CN101810687B - Medicament for treating hyperplasia of mammary glands and preparation method thereof - Google Patents
Medicament for treating hyperplasia of mammary glands and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a medicament for treating hyperplasia of mammary glands and a preparation method thereof. The medicament consists of raw material medicaments such as root of red-rooted salvia, red paeony root, barbed skullcap herb, toad venom, scorpion, centipede and borneol, transdermal enhancer and enepidermic excipient. The formulations can be transdermal patches, ointments and plastic. Toxicology tests show that the formula of the Chinese medicament has the advantages of no toxicity, no irritability and no sensitization to skin and safe use, and achieves good effects of transdermal administration and absorption, direct effects on diseased regions, quick response, good curative effect, small toxic and side effects after long-term use and convenient use.
Description
Technical field
The present invention relates to a kind of medicine of treating cyclomastopathy and preparation method thereof, belong to the field of Chinese medicines.
Background technology
Cyclomastopathy belongs to the traditional Chinese medical science " nodules of the breast " category, is a kind of non-inflammation caking capacity disease, and be characterized in: breast has lump, increases the weight of through before swelling and ache.This disease is mainly in 30～45 years old women, is a kind of commonly encountered diseases, frequently-occurring disease.Give birth to that suckling person's sickness rate is also not high.Its sickness rate accounts for the first place of cystic hyperplasia of breast.Among the patient of cyclomastopathy, some possibly cancerate and become breast carcinoma.Its sickness rate is higher 1.4～1.5 times than healthy women.As everyone knows, Chinese medicine external curing cyclomastopathy is the therapy that traditional traditional Chinese medical science shows unique characteristics, and has good effect, instant effect, the little characteristics of side effect.The Chinese medicine exterior-applied prescription of existing treatment cyclomastopathy is a lot of, but the following problem of ubiquity:
1, dosage form is old.The Chinese medicine exterior-applied formulation is old, is plaster, paste mostly, sticks agent etc.Treatment cyclomastopathy administration time is longer, and frequent pollution clothes;
2, big prescription.It is more to choose flavour of a drug in the Chinese medicine external prescription of existing treatment cyclomastopathy, have 10 surplus kind of medical material, many reach 27 kinds of medical materials.The curative effect of medication of many medical materials is close in the big prescription, reuses comparatively general; The application of big prescription has in addition increased the chance that the toxic and side effects of drug effect takes place;
3, do not extract.Because historical reasons are not understood Effective Components of Chinese Herb, in conventional use, often directly are used as medicine with medical material.Particularly Chinese medicine external all is that it is ground into powder traditionally, cooperates oil or honey or glue or vinegar to stick the affected part and uses.This usage usually influences the absorption of effective ingredient in the medical material.
Summary of the invention
Therefore, still there is demand in people's Chinese medicine preparation that curative effect is better treated cyclomastopathy.Inventor's process pharmacy test, and through animal and clinical test repeated validation, successfully prepare the treatment cyclomastopathy with better curative effect and be fit to enepidermic Chinese medicine external used medicine, thereby accomplished the present invention.
The objective of the invention is to overcome the defective that exists in the prior art, provide a kind of and can effectively treat cyclomastopathy and Chinese medicine medicine easy to use, that toxic and side effects is little, curative effect is high.
Another object of the present invention has provided the method for preparing of this Chinese medicine external used medicine.
