CN1493325A - Chinese medicine for treating osteoporosis and its preparation method - Google Patents

Chinese medicine for treating osteoporosis and its preparation method Download PDF

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Publication number
CN1493325A
CN1493325A CNA031253180A CN03125318A CN1493325A CN 1493325 A CN1493325 A CN 1493325A CN A031253180 A CNA031253180 A CN A031253180A CN 03125318 A CN03125318 A CN 03125318A CN 1493325 A CN1493325 A CN 1493325A
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chinese medicine
paeonol
extractum
preparation
parts
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CN1232281C (en
Inventor
熊富良
张惠明
黄志军
曹智华
徐绍新
许沛虎
梁前荣
鞠瑞芬
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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 the primary osteoporosis is prepared from 8 Chinese-medicinal materials including rehmannia root, yam, Chinese angelica root, tree peony bark, etc through extracting in alcohol or water, peonol extracting, concentrating and shaping.

Description

Cure mainly the Chinese medicine and preparation method thereof of the primary osteoporosis of deficiency of the liver and kindey card
Technical field
The invention belongs to a kind of Chinese medicine, particularly, is a kind of Chinese medicine that cures mainly the primary osteoporosis of deficiency of the liver and kindey card, the present invention further provides its preparation method.
Background technology
Osteoporosis belongs to the disease of skeleton abnormal metabolism, and its pathogeny is not clear and definite as yet, it is generally acknowledged and human senility that endocrine disturbance etc. are relevant.Its sickness rate height, hazardness is big, at present to be listed as old people's common disease with arteriosclerosis, tumor etc.Western medicine at present commonly used is mainly calcium preparation, estrogen, calcitonin etc., and some help calcium absorption and suppress the medicine that sclerotin decomposes, though certain curative effect is arranged, bigger side effect are arranged, drug withdrawal is the shortcoming of bounce-back easily, and Chinese medicine based on integrally-regulated, has clear superiority on the treatment osteoporosis.The Chinese medicine onset is mainly the coefficient result of many target spots, regulates by body and works, and has effectively avoided Western medicine to lack what benefit and so on shortcoming merely.
Summary of the invention
The purpose of this invention is to provide a kind of determined curative effect, few side effects, have nourishing the liver and kidney, strengthening the tendons and bones function, cure mainly the Chinese medicine of the primary osteoporosis of deficiency of the liver and kindey card, to overcome above-mentioned deficiency.
To achieve these goals, characteristics of the present invention are: it is the medicament of being made by following weight ratio proportion raw material:
Radix Rehmanniae Preparata 3-8 part Fructus Corni 1-5 part Rhizoma Cibotii 1-5 part
Herba Epimedii 1-5 part Rhizoma Dioscoreae 1-5 part Radix Angelicae Sinensis 1-5 part
Cortex Moutan 1-4 part Concha Ostreae (forging) 2-6 part
The optimum weight ratio proportioning that constitutes the raw material of above-mentioned medicament is:
2.5 parts of 2.5 parts of Rhizoma Cibotii of 5 parts of Fructus Corni of Radix Rehmanniae Preparata
2.5 parts of 2.5 parts of Radix Angelicae Sinensis of 2.5 portions of Rhizoma Dioscoreaes of Herba Epimedii
3.8 parts of 2 portions of Concha Ostreaes of Cortex Moutan (forging)
Fructus Corni in the above-mentioned raw materials is handled according to the Chinese medicine processing standard, and its purpose is to make the easier extraction of the effective ingredient in the raw material, to strengthen the property of medicine, makes curative effect of medication the best of the present invention.
The above-mentioned Chinese medicine that cures mainly the primary osteoporosis of deficiency of the liver and kindey card can also add medicine excipient or medicine correctives.The medicine excipient can be one or more the combination in sucrose, starch, magnesium stearate, beta-schardinger dextrin-, sorbitol, the microcrystalline Cellulose, with granule or tablet or the capsule that medication preparation of the present invention is become to be convenient to take.The medicine correctives can be one or more the combination in steviol glycosides, Oligomeric maltose, lactose, the edible essence, so that prepared medicament has good sweet felling, after overcoming number flavor Chinese herbal medicine compatibility, the drawback that the five tastes mix, bitter peppery acid becomes to have a nasty taste.The coating of medicine can be a kind of in film-coat, semi-film coating, the enteric coating etc., to reach moistureproof, reduce bad smell, to alleviate to gastric irritation or by gastric juice and destroy and effect attractive in appearance, that easily take.
