CN105381039B - A kind of Chinese medicine composition and preparation method thereof for treating primary osteoporosis - Google Patents

Abstract

The invention discloses a kind of Chinese medicine compositions for treating primary osteoporosis, include following components according to mass parts: 6 parts~15 parts of radix paeoniae rubra, 6 parts~12 parts of cortex moutan, 10 parts~15 parts of Poria cocos, 3 parts~10 parts of Rhizoma Chuanxiong, 3 parts~10 parts of rhizoma corydalis, 3 parts~9 parts of safflower, 10 parts~15 parts of the rhizome of davallia, 5 parts~15 parts of Rhizoma Atractylodis Macrocephalae, 9 parts~15 parts of teasel, 3 parts~10 parts of dried orange peel, 10 parts~20 parts of the fruit of glossy privet, 3 parts~10 parts of Radix Glycyrrhizae.The invention also discloses a kind of preparation methods of Chinese medicine composition for treating primary osteoporosis.Composition of the invention can mitigate ostalgia, improve symptom, improve bone density, improve the quality of life of patient, reduce the incidence of side effect, highly-safe, to reach the purpose that can effectively treat primary osteoporosis and take for a long time.

Description

A kind of Chinese medicine composition and preparation method thereof for treating primary osteoporosis

Technical field

The invention belongs to Chinese herbal medicine preparation technology fields, and in particular to a kind of Chinese medicine group for treating primary osteoporosis Object is closed, the invention further relates to a kind of preparation methods of Chinese medicine composition for treating primary osteoporosis.

Background technique

Primary osteoporosis is common senile, degenerative disease, and disease incidence is high, and patient generally requires to receive length Phase treatment, this just determines that therapeutic agent should have good curative effect, and can be suitable for patient's long-term use, and safe.Chinese medicine is controlled Osteoporosis is treated, the incidence that clinical symptoms can be improved, bone density is improved, reduce fragility fractures.The sclerotin of research and development treatment at present Loose new drug has the following problems: (1) patients with osteoporosis is mostly the elderly, often with a variety of diseases, clinical syndrome It is relative complex.Traditional Chinese medicine thinks that the morbidity Etiological of osteoporosis is kidney deficiency, often and folder liver lose, the card such as weakness of the spleen and the stomach, blood stasis Wait, diagnosis and treatment based on an overall analysis of the illness and the patient's condition when comprehensively considering, and most of existing Chinese medicine new drug be using nourishing disney and strengthening bone as principle, it is dialectical not comprehensive enough, have Certain limitation, not only clinical efficacy is not good enough for clinical application, but also taking for a long time may cause liver and kidney dysfunction etc. is secondary to make With the purpose effectively treated is not achieved.(2) the drug composition of new Chinese medicine is nourishing liver and kidney, promoting blood circulation class drug, entirety mostly at present Prescription pharmacological property partial temperature, takes the side effect in terms of being easy to cause alimentary canal for a long time, and clinic should not be taken for a long time.

Summary of the invention

The object of the present invention is to provide a kind of Chinese medicine compositions for treating primary osteoporosis, solve the prior art Present in the problem of prescription is not reasonable, whole pharmacological property partial temperature, long-term administration may cause the generation of toxic side effect.

It is a further object of the present invention to provide a kind of preparation methods of Chinese medicine composition for treating primary osteoporosis.

First technical solution of the present invention is that a kind of Chinese medicine composition for treating primary osteoporosis is pressed Include following components according to mass parts: 6 parts~15 parts of radix paeoniae rubra, 6 parts~12 parts of cortex moutan, 10 parts~15 parts of Poria cocos, Rhizoma Chuanxiong 3 parts~10 Part, 3 parts~10 parts of rhizoma corydalis, 3 parts~9 parts of safflower, 10 parts~15 parts of the rhizome of davallia, 5 parts~15 parts of Rhizoma Atractylodis Macrocephalae, teasel 9 parts~15 Part, 3 parts~10 parts of dried orange peel, 10 parts~20 parts of the fruit of glossy privet, 3 parts~10 parts of Radix Glycyrrhizae.

Further, which includes following components according to mass parts: 10 parts of radix paeoniae rubra, 10 parts of cortex moutan, Poria cocos 12 parts, 10 parts of Rhizoma Chuanxiong, 10 parts of rhizoma corydalis, 9 parts of safflower, 15 parts of the rhizome of davallia, 8 parts of Rhizoma Atractylodis Macrocephalae, 15 parts of teasel, 5 parts of dried orange peel, the fruit of glossy privet 15 parts, 3 parts of Radix Glycyrrhizae.