The traditional Chinese medical science thinks that mostly the cause of disease that the nodules of the breast primary disease takes place is to be worried angry and gets, and its pathogenesis is a depression of liver-QI, incoordination between the spleen and stomach, Chong and Ren channel disorder; Phlegm and blood stasis, it is marked on liver, and the fundamental cause of water disease being in the kidney is in line with the principle of symptomatic treatment in acute condition; With the depressed liver-energy dispersing and QI regulating analgesia is main, and the phlegm reduction of blood circulation promoting eliminating stagnation is a spoke, and tonifying Chong and Ren channels is for assistant.Finder of the present invention selects Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Herba Scutellariae Barbatae, Venenum Bufonis, Scorpio, Scolopendra, Borneolum Syntheticum prescription for use according to Chinese medical theory and clinical practice.Radix Salviae Miltiorrhizae promoting blood circulation to restore menstrual flow in this prescription, wind-expelling pain-stopping are monarch drug.Apply with Radix Paeoniae Rubra clearing away heat and cooling blood, eliminating stasis to stop pain.Scorpio, Scolopendra, Venenum Bufonis dispersing pathogen accumulation, removing obstruction in the collateral to relieve pain is a ministerial drug with the power that strengthens the monarch drug promoting blood circulation and stopping pain altogether.Herba Scutellariae Barbatae heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling are adjuvant drug.The Borneolum Syntheticum refreshment of having one's ideas straightened out, clearing away heat to alleviate pain, fragrance is walked string, current all through and because of the through the exterior and the interior of all medicines in this prescription be messenger drug.Above monarch, minister, help, make mutually 5 cooperations, play promoting blood circulation to remove obstruction in the collateral altogether, the effect of eliminating stasis to stop pain makes newborn network mediation, the nodules of the breast recovery from illness.
The present invention realizes in the following manner:
The present invention treats the cyclomastopathy medicine and is made up of the crude drug that comprises Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Herba Scutellariae Barbatae, Venenum Bufonis, Scorpio, Scolopendra, Borneolum Syntheticum and short cutaneous permeable agent and dermatologic excipient.
The crude drug component that the present invention treats the cyclomastopathy medicine all has better curative effect in the use of following weight parts scope:
41～43 parts of Radix Salviae Miltiorrhizaes, 41～43 parts of Radix Paeoniae Rubra, 11～14 parts of Herba Scutellariae Barbataes, 1.1～1.4 parts of Scorpio, 1.1～1.4 parts of Scolopendras.
Be preferably: 42 parts of Radix Salviae Miltiorrhizaes, 42 parts of Radix Paeoniae Rubra, 12 parts of Herba Scutellariae Barbataes, 1.4 parts of Scorpio, 1.4 parts of Scolopendras.
Each amounts of components can also be in the raw material of Chinese medicine medicine composition of the present invention: 41～43 parts of Radix Salviae Miltiorrhizaes, 41～43 parts of Radix Paeoniae Rubra, 11～14 parts of Herba Scutellariae Barbataes, 1.1～1.4 parts of Scorpio, 1.1～1.4 parts of Scolopendras, 0.42～0.53 part of Venenum Bufonis, 1.1～1.4 parts of Borneolum Syntheticums.
Be preferably: 42 parts of Radix Salviae Miltiorrhizaes, 42 parts of Radix Paeoniae Rubra, 12 parts of Herba Scutellariae Barbataes, 1.4 parts of Scorpio, 1.4 parts of Scolopendras, 0.42 part of Venenum Bufonis, 1.1 parts of Borneolum Syntheticums.
It is transdermal patch, ointment, liniment that the present invention treats the said dermatologic dosage form of cyclomastopathy external Chinese medicine preparation.
The preferred for preparation method of medicine of the present invention is following:
1, the Chinese medicine concentrated solution produces
Take by weighing each crude drug by above-mentioned weight portion, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Herba Scutellariae Barbatae, Scorpio and Scolopendra are used as medicine twice of decocte with water earlier; For the first time add 8 times of amounts of water, decoct and after 2 hours decocting liquid is poured out, add 6 times of amounts of water for the second time; Decoct and again decocting liquid is poured out after 1 hour; Merge decocting liquid twice, filter filtrating, being condensed into proportion is the Chinese medicine concentrated solution of 1.25～1.30 (60 ℃).
2, the preparation of transdermal patch
Behind dermatologic excipient heating and melting; With above-mentioned Chinese medicine concentrated solution mix homogeneously, when treating that temperature is reduced to 45～50 ℃, adding grinds into 120 purpose Venenum Bufoniss, Borneolum Syntheticum and short cutaneous permeable agent and stirs again; Be applied to non-woven fabrics by material, cover the envelope film again and promptly make transdermal patch.
