered diseases, frequently-occurring disease, is more common in face, how because of wind and heat in the lung meridian, the intestines and stomach damp and hot due to, many clinically is method of treatment with clearing away heat and cooling blood, clearing away heat and eliminating dampness purging FU-organs.From traditional medicine, seek valuable clue, increase a kind of important channel that treatment means has become treatment acne, chloasma.
Summary of the invention
The objective of the invention is to propose a kind of pharmaceutical composition that various acnes, chloasma is had better therapeutical effect.
The pharmaceutical composition of treatment acne of the present invention, chloasma is the medicament of being made by the following weight proportion raw material:
Herba Taraxaci 40-1000, Herba Senecionis Scandentis 50-1100, Cacumen Platycladi 50-1100, Caulis Sargentodoxae 50-1100, Radix Bupleuri 50-1100, Caulis Clematidis Armandii 40-1000, Radix Angelicae Dahuricae 50-1100, Spina Gleditsiae 10-360.
Technical scheme of the present invention is based on Dai Nationality's medical science in the Chinese medicine to acne, the pathogenetic understanding of chloasma and Therapeutic Principle, with reference to the modern pharmacology achievement in research, and the therapeutic scheme that from motherland's medical treasure-house, filters out.The present invention is total Therapeutic Principle with two-ways regulation, dual moistening.Great circulation system in the body of effect body, the balance of conditioning human body QI and blood, oxygen supply, body fluid, moisture is unimpeded; Act on the microcirculqtory system of skin surface again simultaneously, promote the oneself of sebaceous gland, sweat gland, blood capillary to mediate fortuneization function, waste discharge, except that pus, blood circulation promoting, transformation of body flaud.Execute jointly inside and outside and control, simultaneously conditioning.Pharmacology advanced person, reasonable recipe, determined curative effect.
Herba Taraxaci is feverfew Herba Taraxaci Taraxacum mongolicum Hand.-Mazz or alkali ground Herba Taraxaci T.dinicum Katag. or the dry herb that belongs to several plants together in the above-mentioned prescription.Main chemical compositions is that taraxasterol (Taraxaxterol), choline (Choline), inulin (Inulan) and pectin the Dai nationality such as (Pectin) claim " root flavor " (transliteration), function heat-clearing and toxic substances removing, medicinal powder for relieving pain knot.Lijiang Prefecture's national folk is as clearing away heat and cooling blood, detoxicating, relieving inflammation, eliminating stagnation.Qujing Prefecture's national folk is as eliminating inflammation and expelling toxin, cool the blood dissipate blood stasis, diuresis lactogenesis.Mountain of papers area national folk is used for heat-clearing and toxic substances removing, dispersing swelling and dissipating binds.The Red River national folk claims little cauliflower; Zhaotong Prefecture's national folk claims Herba Violae, is used for heat-clearing and toxic substances removing, antiinflammatory, diuresis, lactogenic.Also claim Herba crotalariae albidae, Chinese enkianthus, be used for heat-clearing and toxic substances removing, antiinflammatory, diuresis, " the southern regions of the Yunnan Province draft " is grandmother's fourth again, Hemerocallis citrina Baroni greenery grass, " Yulong's book on Chinese herbal medicine " claims HERBA TARAXACI, sweet in the mouth, flat, nontoxic; Go into liver stomach two warps, married woman's breast knot is controlled in detoxifcation, mastalgia, and congestion and swelling pain, newborn muscle stalk is done swelling firmly." Zhiwu Mingshi Tukao " claims Herba Taraxaci, valgar doctor (pressing: refer to the national folk doctor) to think to control the toxic swelling key medicine.Caulis Clematidis Armandii is the dry rattan of Ranunculaceae Herba Clematidis Lasiandrae Clematis armandiiFranch. or silk ball rattan C.montan Buch.-Gam..Contain akebin (Akebin), the akebin hydrolysis gets CHANGQINGTENG soap ribbon unit (Hederagenin), oleanolic acid (Oleanolic acid), glucose and rhamnose; Contain potassium 0.254% again, the Dai nationality claims " gear wheelization " (transliteration) to imitate: inducing diuresis to remove edema.Area, Red River national folk claims sliding leaf Caulis Akebiae, function expelling wind and removing dampness, pain relieving, diuresis.Yuxi Prefecture's national folk claims Caulis Clematidis pseudopogonandrae, function expelling pathogenic wind from the body surface, dampness removing.Baoshan Prefecture's national folk claims yellow Radix Stephaniae Tetrandrae, function promoting flow of qi by warming channel, dehumidifying." the southern regions of the Yunnan Province draft " claims phoenix rattan grass, rushes down the small intestine meridian excess-heat, and clear dredging water passages is controlled all pruritus due to wind pathogen, and bones and muscles pain is enriched blood, and blood, the blood that looses, and wind-dispelling heat-dissipating, all skin ulcer scabies are fried in shallow oil the best of soup bath.Herba Senecionis Scandentis is feverfew Herba Senecionis Scandentis Senecio scandens Buch.