CN105582476A - Pharmaceutical preparation for treating irregular menstruation and application thereof - Google Patents

Pharmaceutical preparation for treating irregular menstruation and application thereof Download PDF

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CN105582476A
CN105582476A CN201610105131.5A CN201610105131A CN105582476A CN 105582476 A CN105582476 A CN 105582476A CN 201610105131 A CN201610105131 A CN 201610105131A CN 105582476 A CN105582476 A CN 105582476A
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parts
pharmaceutical preparation
grams
radix
herba
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王疆
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/11—Pteridophyta or Filicophyta (ferns)
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/538—Schizonepeta
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
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Abstract

The invention relates to a pharmaceutical preparation for treating irregular menstruation and an application thereof. The pharmaceutical preparation comprises frankincense, houttuynia cordata, cirsium japonicum, herba potentillae chinensis, rhizoma sparganii, herba ecliptae, callicarpa macrophylla, fructus arctii, liquorice, dandelion, herba selaginellae, herba leonuri, Chinese angelica, radix rubiae, curcuma zedoary, herba eupatorii, herba schizonepetae and herba picriae. Guided by the theories of traditional Chinese medicine, the pharmaceutical composition provided by the invention improves blood circulation through yin-yang balancing and mutual collocation of medicines and realizes more comprehensive effects and functions to treat both symptoms and root causes; the pharmaceutical preparation has the functions of reinforcing healthy qi and fostering root, replenishing qi and nourishing blood, activating blood and resolving stasis, nourishing yin and clearing heat and regulating qi and relieving pain, can enhance the blood coagulation and hemostasis functions as well as the contraction of in-vitro and in-vivo uterus, and also participates in the adjustment of hormone and cycle; and moreover, the pharmaceutical preparation provided by the invention is simple in technology, convenient to operate and suitable for industrial mass production.

Description

A kind of pharmaceutical preparation that is used for the treatment of irregular menstruation and uses thereof
Technical field
The invention belongs to medical treatment field, relate in particular to a kind of pharmaceutical preparation that is used for the treatment of irregular menstruation and uses thereof.
Background technology
Along with the development of world, the variation of living environment, rhythm of life is fast in addition, and operating pressure is large, easily causes womenAnxiety, depression, agitation, women is taking blood as main, and blood is capable with gas, the irregular menstruation causing due to the variation of mood.
Irregular menstruation, is common clinical, frequently-occurring disease, treats more thorny. Menstrual cycle is constant, and row exceedes normally through amount,Or the time lengthening of passing through, amount also thereby increase, is called " menorrhalgia ", and menorrheal pathogenesis, is mainly the deficiency of vital energy or bloodDue to heat. It is because being that natural endowment element is contained, excess of YANG QI, and arrogant heat-dissipating, heat blood is overflow and is not kept and increase; Or the pungent dry product of overfeeding,Heat lodging in Chong and Conception Channels, compels the absurd row of blood, causes and makes blood volume add.
Through the test of modern clinic, four normal values of sex hormone in menstrual period: its major function of follicle-stimulating hormone (FSH) is ovaryFollicle development and maturation. The concentration of blood FSH, preovulatory phase be 1.5-10U/L, the onset of ovulation 8-20U/L, ovulation later stage 2-10U/L.FSH value is low see female, progestogen therapy during, rare Cotard etc. FSH value brilliant idea is insensitive comprehensive in premature ovarian failure, ovarySimulator sickness, primary amenorrhea etc. Lutropin major function is ovulation rate, forms corpus luteum secreting hormone. Blood LH concentration,Preovulatory phase 2-15U/L, the onset of ovulation 20-100U/L, ovulation later stage 4-10U/L. Lower than 5U/L reliable point out short sexual gland to swashElement hypofunction, sees rare Cotard. High FSH is as increased LH again, and ovarian function failure is very sure. LH/FSH >=3,Be diagnosis of polycystic ovary syndrome according to one of. Prolactin major function is to promote the hyperplasia of mammary gland and the generation of milk and rowBreast. At non-lactation period, blood PR1 normal value is 0.08-0.92nmol/L. Be hyperprolactinemia higher than 1.0nmol/L. EstradiolMajor function is to make uterus inner gland grow into proliferation period, promotes the growth of women's secondary sex characters. The concentration of blood E2 in the onset of ovulation is48-52lpmol/L, the onset of ovulation 370-1835pmol/L, ovulation later stage 272-793pmol/L. Low value sees hypofunction of ovary, ovumThe early ageing of nest function, Sheehan's syndrome.
The medicine treatment of existing market is still with Western medicine, and especially taking steroids as Main Means, but side effect is larger, also hasMay affect the phenomenons such as fertility, although Chinese medicine preparation also has much, such as White Phoenix Bolus of Black-bone Chicken, ease pill etc., act on better,But need long-term taking, but it is little to play effective effect.