3, the preparation of liniment
Be 60: 13: 50 by weight percentage: 60: 10: 2: 8: 1: 100 ratio is got above-mentioned Chinese medicine concentrated solution, polyvinyl alcohol, third ethanol, ethanol, glycerol, Borneolum Syntheticum, dimethyl sulfoxine, Tween 80 and water; Get Chinese medicine concentrated solution, polyvinyl alcohol and add 1/3rd water logging bubble, add third ethanol, ethanol, glycerol, Borneolum Syntheticum, dimethyl sulfoxine, Tween 80 then, stir; Moisturizing is to full dose; With sodium hydroxide pH value is adjusted to 6.0～7.0, stirs, packing promptly gets.
Above-mentioned raw materials medicated powder is broken into 120 order fine powders, adds the excipient packing that stirs and promptly make ointment.
It is laurocapram or dimethyl sulfoxine that the present invention treats the described short cutaneous permeable agent of cyclomastopathy external Chinese medicine preparation, and its consumption is 1%～10%.
The present invention treats the medicine excipient that the said skin of cyclomastopathy external Chinese medicine preparation uses and is vaseline.
The present invention treats the cyclomastopathy medicine compared with prior art, has following beneficial effect:
1, show this Chinese medicine preparation to skin avirulence, nonirritant, no sensitization through toxicology test, and safe in utilization;
2, realized absorbing, directly acted on diseased region, instant effect, good effect, life-time service toxic and side effects target little, easy to use through transdermal administration.
The specific embodiment
Below further specify the beneficial effect of medicine according to the invention through Test Example, test comprises that the pharmacodynamics test of medicine of the present invention and clinical observation on the therapeutic effect test.
Test Example 1 single-use skin irritant test
Test material: the ointment of selecting medicine of the present invention for use
Test method: get 3 of new zealand white rabbits; Body weight 2.5 ± 0.5kg; Administration was got each 3 * 2 square centimeters of each QUMAO of rabbit back spinal column both sides Chinese medicine preparation ointment 1g and is spread upon a side QUMAO place in preceding 24 hours, and opposite side is coated with Oleum sesami as blank; Coating was removed the residual thing that tried with eliminating cold for resuscitation water after 4 hours, observed 4,24,48,72 hours dermoreaction situation.Result of the test is seen table 1:
Table 1 skin irritation reaction appraisal result
Result of the test shows: according to last table, intact skin IR mean scores is zero, and the Chinese medicine preparation ointment belongs to nonirritant to skin.
Test Example 2 skin acute toxicity tests
Through to the animal intact skin with after damaged skin once contacts the Chinese medicine preparation ointment, the toxic reaction that observation post produces.Get 12 rabbit, male and female half and half are divided into 3 groups at random, 4 every group, are respectively negative control group, Chinese medicine preparation ointment low dose group (for clinical working concentration) and Chinese medicine preparation ointment high dose group (be clinical working concentration 4 times).Preceding 24 hours of administration, at back, rabbit right side with the 20% sodium sulfide 150cm that sheds
2, be coated with respectively and tried each 1g of thing, act on after 24 hours, flush away is tried thing, observes continuously poisoning symptoms such as going to be tried the behavior to the 7th day rabbit in 1,24,48,72 hour behind the thing, activity, fur gloss, diet and body weight, if any the timely postmortem of dead animal.When showing non-toxic reaction, at the 150cm that sheds of rabbit left dorsal portion like intact skin test
2, draw # shape scar with sterile needle behind the preserved skin, do not injure corium to stab epidermis, slight oozing of blood is advisable, coating at once, observation index is the same, and with the negative control thing relatively.
Result of the test shows: the behavior of intact skin group and damaged skin treated animal, activity, fur gloss, diet and body weight are all acted normally, and not seeing has any poisoning symptom, observe in 14 days and do not have animal dead, see the following form 2.