-Ham. dry aerial parts, mainly contains flavoxanthin (Flavoxanthin), chrysanthemaxanthin (Chrysanthenaxantin).The Dai nationality claims " being afraid of to do flavor ", and the detoxifcation of (transliteration) effect is dispeled the wind, clearing away heat to improve acuity of vision.Qujing Prefecture's national folk is used for removing pathogenic wind toxic, refrigerant making eye bright.Mountain of papers area national folk is used for heat-clearing and toxic substances removing, liver-benefiting eye-brightening.Area, Kunming national folk is used for heat clearing away, damp eliminating, killing parasites for relieving itching.Simao Diqu claims " brave exerting " (transliteration), function heat-clearing and toxic substances removing, expelling wind and removing dampness; Also in clearing away heat to improve acuity of vision, detoxifying and relieving itching." Yulong's book on Chinese herbal medicine " claims Herba Senecionis Scandentis, and " the southern regions of the Yunnan Province draft " also claims Herba Senecionis Scandentis, and bitter in the mouth is cold in nature; Wash the mange skin ulcer tinea skin wind heat of dispelling.Radix Bupleuri is the dry root of umbelliferae bupleurum Bupleurum chinense DC. or Radix Bupeuri Scorzonerfolii. B.scorzonerifolium Willd.; The dry herb of or HERBA BUPLEURI: B.mauginatumWall.exDC (=B.falcatum L.ssp.marginatum Wall.ex DC) H.Wolff.Mainly contain saikoside, a chondrillasterol, sucrose (Sucrosu) and polyacetylene compound, Red River mountain of papers area national folk be used to deliver and in, dispersing the stagnated live-QI to relieve the stagnation of QI is brought down a fever.Qujing Prefecture's national folk is used for clearing away heat and expelling pathogen in the exterior.Area, Kunming national folk is called the ribbon grass, effect eliminating inflammation and expelling toxin, dispelling wind for relieving itching.Also use at national folk as analgesic, the soothing the liver strongly fragrant medicine that looses that dispels the wind in areas such as Lijing, Lincang, Dongchuan." Yulong's book on Chinese herbal medicine " is also referred to as Radix Bupleuri; " the southern regions of the Yunnan Province draft " cloud: " Radix Bupleuri bitter in the mouth, cold nature; Cloudy middle-jiao yang, function of the spleen and stomach is also gone into liver and gall two warps, typhoid fever diaphoresis, the key medicine of inducing sweat; Move back the contact of the six channels pathogenic heat, remove liver man pathogenic heat consumptive fever, the gas of row Liver Channel pent-up ends left rib irritability pain, controls married woman's heat in blood and burns warp, can transfer menstruation ", " the tender stamen of diaphoresis is controlled the deficiency-heat regulating menstruation and is taken root ".The Radix Angelicae Dahuricae is the dry root of plant Radix Angelicae Dahuricae Angelica dahurica (Fisch.ex Hoffm.) Benth.et Hook. of umbrella section or Radix angelicae dahuricae A dahurica (Fi sch.ex Hoffm.) Benth.et Hook.f.var.formosana (Boiss.) Shan.et Yuan.Mainly contain volatile oil, 6 kinds of furoeoumarins (Furocoumarin), Dehong the Dai nationality claims " being afraid of the peace miaow " (transliteration), effect: promoting blood circulation to remove blood stasis, promoting the circulation of QI to relieve pain.Caulis Sargentodoxae is the dry rattan of Lardizabalaceae plant Caulis Sargentodoxae Sargentodoxa cunmeata (Oliv) Rehd.et.Wuks..It is about 7% mainly to contain tannin, and Lijiang Prefecture's national folk claims Caulis Spatholobi, function relaxing muscles and tendons to promote blood circulation, expelling wind and removing dampness.Mountain of papers area national folk claims Caulis Sargentodoxae, DAHUOXUE, and bitter in the mouth is warm in nature, function expelling wind and removing dampness, promoting blood circulation and detumescence, hemostasis parasite killing.Cacumen Platycladi is Cupressaceae plant Cacumen Platycladi Platycladus orientalis (L.) Franco (=Biota oriental is (L.) Endl.; Thuja orientais L.) dry branch tip and leaf.Mainly contain volatile oil 0.6-1%, flavonoid, Dehong the Dai nationality and make cooling blood for hemostasis, heat clearing away dissipating blood stasis with it.Spina Gleditsiae is the dry Spina jujubae of leguminous plant Fructus Gleditsia Gleditsia sinensis Lam..Mainly contain flavonoid glycoside, phenols, aminoacid, this product is the conventional Chinese medicine material, function detumescence poison holding, evacuation of pus, parasite killing.