Second technical solution of the present invention is a kind of system for the Chinese medicine composition for treating primary osteoporosis Preparation Method, specifically includes the following steps:

Step 1, it weighs, according to mass parts weighing following components: 6 parts~15 parts of radix paeoniae rubra, 6 parts~12 parts of cortex moutan, Poria cocos 10 parts~15 parts, 3 parts~10 parts of Rhizoma Chuanxiong, 3 parts~10 parts of rhizoma corydalis, 3 parts~9 parts of safflower, 10 parts~15 parts of the rhizome of davallia, Rhizoma Atractylodis Macrocephalae 5 Part~15 parts, 9 parts~15 parts of teasel, 3 parts~10 parts of dried orange peel, 10 parts~20 parts of the fruit of glossy privet, 3 parts~10 parts of Radix Glycyrrhizae；

Step 2, solarization drug is washed,

All medicines removing impurity that step 1 prepares is cleaned, is dried, sunning sterilization is borrowed；

Step 3, it processes,

The rhizome of davallia sheet of step 2 of learning from else's experience processing, carries out sand stir-fry, fries to heaving, takes out, unhairing；

The rhizoma corydalis of step 2 of learning from else's experience processing is added quantitative rice vinegar, mixes thoroughly, and bored profit to vinegar exhausts, and mild fire heats fried dry, takes Out, clast is weeded out；

It is the teasel of step 2 of learning from else's experience processing, Poria cocos, Rhizoma Atractylodis Macrocephalae, dried orange peel, the fruit of glossy privet, radix paeoniae rubra, cortex moutan, safflower, Rhizoma Chuanxiong, sweet Grass, it is raw to use, without processing；

Step 4, it decocts,

It is fitted into after said medicine is mixed drug by said ratio in the container being filled with water, container heating, boiling is boiled 30 minutes, well-done pharmaceutical filtration filtered out the dregs of a decoction, and the dregs of a decoction are added to water 400ml again, boils 10 minutes, then will mix medical fluid twice It closes and decoction is made, as treat the Chinese medicine composition of primary osteoporosis.

The beneficial effects of the present invention are: inventive formulation is the Empirical formula for treating primary osteoporosis, Chinese medicine is cured mainly It is dialectical based on caused by liver and kidney deficiency, have weakness of the spleen and the stomach and blood stasis syndrome patients with osteoporosis concurrently, with avirulent Chinese prescription, Strengthened the bone with nourishing liver and kidney, strengthening the spleen and stomach, blood-activating and qi-promoting, removing blood stasis and acesodyne, clearing heat and cooling blood are treatment criterion, full side's diagnosis and prescription rationally, Comprehensively, zoopery proves that we can significantly improve bone density, and its cure mechanism is illustrated from molecular mechanism, and clinic makes With ostalgia can be mitigated, improve symptom, improves bone density, improve the quality of life of patient, reduce the incidence of side effect, safety Property it is high, to reach the purpose that can effectively treat primary osteoporosis and long-term use.

Specific embodiment

The present invention is described in detail With reference to embodiment.

The present invention provides a kind of Chinese medicine composition for treating primary osteoporosis, includes with the following group according to mass parts Point: 6 parts~15 parts of radix paeoniae rubra, 6 parts~12 parts of cortex moutan, 10 parts~15 parts of Poria cocos, 3 parts~10 parts of Rhizoma Chuanxiong, rhizoma corydalis 3 parts~10 Part, 3 parts~9 parts of safflower, 10 parts~15 parts of the rhizome of davallia, 5 parts~15 parts of Rhizoma Atractylodis Macrocephalae, 9 parts~15 parts of teasel, 3 parts~10 parts of dried orange peel, 10 parts~20 parts of the fruit of glossy privet, 3 parts~10 parts of Radix Glycyrrhizae.

Further, which includes following components according to mass parts: 10 parts of radix paeoniae rubra, 10 parts of cortex moutan, Poria cocos 12 parts, 10 parts of Rhizoma Chuanxiong, 10 parts of rhizoma corydalis, 9 parts of safflower, 15 parts of the rhizome of davallia, 8 parts of Rhizoma Atractylodis Macrocephalae, 15 parts of teasel, 5 parts of dried orange peel, the fruit of glossy privet 15 parts, 3 parts of Radix Glycyrrhizae.