The acute toxicity test of table 2 Chinese medicine preparation ointment (g, X ± SD, n=4)
| Group | Project | Before the administration | The intact skin group | The damaged skin group |
| Negative control group | Body weight has a net increase of the body weight poisoning symptom | 1510 ± 41 do not have | 1570 ± 44 60 do not have | 1662 ± 61 92 do not have |
| Chinese medicine preparation ointment low dose group | Body weight has a net increase of the body weight poisoning symptom | 1665 ± 50 do not have | 1762 ± 61 97 do not have | 1886 ± 59 124 do not have |
| Chinese medicine preparation ointment high dose group | Body weight has a net increase of the body weight poisoning symptom | 1612 ± 58 do not have | 1702 ± 88 90 do not have | 1837 ± 51 135 do not have |
Compare P＞0.05 with negative control group
Conclusion (of pressure testing): Chinese medicine preparation ointment clinical dosage and 4 times of clinical dosage externals all do not cause acute toxic reaction on the intact skin and damaged skin of rabbit.
The clinical treatment test of 3 pairs of cyclomastopathies of Test Example
1, physical data
Test MethodsThe cases enrolled 108 examples are minimum 27 years old of age, the oldest 51 years old, 35 years old mean age, the shortest week of the course of disease, the longest 5 years.
2, diagnostic criteria
All cases all have the red and swollen distending pain symptom of breast, and part patient has the menoxenia symptom.
3, Therapeutic Method
It is through the local skin administration that the present invention treats cyclomastopathy external Chinese medicine preparation, is used to treat cyclomastopathy, and medication was 1 time in per 3 days.
During treatment patch is affixed on lesions position or the focus projection position at body surface.The course of treatment, light disease 2-4 pasted, and patient with severe symptoms 10 pastes a course of treatment.
4, efficacy assessment standard
Recovery from illness disappears for distending pain of the breast, and it is normal that red and swollen skin recovers, and lump disappears;
Produce effects is distending pain of the breast, the red and swollen disappearance, and the lump maximum gauge dwindles more than 1/2;
Effectively for distending pain of the breast alleviates, the lump maximum gauge dwindles less than 1/2; Or distending pain of the breast do not alleviate, and the lump reduced is more than 1/2;
Invalidly do not dwindle or increase, hardening for lump; Or simple distending pain of the breast is alleviated and lump does not have and dwindles.
5, therapeutic outcome (seeing table 3)
The therapeutic evaluation of table 3 Chinese medicine preparation ointment clinical trial
| Curative effect | Recovery from illness | Produce effects | Effectively | Invalid | Total effective rate |
| The example number | 65 | 19 | 18 | 6 | 108 |
| Percentage ratio % | 60.18 | 17.59 | 16.67 | 5.56 | 94.44 |
This test clinical observation does not see that as yet obvious whole body and local untoward reaction take place, and carries out routine blood test, routine urinalysis, liver function test before and after the medication, and is all no abnormal.Clinical observation result shows that the Chinese medicine preparation ointment has clear improvement to the clinical symptoms and the sign of cyclomastopathy, and effective percentage is 94.44%.
The model case of Test Example 4 treatment cyclomastopathies
Case 1 patient Wang Fenglan, the women 46 years old, lives county town, Tongguan, Shaanxi.State when examining: two newborn pain March, increase the weight of a week.Angry whenever back or increase the weight of menstrual period.Look into: two breasts can touch each one of about 2 * 2cm enclosed mass, infrared ray breast examination report: bilateral breast cyclomastopathy.Paste 10 promptly for the Chinese medicine preparation external and paste, every side is pasted at every turn, advises and changes dressings once in its three days, and further consultation is stated after 15 days: pain obviously alleviates.Look into: two newborn enclosed mass before dwindle.Advising it to continue pastes with 10.Back further consultation again: transference cure.The infrared ray breast examination: two breasts are not visited and enclosed mass.The sick announcement fully recovered.
