CN100376253C - External use oil agent for treating proliferation of mammary gland and its prepn. method - Google Patents
External use oil agent for treating proliferation of mammary gland and its prepn. method Download PDFInfo
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- CN100376253C CN100376253C CNB2006100116978A CN200610011697A CN100376253C CN 100376253 C CN100376253 C CN 100376253C CN B2006100116978 A CNB2006100116978 A CN B2006100116978A CN 200610011697 A CN200610011697 A CN 200610011697A CN 100376253 C CN100376253 C CN 100376253C
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Abstract
The present invention relates to an external application oil solution for treating mammary gland hyperplasia. The present invention comprises medicine components and oleaginous matrixes, and the medicine components comprise yew leaves. The use of the oil solution for rubbing and massaging breasts performs the functions of activating blood circulation for eliminating stasis and promoting qi circulation for removing stagnation, so the purposes of the treatment of mammary gland hyperplasia and the prevention of breast tumors are achieved. The present invention absorbs the advantages of the method for the treatment of various kinds of mammary gland hyperplasia, adopts the yew leaves and paclitaxel as principal agents, and adopts auxiliary massage means. Thereby, effective constituents in yew and the paclitaxel are slowly absorbed by skin, mammary gland hyperplasia can be treated, and mammary gland hyperplasia can also be prevented from being converted to tumors. Meanwhile, safflower, red sage root and common prism tuber activate blood circulation and eliminate stasis, so the medicine therapeutic effect is improved and accelerated; borneol clears away heat and alleviates pain, eucommia bark improves the immunity of patients self, and the efficacy of the treatment of both the manifestations and the root causes of diseases is finally achieved.
Description
Technical field
The present invention relates to technical field of Chinese medicines, particularly relate to a kind of external-use oil preparation for the treatment of cyclomastopathy.
Background technology
Cyclomastopathy is lump to occur and distending pain is a kind of proliferative lesion of main clinical manifestation with breast, be because the interior endocrine hormone off-leveling of body, the estrogen secretion surplus, and liver deactivation estrogen function is unusual, makes too much estrogen carry out bad stimulation to mammary gland tissue and causes the mammoplasia sexually transmitted disease (STD) to become.The patient shows as distending pain of the breast mostly, breast can touch differ in size, different lump, pain increases the weight of before the menstruation of being everlasting, lump increases, and presses obviously painfully, alleviates gradually after the menstruation, even disappears.Pain often relates to oxter and shoulder back, or pain changes along with anxious state of mind.Most breast carcinoma are cancerated by cyclomastopathy.Up-to-date medical information shows: China has nearly 200,000 women to die from breast carcinoma and malignant tumor every year, and it has become the main killer who jeopardizes women's health, and its sickness rate is the trend of rising year by year and rejuvenation at present.Cyclomastopathy is early stage as breast tumor, and the rate that cancerates is quite high, and nearly 70% people suffers from mastopathy in the women of China more than 25 years old at present, and wherein diseases such as cyclomastopathy, galactocele, mammary gland fibroma are the most common.Cyclomastopathy is divided into simple property cyclomastopathy and atypia cyclomastopathy two classes, and the latter is relevant with the breast carcinoma morbidity, can regard the cercinoma prophase pathologic change of breast carcinoma as.Theoretically, any cancerous protuberance all is the final pathological changes of hyperplasia, is that cell on the basis of quantitative change qualitative change takes place, and it has experienced the carcinous outgrowth process of slight hypertrophy-atypical hyperplasia-cell mutation, so only from this meaning, the cyclomastopathy part very likely develops into breast carcinoma.Data show have the people of 60%-70% to suffer from various mastopathy approximately in China women of child-bearing age, and the most common with cyclomastopathy.U.S. medical treatment authoritative institution is divided into two groups of follow up surveys of carrying out 14 years to 33000 cyclomastopathy patients, and the result shows: do not carry out one group of patient of curing mammary gland hyperplasia, wherein have 158 people's mammary gland to cancerate; And one group of patient of regular treatment cyclomastopathy, only 23 people's mammary gland hypertrophy cancerate.This shows that the positive therapeutic cyclomastopathy is very important to the prevention breast carcinoma.