Certainly; aforementioned pharmaceutical compositions of the present invention can be prepared into any pharmaceutical dosage form that is suitable for using clinically according to the process of Chinese medicine preparation of routine; for example: tablet; powder; granule; capsule; pill; unguentum; mixture; syrup; injection; the card agent; liniment; suppository etc.; as long as use pharmaceutical composition of the present invention; no matter adopt which kind of dosage form; all belong within protection scope of the present invention; when aforementioned pharmaceutical compositions is prepared into medicament; special requirement according to preparation; the excipient that can add other again, for example: flavoring agent; solubilizing agent; diluent; disintegrating agent; lubricant etc.The preferred dosage form of the present invention is capsule, tablet, oral liquid.
Concrete, when preparation medicine of the present invention, may further comprise the steps:
(1) takes by weighing Cortex Moutan by the set of dispense ratio, add the water distillation and extraction paeonol, enclose or directly be ground into fine powder after the cold drying.
(2) the Cortex Moutan medicinal residues after will distilling are with Radix Rehmanniae Preparata, Rhizoma Cibotii, Fructus Corni, Rhizoma Dioscoreae, Radix Angelicae Sinensis, Herba Epimedii or separately extract, and extracting solution is condensed into extractum, add adjuvant and also make corresponding dosage forms, and mix, promptly get Chinese medicine of the present invention with paeonol that step (1) obtains.
Wherein a kind of step of preparation method of the best is:
(1) takes by weighing Cortex Moutan by the set of dispense ratio, add the water distillation and extracted paeonol in 4 hours, separate paeonol and cold drying, the beta-schardinger dextrin-of paeonol and 4 times of amounts was stirred in water 1 and a half hours, temperature is controlled at 40 ℃, cooling makes and separates out crystal then, filter, dry, crystal pulverized the clathrate that obtains paeonol.
(2) Fructus Corni, Radix Angelicae Sinensis, Herba Epimedii adopt ethanol extraction, and concrete grammar is: take by weighing above three flavor medical materials by the set of dispense ratio, put and add 50%~95% alcohol reflux twice in the hot reflux device, merge the extractum that medicinal liquid reclaims ethanol and is evaporated to certain density.
(3) take by weighing Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Rhizoma Cibotii, and Concha Ostreae (forging) by the set of dispense ratio, merge, decoct with water 2~3 times, merge medicinal liquid and be evaporated to the extractum of certain density with the medicinal residues of alcohol reflux part.
(4) extractum with (2) and (3) merges, and is evaporated to relative density and is 1.30 extractum.
(5) extractum and appropriate amount of starch in the step (4) are mixed and made into granule, and with paeonol bag and thing mixing, the granule that makes is filled with capsule, make every capsules dress 0.5g, promptly get medicament capsule of the present invention.
In the selected medical material of the present invention, monarch drug in the selected Radix Rehmanniae Preparata side of being is with nourishing kidney-yin replenishing essence marrow; Fructus Corni invigorating the liver and kidney and arresting seminal emission, with supporting, Fructus Corni (processed) is puckery with temperature with essence and blood; Rhizoma Cibotii is with invigorating the liver and kidney, strong waist knee joint; Herba Epimedii is with warming the kidney to invigorate YANG; Rhizoma Dioscoreae is controlling nocturnal emission with astringent drugs with the spleen reinforcing kidney, is the merit of assistant Fructus Corni; Radix Angelicae Sinensis is with the affair pain relieving alive of nourishing blood; Concha Ostreae is with convergence, consolidating semen, the effect of more double bone strengthening; Rhizoma Alismatis is with promoting diuresis to eliminate damp pathogen, and the taste of anti-Radix Rehmanniae Preparata is greasy; Cortex Moutan is with the liver heat removing removing heat from blood; Poria helps the power of the kidney invigorating with invigorating spleen to remove dampness.
