CN1660196A - Extractive of Chinese traditional medicine prepared from epimedium and drynaria, and method for producing preparation - Google Patents

Extractive of Chinese traditional medicine prepared from epimedium and drynaria, and method for producing preparation Download PDF

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Publication number
CN1660196A
CN1660196A CN 200410061319 CN200410061319A CN1660196A CN 1660196 A CN1660196 A CN 1660196A CN 200410061319 CN200410061319 CN 200410061319 CN 200410061319 A CN200410061319 A CN 200410061319A CN 1660196 A CN1660196 A CN 1660196A
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extract
herba epimedii
rhizoma drynariae
chinese medicine
aqueous alcohol
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CN1331484C (en
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熊富良
黄志军
李崇明
曾庆恢
徐绍新
刘健伟
朱立彬
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Jianmin Pharmaceutical Groups Corp ltd
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JIANMIN TRADITIONAL CHINESE MEDICINE ENGINEERING Co Ltd WUHAN
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Abstract

A Chinese medicine for treating primary osteoporosis and climacteric syndrome is prepared from epimedium and fortune's drynaria rhizome through extracting in alcohol solution, macroreticular resin separation or extracting by ethyl acetate, and refining.

Description

Chinese medicine extract that a kind of Herba Epimedii, Rhizoma Drynariae are made and formulation preparation method
The present invention relates to the preparation method by the extract and the preparation thereof of Herba Epimedii, Rhizoma Drynariae, wherein Herba Epimedii, Rhizoma Drynariae extract employing branch are put forward or are closed the method for putting forward and make.Extract the osteoporotic medicine of a kind of mixing treatment that obtains by aqueous alcohol or ethyl acetate, purpose is to provide a kind of active constituent content height, toxicity is low, taking dose is little, easy to use, is used for the product of osteoporosis and climacteric syndrome.
Medicine of the present invention is main effective site by Herba Epimedii, Rhizoma Drynariae total flavones.Mainly contain the total flavonoid composition that extracts from above two flavor Chinese crude drugs in this extract, its content is between 50%-95%
Background of invention
Osteoporosis is to reduce with the bone amount, and the micro structure of bone deteriorates to feature, causes the fragility of bone to increase a kind of general skeletal diseases with easy generation fracture.Climacteric syndrome, be the increase of people along with the age, the women causes that along with the decline of ovarian function neurological disorders, endocrine disturbance and dysbolismus are main climacteric syndrome, therefore this prescription is under the modern Chinese medicine guide of theory, preferred multiple kidney invigorating and YANG supporting, on the basis of treatment medicine for treating osteoporosis, a kind of little compound recipe that combines.
Herba Epimedii is a Berberidaceae plant Herba Epimedii, arrow leaf Herba Epimedii, the aerial parts of Herba Epimedii, mainly contain the epimedium flavone glycosides, epimedium flavone time glycosides, epimedin A, B, C etc., and contain potassium, calcium constituent, its function has kidney-replenishing, bone and muscle strengthening, wind-damp dispelling, be used for impotence and seminal emission, the muscles and bones flaccidity is soft, rheumatic arthralgia, numbness contracture, climacteric, hypertension etc., pharmacological action confirms that its effective ingredient of mainly treating diseases such as osteoporosis is mainly total flavonoids substance, in the experimentation and clinical practice of numerous treatment osteoporosis, its curative effect of Chinese medicine Herba Epimedii is generally acknowledged by everybody at present.Xie Hua etc. discover the bone formation rate that can obviously increase to Herba Epimedii etc., reduce bone resorption, bone loss due to the inhibition hydrocortisone, the long-pending increase of surface of bone, Herba Epimedii may be by promoting the proteinic synthetic effects such as promoting to do osteoblastic growth that reaches of osseous tissue, thereby the antagonism adrenocortical hormone decomposes osseous tissue protein, the synthetic effect that reduces of accelerated bone substrate has prevented the generation of osteoporosis.