This medicine is cured " not accounting for " (acne---acne) according to the Dai Nationality, the Therapeutic Principle's of " receive the slightest " (butterfly spot) method of treatment and forming, have benefit " tower is muttered " (water, blood) logical " sieve is reined in sieve and held together " (blood road) and enrich blood and invigorate blood circulation, Luo Fanan floats the function of abiding by (eliminating spots and moisturizing skin).It is principal agent that Ya Luole in the side (in thousand light) Herba Taraxaci is mended " tower is muttered " (water) detoxification and sores of relieving inflammation or internal heat for " refined English " (cold and cool medicine); Cacumen Platycladi; Radix Bupleuri is cool in nature and help principal agent to strengthen and the merit of the detoxification and sores of relieving inflammation or internal heat; be adjuvant; and " he bright dragon " (Caulis Sargentodoxae) has the merit of enriching blood and invigorating blood circulation; red complexion and go into blood; specially control in the blood long-pending; water flowing blood; add Caulis Akebiae phase and the sensible whole body delivery up women's head-ornaments of medicine and skin moistening skin care furuncle; furuncle poison black speck is the extreme misery imbalance; the water hangfire is contained; disaccord and infect external pathogenic wind toxic pathogen in skin is subcutaneous in addition, interior foreign minister is long-pending, becomes the hard furuncle of sore; " tower is muttered " (water) knot stops long-pending person's swelling; " tower bell " (fire) Sheng person erythralgia is selected Spina Gleditsiae for use in the side; the Radix Angelicae Dahuricae, the water of dispelling warm in nature is wet; detoxifcation and logical stagnant principal agent quench in addition gets and the skin ulcer furuncle that disappears; using medicines of both cold and hot natures simultaneously, can quench detoxifcation, again can the wet heresy of Wen Huashui; benefit mutually and open; full side share, and has leveling four towers; remove the wind detoxifcation; the merit of eliminating spots and moisturizing skin and control " not accounting for " (acne---acne), " receive the slightest " diseases such as (butterfly spot).
Medicine major function of the present invention cures mainly and is: expelling wind and clearing away heat, the detoxifcation Cuo that disappears, and is used for contrary acne, the chloasma due to last of wind heat, and the effect of significantly antibiotic, heat-clearing and toxic substances removing, anti-acne skin moistening, loosening bowel to relieve constipation and anti-inflammation detumescence is arranged.Clinical test results shows that also unusual picture of the tongue, pulse condition are all had certain curative effect.Spy's property sent out, Secondary cases patient with chloasma and the acne, pimple, the pustule that belong to the hepatic and renal YIN deficiency, stasis blood stasis applicable to differential diagnosis in tcm show as main I degree, II degree acne, and differential diagnosis in tcm belongs to the acne patient of wind and heat in the lung meridian, the intestines and stomach damp-heat type.
Pharmaceutical dosage form of the present invention is the above a oral formulations of pharmaceutics.The oral liquid of making through conventional technology by raw material of the present invention and corresponding medicinal adjuvant, capsule, tablet, granule, pill, powder, soft capsule, liniment, tincture etc.Its consumption is per day for adults 2.1-6 gram.
The pharmacodynamics test of pharmaceutical composition of the present invention:
One, antibacterial action
Experiment purpose:
Adopt staphylococcus aureus, escherichia coli and propionibacterium acne as representing bacterium, detect the antibacterial action of this pharmaceutical composition; Utilize the propulsion trial of charcoal end in mouse small intestine, judge the influence of this product intestinal motility; Select for use carrageenin to cause rat paw edema and the mice caused by dimethylbenzene xylene swelling of auricle model that rises, observe the resist inflammation on repercussive function of this pharmaceutical composition, thereby provide the pharmacodynamics foundation for the clinical practice of this pharmaceutical composition.
Experiment material:
1. animal: the IRC mice, male and female are usefulness all, provides (No. the 2000023rd, the real moving card word in Yunnan) by Natural Medicine Inst., Yunan Baiyao Group; The wister rat, male, provided (No. 003, middle section moving card word) by Chinese Academy of Sciences's Shanghai Experimental Animal Center.
2. strain: staphylococcus aureus (26102), escherichia coli (35218), propionibacterium acne (65102) identify that by Beijing biological product institute provides, and microorganism teaching and research room of unming Medical College preserves.
3. culture medium: Nutrient agar, nutrient broth, anaerobe special culture media, calf serum are provided by Shanghai Vaccine and Serum Institute; Sheep blood is provided by animal section of unming Medical College.
4. medicine and reagent: this pharmaceutical composition spice extractum, every gram equal 5 gram crude drugs, and this pharmaceutical composition specification: 10ml/ props up, and every ml equals 1 gram crude drug, is provided by Benshan Pharmaceutical Co., Ltd., Yunan Prov.Fructus Gardeniae little leaf deervetch herb acne removing ball, specification: the 10g/ bottle, lot number 20001208, the pharmaceutical factory of traditional Chinese medicine provides by Kunming.YUNNAN BAIYAO, specification: the 4g/ bottle, lot number: 20001113, produce by Yunnan Paiyao Group Corp., Ltd.The Rhizoma Coptidis shangqing pill, specification: the 6g/ bag, lot number: 20001002, work energetically pharmaceutcal corporation, Ltd by Leshan, Sichuan and produce.Dimethylbenzene is available from Wuhan organic synthesis factory, specification 500ml, analytical pure.Carrageenin: institute of materia medica, Liaoning Province provides.
5. instrument: LIBROR AEG-220 balance, German SHIMADZU company product.
Method and result
(1), the bacteriostasis of this pharmaceutical composition
Adopt the test tube double dilution method to measure MIC.