The present state internal therapy cyclomastopathy traditional Chinese medical science is used Drug therapys such as regulating menstruation QI invigorating, blood circulation promoting and blood stasis dispelling, promoting QI to circulate and dispersing the agglomeration of the pathogens medicine more, and (as: 1. Li Xiang is strange, and cyclomastopathy 108 routine observation of curative effect, Shandong journal of Chinese medicine, 2002,21 (12): 712～713 are treated in soothing liver and strengthening spleen ruling by law; 2. Zhang Qicheng, cyclomastopathy 45 examples, Yunnan Chinese medicine magazine, 2002,23 (3): 47 are treated in the ruling by law of dissipating depression and eliminating phlegm blood stasis dispelling; 3. Li Li duckweed, replenishing kidney-YIN to nourish the liver treatment cyclomastopathy 200 examples, traditional Chinese medical science research, 2003,16 (4): 36; 4. Lee likes duckweed, He Changmou, and cyclomastopathy 48 examples are treated in soothing the liver kidney tonifying ruling by law. the Shaanxi traditional Chinese medical science, 2003,24 (5): 420; 5. Zhang Genmu, stasis of blood soup treatment cyclomastopathy 47 examples, Anhui Journal of Traditional Chinese Medicine, 2003,15 (2): 121 are satisfied in the blood mansion; 6. Jiang Rong is super, and TAOHONG SIWU TANG adds flavor treatment cyclomastopathy 48 examples, Liaoning Journal of Traditional Chinese Medicine, 2001,28 (6): 354; 7. the little green grass or young crops of Yin, Zhong Xiuhua, byssus trifoliate orange Chinese herbaceous peony soup treatment cyclomastopathy 64 routine observation of curative effect, the new traditional Chinese medical science, 2001,33 (3): 51～52; 8. defend and the peak Min Huifang, JIAWEI XIAOYAO SAN treatment cyclomastopathy 282 routine observation of curative effect, Heilungkiang Chinese medicine, 2003, (3): 21～22; 9. Zhang Xiaolin, mammary gland soup treatment cyclomastopathy 1000 examples, Chinese medicine information, 2002,19 (3): 45), the Chinese herbal treatment cyclomastopathy truly have certain clinical therapeutic efficacy, take medicine (more than 6 months even 1 year) but need the long period, its curative effect instability, then effective when taking, in case cut out and very fast recurrence; Taking medicine for a long time simultaneously to cause gastrointestinal function disorder, inappetence, dyspepsia, and the patient is abandoning cure often, but in case abandon taking medicine, cyclomastopathy increases the weight of again very soon, has to again take medicine once more again, make cyclomastopathy again and again so like this, finally cause cancerating.The also external treatment principle of the with good grounds traditional Chinese medical science, adopt Chinese medicine make that card applies and unguentum treatment cyclomastopathy (1. extra large will is firm, the lacteal tumor clinical and safety research of cream treatment mastopathia that disappears, Beijing University of Chinese Medicine's journal, 2003,10 (1): 41～42; 2. connect Na, Chen Lingchao, newborn health is pasted external application for curing cyclomastopathy 70 examples, external treatment with Chinese medicine magazine, 2001,10 (3): 12～13; 3. the point application treatment cyclomastopathy 330 routine clinical analysiss of loosing of Zhang Zhiming, the addiction that disappears, Chinese combination of Chinese and Western medicine surgical magazine, 2001,7 (6): 409; 4. Pang Xiang honor, nodules of the breast cream treatment cyclomastopathy 100 examples, external treatment with Chinese medicine magazine, 2000,9 (5): 39).Card applies class only has to a certain degree curative effect to light disease, for relatively more serious or patient that lump is multiple then to no effect; Unguentum then causes skin allergy or skin ulceration easily.
Treatment cyclomastopathy Western medicine commonly used has hormones, Operand and other symptomatic treatment medicines.Traditional hormones preparation mainly is to come estrogen antagonist with androgen, uses the androgen treatment and some side effect may occur, if any some manlike performances: hirsutism, voice chap, acne etc.; Also may have in various degree liver injury, dizziness in addition, feel sick etc.Afterwards, people recognize gradually, cyclomastopathy is not that simple estrogen secretion increases, but because ratios female, progestogen are unbalance, the Progesterone progestogen hyposecretion in the menstrual cycle particularly is due to estrogen increases relatively, so advocate to treat primary disease with Progesterone, female to correct, progestogen are excretory unbalance, take side effect such as feeling sick also can appear in estrogen, vomiting, headache, some conditions of patients increases the weight of on the contrary.In recent years, the hormone therapy primary disease has some new progresses again.Because breakthrough progress has appearred in the research of hormone receptor, people recognize that the generation of cyclomastopathy is female with the mammary gland tissue part, the content of progesterone receptor and sensitivity increase relevantly, therefore, bring into use hormone receptor antagonists to treat primary disease.Can fight for estrogen receptor with estrogen competitively as estrogen receptor antagon-tamoxifen, make estrogen can't bring into play its biological effect, use the tamoxifen oral medication, can obtain certain curative effect.But take tamoxifen and also can produce certain side effect, as amenorrhea, hectic fever, feel sick etc.WomanHealth health care (WHI) project of being implemented by the U.S. in July, 2002 suffers from the women of coronary heart disease after to nearly more than 20,000 menopause, carried out clinical perspective blank research, summary was through the observations in 4 years, find estrogen (estrogen, E) and progestogen (pregestin, P) the associating replacement therapy has certain risk to object of study, wherein the relative risk of coronary heart disease increases by 29%, breast carcinoma morbidity relative risk increases by 26% after medication surpasses 4 years, and therefore this research stops when having carried out 4 years 1 month.Many data in addition show that hormone replacement therapy can increase the danger of carcinoma of endometrium.Therefore, how correctly estimating hormone replacement therapy is the major issue of carrying out reproductive health care at present at climacteric, especially the hazard to hormone replacement therapy and carcinoma of endometrium, breast carcinoma and thrombus disease etc. is subjected to extensive concern (Song Aiqing, Fu Wenjun, Chen Zuoying, the safety of Hormone Replacement Therapy, Chinese oligogenics is mixed 2004 2 phases of 76 will).