Summary of the invention
For the defect of prior art, the present invention be directed to the present situation of current treatment, a kind of medicine for the treatment of irregular menstruation is providedPreparation, and have no side effect, effective.
Particularly, concrete scheme of the present invention is achieved in that
First, inventor provides a kind of pharmaceutical preparation for the treatment of irregular menstruation according to drug matching experience, in prescription, containsTraditional Chinese medicine ingredients is: frankincense, cordate houttuynia, setose thistle, potentilla chinensis, Rhizoma Sparganii, eclipta, bigleafbeautyberry root or leaf, great burdock achene, Radix Glycyrrhizae,Dandelion, Selaginella tamariscina, motherwort, Radix Angelicae Sinensis, madder, curcuma zedoary, eupatorium, schizonepeta, bitter radix scrophulariae.
Further, inventor provides a kind of pharmaceutical preparation for the treatment of irregular menstruation according to drug matching experience, prescription each formerMaterial consumption all has good curative effect in weight portion scope of the present invention, and described formula and weight portion are: frankincense 8-17 part,Cordate houttuynia 10-20 part, setose thistle 5-11 part, potentilla chinensis 3-8 part, Rhizoma Sparganii 3-9 part, eclipta 9-13 part, bigleafbeautyberry root or leaf 5-11Part, great burdock achene 10-30 part, Radix Glycyrrhizae 6-10 part, dandelion 10-30 part, Selaginella tamariscina 8-14 part, motherwort 10-30 part, whenReturn 10-35 part, madder 8-17 part, curcuma zedoary 6-14 part, eupatorium 6-12 part, schizonepeta 8-14 part, bitter radix scrophulariae 3-14 part.
Further, the formula of above-mentioned weight portion is carried out preferably, reaching better technique effect, preferred formula is:12 parts of frankincenses, 15 parts of cordate houttuynias, 8 parts of setose thistles, 6 parts of potentilla chinensis, 6 parts of Rhizoma Sparganiis, 11 parts of ecliptas, bigleafbeautyberry root or leaf 8Part, 20 parts of great burdock achenes, 8 parts, Radix Glycyrrhizae, 20 parts of dandelions, 11 parts of Selaginella tamariscinas, 25 parts of motherworts, 22.5 parts of Radix Angelicae Sinensis, madder11 parts of grass, 10 parts of curcuma zedoarys, 9 parts of eupatoriums, 11 parts of schizonepeta, 8 parts of bitter radix scrophulariaes.
Or: 10 parts of frankincenses, 14 parts of cordate houttuynias, 7 parts of setose thistles, 5 parts of potentilla chinensis, 5 parts of Rhizoma Sparganiis, 10 parts of ecliptas, large7 parts of leaf Japanses beauty-berrys, 20 parts of great burdock achenes, 7 parts, Radix Glycyrrhizae, 18 parts of dandelions, 10 parts of Selaginella tamariscinas, 24 parts of motherworts, Radix Angelicae Sinensis 22.5Part, 10 parts, madder, 9 parts of curcuma zedoarys, 8 parts of eupatoriums, 10 parts of schizonepeta, 8.5 parts of bitter radix scrophulariaes.
In pharmaceutical preparation described above, the Chinese medicine using all uses its conventional medicinal part to be used as medicine, the Chinese medicine usingAmount rationally, has good effect for treatment irregular menstruation after all medicines share.
The function of the each taste Chinese medicine using in the pharmaceutical preparation for the treatment of of the present invention is as follows:
Frankincense: taste is pungent, warm in nature.
Function cures mainly: promoting blood circulation and stopping pain. For all pains of trusted subordinate, the contraction of muscle arteries and veins, traumatic injury, sore, carbuncle and painful swelling; Externally used detumescence myogenic.
Cordate houttuynia: taste is pungent, cold in nature.
Gui Jing: return lung channel.
Function cures mainly: clearing heat and detoxicating, and the carbuncle that disappears apocenosis, inducing diuresis for treating strangurtia. For lung carbuncle pyemesis, phlegm heat panting is coughed, hot dysentery, and heat is drenched, carbuncleSwollen sore.
Setose thistle: taste is sweet is cool.
Function cures mainly: cooling blood and hemostasis, eliminating stasis to subdue swelling. Cure mainly: bleeding from five sense organs or subcutaneous tissue, spitting of blood, spits blood, hematuria, functional uterine bleeding, producesHemorrhage afterwards, hepatitis, ephritis, mastitis, traumatic injury; Traumatism and bleeding is controlled in external application, carbuncle furuncle poison.
Potentilla chinensis: bitter, is slightly cold.
Function cures mainly: clearing heat and detoxicating, and loose stasis of blood hemostasis. Control bone tuberculosis, stomatitis, scrofula, traumatic injury, traumatism and bleeding.