Thereby the present invention has nourishing the liver and kidney, a strengthening the tendons and bones function, and close and sees it the full side of Chinese medicine that cures mainly the primary osteoporosis of deficiency of the liver and kindey card, and its characteristics are arranged: tonifying both YIN and YANG first, both tonifying kidney-yin in the side, kidney-replenishing again, negative and positive mutual aid and fill up marrow; Second based on benefit, reinforcing and reducing concurrently makes tonify without causing stagnation, rushes down and does not just hinder; Three invigorating the liver and kidney are main, hold concurrently with spleen reinforcing, and the lid Liver and kidney part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels of living together is yi and Kui are derived from the same origin, and the spleen kidney is first the foundation of acquired constitution, and three is dirty and mend, essence, gas, blood alternate, and then kidney essense is active; The product of four fundamental rules the kidney invigorating multiselect bone and muscle strengthening wind-damp dispelling are as Rhizoma Cibotii, Herba Epimedii etc.All medicine contracts are grown and oiliness, and temperature and not dry instrumental ensembles that the kidney invigorating, benefit are smart, the effect of bone strengthening.
Animal test results showed before the present invention was clinical: this product can alleviate the adult rat bone loss that spay or retinoic acid cause, bone detects index of correlation improvement after medication; Mouse test model symptom due to the Dichlorodiphenyl Acetate andrographolide has the improvement effect; That reduces that acetic acid causes the pain mice turns round the body number of times; Alleviate that Oleum Tiglii causes mice auricle swelling and Ovum Gallus domesticus album causes the swelling of rat toes.
Acute toxicity test shows: the present invention is very low to the acute toxicity of rat and mice, and LD50 can not survey, and maximum tolerated dose is 30g/Kg/ day (amounting to raw medicinal herbs 164g/Kg/ day), is equivalent to 300 times of clinical application amount.
Long term toxicity test shows: high dose 27.3g/Kg/ day of the present invention (quite adult treatment amount 50 times) and low dosage 13.7g/Kg/ day (suitable adult treatment amount 25 times), and through the continuous coloclysis of rat six months, the no abnormal performance of rat.No overt toxicity detrimental effect and not seeing has pathomorphology infringement phenomenon, 65 times of the quite clinical consumption of its high dose group.Show this product safety non-toxic.
Clinical observation result:
One. method: adopt respectively that the double blinding dual analog contrasts at random, single blind observation that contrasts at random and open, treat patients with osteoporosis 420 examples altogether, BUSHEN JIANGU JIAONANG test group 210 examples wherein, GUSONGBAO KELI matched group 120 examples, the open group of BUSHEN JIANGU JIAONANG 90 examples.
Two. the result: 1. the clinical total effective rate of test group is 89.5%, obvious effective rate is 47.6%, open group total effective rate is 91.1%, obvious effective rate is 47.8%, the matched group total effective rate is 80.8%, and obvious effective rate is 22.5%, and test group and matched group are relatively, have significant difference, the test group curative effect obviously is better than matched group.2. test group more all has significant differences with open group tcm syndrome integration treatment front and back, and the integration drop-out value relatively has significant differences between test group and matched group group, and the test group curative effect obviously is better than matched group.3. test group all has therapeutical effect preferably with open group to osteoporotic every symptom, and significant differences is relatively arranged before and after the treatment.4. bone density, peak bone mass, bone density lifting example number are compared.A, employing dual intensity X line (DEXA) check result: test group, open group compare there was no significant difference before and after self treating, and compare there was no significant difference before and after matched group self treatment; Difference relatively has significant difference between the femoral trochanteric hyte of test group and matched group, illustrates that curative effect is