Rhizoma Drynariae is the dry rhizome of fire hose section plant Mongolian oak Herba pteridii latiusculi, bitter in the mouth, warm in nature, return liver, kidney channel to have the kidney invigorating bone strengthening, promoting blood circulation and stopping pain, cure mainly lumbago due to renal deficiency, foot and knee flaccidity, tinnitus, deafness, toothache, chronic diarrhea, the enuresis, injury and bone fracture, the external treatment alopecia areata.Modern study proves that the Rhizoma Drynariae active component is based on Pericarpium Citri grandis glycoside flavanone kind composition.Yin Jun, Wang Dawei etc. have been studied, and the Rhizoma Drynariae ethanol extract is stronger to the proliferation function of WmR106 skeletonization like cell.And further definite its active part and active component, confirm that it has cell proliferation sample composition to exist to osteoblast, also containing has inhibiting composition to osteoclast propagation, mark is prosperous, Gao Zifan causes osteoporosis model to experimental group injection cortisone acetate, experimental group is irritated drynaria rhizome preparation every day, matched group is irritated the stomach tap water, the result shows the cortical bone of matched group and the demineralization substrate calcium in spongy bone density and the unit volume, the content of phosphorus and hydroxyproline, all be starkly lower than blank group, the every index of experimental group is higher than or apparently higher than matched group, illustrates that the osteomiosis complementary energy obviously suppresses the bone loss that glucocorticoid causes.Bone metabolism is finished jointly by bone resorption and bone formation.Sufferers of osteoporosis face generally is that bone resorption is greater than bone formation, be that osteoclast propagation and rate of differentiation are greater than osteoblastic proliferation and rate of differentiation, therefore, having the Rhizoma Drynariae that suppresses osteoclast propagation and stimulating osteoblast propagation simultaneously concurrently is conspicuous in the value of treatment senile osteoporosis.
Traditional Chinese medical herbal treatment osteoporosis (similar with the atrophic debility of bones disease of the traditional Chinese medical science) is historical to be of long duration, according in the theory of Chinese medical science " kidney storing essence master bone; the smart marrow of giving birth to; then bone marrow biochemistry is active; bone gets it and supports; otherwise; it is crisp easy to break bone to occur, diseases such as back arthralgia " Herba Epimedii in the side; Rhizoma Drynariae is the principal agent in the reinforcing the kidney to strengthen the bone Chinese medicine; little compound recipe is formed in therefore selected above two flavor Chinese medicine passing ratios screenings; at present owing to the reason that causes senile osteoporosis is many-sided; mechanism still imperfectly understands; but the old people since in the body sex hormone level descend, what cause that the osteoclast activity increase finally causes osteoporosis is its major reason, use chemical drugs treatment toxic and side effects big, and reinforcing the kidney to strengthen the bone class Chinese medicine and compound recipe thereof has the effect of parahormone sample, and can suppress osteoclast, to promote osteoblastic generation, bone formation is increased simultaneously, demonstrate the bright prospect of Chinese herb prevention climacteric syndrome and osteoporosis symptom.Also does not form at present by two flavor Chinese medicines, treatment osteoporosis effective parts formulation listing, so and invent this medicine.
Summary of the invention
The further main purpose of the present invention provides the compositions that the composition of the effective therapeutical effect that provides promptly is provided a kind of like this therapeutic combination, they are that Herba Epimedii extract and Rhizoma Drynariae extract branch are carried or closed and propose ratio combination, another technical problem of the present invention has provided and has a kind ofly prepared the method for these stable extracts and the preparation of drug combination that contains this stable extract method is provided, and wherein the amount of the icariin in the said composition, naringin also keeps stable.