Rhizoma Sparganii: taste is pungent, property is flat.
Gui Jing: return liver, the spleen channel
Effect: broken blood gas, long-pending pain relieving disappears.
Eclipta: taste is sweet, cool in nature, return liver, kidney channel.
Function cures mainly: nourishing liver and kidney, cooling blood and hemostasis, can control various haematemesis, the diseases such as enterorrhagia.
Clinical practice: this product is mainly widely used in liver cancer, the ephritis etc. of deficiency of qi and blood, deficiency of liver-blood initiation, for sallow complexion,Rocky symptom is particularly applicable.
Bigleafbeautyberry root or leaf: bitter, property is flat.
Gui Jing: return liver, lung, stomach warp.
Function cures mainly: loose stasis of blood hemostasis, and swelling and pain relieving, for bleeding from five sense organs or subcutaneous tissue, spitting of blood, spits blood, have blood in stool, traumatism and bleeding, tumbling and swelling.
Schizonepeta: taste is pungent, warm in nature.
Gui Jing: return lung, Liver Channel.
Function cures mainly: the loose wind that induces sweat, promoting eruption. For flu, headache, measles, rubella, sore from the beginning of. Fry charcoal treating hematochezia, uterine bleeding,Postpartum anemic fainting.
Eupatorium: taste is pungent, property is flat.
Gui Jing: return spleen, stomach, lung channel.
Function cures mainly: remove dampness by means of aromatics, the appetizing of being amusing, delivers relieving summer-heat. For turbi damp obstructing in middle-JIAO, gastral cavity ruffian evils of vomitting, sweet greasy in mouth, halitosis,Polysialia, summer-heat and damp table disease, alliteration is uncomfortable in chest.
Bitter radix scrophulariae: bitter, cool in nature.
Function cures mainly: clearing heat and detoxicating, and swelling and pain relieving.
Dandelion: bitter, cold in nature.
Gui Jing: return liver, stomach warp.
Function cures mainly: clearing heat and detoxicating, and dispersing swelling and dissipating binds, inducing diuresis for treating strangurtia, for furuncle swelling toxin, acute mastitis scrofula, hot eyes pharyngalgia, lung,
Acute appendicitis, jaundice with damp-heat pathogen, heat is drenched puckery pain.
Selaginella tamariscina: taste is pungent, property is flat.
Gui Jing: return liver, the heart channel of Hang-Shaoyin.
Function cures mainly: activating blood to promote menstruation. Be used for through closing dysmenorrhoea. Wei lump in the abdomen lump in the abdomen, injury from falling down. Selaginella tamariscina charcoal removing blood stasis and hemostasis. For spitting blood,Uterine bleeding, has blood in stool, prolapse of the anus.
Radix Glycyrrhizae: taste is sweet, property is flat.
Gui Jing: enter spleen, stomach, the heart, lung channel.
Function cures mainly: tonifying middle-Jiao and Qi, and clearing heat and detoxicating, expelling phlegm and arresting coughing, relieving spasm to stop pain.
Curcuma zedoary: taste is pungent, warm in nature.
Gui Jing: return liver, the spleen channel.
Function cures mainly: blood is broken in promoting the circulation of qi, and long-pending pain relieving disappears. For Dan lump in the abdomen lump in the abdomen, hemostasis is through closing, dyspepsia distending pain; Early cervical carcinoma.
The various clinical medicine formulations of pharmaceutical preparation of the present invention can be granule, capsule, tablet, injection, tincture,Suppository, pill, syrup, mixture, powder, lotion, film, dripping pill etc.
The present invention is to above prescription through conscientious research, and according to the reasonability of middle medical drugs, invention has proposed concrete onePlant the preparation method of the pharmaceutical preparation for the treatment of irregular menstruation:
(1) get cordate houttuynia, setose thistle, potentilla chinensis, bigleafbeautyberry root or leaf, motherwort and madder and soak 1 hour, extract with volatile oilDevice extracts volatile oil, then obtains volatile oil with anhydrous sodium sulfate drying, then uses beta-cyclodextrin inclusion compound, makes inclusion compound, inclusionThing and the dregs of a decoction are for subsequent use;
(2) get schizonepeta, great burdock achene, dandelion, eupatorium, bitter radix scrophulariae, Rhizoma Sparganii and eclipta and grind to form meal, add 75% ethanol and carryGet 2 times, each 1.5 hours, merge liquid, leave standstill 24 hours, for subsequent use;
(3) Radix Glycyrrhizae, Selaginella tamariscina, Radix Angelicae Sinensis, frankincense and curcuma zedoary be ground into fine powder and step (1) Chinese medicine slag and mix after by appropriate 75% secondAlcohol extracting 2 times, each 1 hour, collect extract, leave standstill 24 hours, for subsequent use;
(4) get (2) and (3) step in the supernatant that makes, decompression recycling ethanol, is concentrated into 60 DEG C～70 DEG C, density is1.03～1.09 medicinal extract, dry rear for subsequent use, in medicinal extract, add the Benexate Hydrochloride making in (1) step, addEnter appropriate amount of auxiliary materials and make various pharmaceutical dosage forms with common process.
