CN101040889A - Traditional Chinese medicinal prepns. for treating osteoporosis - Google Patents

Traditional Chinese medicinal prepns. for treating osteoporosis Download PDF

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Publication number
CN101040889A
CN101040889A CN 200610065215 CN200610065215A CN101040889A CN 101040889 A CN101040889 A CN 101040889A CN 200610065215 CN200610065215 CN 200610065215 CN 200610065215 A CN200610065215 A CN 200610065215A CN 101040889 A CN101040889 A CN 101040889A
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herba epimedii
chinese medicine
total flavones
medicine preparation
epimedii total
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CN101040889B (en
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周亚伟
吉瑞瑞
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Zhejiang Hangzhou Pharmaceutical Co Ltd
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Abstract

The invention relates to a Chinese medicament for treating osteoporosis and its preparation process, wherein the main active constituents of the medicament include barrenwort flavones. The medicament is prepared from barrenwort flavones and pharmacologically acceptable auxiliary materials.

Description

The osteoporotic Chinese medicine preparation of a kind of treatment
Technical field
The present invention relates to a kind of Chinese medicine preparation, belong to new Chinese medicine research and development field with function of resisting osteoporosis.
Background technology
Osteoporosis is a kind of common disease, and sickness rate is the highest in elderly population.And along with the growth in population life-span, increasing of old number, the harm of this disease reveals gradually, vertebral fracture causes pain and deformity, the femoral neck bone fracture needs hospitalization, often also have severe complications or cause death, the people is arranged even can cause permanent afunction, these have all brought great economic loss to society.The people in life, the bone amount that final male loses reaches 25~35%, the women can be up to 45~55%, its bone amount of nephrasthenia syndrome patient is than person who suffer from deficiency of kidney Yang is not low.
At osteoporosis, the modern times clinically medication Diphosphonate, special estrogenic agents, calcitonin, estrogen, parathormone etc. are arranged, belong to Western medicine, have toxic and side effects, and the life-time service safety is also unclear.Be the naturopathic epoch of advocating drug safety at present, Many researchers is placed on treatment by Chinese herbs disease aspect to sight.But the research for the function of resisting osteoporosis Chinese medicine preparation rests on traditional compound preparation conceptual phase more, and dosage is bigger, is inconvenient to take, and a lot of curative effects all can not be satisfactory.
Herba Epimedii is the dry aerial parts of Radix Berberidis Amurensis plant Epimedium Epimedium Brevicornum.Summer, autumn tap when stem, leafiness, remove thick stalk and impurity, dry or dry in the shade.Kind surplus global barrenwort has 40 mainly is distributed in the temperate zone and the subtropical zone in Asia, the Middle East, Europe.Homemade Herba Epimedii has 23 kinds and 4 mutation now, wherein have the distribution in the NORTHERN KOREA area except that Herba Epimedii E.koreanum, all the other are China endemic species, are dispersed throughout all parts of the country, distributed more widely with the Yangtze river basin, wherein Sichuan and Guizhou two provinces respectively are distributed with 13 kinds.Shennong's Herbal is classified them as middle product, and Li Shizhen (1518-1593 A.D.) claims the effect that it has " beneficial vital essence, hard muscle, benefit waist knee joint, heart tonifying power " in Compendium of Material Medica, and " it is certified products that Chinese pharmacopoeia version in 1985 has been collected these genus four kind of plant.
