CN1306948C - Capsule for treating osteoporosis and its preparing method - Google Patents

Capsule for treating osteoporosis and its preparing method Download PDF

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Publication number
CN1306948C
CN1306948C CNB2004100436356A CN200410043635A CN1306948C CN 1306948 C CN1306948 C CN 1306948C CN B2004100436356 A CNB2004100436356 A CN B2004100436356A CN 200410043635 A CN200410043635 A CN 200410043635A CN 1306948 C CN1306948 C CN 1306948C
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rhizoma
osteoporosis
capsule
treatment
cortex eucommiae
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CN1709290A (en
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刘国仁
肖鹏
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Abstract

The present invention provides a Gusongting capsule for curing osteoporosis with obvious therapeutic effect without toxic and side effect. Every 1000 capsules are prepared from 800 to 1500g of drynaria root, 500 to 900g of eucommia bark, 500 to 900g of epimedium, 300 to 600g of ligustrum fruit, 300 to 600g of cibotium root and 300 to 600g of curculigo root.

Description

Capsule of treatment osteoporosis and preparation method thereof
(1), affiliated field
What the present invention relates to is a kind of medical configuration product, specifically a kind of medical preparation that is used for the treatment of osteoporosis.
(2), background technology
Osteoporosis can cause very big influence to health.People mainly adopt some calcium-supplementing preparations or nutraceutical to come prevention of osteoporosis at present.Also there is not a kind of medicine that osteoporosis is had the good curing effect.
(3), summary of the invention
The object of the present invention is to provide a kind ofly has the good curing effect to osteoporosis, the capsule of the treatment osteoporosis that has no side effect.
The object of the present invention is achieved like this: per 1000 capsules are to be made by Rhizoma Drynariae 800-1500g, Cortex Eucommiae 500-900g, Herba Epimedii 500-900g, Fructus Ligustri Lucidi 300-600g, Rhizoma Cibotii 300-600g and Rhizoma Curculiginis 300-600g.
The prescription medical material is suitably pulverized, doubly measured ethanol extraction 2-3 time of 60-65% with 4-6, extracted 1-4 hour at every turn, extracting solution is reclaimed solvent and is concentrated into density under 55-65 ℃ of temperature be 1.3 (60 ℃); With concentrate under 75-85 ℃ of temperature dry 10-15 hour, must extract dry thing; To extract dry thing and be ground into 40 order granules; Mixing, dress is made hard capsule No. 0, and every heavily is 0.52g.
The experiment proved that product of the present invention has the good curing effect to osteoporosis, and without any side effects.What put down in writing below is part of test results to product of the present invention:
1, pharmacodynamic study
The rats with osteoporosis result of the test shows due to the removal ovary, product high dose of the present invention is 6.8g (being equivalent to crude drug)/KG, middle dosage is 3.4g (being equivalent to crude drug)/KG, low dosage is that the continuous gastric infusion of 1.7g (being equivalent to crude drug)/KG can make osteoporosis rat femur bone weight coefficient due to the removal ovary, femur footpath, femur length, bone ash content, femoral bmd, bone calcium, bone phosphorus significantly increase (P<0.05, P<0.01) in 90 days; Serum alkaline phosphatase there is the reduction effect, but does not have significant difference; Urinary hydroxyproline there is significance reduction effect (P<0.05, P<0.01).
Go that the rats with osteoporosis result of the test shows due to the testis, product high dose of the present invention is 6.4g (being equivalent to crude drug)/kg, middle dosage is 3.4g (being equivalent to crude drug)/kg, low dosage is that the continuous gastric infusion of 1.7g (being equivalent to crude drug)/kg can make osteoporosis rat femur bone weight coefficient due to the testis, femur footpath, femur length, bone ash content, femoral bmd, bone calcium, bone phosphorus significantly increase (P P<0.05, P<0.01) in 90 days; Serum alkaline phosphatase there is the reduction effect, but does not have significant difference: urinary hydroxyproline is had significance reduction effect (P<0.05, P<0.01).