We are strengthened the bone using nourishing liver and kidney, strengthening the spleen and stomach, blood-activating and qi-promoting, removing blood stasis and acesodyne, clearing heat and cooling blood is the rules for the treatment of, teasel, bone Broken mend is monarch drug in a prescription, and function takes its nourishing liver and kidney, strengthening the bones and muscles, and it is all ministerial drug, while being equipped with red that Rhizoma Atractylodis Macrocephalae, Poria cocos, dried orange peel, which replenish qi to invigorate the spleen stomach, Flower, Rhizoma Chuanxiong, rhizoma corydalis be promoting blood circulation and removing obstruction in channels, promoting qi circulation and relieving pain, and radix paeoniae rubra, cortex moutan clearing heat and cooling blood, are adjutant with fruit of glossy privet enriching yin and nourishing kidney altogether, Radix Glycyrrhizae be make coordinating the drug actions of a prescription, all medicines share, Chinese medical discrimination is more comprehensive, solve clinically caused by liver and kidney deficiency and folder it is weakness of the spleen and the stomach, The treatment problem of the Osteoporosis complexity syndrome of blood stasis syndrome；Compatibility clearing heat and cooling blood drug simultaneously, reduces The partial temperature of whole prescription medicine is conducive to take for a long time in this way, and safety is good.Pass through above-mentioned reasonable formula, clinical practice card Bright we can significantly improve bone mineral density, mitigate ostalgia, improve constitutional symptom, improve the quality of living, take safety, play Effectively treat the purpose of primary osteoporosis.Zoopery proves that our cure mechanism is: by improving OPG gene Protein expression level, reduce the protein expression level of RNAKL gene, influence OPG-RANKL-RANK system, to adjust broken The differentiation of osteocyte reduces I type Procollagen C propetide (PICP) level, improves serum bone alkaline phosphatase (BALP) level, shows Write the bone density for improving osteoporosis model rat；Biomechanics experiment proves: we can significantly increase the bone of rat model The load and stress of breaking point improve the sclerotin intensity of rat model.

The present invention also provides a kind of preparation method of Chinese medicine composition for treating primary osteoporosis, specifically include with Lower step:

Step 1, it weighs, according to mass parts weighing following components: 6 parts~15 parts of radix paeoniae rubra, 6 parts~12 parts of cortex moutan, Poria cocos 10 parts~15 parts, 3 parts~10 parts of Rhizoma Chuanxiong, 3 parts~10 parts of rhizoma corydalis, 3 parts~9 parts of safflower, 10 parts~15 parts of the rhizome of davallia, Rhizoma Atractylodis Macrocephalae 5 Part~15 parts, 9 parts~15 parts of teasel, 3 parts~10 parts of dried orange peel, 10 parts~20 parts of the fruit of glossy privet, 3 parts~10 parts of Radix Glycyrrhizae.

Step 2, solarization drug is washed

All medicines removing impurity that step 1 prepares is cleaned, is dried, sunning sterilization is borrowed.

Step 3, it processes,

The rhizome of davallia sheet of step 2 of learning from else's experience processing, carries out sand stir-fry, fries to heaving, takes out, unhairing.

The rhizoma corydalis of step 2 of learning from else's experience processing is added quantitative rice vinegar, mixes thoroughly, and bored profit to vinegar exhausts, and mild fire heats fried dry, takes Out, clast is weeded out.

It is the teasel of step 2 of learning from else's experience processing, Poria cocos, Rhizoma Atractylodis Macrocephalae, dried orange peel, the fruit of glossy privet, radix paeoniae rubra, cortex moutan, safflower, Rhizoma Chuanxiong, sweet Grass, it is raw to use, without processing.

Step 4, it decocts,

It is fitted into after said medicine is mixed drug by said ratio in the container being filled with water, container heating, boiling is boiled 30 minutes, well-done pharmaceutical filtration filtered out the dregs of a decoction, and the dregs of a decoction are added to water 400ml again, boils 10 minutes, then will mix medical fluid twice It closes and decoction is made, take after the meal in two times.

Under instruction of Chinese Medicine theory, Chinese medicine composition critical medication are as follows: teasel function takes nourishing liver and kidney, strong waist and knee, and bone is broken It mends function and takes The strong bone of kidney tonifying effect, two medicines are the same as with for monarch drug in a prescription.Rhizoma Atractylodis Macrocephalae function takes strengthening the spleen and replenishing qi, and Poria cocos function takes invigorating the spleen excreting dampness, and dried orange peel function takes Regulating qi-flowing for strengthening spleen, three medicines are ministerial drug.Safflower takes its blood circulation, stasis-dispelling and pain-killing effect, and Rhizoma Chuanxiong takes blood-activating and qi-promoting analgesic efficacy, prolongs recklessly Rope promoting blood circulation to remove blood stasis regulating qi-flowing for relieving pain, three medicines, which share, has the function of promoting blood circulation and removing obstruction in channels, promoting qi circulation and relieving pain；Radix paeoniae rubra, cortex moutan cold nature, there is heat-clearing Cool blood effect, assistant control the property of above-mentioned many medicine warms, and fruit of glossy privet enriching yin and nourishing kidney, many medicines are adjutant.Radix Glycyrrhizae is to make coordinating the drug actions of a prescription, all medicines Share, it is indispensable, play altogether nourishing disney and strengthening bone, replenish qi to invigorate the spleen, promoting blood circulation, dredging meridian and relieving pain the effect of.