According to pharmacopeia record, the extract of Herba Epimedii has kidney-replenishing, bone and muscle strengthening, the effect of wind-damp dispelling, and osteoporosis is a kind of and aging and the relevant osteopathia of bone calcium loss, the traditional Chinese medical science is thought, the kidney generating marrow and dominating bone, kidney and bone are in close relations, and the while kidney is closely related with aging again.Suffering from a deficiency of the kidney itself is old and feeble result, and it also can become causes old and feeble reason, suffers from a deficiency of the kidney and can directly or indirectly cause a large amount of losses of bone calcium; Osteoporosis is one of traditional Chinese medical science arthromyodynia, suffers from a deficiency of the kidney and the atrophic debility of bones, suffer from a deficiency of the kidney and osteodynia, and be main pathogenesis to suffer from a deficiency of the kidney, expectorant stasis of blood resistance arteries and veins is a promoting factor.Therefore, primary osteoporosis, secondary osteoporosis such as osteofluorosis etc. come from suffer from a deficiency of the kidney, insufficiency of vital energy and blood.Treatment then should be started with from the kidney invigorating, reaches the effect for the treatment of both the principal and secondary aspects of a disease by the kidney invigorating.
Summary of the invention
The purpose of this invention is to provide a kind of pure Chinese medicine pharmaceutical preparation that contains Herba Epimedii total flavones, be used for the treatment of osteoporosis.
The present invention is according to theory of Chinese medical science: the kidney generating marrow and dominating bone, and kidney and bone are in close relations, and kidney is closely related with aging again simultaneously, and suffering from a deficiency of the kidney itself is old and feeble result, and it also can become causes old and feeble reason, and directly or indirectly causes a large amount of losses of bone calcium.The present invention starts with from the kidney invigorating, by the kidney invigorating and then reach the curative effect of osteoporosis, has developed a kind of Chinese medicine preparation with function of resisting osteoporosis by a large amount of pharmacology, the test of pesticide effectiveness.
The present invention is made by the raw material of following weight portion:
Herba Epimedii total flavones 10-70%
Pharmaceutic adjuvant 30-90%
Herba Epimedii total flavones of the present invention can be by disclosed preparation method preparation in this area, and the present invention provides a kind of feasible preparation method at this: get Korea barren wort medicinal material, use 70% alcohol reflux.Filter, concentrated, with dissolved in distilled water, filter, filtrate is crossed the D-101 macroporous adsorptive resins, washes with 5 times of resinite hydrops earlier, and 70% ethanol of 6 times of resin volumes of reuse is collected eluent, and decompression recycling ethanol concentrates, and vacuum drying gets Herba Epimedii total flavones.The content of Herba Epimedii total flavones is more than 50%, and content Determination of Icariin is more than 15%.
The present invention adopts described method of embodiment or pharmaceutics prior art that the pharmaceutic adjuvant of accepting on described Herba Epimedii total flavones and the pharmaceutics is prepared into capsule, tablet, oral liquid, granule, pill, medicinal tea or Emulsion.Wherein preferred dosage form is a capsule.
The preparation method of capsule of the present invention comprises the steps: to get Herba Epimedii total flavones, grinds, and crosses 80 mesh sieves.Add pharmaceutic adjuvant, sieve mix homogeneously.Be sub-packed in the capsule, packing, promptly.
The present invention sets forth useful effect of the present invention by the following test of pesticide effectiveness:
(1) Herba Epimedii total flavones is to the influence of osteoporosis rat model due to the prednisone