Pharmaceutical preparation of the present invention is used for, and compared with prior art has following advantage:
Pharmaceutical composition of the present invention is taking traditional Chinese medical theory as guidance, negative and positive equilibrium, and all medicines are mutually arranged in pairs or groups to reach and are improved bloodCirculation, makes drug effect and function more comprehensive and treat both principal and secondary aspect of disease, and pharmaceutical preparation has righting reinforcing, and nourishing qi and blood is promoting blood circulation and removing blood stasis,Nourishing Yin and clearing heat, the effect of regulating qi-flowing for relieving pain, it can strengthen blood coagulation hemostatic function, strengthen in vitro and in the contraction in body uterus,And participate in the adjusting in hormone and cycle, and in addition, simple, the easy to operate applicable industrialized production of technique of the present invention.
Specific embodiment
To those skilled in the art, the obviously details of the embodiment of the present invention, and do not deviating from spirit of the present invention or baseIn the situation of eigen, can realize the present invention with other concrete form. All should regard embodiment as exemplary, andBe nonrestrictive, be therefore intended to all changes that drop in the implication and the scope that are equal to important document of claim to include at thisIn bright.
Embodiment 1: a kind of pharmaceutical preparation for the treatment of irregular menstruation, comprises following and weight portion:
8 grams of frankincenses, 10 grams of cordate houttuynias, 5 grams of setose thistles, 3 grams of potentilla chinensis, 3 grams of Rhizoma Sparganiis, 9 grams of ecliptas, bigleafbeautyberry root or leaf5 grams, 10 grams of great burdock achenes, 6 grams, Radix Glycyrrhizae, 10 grams of dandelions, 8 grams of Selaginella tamariscinas, 10 grams of motherworts, 10 grams of Radix Angelicae Sinensis, madder8 grams, 6 grams of curcuma zedoarys, 6 grams of eupatoriums, 8 grams of schizonepeta, 3 grams of bitter radix scrophulariaes.
Concrete preparation method:
(1) get cordate houttuynia, setose thistle, potentilla chinensis, bigleafbeautyberry root or leaf, motherwort and madder and soak 1 hour, extract with volatile oilDevice extracts volatile oil, then obtains volatile oil with anhydrous sodium sulfate drying, then uses beta-cyclodextrin inclusion compound, makes inclusion compound, inclusionThing and the dregs of a decoction are for subsequent use;
(2) get schizonepeta, great burdock achene, dandelion, eupatorium, bitter radix scrophulariae, Rhizoma Sparganii and eclipta and grind to form meal, add 70% ethanol and carryGet 2 times, each 1.5 hours, merge liquid, leave standstill 24 hours, for subsequent use;
(3) Radix Glycyrrhizae, Selaginella tamariscina, Radix Angelicae Sinensis, frankincense and curcuma zedoary be ground into fine powder and step (1) Chinese medicine slag and mix after by appropriate 75% secondAlcohol extracting 2 times, each 1 hour, collect extract, leave standstill 24 hours, for subsequent use;
(4) get (2) and (3) step in the supernatant that makes, decompression recycling ethanol, is concentrated into 60 DEG C～70 DEG C, density is1.03～1.09 medicinal extract, dry rear for subsequent use, in medicinal extract, add the Benexate Hydrochloride making in (1) step, addThe dextrin and the lactose (weight ratio of lactose and dextrin is 1:1) that enter its weight 10%, incapsulate, every heavy 200mg.
Embodiment 2: a kind of pharmaceutical preparation for the treatment of irregular menstruation, comprises following and weight portion:
17 grams of frankincenses, 20 grams of cordate houttuynias, 11 grams of setose thistles, 8 grams of potentilla chinensis, 9 grams of Rhizoma Sparganiis, 13 grams of ecliptas, great Ye11 grams of Japanses beauty-berrys, 30 grams of great burdock achenes, 10 grams, Radix Glycyrrhizae, 30 grams of dandelions, 14 grams of Selaginella tamariscinas, 30 grams of motherworts, Radix Angelicae Sinensis 35Gram, 17 grams, madder, 14 grams of curcuma zedoarys, 12 grams of eupatoriums, 14 grams of schizonepeta, 14 grams of bitter radix scrophulariaes.
Preparation method is with embodiment 1.