According to the extract of these technical problems of the present invention with claim 1-6, with the method for claim 7-8, and claim drug regimen method and dosage form, relevant issues solve.
The preferred embodiment that the present invention prepares Herba Epimedii, Rhizoma Drynariae stable extract method has following steps;
1; With Herba Epimedii, Rhizoma Drynariae, water, aqueous alcohol, methanol, acetone extraction obtain extracting solution.
2; Use vacuum or other optional concentrator to concentrate
3; Wherein make water, methanol, aqueous alcohol carry out the dilution of above concentrated solution, centrifugal
4; With the polystyrene macroporous resin purification is carried out in Herba Epimedii, the active ingredient of Rhizoma Drynariae total flavonoid, and use degree of passing eluting separates, drying obtains extract.
5; With aqueous alcohol or ethyl acetate Herba Epimedii, Rhizoma Drynariae branch are carried or closed and carry thing and make with extra care, and concentrate, obtain the higher extract of content with vacuum and optional miscellaneous equipment.
6; Reach optional miscellaneous equipment drying with vacuum or spray drying and obtain qualified extract.
The specific embodiment
Preferred realization method of the present invention is; Chinese medicine extract as claimed in claim 2, Herba Epimedii, Rhizoma Drynariae weight proportion ratio are 4: 1~6, the Herba Epimedii ratio also can be 1~4.
Be used for claim 3, (1) with aqueous alcohol or acetone extraction Herba Epimedii branch and leaf, Rhizoma Drynariae rhizome position; Aqueous alcohol can be ethanol or methanol;
Be used for claim 3, (2) filter this extracting solution, and use vacuum concentration equipment to concentrate, reclaim solvent;
Be used for claim 3, (3) water or aqueous alcohol mixture diluted step (2), and its centrifugal slagging-off is obtained centrifugal liquid.Aqueous alcohol can be ethanol or methanol;
Being used for claim 3, (4), that gained centrifugal liquid is crossed the polystyrene type macroporous resin is refining, and uses degree of passing eluting.Selected range of resin can be silica gel, polyamide, macroporous adsorbent resin, be the best with the polystyrene type macroporous resin;
Be used for claim 3, (5) (4) resultant eluent is concentrated into thick paste and dry, and drying mode is optional; Drying mode can be lyophilization, vacuum drying, spray drying;
Be used for claim 3, (6) with (5) extract obtained can be solvent dissolving or with ethyl acetate extraction and refining with aquiferous ethanol, and solvent is reclaimed in the evaporation of the temperature about 40-80 ℃; Aqueous alcohol can be ethanol or methanol, is the best with ethanol, ethyl acetate;
Be used for claim 3, (7) with the gained extract dry, become optional powdered extract or granule; Be meant with extract dry to become extract powder or add adjuvant to make granule and fine powder.
Be used for the described extract of claim 6, it contains the total flavones (in icariin and naringin) of 10-90% (weight).
The method of the above-mentioned extraction Herba Epimedii of the present invention, Rhizoma Drynariae total flavones adopts kind Korea Herba Epimedii, arrow leaf Herba Epimedii or the pubescence Herba Epimedii of pharmacopeia regulation, and Rhizoma Drynariae adopts the dry rhizome of Polypodiaceae plant Mongolian oak Herba pteridii latiusculi.After obtaining qualified extract.And the implementation column of being correlated with prepares implementation, and he comprises relevant dosage forms such as ordinary tablet, capsule, dispersible tablet and soft capsule.
Embodiment 1 preparation capsule
Herba Epimedii extract 10g
Rhizoma Drynariae extract 2.5g
Starch 3g
Dextrin 1.5g
Magnesium stearate 0.1g
Medicinal alcohol 2-3ml
Embodiment 2 preparation conventional tablet and coatings
Herba Epimedii extract 10g
Rhizoma Drynariae extract 2.5g
Celluloasun Microcrystallisatum 8g
Starch Sodium 2g
Starch 3g
Magnesium stearate 0.2g
Coating powder 1g
Embodiment 3 preparation dispersible tablets
Herba Epimedii extract 10g
Rhizoma Drynariae extract 2.5g
Celluloasun Microcrystallisatum 8g
Starch Sodium 2g
Polyvinylpyrrolidone 1g
Micropowder silica gel 0.5g
Medicinal alcohol 3ml
Embodiment 4 preparation soft capsules
Herba Epimedii extract 10g
Rhizoma Drynariae extract 2.5g
Soybean oil 10ml
Polyethylene Glycol 2ml
Glycerol 2ml
Gelatin 8g
Purified water 3ml