Irritate stomach and give rat acetic acid prednisone (PAT), make the formation osteoporosis, irritate simultaneously stomach give Herba Epimedii total flavones little (50mg/kg), in (100mg/kg), big (150mg/kg) three dosage, femoral bmd (BMD), biochemical indicator and the trace element of measuring administration 13 all animals change.The results are shown in Table 1, table 2, table 3.The result shows: three dosage of Herba Epimedii total flavones cause osteoporosis rat to prednisone and improve significantly.
Table 1: Herba Epimedii total flavones is to the influence of rat femur bone density (BMD) (x ± s)
Group Dosage (mg/kg) n BMD (g/cm2)
Blank group model matched group GUSHUKANG group 3000 15 14 11 0.339±0.027 0.314±0.021 0.336±0.022 *
Excessive sheep Small dose group 50 15 0.325±0.024
Leaves of pulse plants total flavones The heavy dose of group of middle dosage group 100 150 13 15 0.334±0.023 * 0.337±0.0155 **
Annotate: compare with the blank group, P<0.05; Compare with model group, *P<0.05, *P<0.01.
The bone density of model group has been compared significance decline (P<0.05) with the blank group, the GUSHUKANG group is compared bone density and is significantly raise (P<0.05) with model group, big or middle dosage group of Herba Epimedii total flavones and model group comparison bone density have remarkable rising (P<0.05 or P<0.01).
Table 2 Herba Epimedii total flavones is to the influence of Serum from Model Rats with Osteoporosis TRAP, ALP, Ca, P and SOD (x ± s)
Group Dosage mg/kg n TRAP (U/L) ALP (U/L) Ca (mmol/L) P (mmol/L) SOD (NU/ml)
Blank group model matched group GUSHUKANG group 3000 15 13 11 3.17± 0.24 4.09± 0.47 △△△ 3.19± 0.11 *** 45.88± 7.00 59.76± 16.66 △△ 58.16± 8.22 2.61± 0.27 2.39± 0.24 2.64± 0.35 2.01± 0.39 1.88± 0.31 1.81± 0.18 230.5± 24.4 131.6± 41.2 △△△ 181.9± 31.3 **
Herba Epimedii total flavones The heavy dose of group of dosage group in the small dose group 50 100 150 14 13 15 4.09± 0.08 3.78± 0.10 * 3.43± 0.42 *** 58.95± 13.43 54.06± 12.03 45.28± 10.85 * 2.63± 0.36 2.72± 0.29 ** 2.86± 0.45 ** 1.99± 0.57 1.77± 0.34 1.84± 0.26 143.9± 26.1 163.4± 29.4 * 202.3± 44.0 ***
Annotate: compare △ P<0.05 with the blank group; Compare * P<0.05, * * P<0.01, * * * P<0.01 with model group.
TRAP: tartrate-resistant acid phosphatase; ALP: alkali phosphatase; SOD: superoxide dismutase.
Compare with the blank group, serum T RAP, the ALP of model group significantly raises (P<0.01 or P<0.05), and serum Ca and SOD significantly reduce (P<0.01 or P<0.001); Compare with model group, positive controls TRAP, SOD significantly reduce (P<0.01 or P<0.001); Compare with model group, the serum T RAP of the big or middle dosage group of Herba Epimedii total flavones significantly reduces (P<0.01 or P<0.001), the serum levels of ALP of heavy dose of group significantly reduces (P<0.05), the serum Ca and the SOD of big or middle dosage group significantly raise (P<0.01 or P<0.05 or P<0.001).
Table 3 Herba Epimedii total flavones is to the influence of osteoporosis rat model femur calcium, phosphorus and trace element (x ± s)
Group Dosage mg/kg n Ca (%) P (%) Mg (mg/kg) Zn (mg/kg) Mn (mg/kg) Cu (mg/kg)
Blank group model matched group GUSHUKANG group 3000 15 14 11 4.91± 0.12 4.57± 0.31 △△△ 4.96± 0.13 *** 3.40± 0.37 3.12± 0.19 3.60± 0.40 ** 3786.6± 166.8 3845.5± 171.9 3765.4± 143.4 497.2± 126.8 518.6± 123.3 467.7± 106.5 29.08± 0.71 28.35± 0.78 31.88± 1.19 *** 29.92± 0.90 29.14± 0.89 29.05± 0.64
Herba Epimedii total flavones The heavy dose of group of dosage group in the small dose group 50 100 150 14 13 15 4.84± 0.21 * 4.91± 0.17 ** 4.95± 0.10 *** 3.32± 0.29 * 3.37± 0.24 ** 3.60± 0.37 *** 3719.6± 330.3 3875.2± 133.5 3872.9± 174.4 495.7± 93.0 522.0± 99.9 501.6± 108.0 29.41± 0.53 *** 28.97± 0.44 * 30.94± 1.01 *** 28.41± 0.62 * 28.52± 0.40 * 28.60± 0.52
Annotate: compare with the blank group, P<0.05, △ △ △P<0.001; Compare with model group, *P<0.05, *P<0.01, * *P<0.01.
Compare with the blank group, rat femur Ca, the P of model group, Mn, Cu all have significance to reduce (P<0.05, P<0.001); Compare with model group, positive controls rat femur Ca, P, Mn all have significance rising (P<0.01 or P<0.001); Compare with model group, femur Ca, P, Mn, the Cu of the large, medium and small dosage group of Herba Epimedii total flavones has significant difference (P<0.05, P<0.01 or P<0.001) in various degree.