Embodiment 3: a kind of pharmaceutical preparation for the treatment of irregular menstruation, comprises following and weight portion:
12 grams of frankincenses, 15 grams of cordate houttuynias, 8 grams of setose thistles, 6 grams of potentilla chinensis, 6 grams of Rhizoma Sparganiis, 11 grams of ecliptas, great Ye purple8 grams, pearl, 20 grams of great burdock achenes, 8 grams, Radix Glycyrrhizae, 20 grams of dandelions, 11 grams of Selaginella tamariscinas, 25 grams of motherworts, 22.5 grams of Radix Angelicae Sinensis,11 grams, madder, 10 grams of curcuma zedoarys, 9 grams of eupatoriums, 11 grams of schizonepeta, 8 grams of bitter radix scrophulariaes.
Preparation method is with embodiment 1.
Embodiment 4: a kind of pharmaceutical preparation for the treatment of irregular menstruation, comprises following and weight portion:
10 grams of frankincenses, 14 grams of cordate houttuynias, 7 grams of setose thistles, 5 grams of potentilla chinensis, 5 grams of Rhizoma Sparganiis, 10 grams of ecliptas, great Ye purple7 grams, pearl, 20 grams of great burdock achenes, 7 grams, Radix Glycyrrhizae, 18 grams of dandelions, 10 grams of Selaginella tamariscinas, 24 grams of motherworts, 22.5 grams of Radix Angelicae Sinensis,10 grams, madder, 9 grams of curcuma zedoarys, 8 grams of eupatoriums, 10 grams of schizonepeta, 8.5 grams of bitter radix scrophulariaes.
Preparation method is with embodiment 1.
Embodiment 5: pharmacodynamic experiment
5.1, the impact on female underage rat sexual organ and sex hormone
Get 50 of female underage rats, 10 every group, be divided into 5 groups, i.e. Normal group group (isometric(al)), the positiveControl group (Herba Clinopodii Tabellae 0.6gkg-1), three dosage group (low dosage 4gkg of pharmaceutical composition of the present invention-1, middle dosage group8g·kg-1And heavy dose of group 16gkg-1). Continuous 14 days, administering mode was as table 1:
The each group of table 1 administering mode, quantity, administration kind and dosage are as follows
Group Quantity Administering mode Administration kind Dosage (g/kg)
Normal group 10 Gavage Physiological saline 2
Positive controls 10 Gavage Herba Clinopodii Tabellae 0.6
Capsule high dose group 10 Gavage The embodiment of the present invention 3 16
Dosage group in capsule 10 Gavage The embodiment of the present invention 3 8
Capsule low dose group 10 Gavage The embodiment of the present invention 3 4
45min after last administration, abdominal aortic blood, separation of serum, surveys serum estradiol (E with radioimmunology2)、The content of progesterone (P), follicle-stimulating hormone (FSH) (FSH) and luteinizing principle (LH); Separate uterus and the ovary of rat, claimWeight in wet base, calculates organ coefficient, then uterus and ovary is fixed to the reason section of routine paraffin wax bag, the HE mirror that dyes with formalinInspection. Found that, the uterus of four groups of mouse and ovary are all hyperplasia late period or Early secretory phase changes, and respectively organizes in ovary all visibleGrowing follicle and corpus luteum form, but have no notable difference between each group; Medicine of the present invention has no significant effect ovary and uterus weight;Medicine of the present invention is to FSH, LH and E2There is the impact that degree is different, can increase its content, the adjusting that has participated in hormone is describedProcess, in table 2.
The E of the each group of table 22, P, FSH, LH concrete condition be as follows
Note:
Compared with auxiliary material group￥P＜0.05，￥￥P＜0.01
Compared with positive controls groupP＜0.05，P＜0.01
As can be seen from Table 2, the serum estradiol (E of the each group of capsule2), the content of luteinizing principle (LH) with justNormal control group is compared, and has significant difference (P < 0.01), wherein serum estradiol (the E of high, middle group of capsule2) containAmount, compared with positive controls, has significant difference (P < 0.05), illustrates that the result for the treatment of of pharmaceutical preparation of the present invention is better,Be applicable to further applying.
Embodiment 6: animal model test and experiment in vitro
By the capsule of the embodiment 3 using in the capsule alternate embodiment 5 of embodiment 1,2,4 preparations, repeat to implementExample 5, found that the result for the treatment of of capsule of embodiment 1,2,4 preparation is identical with the capsule of embodiment 3.
Embodiment 7: clinical testing
7.1, ordinary circumstance
2013-2015 Nian Wo institute has collected 368 routine menstrual disturbance patients altogether, tests the age through selecting 320 patientsIn 18-40 year, 31.6 years old mean age, 320 routine patients are divided into two groups at random, mean age, average course of disease, the state of an illness between two groupsDifference (p > 0.05) that above there are no significant, has comparativity.