The rats with osteoporosis result of the test shows due to the retinoic acid: product high dose of the present invention is 6.8g (being equivalent to crude drug)/kg, middle dosage is 3.4g (being equivalent to crude drug)/kg, low dosage is 1.7g (being equivalent to the crude drug)/continuous gastric infusion of kg one month to making osteoporosis rat femur bone weight coefficient due to the retinoic acid, femur footpath, femur length, bone ash content, bone mineral density, bone calcium obviously increase P<0.05, P<0.01); Though bone phosphorus is had rising, not significant difference; Serum alkaline phosphatase there is the reduction effect, but does not have significant difference: urinary hydroxyproline is had significance reduction effect (P<0.05, P<0.01).
Go the testis mouse test to show: product high dose of the present invention is that testis mice seminal vesicle and preputial glands weight are increased, and middle dosage is that 6.8g (being equivalent to crude drug)/kg, low dosage are that 3.4g (being equivalent to crude drug)/kg does not have obvious influence.
More than the experiment positive control drug is: YILIN PIANJI, the honest day fine pharmaceutical Co. Ltd in Lianyun Harbour provides.
The pharmacodynamic experiment result of study shows: product of the present invention has the definite curative effect of treatment experimental animal models osteoporosis.
2, rat long term toxicity test
Product rat long term toxicity test result of the present invention shows, this pharmaceutical quantities is 34g (being equivalent to crude drug)/kg, 17g (being equivalent to crude drug)/kg, (8.5g being equivalent to crude drug)/kg (be equivalent to human dosage 60 times, 30 times, 15 times), gastric infusion (ig), once a day, administration is 6 days weekly, respectively at after the administration 3 months, 6 months, 7 months, dissect 1/3 animal respectively for every group.Observe general performance, food consumption, the body weight change of rat; Measure hematological indices, each hematological indices numerical value of three dosage groups of this medicine is compared equal no significant difference (P>0.05) with corresponding time point matched group, belongs in normal range; Blood biochemical is learned index, and other blood biochemicals of three dosage groups of this medicine are learned index value and compared equal no significant difference (P>0.05) with corresponding time point matched group.System becomes celestial, and 12 kinds of organ indexs and 20 kinds of internal organs are carried out the histopathology detection.
The rat long term toxicity test is the result show: do not find the toxic and side effects relevant with taking GSBJN, product of the present invention is taken has safety.
3, animal acute toxicity test data
(1), LD50 prerun gets the Kunming mouse of 18-22g body weight, establishes 3 dosage of product of the present invention, high dose group dosage is 4g (being equivalent to crude drug)/0.8ml/20g (maximum drug level, the maximum body of stomach of irritating are long-pending, irritate push away irrigation stomach device when feeding acquire a certain degree of difficulty); Middle dosage group dosage is 2g (being equivalent to crude drug)/0.8ml/20g; Low dose group dosage is that 1g is equivalent to crude drug)/0.8ml/20g; Observed 14 days continuously behind the gastric infusion, the result respectively organizes mice, and none is only dead, shows that this product can't obtain the LD50 value of mice, can only carry out maximum dosage-feeding mensuration.
(2), maximum dosage-feeding is measured
With maximum drug level 4g (being equivalent to crude drug)/ml (filling pushes away irrigation stomach device when feeding and acquires a certain degree of difficulty), maximum administration volume 0.8ml/20g, the gastric infusion secondary, observed 14 days continuously after the administration, none only death of mice as a result, give the back movable normal, the end find mice on the feed, aspects such as breathing, heart rate, chroma of hair unusual.