But glucocorticoid medicine induced osteoporosis such as prolonged application prednisolone acetate, it is by reducing sex hormones secretion, secondary causes hyperparathyroidism, cause inhibition of intestinal calcium absorption and renal tubules that calcium is heavily absorbed and reduce the direct influence a plurality of approach such as (comprise and suppress bone formation and strengthen bone resorption) that reach bone, cause that bone density reduces, bone mineral content reduces; Bone resorption is hyperfunction, and bone calcium is released into blood, and UCaE increases, and ossein is decomposed acceleration, and urinary hydroxyproline rises.
Originally studies show that its bone density obviously increases, and illustrates that Herba Epimedii total flavones can increase animal pattern bone amount with the rat after the Herba Epimedii total flavones treatment; The content of the amount of trace element such as calcium, phosphorus reflection bone mineral in the bone mineral, osteoclast is at first removed mineral, carries out bone gelatin subsequently and decomposes.So showing as dissolving of tangible bone ore deposit and calcium content of bone during osteoporosis descends.Herba Epimedii total flavones can improve micronutrient levelss such as calcium in the bone, phosphorus, manganese, copper, illustrates that it can suppress the dissolving in bone ore deposit and loses; Simultaneously Herba Epimedii total flavones can significantly increase the body blood calcium, illustrates that it can obviously improve negative calcium balance, improves calcium loss.
Tartrate-resistant acid phosphatase in the serum (TRAP) mainly is to be discharged in the blood by osteoclast, the level of TRAP can reflect the activity of osteoclast and the state of bone resorption basically in the blood, and osteoporosis rat can show as the TRAP level that discharges in the body blood to be increased.The TRAP level obviously reduces in the osteoporosis rat blood with making after the Herba Epimedii total flavones treatment, illustrates that it can suppress osteoclast activity, reduces bone resorption.
Blood neutral and alkali phosphatase 50% derives from bone, the ALP activity can reflect the osteoblast activity, and ALP content all raise when bone formation or bone resorption were hyperfunction, and this experiment shows that Herba Epimedii total flavones can reduce the ALP activity, the prompting Herba Epimedii total flavones can improve the hypermetabolism state of bone, increases the formation of bone.
In sum, Herba Epimedii total flavones can effectively be prevented and treated the osteoporosis that hormone brings out, and shows as bone density improving, reduces the bone conversion.
The specific embodiment:
The present invention specifies the preparation method of the pharmaceutical preparation with function of resisting osteoporosis by following examples, but the present invention is not limited to the content that the following example comprises.
Embodiment 1:
Get Herba Epimedii total flavones 100g and grind, the microcrystalline Cellulose 98g of adding and micropowder silica gel 2g cross 80 mesh sieves three times, mix homogeneously.Be sub-packed in the capsule, promptly.
Embodiment 2:
Get Herba Epimedii total flavones 100g and grind, add pregelatinized Starch 49g, microcrystalline Cellulose 49g and micropowder silica gel 2g, cross 80 mesh sieves three times, mix homogeneously.Be sub-packed in the capsule, promptly.
Embodiment 3:
Get Herba Epimedii total flavones 25g and grind, add microcrystalline Cellulose 78g and carboxylic first class Starch Sodium 20g and mix evenly, use 60% alcohol granulation, 60 ℃ of dryings, granulate, with magnesium stearate 2g, mix homogeneously, tabletting are promptly.
Embodiment 4:
Get Herba Epimedii total flavones 100g and grind, add pregelatinized Starch 87g and lactose 60g and mix evenly, use 95% alcohol granulation, 60 ℃ of dryings, granulate, with magnesium stearate 3g, mix homogeneously is made granule promptly.