Chinese medicine combination object space key is: teasel, the rhizome of davallia, Rhizoma Atractylodis Macrocephalae, Poria cocos, dried orange peel, radix paeoniae rubra and cortex moutan.River is continuous Disconnected, rhizome of davallia function is in nourishing disney and strengthening bone, from osteoporosis main cause -- and kidney deficiency, which is started with, carries out treatment, solves root problem；And Rhizoma Atractylodis Macrocephalae, Poria cocos and three medicine of dried orange peel solve to lead to body insufficiency of natural endowment because weakness of the spleen and the stomach, occur then from human body the foundation of acquired constitution -- taste are set about The problem of osteoporosis；Radix paeoniae rubra and cortex moutan effect are clearing heat and cooling blood, reduce the warm nature of whole drug, avoid because taking for a long time Chinese medicine leads to the generation of toxic side effect.

Said medicine dosage the dosage as defined in National Pharmacopeia within the scope of, verify and determine repeatedly through clinic, Dosage is more, there are problems that drug safety, few then clinical efficacy is not good enough, while considering economic problems, and Chinese medicine combines object space Valence is than best.

Embodiment 1

A kind of preparation method of Chinese medicine composition that treating primary osteoporosis, specifically includes the following steps:

Step 1, it weighs, weigh following components: 10 parts of radix paeoniae rubra, 10 parts of cortex moutan, 12 parts of Poria cocos, Rhizoma Chuanxiong 10 according to mass parts Part, 10 parts of rhizoma corydalis, 9 parts of safflower, 15 parts of the rhizome of davallia, 8 parts of Rhizoma Atractylodis Macrocephalae, 15 parts of teasel, 5 parts of dried orange peel, 15 parts of the fruit of glossy privet, Radix Glycyrrhizae 3 Part.

Step 2, solarization drug is washed

All medicines removing impurity that step 1 prepares is cleaned, is dried, sunning sterilization is borrowed.

Step 3, it processes,

The rhizome of davallia sheet of step 2 of learning from else's experience processing, carries out sand stir-fry, fries to heaving, takes out, unhairing.

The rhizoma corydalis of step 2 of learning from else's experience processing is added quantitative rice vinegar, mixes thoroughly, and bored profit to vinegar exhausts, and mild fire heats fried dry, takes Out, clast is weeded out.

It is the teasel of step 2 of learning from else's experience processing, Poria cocos, Rhizoma Atractylodis Macrocephalae, dried orange peel, the fruit of glossy privet, radix paeoniae rubra, cortex moutan, safflower, Rhizoma Chuanxiong, sweet Grass, it is raw to use, without processing.

Step 4, it decocts,

It is fitted into after said medicine is mixed drug by said ratio in the container being filled with water, container heating, boiling is boiled 30 minutes, well-done pharmaceutical filtration filtered out the dregs of a decoction, and the dregs of a decoction are added to water 400ml again, boils 10 minutes, then will mix medical fluid twice It closes and decoction is made, take after the meal in two times.

Embodiment 2

A kind of preparation method of Chinese medicine composition that treating primary osteoporosis, specifically includes the following steps:

Step 1, it weighs, according to mass parts weighing following components: 6 parts of radix paeoniae rubra, 12 parts of cortex moutan, 10 parts of Poria cocos, Rhizoma Chuanxiong 10 Part, 3 parts of rhizoma corydalis, 9 parts of safflower, 10 parts of the rhizome of davallia, 15 parts of Rhizoma Atractylodis Macrocephalae, 9 parts of teasel, 10 parts of dried orange peel, 10 parts of the fruit of glossy privet, Radix Glycyrrhizae 10 Part.

Step 2, solarization drug is washed

All medicines removing impurity that step 1 prepares is cleaned, is dried, sunning sterilization is borrowed.

Step 3, it processes,

The rhizome of davallia sheet of step 2 of learning from else's experience processing, carries out sand stir-fry, fries to heaving, takes out, unhairing.