1. the preparation of medicine:
It is standby that this pharmaceutical composition stock solution 10ml (0.2g/ml) gets in the sterile working, gets Fructus Gardeniae little leaf deervetch herb acne removing ball 1g, and it is standby to be dissolved in 10ml physiological saline solution (0.1g/ml).
2, the preparation of strain: will test respectively aerobic strain be inoculated in the serum broth pipe 37 ℃ cultivate behind the 18h with McFar LandShi turbidity standard pipe than turbid be 3 * 10
5The antibacterial liquid of cfu/ml is standby; Propionibacterium acne recovers in the anaerobism culture fluid, through the ventilation of bleeding put 37 ℃ cultivate 48-72h after than turbid be 3 * 10
5The antibacterial liquid of cfu/ml is standby.
3. the test tube double dilution method is measured MIC.
5. conclusion
Above this pharmaceutical composition of presentation of results and Fructus Gardeniae little leaf deervetch herb acne removing ball all have inhibitory action to the growth of staphylococcus aureus and propionibacterium acne.And this pharmaceutical composition in trial stretch not to colibacillary MIC.
(2), this pharmaceutical composition is to the influence of mouse small intestine motion
The ICR mice, 23-25g behind the fasting 24h, is divided into 5 groups at random, and 10 every group, promptly 10% charcoal ultimogeniture reason saline group, this pharmaceutical composition 0.5,1 and 2g/kg organize Rhizoma Coptidis shangqing pill 3g/kg (above-mentioned each medicinal liquid all contains 10% charcoal end).Each treated animal is all irritated stomach with the 0.2mL/10g body weight, and 1 time/d, be total to 5d, 15min after the last administration takes off neck and causes death, and opens the abdominal cavity and separates mesentery, and the clip upper end is to pylorus, and the lower end places on the pallet to the intestinal tube of ileocecus.Gently small intestinal is pulled into straight line, measure intestinal tube length as the small intestinal total length.The distance in forward position, end, is calculated with the propelling rate at the enteral advance distance as the charcoal end from pylorus to charcoal.
Presentation of results, the same promotion mouse small intestine progradation (p＜0.01vs normal saline group) that all has highly significant of this pharmaceutical composition high, medium and low three each dosage groups with positive control drug Rhizoma Coptidis shangqing pill.
(3), this pharmaceutical composition on Carrageenan causes the influence of rat paw edema
The Wister rat, body weight 216 ± 20g, male, divide 5 groups at random, promptly equal-volume normal saline group, this pharmaceutical composition 0.5,1,2g/kg organize, YUNNAN BAIYAO 0.8g/kg group.The equal gastric infusion of each treated animal 1 time/d, is total to 7d.Behind last administration 60min, rat one parapodum plantar subcutaneous injection 1% carrageenin suspension 0.1ml, rat hindlimb is stretching, with 1h after girth and the administration before the Zhou Changfa measurement administration, 2h, 4h, 6h, 24h foot sole of the foot girth is surveyed respectively twice, get its meansigma methods, with comparing between the difference of girth is organized as the swelling degree after the administration and before the administration.
The result shows, the obviously swelling of the right foot of control rats.The YUNNAN BAIYAO of this pharmaceutical composition of 2g/kg and 0.8g/kg all significantly reduces right swelling degree of the paw, and 1h promptly demonstrates tangible effect, acts on more than the sustainable 6h; 1 and this pharmaceutical composition of 0.5mg/kg at 4h, obvious detumescence effect appears during 6h, more than the sustainable 2h of drug effect.The result shows that this pharmaceutical composition (be equivalent to clinical consumption 10,5 and 2.5 times) of high, medium and low dosage all has tangible resist inflammation on repercussive function.
(4), this pharmaceutical composition xylol causes the influence of mice auricle swelling
The ICR mice, the male and female dual-purpose, body weight 25-28g is divided into 5 groups at random, and 10 every group, promptly isopyknic normal saline group, this pharmaceutical composition 0.5,1,2g/kg group and YUNNAN BAIYAO 0.8g/kg group.Each group of test presses 0.2 with the mL/10g gastric infusion, and 1 time/d, continuous 7d.60min draws dimethylbenzene (0.03ml/ only) with micro sample adding appliance and drips in mouse right ear after the last administration, puts to death animal behind the 15min.The hole device of wanting with diameter 8mm is drawn materials along the punching of left and right sides auricle same area.Weigh respectively, with two auricle method of double differences values as swelling degree index.Compare the difference of administration group and matched group, and obtain the swelling degree.
The result shows, the obvious swelling of normal saline control group mice auris dextra, and thickness increases, and two auricle weight differ bigger; This pharmaceutical composition of high dose (2g/kg) is the same with YUNNAN BAIYAO can to suppress mice ear (p＜0.01vs normal saline group) very significantly, and resist inflammation on repercussive function is very obvious; This pharmaceutical composition (1g/kg) of middle dosage also has the antiinflammatory action (p＜0.01vs normal saline group) of highly significant.
Discuss and conclusion:
This experimental result shows that this pharmaceutical composition all has inhibitory action to gold-coloured staphylococci and propionibacterium acne, and minimum inhibitory concentration (MIC) is respectively 25mg/ml and 50mg/ml, but does not measure colibacillary MIC in trial stretch.