Claims (9)

1. one kind is used to prepare the Chinese medicine extract for the treatment of constitutional sclerotin vegetables pine, climacteric syndrome medicament.This extract is made up of Herba Epimedii, Rhizoma Drynariae two flavor Chinese medicines.
2. Chinese medicine extract as claimed in claim 1, wherein Herba Epimedii, Rhizoma Drynariae part by weight proportioning are 4: 1~6.
3. as the preparation method of claim 1 described Chinese medicine extract, its operating procedure is
(1) with aqueous alcohol or acetone extraction Herba Epimedii branch and leaf, Rhizoma Drynariae rhizome position.
(2) filter this extracting solution, and use vacuum concentration equipment to concentrate, reclaim solvent.
(3) water or aqueous alcohol mixture diluted step (2), and its centrifugal slagging-off obtained centrifugal liquid.
(4) gained centrifugal liquid is crossed the polystyrene type macroporous resin and made with extra care, and use degree of passing eluting.
(5) (4) resultant eluent is concentrated into thick paste and dry, and drying mode is optional.
(6) with (5) extract obtained can be solvent dissolving or with ethyl acetate extraction and refining with aquiferous ethanol, and solvent is reclaimed in the evaporation of the temperature about 40-80 ℃;
(7), become optional powdered extract or granule with the gained extract dry.
4. method according to claim 3, wherein aqueous alcohol comprises that methanol, ethanol carry out step (1), extract (3).
5. can be D101 according to the described step of claim 3 (4) with the polystyrene type macroporous resin, DM130, XAD-16 etc. make with extra care Herba Epimedii, Rhizoma Drynariae total flavonoid effective ingredient.
6. according to the described step of claim 3 (6) Herba Epimedii, Rhizoma Drynariae are closed that to carry thing refining, wherein use methanol, ethanol, ethyl acetate.
7. according to the described extract of claim 6, it contains the total flavones (in icariin and naringin) of 10-95% (weight).
8. contain 7 the combined extracts of having the right and make composition of active components.
The extract of claim 8 preparation be the kidney invigorating, bone strengthening, strong muscle, pain relieving, be used for primary osteoporosis, climacteric syndrome, the sick aspect of cardiovascular a small bundle of straw, etc. for silkworms to spin cocoons on purposes.
CNB2004100613191A 2004-12-13 2004-12-13 Extractive of Chinese traditional medicine prepared from epimedium and drynaria, and method for producing preparation Expired - Fee Related CN1331484C (en)