In sum, but a kind ofly meet female pathology feature prolonged application and Chinese medicine preparation without any side effects, treatment cyclomastopathy prevention canceration still belongs to blank at present.
Summary of the invention
The present invention is directed to the blank in the above-mentioned field, a kind of external-use oil preparation for the treatment of cyclomastopathy is provided, be coated with this oil preparation and put and massage breast on the skin, reach activating blood circulation to dissipate blood stasis, promoting QI to circulate and dispersing the agglomeration of the pathogens, thereby reach the purpose of treatment cyclomastopathy and prevention breast tumor.
A kind of external-use oil preparation for the treatment of cyclomastopathy, comprise drug component and greasing base, described drug component is made by following bulk drugs: Ramulus et folium taxi cuspidatae 1-500 part, paclitaxel 0.1-5 part, Flos Carthami 5-400 part, Radix Salviae Miltiorrhizae 10-400 part, rhizoma sparganic 10-500 part, Cortex Eucommiae 5-300 part and Borneolum Syntheticum 0.5-3 part.
The weight portion of described crude drug is Ramulus et folium taxi cuspidatae 50-300 part, paclitaxel 0.5-2.5 part, Flos Carthami 20-300 part, Radix Salviae Miltiorrhizae 20-300 part, rhizoma sparganic 20-300 part, Cortex Eucommiae 10-200 part and Borneolum Syntheticum 1-2.5 part.
The weight portion of described crude drug is Ramulus et folium taxi cuspidatae 100-200 part, paclitaxel 1-1.5 part, Flos Carthami 50-250 part, Radix Salviae Miltiorrhizae 50-200 part, rhizoma sparganic 50-200 part, Cortex Eucommiae 20-100 part and Borneolum Syntheticum 1-1.5 part.
Described greasing base is a kind of or its combination in vegetable oil, lanoline and the vaseline.
Described vegetable oil is Oleum sesami, Oleum Arachidis hypogaeae semen, Semen Maydis oil, Oleum Gossypii semen, Oleum Camelliae, olive oil, macadamia nut oil or soybean oil.
The preparation method of above-mentioned external-use oil preparation is to extract the active component in the crude drug and make with greasing base.
It is main and auxiliaryly to make external-use oil preparation with Flos Carthami, Radix Salviae Miltiorrhizae, rhizoma sparganic, the Cortex Eucommiae, Borneolum Syntheticum and greasing base that the present invention adopts Chinese yew branch and leaf and commercially available paclitaxel.
Described Ramulus et folium taxi cuspidatae comprises the various Chinese yews that China is wild and plant within the border, comprises Ramulus et folium taxi cuspidatae (Taxus cuspidataSieb.et Zucc.); T. yunnanensis (Taxus yunnanensis Cheng et L.K.Fu); Xizang Taxus chinensis (Taxuswallichiana Zucc.); Taxus mairei (Taxus chinensis (Pilger) Rehd.var.Mairei (Lemee et Levl.) Cheng) et L.K.Fu) and Taxus media (Taxus media).Taxus media is the Hybrid that China is introduced a fine variety at the twentieth century end, and its female parent is Ramulus et folium taxi cuspidatae (Taxus cuspidata Sieb.et Zucc.), and male parent is Taxus baccata (Taxus baccata).Described Chinese yew branch and leaf comprise its fresh and exsiccant leaves and branch and rhizome.Be rich in paclitaxel in the Ramulus et folium taxi cuspidatae.Paclitaxel (Pacilitaxcl, trade name: Taxol) be the monomer diterpene-kind compound that Americanized scholar Wall in 1967 and Wami etc. at first extract from Pacific yew (yewtree, Taxus brevifolia) bark with unique anti-tumor activity.Its mechanism of action is completely different with other synthesizing antitumor medicines or the phytogenic anticarcinogen that have gone on the market, it is mainly by suppressing the important divisional mode of tumor cell---and tubulin is synthetic, be that it can promote the polymerization of tubulin and make it be difficult for depolymerization, thereby the division (Pan Qichao of anticancer, the pharmacology of new anti-cancer drug-paclitaxel and clinical efficacy, cancer, 1994,13 (6): 553).Afterwards, U.S.'s clinical medicine circle has found that again paclitaxel can improve metastatic breast cancer patient's survival rate (1. Qian Zhiying etc., the clinical research of the intractable or recurrent advanced breast cancer of paclitaxel combination with cisplatin treatment, tumor research and clinical, 1997,9 (3): 49; 2. paclitaxel improves metastatic breast cancer patient's survival rate; External medicine " plant amedica " fascicle, 2003, Vol.18.No.3:131), further clinical trial shows, paclitaxel injection has significant curative effect to multiple cancers such as treatment advanced ovarian cancer, breast carcinoma, uterus carcinoma, head and neck cancer, pulmonary carcinoma, esophageal carcinoma, carcinoma of prostate, leukemia, and total effective rate reaches more than 75%.Paclitaxel is considered to best in the world cancer therapy drug at present, but paclitaxel injection is very expensive, 20 milliliters every about 1900 yuans, and also as easy as rolling off a log severe anaphylactic reaction and the toxic and side effects (bone marrow depression, peripheral nervous toxicity) of causing of direct injection paclitaxel.Therefore, the present invention is a primary raw material with the Chinese yew branch and leaf of the domestic growth of China, appliable plant innage temperature is extracted paclitaxel and paclitaxel precursor 10-DABIII, and add a small amount of commercially available paclitaxel, make that paclitaxel reaches finite concentration in the quintessence oil,, and prevent it to develop to canceration by external treatment treatment cyclomastopathy and tumor, also can avoid the toxic and side effects of paclitaxel effectively, but prolonged application.
In above-mentioned quintessence oil, can also add Flos Carthami; Perhaps add Radix Salviae Miltiorrhizae; Perhaps add rhizoma sparganic; Perhaps add the Cortex Eucommiae, perhaps Borneolum Syntheticum also can add Radix Salviae Miltiorrhizae, rhizoma sparganic, the Cortex Eucommiae and Borneolum Syntheticum simultaneously.
Described Flos Carthami is the tubular corolla of commercially available Compositae biennial herb plant Flos Carthami Carthamus tinctorius L., comprises its flower, dry product and dry powder.Compendium of Material Medica: Flos Carthami can " invigorate blood circulation and moisturize, the pain relieving eliminating stagnation be stimulated the menstrual flow ".Record Flos Carthami in " Kaibao Bencao " " its Seedling life is smashed to pieces, applies trip and swells ".Aforementioned documents shows that all Flos Carthami has the effect of promoting blood circulation to restore menstrual flow, eliminating stasis to stop pain.Modern study finds that the chemical constituent of Flos Carthami is abundant, contains the glyceric acid esters that Palmic acid, lauric acid and linolenic acid etc. are formed; Still contain saffloside, carthamone, Carthamus yellow, Flos Carthami wet goods in addition.Its analgesic activity, the effect that improves the periphery microcirculation and eliminate local scleroma lump, be specially adapted to treat cyclomastopathy and tumor (1. Huang is just good. the pharmacological research of Carthamus yellow. Chinese herbal medicine, 1987,18 (4): 22).2. cloudy strong. Chinese medicine modern study and clinical practice (1). Beijing: Xueyuan Press, 1993.332).
Described Radix Salviae Miltiorrhizae is root and the decoction pieces thereof of commercially available Labiatae herbaceos perennial Radix Salviae Miltiorrhizae Salvia miltiorrhiza Bge.; Or root and the decoction pieces thereof of Salvia przewalskii Maxim. Salvia przewalskii Maxim.; Or root and the decoction pieces thereof of brown hair Radix Salviae Miltiorrhizae Salvia przewalskii Maxim.var.mandarinorum (Diels) Stib or Salvia miltiorrhiza Bge Salvia yunnanensis C.H.Wright and salvia trijuga Diels Salviatrijuga Diels." herbal classic " put down in writing it and can " be broken disease and remove abdominal mass, QI invigorating "; Compendium of Material Medica is carried it: " invigorate blood circulation, use percardium ".Contain Tanshinone I, IIA, IIB (tanshinone I, IIA, IIB) iso tanshinone I, IIA (isotanshinone I, II A), cryptotanshinone (cryptotanshinone), different cryptotanshinone (isocryptotanshin-one), methyltanshinone (methyItanshinone), hydroxyl TANSHINONES etc.Clinical report Radix Salviae Miltiorrhizae and other Chinese medicine and with can treat cyclomastopathy (Yi Jinli, Liu Ronglu. the newborn health treatment cyclomastopathy observation of curative effect that looses. practical combination of Chinese and Western medicine magazine, 1993,6 (3): 135).The present invention selects for use Radix Salviae Miltiorrhizae to be intended to the effect of its activating blood circulation to dissipate blood stasis, to promote the blood circulation of breast.