7.2, grouping and administration
Treatment group: 160 examples: age 18～40,31.5 years old mean age; The course of disease is the shortest 6 months, the longest 15 years, average course of disease5.1 year; Preceded menstural cycle 33 examples, delayed menstrual cycles 51 example, irregular menstrual bloods 26 example, paramenia 20 examples, hypomenorrhia 30 examples.The capsule of the embodiment of the present invention 3, oral, one time 2,2 times on the one, warm water delivery service, 3 months is 1 course for the treatment of, treatment 2The individual course for the treatment of.
Observation group: 160 examples: 18～40 years old age, 31.7 years old mean age; The course of disease is the shortest 6 months, the longest 15 years, on average sickJourney 5.3 years; Preceded menstural cycle 36 examples, delayed menstrual cycles 53 example, irregular menstrual bloods 26 example, paramenia 20 examples, hypomenorrhia 25Example. Adopt White Phoenix Bolus of Black-bone Chicken, oral, one time 6 grams (1 ball), 2 times on the one, warm water delivery service, 3 months is 1 course for the treatment of, treatment2 courses for the treatment of.
7.3, diagnostic criteria
Irregular menstruation. In " traditional Chinese medicine card Standardization of diagnosis and curative effect " that all case diagnosis are all issued with reference to national Chinese Medicine Pharmacy in 1994The diagnostic criteria of irregular menstruation carry out. Preceded menstural cycle: the menstrual cycle is in advance more than 7 days; Delayed menstrual cycle: the menstrual cycle postpones 7More than it; Irregular menstrual blood: menstruation was risen not according to the cycle, or before or after; Paramenia: the menstrual cycle is normal, and warpAmount exceedes menorrhea person; Hypomenorrhia: the menstrual cycle is normal, and through measuring obvious minimizing, or pass through time shorten or dropOnly.
7.4, criterion of therapeutical effect
Cure: menstrual blood loss, menstrual cycle recover normal, after drug withdrawal, 5 menstrual cycles are without repeatedly.
Effective: menstrual blood loss, menstrual cycle normal, have clear improvement, after drug withdrawal, 5 menstrual cycles are without repeatedly.
Invalid: menstrual blood loss, menstrual cycle are not improved.
7.5, treatment results
Through the treatment of 6 months, the result for the treatment of of treatment group and observation group was as table 3.
The result for the treatment of of table 3 treatment group and observation group
Group Cure Effective Invalid Efficient (%)
Treatment group 120 38 2 98.75
Observation group 41 69 50 66.67
As can be seen from Table 3, treatment group: recovery from illness 120 examples, effective 38 examples, invalid 2 examples, efficient (recovery from illness+effective) 98.75%;Observation group's 41 examples of fully recovering, effective 69 examples, invalid 50 examples, efficient (recovery from illness+effective) 66.67%. Treatment group and observation group's groupTotal effective rate passes through χ2Inspection, has otherness remarkable, p≤0.01. The capsule effect of regulating menstruation of the present invention is remarkable, efficientHigh.
7.6, model case
Case 1: together so-and-so, female, 31 years old, Shandong Tancheng people, menstruation first over 10 months after child has been given birth in patient's private prosecution, thisUndesired with regard to menstruation afterwards, and amount is also undesired, and the menstrual cycle before fertility is 30 days, and menstrual cycle 15-20 days are not afterwards etc.,And fidgety with ambition, empty and bearing-down sensation of the lower abdomen, swollen breasts symptom. Take the capsule of the embodiment of the present invention 3, inferior month cycle in menstrual periodChange 22 days into. Continue to take 2 months, recover normal, 1 year Effect of follow-up visit by telephone, not recurrence.
Case 2: Xiao, female, 18 years old, Wenzhou District of Zhejiang Province people, the patient 155cm that raises, 178 kilograms of body weight, at the beginning of menstruationJust undesired after inferior, and amount few (patient's private prosecution), existing 5 years of ill cycle, ate plurality of Chinese, the fat-reducing of going on a diet waits and arrangesExecute, effect is poor, introduces Lai Wo institute check through friend, takes the capsule of the embodiment of the present invention 4, and it is many that inferior month MBV is shown in, monthBe 26 days through the cycle, continue to take 2 months, it is normal that MBV recovers, and the menstrual cycle is 28 days, 1 year Effect of follow-up visit by telephone, not recurrence.
Case 3, Xue so-and-so, female, 42 years old, Zhejiang Hangzhou people, patient's private prosecution has menstruation to shift to an earlier date medical history, feels tired spirit recently time,The turgor of underbelly tenesmus in the recent period, the thin look of tongue fur is white, and with dysphoria, the poor symptom of appetite, introduces Lai Wo institute through friend and checks,Take the capsule of the embodiment of the present invention 2, the menstrual cycle is 23 days, continues to take 2 months, and the menstrual cycle is 27 days, drug withdrawal, 1Year Effect of follow-up visit by telephone, not recurrence.