better than matched group to test group aspect some position bone density improving.B, employing ultrasound wave borne densitometers (UBIS-3000) are checked the calcaneus result: before relatively having significant difference, the result after the treatment to be better than treatment before and after T value (standard deviation) and BUA value (ultrasonic amplitude decay) treatment; Compare there was no significant difference between test group and matched group group.5. the biochemical indicator check result compares: before and after test group and matched group blood calcium self treatment significant difference is arranged relatively, there is obvious rising the treatment back before treating; Compare there was no significant difference before and after open group self treatment.Difference there was no significant difference relatively between test group and matched group group, illustrate test group improve aspect the biochemical indicator suitable with matched group.6. in therapeutic process, have the only a few patient slight xerostomia, constipation to occur in taking BUSHEN JIANGU JIAONANG and GUSONGBAO KELI process, after dietary adjustments, remission, disappearance do not influence and continue to take.Do not find other untoward reaction.
Three. conclusion: BUSHEN JIANGU JIAONANG is in present oral dose, course of treatment scope, and drug safety has no side effect, and is a kind of treatment primary osteoporosis safe and effective medicine.
The specific embodiment
The present invention is described in detail below in conjunction with embodiment, but should not be construed as limitation of the present invention.
Embodiment 1:
Get Cortex Moutan 10Kg and add water distillation and extracted paeonol in 4 hours, separate paeonol and cold drying, be ground into behind the fine powder standby; Cortex Moutan medicinal residues after the distillation are decocted with water 2 times with Radix Rehmanniae Preparata 30Kg, Rhizoma Cibotii 10Kg, Fructus Corni 10Kg, Rhizoma Dioscoreae 10Kg, Radix Angelicae Sinensis 10Kg, Herba Epimedii 10Kg, merging medicinal liquid and being condensed into relative density is 1.30 extractum, with extractum and appropriate amount of starch mixing granulation, the granule that makes is added an amount of magnesium stearate as lubricant, and tabletting promptly gets tablet of the present invention.
The present invention has nourishing the liver and kidney, a strengthening the tendons and bones function, and its usage and dosage of Chinese medicinal tablet that cures mainly the primary osteoporosis of deficiency of the liver and kindey card is: oral, three times on the one, one time 2~3, or follow the doctor's advice.
Embodiment 2:
Get Cortex Moutan 30Kg and add water distillation extraction in 4 hours paeonol, separate paeonol and cold drying, the beta-schardinger dextrin-of paeonol and 4 times of amounts was stirred in water 1 and a half hours, temperature is controlled at 40 ℃, cooling makes and separates out crystal then, filter, dry, that crystal is pulverized the clathrate that obtains paeonol is standby; Get Fructus Corni 20Kg, Radix Angelicae Sinensis 30Kg, Herba Epimedii 10Kg adopts ethanol extraction, concrete grammar is: above three flavor medical materials, put and add 50% alcohol reflux twice in the hot reflux device, merge the extractum that medicinal liquid reclaims ethanol and is evaporated to certain density; Take by weighing Radix Rehmanniae Preparata 70Kg, Rhizoma Dioscoreae 15Kg, Rhizoma Cibotii 20Kg and Concha Ostreae (forging) 40Kg, merge, decoct with water 2 times, merge medicinal liquid and be evaporated to the extractum of certain density with the medicinal residues of alcohol reflux part; Two kinds of extractum are merged, be evaporated to relative density and be 1.30 extractum; Extractum and appropriate amount of starch are mixed and made into granule, and with paeonol bag and thing mixing, the granule that makes is filled with capsule, make every capsules dress 0.5g, promptly get medicament capsule of the present invention.
Embodiment 3:
In the present embodiment, the preparation method of this medicine, function cure mainly and usage and dosage all with embodiment 2, the consumption of different is prescription Chinese crude drug is distinguished to some extent.Its medical material consumption is respectively: Cortex Moutan 20Kg, Fructus Corni 25Kg, Radix Angelicae Sinensis 25Kg, Herba Epimedii 25Kg, Radix Rehmanniae Preparata 50Kg, Rhizoma Dioscoreae 15Kg, Rhizoma Cibotii 25Kg and Concha Ostreae (forging) 38Kg.