Described rhizoma sparganic is tuber and the decoction pieces thereof of commercially available Sparganiaceae plant rhizoma scirpi Sparganium stoloniferum Buch.-Ham.; Or tuber and the decoction pieces thereof of the little rhizoma scirpi Spargamium of congener simplex Huds and spire rhizoma scirpi Spargamium stenophyliumMaxim.; Or tuber and the decoction pieces thereof of Cyperaceae herbaceos perennial cyperus iria L. rhizoma scirpi (rhizoma scirpi) Scirpus fluviatilis (Torr.) A.Gray." Kaibao Bencao " carries it: " main old addiction lump in the abdomen caking "; Compendium of Material Medica is carried it: " the energy relieving stagnant and resolving masses, power is high, difficulty is obeyed for a long time ".Rhizoma sparganic has inhibitory action to cancer, its injection (30%) to murine sarcoma have the obvious suppression effect (Chengdu Traditional Chinese Medical College. Chinese materia medica. front page .1977 JIUYUE, 215 pages).
The described Cortex Eucommiae is dry bark and the decoction pieces thereof of commercially available Eucommiaceae deciduous tree plant Cortex Eucommiae Eucommia ulmoides Oliv.." herbal classic " carries it: " main pain along the spinal column, invigorating middle warmer, beneficial vital essence ".It mainly contains Cortex Eucommiae glycosides, Cortex Eucommiae element, pinoresinol glycosides, flavonoid and several amino acids and trace element.Can improve body's immunological function (1. Xu's generation human relations, the Cortex Eucommiae is to the influence of body non-specific immunity, Chinese herbal medicine, 1983,4 (8): 27), also have defying age simultaneously, (1. Lee offers flat antineoplastic action, Wang Qin, the kidney invigorating effect pre-test before and after the Cortex Eucommiae is concocted, Chinese patent medicine research, 1988,10 (1): 15; 2. Dodd's Chinese, Xie Dingcheng, Ran Changqing, the antitumor of Radix seu Caulis Parabarii and antiinflammatory action, Pharmacology and Clinics of Chinese Materia Medica, 1987,3 (1): 62).The present invention selects for use the Cortex Eucommiae to be intended to improve cyclomastopathy person's immune function, slow down aging, the generation of prophylaxis of tumours.
The crystallization that the trunk of the Dipterocarpaceae aiphyllium Borneolum Syntheticum Dryobalanops aromatica Gaertn.f. that described Borneolum Syntheticum is commercially available gets through the distillation cooling claims " borneol "; Or split to cut through processing by the sublimate of the fragrant Blumea balsamiferaDC. of Compositae herbaceos perennial Chinese mugwort sodium leaf and form, claim " Blumeae preparatum Tabellae "; Also comprise through chemical method synthetic " BORNEOLUM SYNTHETICUM ".The Borneolum Syntheticum external can the heat clearing away granulation promoting, pain relieving anticorrosion (Chengdu Traditional Chinese Medical College. Chinese materia medica, front page, in JIUYUE, 1977,144 pages).
Described greasing base comprises vegetable oil, lanoline, vaseline, vegetable oil comprises the commercially available Oleum sesami that meets national production standard, Oleum Arachidis hypogaeae semen, Semen Maydis oil, Oleum Gossypii semen, Oleum Camelliae, olive oil, macadamia nut oil and soybean oil at present, and vaseline comprises Yellow Vaselin and white vaseline.
In the manufacturing process of oil preparation, each rises the Ramulus et folium taxi cuspidatae that can add arbitrary proportion or content in the vegetable oil, paclitaxel, Flos Carthami, Radix Salviae Miltiorrhizae, rhizoma sparganic, the Cortex Eucommiae and Borneolum Syntheticum.But, after a large amount of repetition tests of inventor and checking, found clinically the most effectively appropriate level scope:
Contain Ramulus et folium taxi cuspidatae in the medicine oil and should be 1～500g/L; Preferred content is 50～300g/L; More preferred content is 100～200g/L.Paclitaxel should be 0.1～5g/L; Preferred content is 0.5～2.5g/L; More preferred content is 1～1.5g/L.
Flos Carthami should be 5～400g/L in the medicine oil; Preferred content is 20～300g/L; Preferred content 50～250g/L more.
Radix Salviae Miltiorrhizae is 10～400g/L; Preferred content is 20～300g/L; More preferred content is 50～200g/L.
Rhizoma sparganic is 10～500g/L; Preferred content is 20～300g/L; More preferred content is 50～200g/L.
The Cortex Eucommiae is 5～300g/L; Preferred content is 10～200g/L; Preferred content 20～100g/L more.
Borneolum Syntheticum is 0.5～3g/L; Preferred content is 1～2.5g/L; Preferred content 1～1.5g/L more.