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Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101579390B (en) * 2008-05-15 2011-07-20 北京北大维信生物科技有限公司 Medicinal dripping pill for treating osteoporosis
CN101780132B (en) * 2009-01-17 2012-03-07 毕力夫 Mongolian medicine for treating osteoporosis and preparation method thereof
CN102716233A (en) * 2012-05-18 2012-10-10 北京师范大学 Flavonoids extract containing naringin and application thereof
CN103251671A (en) * 2012-12-28 2013-08-21 北京中研同仁堂医药研发有限公司 Traditional Chinese medicine containing composition for increasing bone mineral density and preparation method thereof
CN104224888A (en) * 2014-09-03 2014-12-24 上海焦点生物技术有限公司 Traditional Chinese medicinal composition used for strengthening bone
CN104666394A (en) * 2014-09-24 2015-06-03 普正药业股份有限公司 Eucommia product having health protection efficacy on osteoporosis and preparation method of eucommia product
CN107184657A (en) * 2016-03-15 2017-09-22 上海中医药大学附属龙华医院 It is a kind of to treat compound Chinese medicinal preparation of primary osteoporosis and preparation method thereof
CN107320524A (en) * 2017-06-30 2017-11-07 北京甄和利康生物科技有限公司 A kind of pharmaceutical composition for being used to preventing and/or treating perimenopausal syndrome
CN108095074A (en) * 2017-12-12 2018-06-01 浙江海洋大学 A kind of tuna fish-bone health food of auxiliary treatment osteoporosis and preparation method thereof
CN111904992A (en) * 2020-07-09 2020-11-10 华中科技大学鄂州工业技术研究院 Composition for regulating intestinal flora of people with estrogen deficiency after climacteric period and preparation method thereof
CN113332338A (en) * 2021-05-21 2021-09-03 陆华 Pharmaceutical composition for warming kidney and tonifying yang
CN113533563A (en) * 2021-07-07 2021-10-22 健民药业集团股份有限公司 Method for simultaneously detecting contents of four components of liver-soothing, stomach-harmonizing and pain-relieving traditional Chinese medicine

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CN1128625A (en) * 1995-12-01 1996-08-14 王群 Nutrition and medicinal type corn or carrot instant food, mfg. method thereof
CN1498629A (en) * 2002-11-11 2004-05-26 刘香斌 Chinese traditional medicine for treating osteoporosis and its prepn. method

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101579390B (en) * 2008-05-15 2011-07-20 北京北大维信生物科技有限公司 Medicinal dripping pill for treating osteoporosis
CN101780132B (en) * 2009-01-17 2012-03-07 毕力夫 Mongolian medicine for treating osteoporosis and preparation method thereof
CN102716233A (en) * 2012-05-18 2012-10-10 北京师范大学 Flavonoids extract containing naringin and application thereof
CN103251671B (en) * 2012-12-28 2015-11-18 北京中研同仁堂医药研发有限公司 A kind of composition and method of making the same containing Chinese medicine increasing bone density
CN103251671A (en) * 2012-12-28 2013-08-21 北京中研同仁堂医药研发有限公司 Traditional Chinese medicine containing composition for increasing bone mineral density and preparation method thereof
CN104224888A (en) * 2014-09-03 2014-12-24 上海焦点生物技术有限公司 Traditional Chinese medicinal composition used for strengthening bone
CN104666394A (en) * 2014-09-24 2015-06-03 普正药业股份有限公司 Eucommia product having health protection efficacy on osteoporosis and preparation method of eucommia product
CN107184657A (en) * 2016-03-15 2017-09-22 上海中医药大学附属龙华医院 It is a kind of to treat compound Chinese medicinal preparation of primary osteoporosis and preparation method thereof
CN107320524A (en) * 2017-06-30 2017-11-07 北京甄和利康生物科技有限公司 A kind of pharmaceutical composition for being used to preventing and/or treating perimenopausal syndrome
CN108095074A (en) * 2017-12-12 2018-06-01 浙江海洋大学 A kind of tuna fish-bone health food of auxiliary treatment osteoporosis and preparation method thereof
CN108095074B (en) * 2017-12-12 2021-02-02 浙江海洋大学 Tuna fishbone health food for adjuvant treatment of osteoporosis and preparation method thereof
CN111904992A (en) * 2020-07-09 2020-11-10 华中科技大学鄂州工业技术研究院 Composition for regulating intestinal flora of people with estrogen deficiency after climacteric period and preparation method thereof
CN113332338A (en) * 2021-05-21 2021-09-03 陆华 Pharmaceutical composition for warming kidney and tonifying yang
CN113533563A (en) * 2021-07-07 2021-10-22 健民药业集团股份有限公司 Method for simultaneously detecting contents of four components of liver-soothing, stomach-harmonizing and pain-relieving traditional Chinese medicine

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