In the propulsion trial of the charcoal end of mouse small intestine, this pharmaceutical composition of high, medium and low dosage (be equivalent to clinical consumption 10,5,2.5 times) can obviously suppress rat paw edema, the height of this product, middle dosage (be equivalent to clinical consumption 10,5 times) also can significantly suppress the swelling of Mice Auricle, and show dose-effect relationship preferably.
The result shows that this pharmaceutical composition has the effect of significantly antibiotic, loosening bowel to relieve constipation and anti-inflammation detumescence.This experimental result provides the pharmacodynamics foundation for its clinical practice.
The clinical verification of pharmaceutical composition of the present invention is summed up:
One, is used for the treatment of chloasma
(1), physical data
1. case is selected: require 150 routine patients all to derive from the outpatient of the unit of being tried according to clinical verification.
2. age and sex: (because of the main tennis women of chloasma, so the patient that this clinical verification is selected is the women), 100 examples are organized in treatment, matched group 50 examples, and between age 18-47 year, it is not extramarital to remove 5 people, and all the other are married and have given birth to a tire.Two groups of age distribution situations are learned by statistics and are handled there was no significant difference (P＞0.05), have comparability.
3. the course of disease distributes
It is be patient's the course of disease from first attack when going to a doctor that the course of disease distributes, wherein the shortest 5 months, and year surplus in the of the longest 10.Two groups of courses of disease are learned processing (P＞0.05, X by statistics
2Check), shows there was no significant difference between two groups, have comparability.
4. Western medicine diagnose typing and clinical symptoms distribute
Treat preceding two groups of Western medicine diagnose typings and clinical symptoms and distribute, there was no significant difference has comparability.
5. two groups of tcm syndrome differentiation and typing situations
Select syndrome of qi stagnation and blood stasis and syndrome of yin deficiency of liver and kidney amphitypy, learn processing by statistics for two groups, there was no significant difference, P＞0.05.
(2), case choice criteria
1. the Western medicine diagnose standard is [with reference to CAIM (Chinese Association Of Integrative Medicine) Dermatology Professional Committee pigment disease group, the clinical diagnosis of chloasma and curative effect determinate standard (draft)] 1. facial filbert to dark brown, well-defined patch is symmetrically distributed usually, NIP performance and squama.2. there is not obvious subjective symptoms.3. after mainly occurring in adolescence, women's pilosity.4. the state of an illness has certain seasonality, and Xia Chongdong is light.5. get rid of the pigmentation that other disease (as the brown cyan of cheekbone portion, Rirhl melanosis and pigment actinic lichen planus etc.) causes.6. the optical density value of pigmented area is greater than self more than 20% of facial average optical density value.
2. tcm syndrome differentiation and typing standard: (with reference to People's Republic of China's Chinese medicine industry standard) selects liver-kidney yin deficiency, qi stagnation and blood stasis type to include this test in.
2.1 the hepatic and renal YIN deficiency: brown black, the companion's soreness of the waist and knees of macula lutea, indolent and listless unable, health is won thin.Red tongue, few, the deep-thready pulse of tongue.
2.2 qi depression to blood stasis: the yellowish-brown patch appears in face, soreness of the waist and knees, or being irritable and getting angry easily, distending pain in the chest and hypochondrium dark tongue quality, white and thin fur, deep-thready pulse.
3. test the case standard
3.1 include the case standard in
Age meets the diagnosis and the differential diagnosis in tcm person of above chloasma at the 18-50 female patient in year, all can include the test case in.
3.2 get rid of case standard (comprising inadaptation or rejecting standard)
(1) age is at under-18s or more than 50 years old, allergic constitution or to this medicine allergy sufferers.
(2) be associated with serious primary disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, psychotic.
(3) do not meet the standard of including in: not medication in accordance with regulations, can't judge curative effect, or data not umbra ring curative effect or safety judgement person.
(3), curative effect judging standard
Being almost recovered: naked eyes look the mottle area and disappear＞and 90%, color disappears substantially;
Produce effects: naked eyes look the mottle area and disappear＞and 60%, color obviously disappears;
Taking a turn for the better: naked eyes look the mottle area and disappear＞and 30%, color is thin out;
Invalid: naked eyes look the mottle area and disappear＞and 30%, change color is not obvious.
(4), test method
1. medicine: being subjected to the reagent thing is this pharmaceutical composition, and Benshan Pharmaceutical Co., Ltd., Yunan Prov produces; Control drug is: liver-soothing infusion [ZZ-5320-defends in Yunnan the accurate word (1995) of medicine No. 002403], the Kunming pharmaceutical factory of traditional Chinese medicine produces.
2. test method: adopt single blind random packet to carry out, duration of test must not use other medicines, and 30 days is a course of treatment, carries out efficacy determination after observing two courses of treatment of treatment continuously.
3. observe skin lesion and related indication improvement situation before and after the treatment, simultaneously before and after treatment, respectively look into blood, urine, just routine, hepatic and renal function, electrocardiogram by irregular selection 30 examples of designer, to understand the influence of medicine to main organs, all items is record conscientiously, according to the result, judge curative effect.