The different proportioning tables of available adding medical material content (g) in per 1 liter of (L) vegetable oil that below are the present invention in making medicine oil:
| Prescription | Ramulus et folium taxi cuspidatae (g/L) | Paclitaxel (g/L) | Flos Carthami (g/L) | Radix Salviae Miltiorrhizae (g/L) | Rhizoma sparganic (g/L) | The Cortex Eucommiae (g/L) | Borneolum Syntheticum (g/L) |
| 1 | 5 | 3.0 | 300 | 300 | 400 | 300 | 3 |
| 2 | 10 | 2.5 | 250 | 300 | 400 | 300 | 3 |
| 3 | 25 | 2.0 | 200 | 250 | 350 | 250 | 2.5 |
| 4 | 50 | 2.0 | 200 | 250 | 300 | 250 | 2.5 |
| 5 | 100 | 1.5 | 150 | 200 | 250 | 200 | 2 |
| 6 | 150 | 1.5 | 150 | 200 | 200 | 150 | 2 |
| 7 | 200 | 1.0 | 100 | 100 | 150 | 100 | 1.5 |
| 8 | 250 | 1.5 | 100 | 50 | 100 | 50 | 1.5 |
| 9 | 300 | 1.0 | 50 | 25 | 50 | 25 | 1 |
| 10 | 350 | 0.5 | 50 | 10 | 10 | 10 | 1 |
The example of enumerating these content ratio is the convenience of calculation in order to dispose.In fact, the raw material of different content ratio all can be used for disposing medicine oil of the present invention, not necessarily is so limited.
The present invention wins the strong point of above-mentioned all kinds of treatment cyclomastopathy methods, adopt Ramulus et folium taxi cuspidatae and paclitaxel as host, and with auxiliary massage means, make effective ingredient in the Ramulus et folium taxi cuspidatae and paclitaxel along with oil preparation is slowly absorbed by skin, can treat cyclomastopathy and can prevent again to change, adopt Flos Carthami, Radix Salviae Miltiorrhizae and rhizoma sparganic activating blood circulation to dissipate blood stasis simultaneously, improve and accelerate curative effect of medication to tumor, alleviate pain, improve patient's self immunity with the Borneolum Syntheticum heat clearing away, finally reach the purpose for the treatment of both the principal and secondary aspects of a disease with the Cortex Eucommiae.
The invention belongs to the oil formulation in the Chinese medicine preparation, so-called oil formulation means that with vegetable and animals oils be effective ingredient in the solvent extraction medical material, or dissolving, the made medicinal oil preparation of dispersion medicine, can be for external application.This technology is that those of ordinary skills know technology in the prior art, the ripe production method that is conventional, standard and can realizes (as commercially available " SANHUANG Radix Sanguisorbae oil " and " compound recipe Radix Arnebiae (Radix Lithospermi) burn oil preparation "), and, the existing corresponding production standard of country.Paclitaxel is soluble in ethyl acetate, chloroform and vegetable oil, be slightly soluble in water, the present invention is prepared into oil preparation, help the stripping of ingredient, oil preparation is used for the treatment of cyclomastopathy simultaneously, under the effect of external force massage, strengthened sufferer place absorbing to medicine, avoided for oral administration again and produced intensive side effect, also do not resembled and to make local skin produce phenomenon hypersensitive the patch, so this programme is truly feasible.
The specific embodiment:
Embodiment 1: the preparation of oil preparation of the present invention: (Oleum sesami fundamental mode)
One, prescription: Ramulus et folium taxi cuspidatae 150g; Paclitaxel 1g; Flos Carthami 100g; Radix Salviae Miltiorrhizae 100g; Rhizoma sparganic 100g; Cortex Eucommiae 50g; Borneolum Syntheticum 1g; Oleum sesami 1L.
Two, method for making: will be in stainless-steel pan earlier with Radix Salviae Miltiorrhizae, rhizoma sparganic, the Cortex Eucommiae was soaked 2-4 hour with Oleum sesami, be heated to gradually then and boil, treat that it fries in shallow oil defocused (being as the criterion with the rhizoma sparganic zoom) and pull out, annealing cools, add Ramulus et folium taxi cuspidatae again and be heated to gradually and boil, treat that it fries in shallow oil the defocused annealing of pulling out.Put into Flos Carthami when treating oily temperature drop, be heated to and boil, treat that the Flos Carthami zoom is ceased fire to drag for slag to 60-70 ℃.When treating below the oily temperature drop to 60 ℃, the paclitaxel porphyrize is added, add Borneolum Syntheticum again and slowly stir and treat it all after the dissolving, it is stand-by to filter packing.
Three, usage: be coated with every day and put on the skin and massage 2-3 time, each 20-30 minute, each consumption 2-5ml.