Case 2 patient Hong Fenglou, the women, 48 years old, the peasant lived Tongguan, Shaanxi Ma Jicun.State when examining: two mammary swellings are half a year bitterly, increases the weight of January.Check result: two breasts can touch respectively and thicken body of gland, and the swollen thing of ovum garden type can be touched in left newborn inboard, and matter is tough, does not have obvious tenderness, and axillary lymph does not have enlargement, infrared ray breast examination report: 1, bilateral breast hypertrophy; 2, left mammary gland fibroma.Paste 10 promptly for the Chinese medicine preparation external and paste,, every side is pasted at every turn, changes dressings once in 3rd, and further consultation is stated after 15 days: pain obviously alleviates, and the swollen thing of bilateral breast all obviously dwindles.Look into: two newborn enclosed mass before dwindle.Advising it to continue pastes with 10.Further consultation after 20 days: two swelling of the breast things light tenderness that disappears basically once in a while.The infrared ray breast examination: two breasts are not visited and enclosed mass.
Case 3 patient's hair Armeniaca mume Sieb.s, the women, 22 years old, the peasant lived Shi Lipu village, Tongguan County.State when examining: newborn inboard 1 week of pain of a left side.Look into: left newborn inboard can be touched and thicken body of gland, and matter is soft, and tenderness is obvious, infrared ray breast examination report: left breast cyclomastopathy.Paste 5 promptly for the Chinese medicine preparation external and paste, advise and changed dressings once in its three days, further consultation is stated after 15 days: pain relief.Advising it to continue pastes with 10.Back further consultation again: two newborn pain reliefs, swollen thing deliquescing is dwindled.Continue and paste with 10, further consultation is stated: before the newborn menstrual cycle in a left side pain once, the swollen thing of breast disappears basically.The infrared ray breast examination: left breast is not visited and enclosed mass.
Below further specify the method for preparing of medicine of the present invention through embodiment, but should it be regarded as limitation of the present invention.
The concentrated solution preparation of embodiment 1 medicine of the present invention
With Radix Salviae Miltiorrhizae 250g, Radix Paeoniae Rubra 250g, Herba Scutellariae Barbatae 70g, Scorpio 10g, Scolopendra 10g, twice of decocte with water.For the first time add water, the water yield is 8 times of amounts of dose volume, decocts and after 2 hours decocting liquid is poured out; For the second time add water, the water yield is 6 times of amounts of dose volume, decocts and decocting liquid is poured out after 1 hour again.Merge decocting liquid twice, filter and be evaporated to relative density 1.25～1.30 (60 ℃) and make the Chinese medicine concentrated solution.
The Chinese medicine concentrated solution that more than extracts is used to prepare the dermatologic dosage form.
The preparation of the transdermal patch of embodiment 2 medicines of the present invention
Ingredient and consumption:
Above-mentioned Chinese medicine concentrated solution 300g, Venenum Bufonis 3g, Borneolum Syntheticum 5g, laurocapram 10g, vaseline 1000g
Method for preparing:
1, get 600g vaseline heating and melting after, slowly add the Chinese medicine concentrated solution, stir, when treating that temperature is reduced to 45～50 ℃ of left and right sides, add Venenum Bufonis and Borneolum Syntheticum again, and laurocapram, mend vaseline to full dose.
2, the unguentum of producing is applied to non-woven fabrics by material, coverlay, system is pasted and is promptly got.
The liniment preparation of embodiment 3 medicines of the present invention
Ingredient and consumption
Chinese medicine concentrates 300g, dimethyl sulfoxine 40g, propylene glycol 250g, polyvinyl alcohol 65g, glycerol 50g, Borneolum Syntheticum 10g, Tween 80 (Tween 80) 5g, ethanol 300g, sodium hydroxide, water 1000g.
Method for preparing:
Get Chinese medicine concentrated solution, polyvinyl alcohol and add 600g water logging bubble, add third ethanol, ethanol, glycerol, Borneolum Syntheticum, dimethyl sulfoxine, Tween 80 then, stir, moisturizing is adjusted to 6.0～7.0 with sodium hydroxide with pH value to full dose, stirs, and packing promptly gets.