(5), result of the test
1. by clinical trial, organize in 100 examples in treatment, 21 examples that are almost recovered, produce effects 29 examples, obvious effective rate is 50%, 10 examples that take a turn for the better, total effective rate is 90%; In matched group 50 examples, 10 examples that are almost recovered, 16 examples that take a turn for the better, obvious effective rate is 52%, effective 18 examples, total effective rate is 88%.Compare to learn by statistics for two groups and handle obvious effective rate, two groups of there was no significant difference P＞0.05 of total effective rate.
2. this pharmaceutical composition all has curative effect preferably to the hepatic and renal YIN deficiency in the tcm syndrome differentiation and typing, qi stagnation and blood stasis type, two groups of curative effects relatively, there are no significant difference P＞0.05.
3. this pharmaceutical composition is to the observation of tongue arteries and veins curative effect, and two groups of picture of the tongues, pulse condition normalization rates do not have significant difference P＞0.05.
4. want the influence of internal organs in order to separate the medicine counterweight, select treatment to organize 30 routine patients at random and carry out routine blood test, routine urinalysis, hepatic and renal function, Electrocardiographic inspection.Erythrocyte, hematochrome, leukocyte before and after the treatment are 30 examples normally; Liver function test, normal 27 examples before treating are treated normal 27 examples in back; Kidney function test, 30 examples are treated the front and back blood urea nitrogens, inosine is no abnormal; No abnormal before and after urine, the stool routine examination 30 example treatments; Electrocardiographic inspection, no abnormal before and after the 24 example treatments.Be the change of T ripple before and after 1 example treatment is arranged, be arrhythmia before and after the 4 example treatments,, show that this pharmaceutical composition does not have ill effect to the human body important organ by above inspection.
(6), untoward reaction
The treatment group is not found adverse effect in therapeutic process.
(7), conclusion
1. determined curative effect: clinical observation shows that this pharmaceutical composition is 50% to the hepatic and renal YIN deficiency of chloasma, the rate of being almost recovered of syndrome of qi stagnation and blood stasis, and total effective rate is 90%; The matched group rate of being almost recovered is 52%, and total effective rate is 88%, two group of there was no significant difference of comparing.
2. indication: this pharmaceutical composition is applicable to special property, the Secondary cases chloasma sent out, and is applicable to the hepatic and renal YIN deficiency of tcm syndrome differentiation and typing and the chloasma of qi depression to blood stasis.
3. safe and reliable: as during the clinical observation, 30 routine patients to be carried out lab testings such as liver, renal function, electrocardiogram, three big routines, all do not have change before and after the treatment, show that this medicine has no side effect to important organ, be worthy of popularization.
Two, be used for the treatment of acne (acne)
(1), physical data
1. case is originated: require 155 routine patients all to derive from the outpatient of the unit of being tried according to clinical verification.
2. age and sex:
100 examples are organized in treatment, male patient's 27 examples wherein, female patient 73 examples; Matched group 55 examples, male patient's 19 examples wherein, female patient 36 examples; Age and sex distribution situation statistical procedures there was no significant difference (P＞0.05) have comparability.
3. the course of disease distributes
It is be patient's the course of disease, wherein the shortest 3 weeks, year surplus in the of the longest 10 from first attack when going to a doctor that the course of disease is calculated.Two groups of course of disease distribution situations are learned processing (P＞0.05 X by statistics
2Check), shows there was no significant difference between two groups, have comparability.
4. Western medicine diagnose typing and clinical symptoms distribute
Treat preceding two groups of Western medicine diagnose typings and clinical symptoms and distribute, there was no significant difference has comparability.
5. two groups of tcm syndrome differentiation and typing situations
Only select wind and heat in the lung meridian disease and the intestines and stomach damp-heat syndrome amphitypy, learn processing by statistics for two groups, there was no significant difference, P＞0.05.
(2), case choice criteria
1. Western medicine diagnose standard: (with reference to the clinical research guideline of new Chinese medicine treatment acne) I degree (slightly): hoary hair or blackhead, be distributed to pilosity, the inflammatory pimple is distributed; II degree (moderate): I degree+shallow at the property pustule, inflammatory pimple number increases, and is confined to face.
2. tcm syndrome differentiation and typing standard: (with reference to the clinical research guideline of new Chinese medicine treatment acne).Select wind and heat in the lung meridian card, the intestines and stomach damp-heat syndrome to include this test in.
2.1 wind and heat in the lung meridian card: the red or companion's face flushed face in the afternoon inflammation heat of pimple color, or born of the same parents' bleb is arranged, itch pain, breath gas heat, red tongue, Tai Bai or Huang, thready and rapid pulse.
2.2 the intestines and stomach damp-heat syndrome: the cunning light of face, the pimple color is red, and a nodosity swells and ache, the pustule increase is many, companion's xerostomia hardship, constipation is urinated red, red tongue, yellow and greasy fur, thready and rolling pulse.
3. test the case standard
3.1 include the case standard in
Age meets above acne (acne) diagnosis and doctor apologist the men and women patient in 13-40 year, all can include the test case in.