Claims (8)

1, the osteoporotic Chinese medicine preparation of a kind of treatment is characterized in that said preparation is to be prepared from by acceptable auxiliary on Herba Epimedii total flavones and the pharmaceutics.
2, Chinese medicine preparation according to claim 1 is characterized in that content of total flavone is more than 50% in the Herba Epimedii total flavones, and wherein content Determination of Icariin is greater than 15%.
3, Chinese medicine preparation according to claim 1 is characterized in that consisting of of Herba Epimedii total flavones and pharmaceutic adjuvant two components: Herba Epimedii total flavones 10-70%, pharmaceutic adjuvant 30-90%.
4, Chinese medicine preparation according to claim 1, it is characterized in that pharmaceutic adjuvant be selected from medical starch, pregelatinized Starch, beta-schardinger dextrin-, carboxylic first class Starch Sodium, lactose, dextrin, micropowder silica gel or the microcrystalline Cellulose any or several.
5, Chinese medicine preparation according to claim 1 is characterized in that said preparation can be capsule, tablet, oral liquid, granule, pill, medicinal tea or Emulsion.
6, Chinese medicine preparation according to claim 5, the preferred dosage form that it is characterized in that said preparation is a capsule.
7, Chinese medicine preparation according to claim 6 is characterized in that the preparation method of capsule comprises the steps: to get Herba Epimedii total flavones, grinds, and crosses 80 mesh sieves.Add pharmaceutic adjuvant, sieve mix homogeneously.Be sub-packed in the capsule, packing, promptly.
8, the application of the described Chinese medicine preparation of the arbitrary claim of claim 1~6 in preparation treatment medicine for treating osteoporosis.
CN2006100652157A 2006-03-20 2006-03-20 Traditional Chinese medicinal prepns. for treating osteoporosis Expired - Fee Related CN101040889B (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101485726B (en) * 2008-01-14 2011-04-13 浙江省新华医院 Chinese medicine for osteoporosis and healing waistband
CN104095863A (en) * 2014-08-06 2014-10-15 国药集团国瑞药业有限公司 Pharmaceutical composition containing zoledronic acid and preparation thereof
CN105663239A (en) * 2016-03-08 2016-06-15 宁夏医科大学 Application of cinnamomum burmannii leaf extract in preparation of medicine used for treating osteoporosis and pharmaceutical composition of cinnamomum burmannii leaf extract
CN105687317A (en) * 2016-03-08 2016-06-22 宁夏医科大学 Application of total flavonoids in leaves of cinnamomum burmanni in preparation of medicine for treating osteroporosis and medicine composition

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1176677C (en) * 2001-05-23 2004-11-24 周亚伟 Chinese medicine composition for treating cardiovascular and cerebrovascular diseases and its preparing process

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101485726B (en) * 2008-01-14 2011-04-13 浙江省新华医院 Chinese medicine for osteoporosis and healing waistband
CN104095863A (en) * 2014-08-06 2014-10-15 国药集团国瑞药业有限公司 Pharmaceutical composition containing zoledronic acid and preparation thereof
CN104095863B (en) * 2014-08-06 2016-03-30 国药集团国瑞药业有限公司 A kind of pharmaceutical composition and preparation thereof comprising zoledronic acid
CN105663239A (en) * 2016-03-08 2016-06-15 宁夏医科大学 Application of cinnamomum burmannii leaf extract in preparation of medicine used for treating osteoporosis and pharmaceutical composition of cinnamomum burmannii leaf extract
CN105687317A (en) * 2016-03-08 2016-06-22 宁夏医科大学 Application of total flavonoids in leaves of cinnamomum burmanni in preparation of medicine for treating osteroporosis and medicine composition
CN105687317B (en) * 2016-03-08 2021-01-01 宁夏医科大学 Application of total flavonoids of cinnamomum burmannii leaves in preparation of medicine for treating osteoporosis and medicine composition

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