Experimental result shows: product maximum dosage-feeding of the present invention is 160g crude drug/kg, is 280.70 times (it is 0.57g/k8 that clinical people intends consumption) that clinical people intends consumption, this poison of drug, and animal is taken safety.
(4), specific embodiments
For example the present invention is done in more detail below and describes:
Ratio in per 1000 capsules Rhizoma Drynariae 800-1500g, Cortex Eucommiae 500-900g, Herba Epimedii 500-900g, Fructus Ligustri Lucidi 300-600g, Rhizoma Cibotii 300-600g, Rhizoma Curculiginis 300-600g is got raw material ready.Each raw material is suitably pulverized, and with the ethanol extraction 3 times of 6,4,4 times of amount 60-65%, extraction time was respectively 4,2,1 hours respectively, and extracting solution is reclaimed solvent and is concentrated into density under 60 ℃, 0.07Mpa condition is 1.3 (60 ℃); With concentrate under 80 ℃, 0.08Mpa condition dry 12 hours, must extract dry thing; To extract dry thing and be ground into 40 order granules; Add suitable adjuvant, mixing, dress is made hard capsule No. 0, and every heavily is 0.52g.
Ratio in per 1000 capsules Rhizoma Drynariae 900-1200g, Cortex Eucommiae 600-800g, Herba Epimedii 600-800g, Fructus Ligustri Lucidi 400-600g, Rhizoma Cibotii 400-600g, Rhizoma Curculiginis 400-600g is got raw material ready.Each raw material is suitably pulverized, and with the ethanol extraction 3 times of 6,4,4 times of amount 60-65%, extraction time was respectively 4,2,1 hours respectively, and extracting solution is reclaimed solvent and is concentrated into density under 60 ℃, 0.07Mpa condition is 1.3 (60 ℃); With concentrate under 80 ℃, 0.08Mpa condition dry 12 hours, must extract dry thing; To extract dry thing and be ground into 40 order granules; Add suitable adjuvant, mixing, dress is made hard capsule No. 0, and every heavily is 0.52g.
Ratio in per 1000 capsules Rhizoma Drynariae 900g, Cortex Eucommiae 600g, Herba Epimedii 600g, Fructus Ligustri Lucidi 400g, Rhizoma Cibotii 400g, Rhizoma Curculiginis 400g is got raw material ready.Each raw material is suitably pulverized, and with 6,4,4 times of amount ethanol extractions of 60% 3 times, extraction time was respectively 4,2,1 hours respectively, and extracting solution is reclaimed solvent and is concentrated into density under 60 ℃, 0.07Mpa condition is 1.3 (60 ℃); With concentrate under 80 ℃, 0.08Mpa condition dry 12 hours, must extract dry thing; To extract dry thing and be ground into 40 order granules; Add suitable adjuvant, mixing, dress is made hard capsule No. 0, and every heavily is 0.52g.
Ratio in per 1000 capsules Rhizoma Drynariae 1200g, Cortex Eucommiae 800g, Herba Epimedii 800g, Fructus Ligustri Lucidi 600g, Rhizoma Cibotii 600g, Rhizoma Curculiginis 600g is got raw material ready.Each raw material is suitably pulverized, and with the ethanol extraction 3 times of 6,4,4 times of amount 60-65%, extraction time was respectively 4,2,1 hours respectively, and extracting solution is reclaimed solvent and is concentrated into density under 60 ℃, 0.07Mpa condition is 1.3 (60 ℃); With concentrate under 80 ℃, 0.08Mpa condition dry 12 hours, must extract dry thing; To extract dry thing and be ground into 40 order granules; Add suitable adjuvant, mixing, dress is made hard capsule No. 0, and every heavily is 0.52g.
Ratio in per 1000 capsules Rhizoma Drynariae 1000g, Cortex Eucommiae 700g, Herba Epimedii 700g, Fructus Ligustri Lucidi 500g, Rhizoma Cibotii 500g, Rhizoma Curculiginis 500g is got raw material ready.Each raw material is suitably pulverized, and with 6,4,4 times of amount ethanol extractions of 60% 3 times, extraction time was respectively 4,2,1 hours respectively, and extracting solution is reclaimed solvent and is concentrated into density under 60 ℃, 0.07Mpa condition is 1.3 (60 ℃); With concentrate under 80 ℃, 0.08Mpa condition dry 12 hours, must extract dry thing; To extract dry thing and be ground into 40 order granules; Add suitable adjuvant, mixing, dress is made hard capsule No. 0, and every heavily is 0.52g.