3.2 get rid of the case standard: (comprising inadaptation or rejecting standard)
(1) age is below 13 years old or more than 40 years old, gestation or women breast-feeding their children, allergic constitution or to this medicine allergy sufferers.
(2) be associated with serious primary disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, psychotic.
(3) occupational acne due to the chemical substance, drug-induced acne.
(4) do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect, or data not umbra ring curative effect or safety judgement person.
(3), curative effect judging standard:
Recovery from illness: skin lesion all disappears, and only stays pigmentation and cicatrix person.
Produce effects: skin lesion disappears more than 70%.
Effectively: skin lesion disappears more than 30%.
Invalid: skin lesion disappears below 30%, or the person of increasing the weight of.
For making things convenient for clinical efficacy to judge accurately, when observing above-mentioned standard, we quantize skin lesion area and related symptoms according to heavy degree in light, and concrete quantitative criteria is as follows:
Slightly: the skin lesion area accounts for entire face 30%
Moderate: the skin lesion area accounts for entire face 50%
Severe: the skin lesion area accounts for entire face 80%
Constipation: slight: constipation with dry stool, defecation time 1-2 days; Moderate: constipation with dry stool, defecation time 2-3 days; Severe: constipation with dry stool, defecation time is more than 3 days.
(4), test method
1. medicine: being subjected to the reagent thing is this pharmaceutical composition, and Benshan Pharmaceutical Co., Ltd., Yunan Prov produces; Control drug is the little leaf deervetch herb acne removing ball, and the Kunming pharmaceutical factory of traditional Chinese medicine produces, and ZZ-4151-defends in Yunnan the accurate word (1996) of medicine No. 002887, lot number: 010404.
2. test method: adopt single blind random packet to carry out, duration of test must not use other medicines, and 15 days is a course of treatment, the skin lesion that finishes back observed and recorded patient the course of treatment situation that disappears.
3. observation index: observe skin lesion and related indication improvement situation before and after the treatment, simultaneously by irregular selection 30 examples of designer before and after treatment, respectively look into hematuria, just routine, hepatic and renal function, electrocardiogram, with of the influence of understanding medicine to main organs, all items is record conscientiously, according to the result, judge curative effect.
(5), result of the test
1. by clinical trial, organize in 100 examples in treatment, 14 examples of fully recovering, produce effects 378 examples, obvious effective rate is 52%, effective 39 examples, total effective rate is 91%; In matched group 55 examples, 3 examples of fully recovering, produce effects 12 examples, obvious effective rate is 27%, total effective rate is 76.36%.Compare to learn by statistics for two groups and handle, obvious effective rate treatment group is better than matched group, P＜0.01; Total effective rate treatment group obviously is better than matched group, P＜0.01.
2. this pharmaceutical composition all has curative effect preferably to the wind and heat in the lung meridian in the tcm syndrome differentiation and typing, the intestines and stomach damp-heat type, and two groups of curative effects compare, and wind and heat in the lung meridian type treatment group is better than matched group P＜0.01, two groups of there was no significant difference P＞0.05 of the intestines and stomach damp-heat type.
3. this pharmaceutical composition is to the observation of tongue arteries and veins curative effect, two groups of picture of the tongues, pulse condition normalization rate there was no significant difference, P＞0.05.
4. want the influence of internal organs in order to separate the medicine counterweight, select treatment to organize 30 routine patients at random and carry out routine blood test, routine urinalysis, hepatic and renal function, Electrocardiographic inspection, erythrocyte, hematochrome, leukocyte before and after its check result treatment are 30 examples normally, liver function test, being 29 examples normally before the treatment, normally is 30 examples after the treatment; Kidney function test, 30 examples are treated the front and back blood urea nitrogens, inosine is no abnormal; No abnormal before and after routine urinalysis, the stool routine examination 30 example treatments; Electrocardiographic inspection, no abnormal before and after the 25 example treatments, have that to be sinus bradycardia companion rule after the 2 example treatments uneven, show as arrhythmia before and after the 3 example treatments.By above-mentioned inspection, show that this pharmaceutical composition does not have ill effect to the human body important organ.
(6), untoward reaction:
All the treatment group has 1 example anaphylaxis (puffiness of face, pruritus) to occur after taking medicine in therapeutic process, fully recovers after drug withdrawal and the antianaphylactic treatment, does not find toxic and side effects after all the other patients take medicine.
(7), conclusion
1. determined curative effect: observe and show this pharmaceutical composition to acne I degree, II degree, the healing obvious effective rate of the wind and heat in the lung meridian of acne, the intestines and stomach damp-heat syndrome is 52%, and total effective rate is 91%; It is 27% that matched group is cured obvious effective rate, and total effective rate is 76.36%.P＜0.01 of comparing, the treatment group obviously is better than matched group.
2. indication: this pharmaceutical composition is applicable to diseases such as treatment I degree, acne that the II degree occurred, pimple, pustule constipation, is applicable to the wind and heat in the lung meridian type of tcm syndrome differentiation and typing and the acne of the intestines and stomach damp-heat type.
3., safe and reliable: as during the clinical observation, 30 routine patients to be carried out lab testings such as liver, renal function, electrocardiogram, three big routines, all do not have change after treating before treating, show that this medicine has no side effect to important organ.