Embodiment 8: toxicity checking
8.1, acute toxicity test
Tested Chinese medicine preparation: the capsule of embodiment of the present invention 1-4 manufacturing, add purified water by 1:2, make solution, for subsequent use.Experimental animal: regular grade kunming mice, body weight 20g ± 5g, male and female half and half, female mice is all without pregnant.
The solution of mouse stomach Chinese medicine capsules preparation of the present invention, in the time that gavage dosage reaches 735.5g crude drug/kg dosage, mouse after administrationOccur that light activity reduces, about 1 hour, recover normal, Continuous Observation 7 days after administration, none animal dead, its overall health of patients,Diet, to take the photograph water, urine and body weight gain all normal.
Result of the test shows: the maximum dosage-feeding of the capsule of mouse stomach embodiment 1-4 manufacturing is 735.5g crude drug/ kg/d (LD50 > 735.5g crude drug/kg). Traditional Chinese medicine powder clinical application every day total amount of the present invention is 0.15g crude drug/kg/d to the maximum; Press bodyRestatement, the dosis tolerata of mouse stomach capsule is clinical patient 4903.3 times. Point out this medicine acute toxicity extremely low, clinical applicationSafety.
8.2, long-term toxicity test for animals
Tested Chinese medicine preparation: embodiment of the present invention 1-4 gained Chinese medicine capsules, add purified water by 1:2, make solution, for subsequent use.Experimental animal: regular grade SD rat, body weight 210g ± 14g, male and female half and half, female rats is all without pregnant.
8.3, method and result:
4 kinds of Chinese medicine capsules: be divided into high, medium and low three dosage groups, per weight dosage be respectively patient's dose 180,60,20 times; Experimental mouse is divided into 13 groups at random, and wherein the capsule solution of 3 kinds of three dosage of 12 groups of difference gavages, remains 1 groupGavage physiological saline (patient's dose 40 times); All 13 groups of equal continuous gavages 180 days, observe animal general toxic reaction and tightHeavy degree, checks each position by operational procedure after execution, and carries out hematology, ALT, BUN and the heart, liver, spleen, lung, kidney,The pathological examination of the main organs such as stomach; Through long-term feeding, all there is not toxic reaction in 13 groups of rats. Physically well develop. Naked eyesOutward appearance and main organs no abnormality seen. Peripheral hemogram and Serum ALT, BUN and control group relatively change without pathologic. Pathology reportAccuse all not significant changes such as the heart, liver, spleen, lung, kidney, stomach, therefore, think through proved by pathology, 3 kinds of Chinese medicine capsules pairAnimal shows without chronic toxicity.
By above two toxicity tests, prove that the Chinese medicine capsules that the present invention makes by embodiment 1-4 is safe, nontoxic secondary workWith, can be taken by patient.

Claims (8)

1. a pharmaceutical preparation that is used for the treatment of irregular menstruation, is characterized in that, described pharmaceutical preparation comprises following Chinese medicine: frankincense,Cordate houttuynia, setose thistle, potentilla chinensis, Rhizoma Sparganii, eclipta, bigleafbeautyberry root or leaf, great burdock achene, Radix Glycyrrhizae, dandelion, Selaginella tamariscina, motherwort,Radix Angelicae Sinensis, madder, curcuma zedoary, eupatorium, schizonepeta, bitter radix scrophulariae.
2. pharmaceutical preparation according to claim 1, is characterized in that, described pharmaceutical preparation comprises following weight portion Chinese medicine:Frankincense 8-17 part, cordate houttuynia 10-20 part, setose thistle 5-11 part, potentilla chinensis 3-8 part, Rhizoma Sparganii 3-9 part, eclipta 9-13 part,Bigleafbeautyberry root or leaf 5-11 part, great burdock achene 10-30 part, Radix Glycyrrhizae 6-10 part, dandelion 10-30 part, Selaginella tamariscina 8-14 part, motherwort10-30 part, Radix Angelicae Sinensis 10-35 part, madder 8-17 part, curcuma zedoary 6-14 part, eupatorium 6-12 part, schizonepeta 8-14 part, bitter radix scrophulariae3-14 part.
3. pharmaceutical preparation according to claim 1, is characterized in that, described pharmaceutical preparation comprises following weight portion Chinese medicine breastFragrant 12 parts, 15 parts of cordate houttuynias, 8 parts of setose thistles, 6 parts of potentilla chinensis, 6 parts of Rhizoma Sparganiis, 11 parts of ecliptas, 8 parts of bigleafbeautyberry root or leafs,20 parts of great burdock achenes, 8 parts, Radix Glycyrrhizae, 20 parts of dandelions, 11 parts of Selaginella tamariscinas, 25 parts of motherworts, 22.5 parts of Radix Angelicae Sinensis, madder 11Part, 10 parts of curcuma zedoarys, 9 parts of eupatoriums, 11 parts of schizonepeta, 8 parts of bitter radix scrophulariaes.