Embodiment 2: the preparation of oil preparation of the present invention: (soybean oil fundamental mode)
One, prescription: Ramulus et folium taxi cuspidatae 50g; Paclitaxel 2g; Flos Carthami 50g; Radix Salviae Miltiorrhizae 100g; Rhizoma sparganic 100g; Cortex Eucommiae 50g; Borneolum Syntheticum 1g; Soybean oil 1L.
Two, method for making: earlier Ramulus et folium taxi cuspidatae is separated.The Ramulus et folium taxi cuspidatae branch is cut into about 1cm; together with Radix Salviae Miltiorrhizae; rhizoma sparganic; the Cortex Eucommiae was soaked 2-4 hour with Oleum sesami in stainless-steel pan, was heated to gradually then and boiled, and treated that it fries in shallow oil defocused (being as the criterion with the rhizoma sparganic zoom) and pull out; annealing cools; put into Flos Carthami when treating oily temperature drop, be heated to and boil, treat that the Flos Carthami zoom is ceased fire to drag for slag to 60-70 ℃.Add leaf of Japanese Yew again and be heated to gradually and boil, treat to pull annealing immediately out after its variable color.When treating below the oily temperature drop to 60 ℃, the paclitaxel porphyrize is added, add Borneolum Syntheticum again and slowly stir and treat it all after the dissolving, it is stand-by to filter packing
Three, usage: be coated with every day and put on the skin and massage 2-3 time, each 20-30 minute, each consumption 2-5ml.
Embodiment 3: oil preparation of the present invention can be prepared into unguentum (add beeswax in the greasing base and make unguentum)
One, prescription: Ramulus et folium taxi cuspidatae 150g; Paclitaxel 2g; Flos Carthami 100g; Radix Salviae Miltiorrhizae 100g; Rhizoma sparganic 100g; Cortex Eucommiae 50g; Borneolum Syntheticum 1g; Oleum sesami 1L; Beeswax 300g; White vaseline 200g.
Two, method for making: earlier Ramulus et folium taxi cuspidatae is separated.The Ramulus et folium taxi cuspidatae branch is cut into about 1cm; together with Radix Salviae Miltiorrhizae; rhizoma sparganic; the Cortex Eucommiae was soaked 2-4 hour with Oleum sesami in stainless-steel pan, was heated to gradually then and boiled, and treated that it fries in shallow oil defocused (being as the criterion with the rhizoma sparganic zoom) and pull out; annealing cools; put into Flos Carthami when treating oily temperature drop, be heated to and boil, treat that the Flos Carthami zoom is ceased fire to drag for slag to 60-70 ℃.Add leaf of Japanese Yew again and be heated to gradually and boil, treat to pull annealing immediately out after its variable color.With beeswax and vaseline fusing, put into aforementioned medicine oil and merge in addition, the paclitaxel porphyrize is added, at last Borneolum Syntheticum is ground into segmentation, add mixing, cooling back packing is standby.
Three, usage: be coated with every day and put on the skin and massage 2-3 time, each 20-30 minute, each consumption 2-5g.
The clinical observation of the oil preparation treatment cyclomastopathy of the present invention's preparation
Object and physical data: organize 220 examples entirely, be the women.14～59 years old age, The median age 35.51 years old.The course of disease 3 months～5 years; Main clinical manifestation: 1. through fore udder distending pain or twinge, through after alleviate or disappearance person's 220 examples (accounting for 100%);
2. mammoplasia lump, the sore place tenderness is obvious, the lump obscure boundary, quality is than film shape lump or streak caking, similar botryoidalis lump.Belong to and increase survivor's 126 examples (accounting for 57.2%) merely, cryptomere increases survivor's 88 examples (accounting for 40%); 3. near infrared ray scans or the visible mammoplasia of ultrasound diagnosis lump.This group near infrared ray scans 220 examples, finds lump 220 examples, positive rate 100%; B ultrasonic 208 examples are found lump 200 examples, positive rate 99.1%; 4. puncture or excision biopsy are made a definite diagnosis.This group 82 examples that puncture in cryptomere hypertrophy case are found canceration 3 examples (3.65%), merge fibroadenoma 27 examples (12.27%).
1, grouping and Therapeutic Method: 220 examples are divided into 2 groups at random, are divided into treatment group (the present invention's preparation) 120 examples, matched group (commercially available safflower oil) 120 examples.The treatment group is used the oil preparation of the present invention's preparation to be coated with and is put and massage breast on the skin, every day 2 times, each 2-5 milliliter; Matched group then uses commercially available safflower oil to be coated with and puts and massage breast on the skin, every day 2 times, each 2-5 milliliter.Detect female 2 alcohol of serum, lump in breast size and pain degree before and after the treatment respectively.
2, the result: treatment is organized and 1 week was begun to take effect, and 4 all back pain and lump disappear substantially or alleviate, and the clinical effectiveness of matched group is not obvious, and 2 groups of clinical effectiveness compare, and there were significant differences (P＜0.001) (table 1,2).