Claims (6)

1. Chinese medicine that cures mainly the primary osteoporosis of deficiency of the liver and kindey card is characterized in that it is the medicament of being made by following weight ratio proportion raw material:
Radix Rehmanniae Preparata 3-8 part Fructus Corni 1-5 part Rhizoma Cibotii 1-5 part
Herba Epimedii 1-5 part Rhizoma Dioscoreae 1-5 part Radix Angelicae Sinensis 1-5 part
Cortex Moutan 1-4 part Concha Ostreae (forging) 2-6 part
2. the Chinese medicine that cures mainly the primary osteoporosis of deficiency of the liver and kindey card as claimed in claim 1, wherein the optimum weight ratio proportioning of each raw material is:
2.5 parts of 2.5 parts of Rhizoma Cibotii of 5 parts of Fructus Corni of Radix Rehmanniae Preparata
2.5 parts of 2.5 parts of Radix Angelicae Sinensis of 2.5 portions of Rhizoma Dioscoreaes of Herba Epimedii
3.8 parts of 2 portions of Concha Ostreaes of Cortex Moutan (forging)
3. Chinese medicine as claimed in claim 1 or 2, its pharmaceutical composition can be prepared into any pharmaceutical dosage form that is suitable for using clinically according to the process of Chinese medicine preparation of routine.
4. Chinese medicine as claimed in claim 1 or 2 can also add medicine excipient or medicine correctives.
5. preparation method of Chinese medicine that cures mainly the primary osteoporosis of deficiency of the liver and kindey card, the step of its preparation method is:
(1) takes by weighing Cortex Moutan by the set of dispense ratio, add the water distillation and extraction paeonol, enclose or directly be ground into fine powder after the cold drying.
(2) the Cortex Moutan medicinal residues after will distilling are with Radix Rehmanniae Preparata, Rhizoma Cibotii, Fructus Corni, Rhizoma Dioscoreae, Radix Angelicae Sinensis, Herba Epimedii or separately extract, and extracting solution is condensed into extractum, add adjuvant and mix with paeonol that step (1) obtains and make corresponding dosage forms, promptly get Chinese medicine of the present invention.
6. preparation method of Chinese medicine as claimed in claim 5, wherein a kind of step of preparation method of the best is:
(1) takes by weighing Cortex Moutan by the set of dispense ratio, add the water distillation and extracted paeonol in 4 hours, separate paeonol and cold drying, the beta-schardinger dextrin-of paeonol and 4 times of amounts was stirred in water 1 and a half hours, temperature is controlled at 40 ℃, cooling makes and separates out crystal then, filter, dry, crystal pulverized the clathrate that obtains paeonol.
(2) Fructus Corni, Radix Angelicae Sinensis, Herba Epimedii adopt ethanol extraction, and concrete grammar is: take by weighing above three flavor medical materials by the set of dispense ratio, put and add 50%~95% alcohol reflux twice in the hot reflux device, merge the extractum that medicinal liquid reclaims ethanol and is evaporated to certain density.
(3) take by weighing Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Rhizoma Cibotii, and Concha Ostreae (forging) by the set of dispense ratio, merge, decoct with water 2~3 times, merge medicinal liquid and be evaporated to the extractum of certain density with the medicinal residues of alcohol reflux part.
(4) extractum with (2) and (3) merges, and is evaporated to relative density and is 1.30 extractum.
(5) extractum and starch in the step (4) are mixed and made into granule, and with paeonol bag and thing mixing, the granule that makes is filled with capsule, make every capsules dress 0.5g, promptly get medicament capsule of the present invention.
CN 03125318 2003-08-25 2003-08-25 Chinese medicine for treating osteoporosis and its preparation method Active CN1232281C (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103340341A (en) * 2013-07-03 2013-10-09 山西大学 Functional food with bone strengthening effect and preparation method thereof
CN104548049A (en) * 2015-01-30 2015-04-29 杜卫兵 Traditional Chinese medicine composition for treating senile osteoporosis and preparation method thereof
CN104888038A (en) * 2015-06-16 2015-09-09 林倩 Traditional Chinese medicine for treating kidney-yang deficiency type primary osteoporosis and preparation method

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103340341A (en) * 2013-07-03 2013-10-09 山西大学 Functional food with bone strengthening effect and preparation method thereof
CN104548049A (en) * 2015-01-30 2015-04-29 杜卫兵 Traditional Chinese medicine composition for treating senile osteoporosis and preparation method thereof
CN104888038A (en) * 2015-06-16 2015-09-09 林倩 Traditional Chinese medicine for treating kidney-yang deficiency type primary osteoporosis and preparation method

Also Published As

Publication number Publication date
CN1232281C (en) 2005-12-21

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