The ointment preparation of embodiment 4 medicines of the present invention
Get Radix Salviae Miltiorrhizae 250g, Radix Paeoniae Rubra 250g, Herba Scutellariae Barbatae 70g, Scorpio 10g, Scolopendra 10g and be ground into and can cross 120 purpose fine powders, it is 120 order fine powders that Venenum Bufonis 3g, Borneolum Syntheticum 5g use mortar to grind, and adds vaseline 1000g, stirs, and packing promptly gets.
Claims (6)
1. the medicine of an external curing cyclomastopathy; It is characterized in that it is processed by following bulk drugs: 41～43 parts of Radix Salviae Miltiorrhizaes, 41～43 parts of Radix Paeoniae Rubra, 11～14 parts of Herba Scutellariae Barbataes, 1.1～1.4 parts of Scorpio, 1.1～1.4 parts of Scolopendras, 0.42～0.53 part of Venenum Bufonis, 1.1～1.4 parts of Borneolum Syntheticums.
2. the medicine of external curing cyclomastopathy according to claim 1 is characterized in that, wherein the consumption of each crude drug is: 42 parts of Radix Salviae Miltiorrhizaes, 42 parts of Radix Paeoniae Rubra, 12 parts of Herba Scutellariae Barbataes, 1.4 parts of Scorpio, 1.4 parts of Scolopendras, 0.42 part of Venenum Bufonis, 1.1 parts of Borneolum Syntheticums.
3. according to the method for preparing of claim 1 or 2 said medicines, it is characterized in that,
(1) take by weighing each crude drug, with Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Herba Scutellariae Barbatae, Scorpio, Scolopendra, decocte with water twice adds 8 times of amounts of water for the first time; Decocted 2 hours, and added 6 times of amounts of water for the second time, decocted 1 hour; Merge decocting liquid twice, filter filtrating, proportion is 1.25～1.30 Chinese medicine concentrated solution when being condensed into 60 ℃;
(2) with behind the dermatologic excipient heating and melting, add above-mentioned Chinese medicine concentrated solution, mix homogeneously; When treating that temperature is reduced to 45 ℃～50 ℃; Add again and grind into 120 purpose Venenum Bufoniss, Borneolum Syntheticum, short cutaneous permeable agent and stir, be applied to non-woven fabrics, cover the envelope film again and promptly make transdermal patch by material.
4. according to the method for preparing of claim 1 or 2 said medicines, it is characterized in that, said crude drug is ground into 120 order fine powders, add the excipient packing that stirs and promptly make ointment.
5. according to the method for preparing of the said medicine of claim 3, it is characterized in that described short cutaneous permeable agent is a kind of in laurocapram or the dimethyl sulfoxine.
6. according to the method for preparing of claim 3 or 4 said medicines, it is characterized in that described excipient is a vaseline.
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| CN102343028B (en) * | 2011-09-30 | 2013-07-10 | 蚌埠丰原涂山制药有限公司 | Chinese medicinal composition for treating cyclomastopathy and preparation method thereof |
| CN111840365A (en) * | 2019-04-26 | 2020-10-30 | 何波 | A pharmaceutical composition for treating breast diseases, and its preparation method |
Citations (2)
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| CN1559514A (en) * | 2004-03-05 | 2005-01-05 | 健 张 | Skin penetration and adsorption medicine for treating proliferation of mammary gland |
| CN101297866A (en) * | 2008-06-27 | 2008-11-05 | 王祥瑞 | Chinese medicament oil solution for treating burn and preparation thereof |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1559514A (en) * | 2004-03-05 | 2005-01-05 | 健 张 | Skin penetration and adsorption medicine for treating proliferation of mammary gland |
| CN101297866A (en) * | 2008-06-27 | 2008-11-05 | 王祥瑞 | Chinese medicament oil solution for treating burn and preparation thereof |
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| Title |
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| 彭怀晴等.乳癖散治疗乳腺增生症136例.《四川中医》.2008,第26卷(第8期),92-93. * |
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