Table 1: the comparison of oil preparation treatment cyclomastopathy clinical effectiveness of the present invention
| Grouping | The example number | Lump disappearance degree | The P value | ||
| Disappear 100% | Disappearance 50-80% | Disappearance 20-50 | |||
| Oil preparation of the present invention | 120 | 34(28.3％) | 64(53.3％) | 22(18.3％) | ＜0.001 |
| Safflower oil | 120 | 8(6.7％) | 15(12.5％) | 97(80.8％) | |
Table 2: oil preparation of the present invention is to the comparison of cyclomastopathy patient clinical effectiveness
| Grouping | The example number | Pain disappearance degree | The P value |
| Disappear 100% | Disappearance 50-80% | Disappearance 20-50 |
| Oil preparation of the present invention | 120 | 78(65.0％) | 25(20.8％) | 17(14.2％) | ＜0.001 |
| Safflower oil | 120 | 8(6.7％) | 8(6.7％) | 104(86.7％) |
The cause of disease of cyclomastopathy it is generally acknowledged estrogen secretion too high due to (yellow front yard is etc. mastopathy symposium summary for 1. Gong Jia town, Wang Yu. Chinese surgical magazine, 1988,26 (11): 653～655; 2. Zhang Wende. mammary gland physiology and clinical. practical surgical magazine, 1988,8 (9): 479～481.), the antagonism estrin treatment is to reach therapeutic purposes from the cause of disease.All use the western medicine breast disease both at home and abroad, though certain clinical effectiveness is arranged.But side effect is obvious: nausea and vomiting, menstruation or leucorrhoea grow in quantity, blurred vision, headache, transference cure after the drug withdrawal.And the treatment group use 1 month after estrogen be adjusted to example normal ranges 109, account for 98.8%, do not have 1 example side effect takes place, and (P＜0.01 sees Table 3 with matched group more also there were significant differences property.)。Illustrate that the side reaction of oil preparation of the present invention treatment cyclomastopathy is few, good effect can be treated cyclomastopathy, again can prophylaxis of tumours, be worthy of popularization.
Table 3: oil preparation of the present invention is to cyclomastopathy patients serum estradiol (E
2) comparison of concentration affects
| Group | The example number | Treatment back E follicular phase 2Value (pmol/L) | The P value | |
| Less than 330pmol/L | Greater than 330pmol/L | |||
| Oil preparation of the present invention | 120 | 109(98.8％) | 11(9.2％) | ＜0.01 |
| Safflower oil | 120 | 33(27.5％) | 87(72.5％) | |
Claims (6)
1. external-use oil preparation for the treatment of cyclomastopathy, comprise drug component and greasing base, described drug component is made by following bulk drugs: Ramulus et folium taxi cuspidatae 1-500 part, paclitaxel 0.1-5 part, Flos Carthami 5-400 part, Radix Salviae Miltiorrhizae 10-400 part, rhizoma sparganic 10-500 part, Cortex Eucommiae 5-300 part and Borneolum Syntheticum 0.5-3 part.
2. the external-use oil preparation of treatment cyclomastopathy according to claim 1, each weight portion of described crude drug are Ramulus et folium taxi cuspidatae 50-300 part, paclitaxel 0.5-2.5 part, Flos Carthami 20-300 part, Radix Salviae Miltiorrhizae 20-300 part, rhizoma sparganic 20-300 part, Cortex Eucommiae 10-200 part and Borneolum Syntheticum 1-2.5 part.
3. the external-use oil preparation of treatment cyclomastopathy according to claim 1 and 2, the weight portion of described crude drug are Ramulus et folium taxi cuspidatae 100-200 part, paclitaxel 1-1.5 part, Flos Carthami 50-250 part, Radix Salviae Miltiorrhizae 50-200 part, rhizoma sparganic 50-200 part, Cortex Eucommiae 20-100 part and Borneolum Syntheticum 1-1.5 part.
4. the external-use oil preparation of treatment cyclomastopathy according to claim 1, described greasing base are a kind of or its combination in vegetable oil, lanoline and the vaseline.
5. the external-use oil preparation of treatment cyclomastopathy according to claim 4, described vegetable oil are Oleum sesami, Oleum Arachidis hypogaeae semen, Semen Maydis oil, Oleum Gossypii semen, Oleum Camelliae, olive oil, macadamia nut oil or soybean oil.
6. the preparation method of the external-use oil preparation of the described arbitrary treatment cyclomastopathy of claim 1-5 is characterized in that extracting the active component in the crude drug and making with greasing base.
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| Title |
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| 神威膏治疗乳腺小叶增生病100例. 宋爱莉，张云杰，孙贻安.山东中医学院学报，第19卷第6期. 1995 * |
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