The specific embodiment
Embodiment 1:
Get Herba Taraxaci 107g, Herba Senecionis Scandentis 130g, Cacumen Platycladi 160g, Caulis Sargentodoxae 180g, Radix Bupleuri 130g, Caulis Clematidis Armandii 107g, Radix Angelicae Dahuricae 180g, Spina Gleditsiae 36g, more than eight the flavor medical materials, decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction, left standstill 12 ~ 24 hours, and filtered, filtrate decompression is concentrated into the plaster that relative density is 1.06 ~ 1.08 (60 ℃), add Mel 50g, potassium sorbate 0.8g, add water to ormal weight, stir evenly, filter, packing, sterilization promptly makes oral liquid.
Embodiment 2:
Get Herba Taraxaci 535g, Herba Senecionis Scandentis 650g, Cacumen Platycladi 650g, Caulis Sargentodoxae 900g, Radix Bupleuri 650g, Caulis Clematidis Armandii 535g, Radix Angelicae Dahuricae 900g, Spina Gleditsiae 180g, more than eight the flavor medical materials, decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction, leave standstill, filter; Filtrate is concentrated into the clear paste that every relative density is 1.20 ~ 1.22 (60 ℃); Drying is pulverized, and adds starch 3.5g, Pulvis Talci 16g, magnesium stearate 0.5g, and the mixing granule incapsulates, promptly.
Embodiment 3:
Get Herba Taraxaci 800g, Herba Senecionis Scandentis 800g, Cacumen Platycladi 400g, Caulis Sargentodoxae 400g, Radix Bupleuri 350g, Caulis Clematidis Armandii 400g, Radix Angelicae Dahuricae 500g, Spina Gleditsiae 250g, more than eight the flavor medical materials, decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction, leave standstill, filter; Filtrate is concentrated into the clear paste that every relative density is 1.20 ~ 1.22 (60 ℃); Drying is pulverized, and adds starch 3.5g, Pulvis Talci 16g, magnesium stearate 0.5g, the mixing granule, and tabletting, promptly.
Embodiment 4:
Get Herba Taraxaci 250g, Herba Senecionis Scandentis 180g, Cacumen Platycladi 80g, Caulis Sargentodoxae 90g, Radix Bupleuri 150g, Caulis Clematidis Armandii 80g, Radix Angelicae Dahuricae 90g, Spina Gleditsiae 20g, more than eight the flavor medical materials, be ground into fine powder, sieve mixing.Every 100g powder adds refined honey 120 ~ 140g, makes big honeyed pills, promptly.
Embodiment 5:
Repeat the proportioning raw materials example of embodiment 2, difference is, after the concentrated solution cooling, adds each 1 part of dextrin, sucrose, makes granule, drying, and sterilization, packing promptly gets the granule finished product.
Embodiment 6:
Repeat the proportioning raw materials example of embodiment 3, get crude drug respectively and be ground into fine powder, mixing, packing promptly gets the powder finished product.
Claims (4)
1, a kind of pharmaceutical composition for the treatment of acne, chloasma is characterized in that it being the medicament of being made by the following weight proportion raw material:
Herba Taraxaci 107, Herba Senecionis Scandentis 130, Cacumen Platycladi 160, Caulis Sargentodoxae 180, Radix Bupleuri 130, Caulis Clematidis Armandii 107, the Radix Angelicae Dahuricae 180, Spina Gleditsiae 36.
2, a kind of pharmaceutical composition for the treatment of acne, chloasma is characterized in that it being the medicament of being made by the following weight proportion raw material:
Herba Taraxaci 535, Herba Senecionis Scandentis 650, Cacumen Platycladi 650, Caulis Sargentodoxae 900, Radix Bupleuri 650, Caulis Clematidis Armandii 535, the Radix Angelicae Dahuricae 900, Spina Gleditsiae 180.
3, a kind of pharmaceutical composition for the treatment of acne, chloasma is characterized in that it being the medicament of being made by the following weight proportion raw material:
Herba Taraxaci 800, Herba Senecionis Scandentis 800, Cacumen Platycladi 400, Caulis Sargentodoxae 400, Radix Bupleuri 350, Caulis Clematidis Armandii 400, the Radix Angelicae Dahuricae 500, Spina Gleditsiae 250.
4, a kind of pharmaceutical composition for the treatment of acne, chloasma is characterized in that it being the medicament of being made by the following weight proportion raw material:
Herba Taraxaci 250, Herba Senecionis Scandentis 180, Cacumen Platycladi 80, Caulis Sargentodoxae 90, Radix Bupleuri 150, Caulis Clematidis Armandii 80, the Radix Angelicae Dahuricae 90, Spina Gleditsiae 20.
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| CN105168630A (en) * | 2015-10-19 | 2015-12-23 | 杜翠云 | Traditional Chinese medicine for treating liver and kidney yin deficiency type acne |
| CN111821405A (en) * | 2019-04-22 | 2020-10-27 | 厦门市中萪研生物科技有限公司 | Acne-removing traditional Chinese medicine composition and preparation method thereof |
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