4. pharmaceutical preparation according to claim 1, is characterized in that, described pharmaceutical preparation comprises following weight portion Chinese medicine:10 parts of frankincenses, 14 parts of cordate houttuynias, 7 parts of setose thistles, 5 parts of potentilla chinensis, 5 parts of Rhizoma Sparganiis, 10 parts of ecliptas, bigleafbeautyberry root or leaf 7Part, 20 parts of great burdock achenes, 7 parts, Radix Glycyrrhizae, 18 parts of dandelions, 10 parts of Selaginella tamariscinas, 24 parts of motherworts, 22.5 parts of Radix Angelicae Sinensis, madder10 parts of grass, 9 parts of curcuma zedoarys, 8 parts of eupatoriums, 10 parts of schizonepeta, 8.5 parts of bitter radix scrophulariaes.
5. a preparation method who prepares the pharmaceutical preparation described in claim 1-4, is characterized in that, concrete step is: get (1)Cordate houttuynia, setose thistle, potentilla chinensis, bigleafbeautyberry root or leaf, motherwort and madder are soaked 1 hour, extract with volatile oil extractorVolatile oil, then obtain volatile oil with anhydrous sodium sulfate drying, then use beta-cyclodextrin inclusion compound, make inclusion compound, inclusion compound and medicineSlag is for subsequent use;
(2) get schizonepeta, great burdock achene, dandelion, eupatorium, bitter radix scrophulariae, Rhizoma Sparganii and eclipta and grind to form meal, add 75% ethanol and carryGet 2 times, each 1.5 hours, merge liquid, leave standstill 24 hours, for subsequent use;
(3) Radix Glycyrrhizae, Selaginella tamariscina, Radix Angelicae Sinensis, frankincense and curcuma zedoary be ground into fine powder and step (1) Chinese medicine slag and mix after by appropriate 75% secondAlcohol extracting 2 times, each 1 hour, collect extract, leave standstill 24 hours, for subsequent use;
(4) get (2) and (3) step in the supernatant that makes, decompression recycling ethanol, is concentrated into 60 DEG C～70 DEG C, density is1.03～1.09 medicinal extract, dry rear for subsequent use, in medicinal extract, add the Benexate Hydrochloride making in (1) step, addEnter appropriate amount of auxiliary materials and make various pharmaceutical dosage forms with common process.
6. the preparation method of pharmaceutical preparation according to claim 5, is characterized in that: the described pharmaceutical dosage form of step (4) is selected fromGranule, capsule, tablet, injection, tincture, suppository, pill, syrup, mixture, powder, lotion, film,One in dripping pill.
7. the preparation method of pharmaceutical preparation according to claim 5, is characterized in that: described pharmaceutical dosage form is selected from capsule.
8. pharmaceutical preparation according to claim 1, is characterized in that: described pharmaceutical preparation is in preparation treatment irregular menstruation medicinePurposes.
CN201610105131.5A 2016-02-25 2016-02-25 Pharmaceutical preparation for treating irregular menstruation and application thereof Withdrawn CN105582476A (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1519017A (en) * 2003-09-03 2004-08-11 临沂新时代药业有限公司 Combination of Chinese traditional medicine for treating menorrhagia as well as pharmaceutics and preparation method
CN101850021A (en) * 2009-11-18 2010-10-06 北京绿源求证科技发展有限责任公司 Chinese medicament for treating abnormal menstruation
CN103127351A (en) * 2013-02-18 2013-06-05 李莉 Traditional Chinese medicine for treating premature menstruation
CN103550711A (en) * 2013-11-14 2014-02-05 李秀湘 Medicine for treating menses disease and preparation method
CN104474303A (en) * 2014-12-06 2015-04-01 邹士东 Chinese medicinal composition for treating refractory epilepsy and preparation method thereof

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1519017A (en) * 2003-09-03 2004-08-11 临沂新时代药业有限公司 Combination of Chinese traditional medicine for treating menorrhagia as well as pharmaceutics and preparation method
CN101850021A (en) * 2009-11-18 2010-10-06 北京绿源求证科技发展有限责任公司 Chinese medicament for treating abnormal menstruation
CN103127351A (en) * 2013-02-18 2013-06-05 李莉 Traditional Chinese medicine for treating premature menstruation
CN103550711A (en) * 2013-11-14 2014-02-05 李秀湘 Medicine for treating menses disease and preparation method
CN104474303A (en) * 2014-12-06 2015-04-01 邹士东 Chinese medicinal composition for treating refractory epilepsy and preparation method thereof

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Application publication date: 20160518