Claims (4)

1, a kind of capsule for the treatment of osteoporosis is characterized in that: per 1000 capsules are to be made by Rhizoma Drynariae 800-1500g, Cortex Eucommiae 500-900g, Herba Epimedii 500-900g, Fructus Ligustri Lucidi 300-600g, Rhizoma Cibotii 300-600g and Rhizoma Curculiginis 300-600g.
2, the capsule of treatment osteoporosis according to claim 1 is characterized in that: per 1000 capsules are to be made by Rhizoma Drynariae 900-1200g, Cortex Eucommiae 600-800g, Herba Epimedii 600-800g, Fructus Ligustri Lucidi 400-600g, Rhizoma Cibotii 400-600g and Rhizoma Curculiginis 400-600g.
3, a kind of capsular manufacture method for the treatment of osteoporosis, it is characterized in that: the ratio in Rhizoma Drynariae 800-1500g, Cortex Eucommiae 500-900g, Herba Epimedii 500-900g, Fructus Ligustri Lucidi 300-600g, Rhizoma Cibotii 300-600g and Rhizoma Curculiginis 300-600g is got raw material ready, with each raw material pulverizing, doubly measure ethanol extraction 2-3 time of 60-65% with 4-6, the each extraction 1-4 hour, extracting solution is reclaimed solvent and is concentrated into density under 55-65 ℃ of temperature be 1.3; With concentrate under 75-85 ℃ of temperature dry 10-15 hour, must extract dry thing; To extract dry thing and be ground into 40 order granules, canned one-tenth capsule.
4, the capsular manufacture method of treatment osteoporosis according to claim 3 is characterized in that: with the ethanol extraction 3 times of 6,4,4 times of amount 60-65%, extraction time was respectively 4,2,1 hours respectively.
CNB2004100436356A 2004-06-18 2004-06-18 Capsule for treating osteoporosis and its preparing method Expired - Fee Related CN1306948C (en)

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Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102389440B (en) * 2011-12-09 2014-08-20 四川浩源生物科技有限公司 Application of iridoid in preparation of anti-osteoporosis medicines
CN103083479B (en) * 2013-03-07 2014-10-01 李其英 Traditional Chinese medical composition for treating postmenopausal osteoporosis
CN106309566A (en) * 2016-08-29 2017-01-11 肖京平 Medicine for treating cardiovascular and cerebtovascular diseases and osteoarthrosis and preparation method of capsule
CN106619903A (en) * 2016-11-30 2017-05-10 广西万德药业有限公司 Traditional Chinese medicine composition for treating osteoporosis and preparation method of traditional Chinese medicine composition
CN106361856A (en) * 2016-11-30 2017-02-01 广西万德药业有限公司 Anti-osteoporosis traditional Chinese medicinal composition and preparation method thereof
CN106511549A (en) * 2016-11-30 2017-03-22 广西万德药业有限公司 Traditional Chinese medicine composition containing millettia specisoa and preparation method of traditional Chinese medicine composition
CN106474243A (en) * 2016-11-30 2017-03-08 广西万德药业有限公司 A kind of liver and kidney benefiting, Chinese medicine composition of strengthening the bones and muscles and preparation method thereof
CN108743748A (en) * 2018-08-08 2018-11-06 陕西中医药大学 A kind of Chinese medicinal composition preparation that treating osteoporosis and its preparation and application

Citations (1)

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Publication number Priority date Publication date Assignee Title
CN1413680A (en) * 2002-10-21 2003-04-30 罗孝华 Chinese medicine for treating hyperosteogeny

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
CN1413680A (en) * 2002-10-21 2003-04-30 罗孝华 Chinese medicine for treating hyperosteogeny

Non-Patent Citations (1)

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