The rhizoma corydalis of step 2 of learning from else's experience processing is added quantitative rice vinegar, mixes thoroughly, and bored profit to vinegar exhausts, and mild fire heats fried dry, takes Out, clast is weeded out.

It is the teasel of step 2 of learning from else's experience processing, Poria cocos, Rhizoma Atractylodis Macrocephalae, dried orange peel, the fruit of glossy privet, radix paeoniae rubra, cortex moutan, safflower, Rhizoma Chuanxiong, sweet Grass, it is raw to use, without processing.

Step 4, it decocts,

It is fitted into after said medicine is mixed drug by said ratio in the container being filled with water, container heating, boiling is boiled 30 minutes, well-done pharmaceutical filtration filtered out the dregs of a decoction, and the dregs of a decoction are added to water 400ml again, boils 10 minutes, then will mix medical fluid twice It closes and decoction is made, take after the meal in two times.

Embodiment 3

A kind of preparation method of Chinese medicine composition that treating primary osteoporosis, specifically includes the following steps:

Step 1, it weighs, according to mass parts weighing following components: 15 parts of radix paeoniae rubra, 6 parts of cortex moutan, 15 parts of Poria cocos, Rhizoma Chuanxiong 3 Part, 10 parts of rhizoma corydalis, 3 parts of safflower, 15 parts of the rhizome of davallia, 5 parts of Rhizoma Atractylodis Macrocephalae, 15 parts of teasel, 3 parts of dried orange peel, 20 parts of the fruit of glossy privet, Radix Glycyrrhizae 3 Part.

Step 2, solarization drug is washed

All medicines removing impurity that step 1 prepares is cleaned, is dried, sunning sterilization is borrowed.

Step 3, it processes,

The rhizome of davallia sheet of step 2 of learning from else's experience processing, carries out sand stir-fry, fries to heaving, takes out, unhairing.

The rhizoma corydalis of step 2 of learning from else's experience processing is added quantitative rice vinegar, mixes thoroughly, and bored profit to vinegar exhausts, and mild fire heats fried dry, takes Out, clast is weeded out.

It is the teasel of step 2 of learning from else's experience processing, Poria cocos, Rhizoma Atractylodis Macrocephalae, dried orange peel, the fruit of glossy privet, radix paeoniae rubra, cortex moutan, safflower, Rhizoma Chuanxiong, sweet Grass, it is raw to use, without processing.

Step 4, it decocts,

It is fitted into after said medicine is mixed drug by said ratio in the container being filled with water, container heating, boiling is boiled 30 minutes, well-done pharmaceutical filtration filtered out the dregs of a decoction, and the dregs of a decoction are added to water 400ml again, boils 10 minutes, then will mix medical fluid twice It closes and decoction is made, take after the meal in two times.

Embodiment 4

A kind of preparation method of Chinese medicine composition that treating primary osteoporosis, specifically includes the following steps:

Step 1, it weighs, according to mass parts weighing following components: 9 parts of radix paeoniae rubra, 8 parts of cortex moutan, 14 parts of Poria cocos, 5 parts of Rhizoma Chuanxiong, 5 parts of rhizoma corydalis, 5 parts of safflower, 12 parts of the rhizome of davallia, 10 parts of Rhizoma Atractylodis Macrocephalae, 12 parts of teasel, 8 parts of dried orange peel, 12 parts of the fruit of glossy privet, 8 parts of Radix Glycyrrhizae.

Step 2, solarization drug is washed

All medicines removing impurity that step 1 prepares is cleaned, is dried, sunning sterilization is borrowed.

Step 3, it processes,

The rhizome of davallia sheet of step 2 of learning from else's experience processing, carries out sand stir-fry, fries to heaving, takes out, unhairing.

The rhizoma corydalis of step 2 of learning from else's experience processing is added quantitative rice vinegar, mixes thoroughly, and bored profit to vinegar exhausts, and mild fire heats fried dry, takes Out, clast is weeded out.

It is the teasel of step 2 of learning from else's experience processing, Poria cocos, Rhizoma Atractylodis Macrocephalae, dried orange peel, the fruit of glossy privet, radix paeoniae rubra, cortex moutan, safflower, Rhizoma Chuanxiong, sweet Grass, it is raw to use, without processing.

Step 4, it decocts,

It is fitted into after said medicine is mixed drug by said ratio in the container being filled with water, container heating, boiling is boiled 30 minutes, well-done pharmaceutical filtration filtered out the dregs of a decoction, and the dregs of a decoction are added to water 400ml again, boils 10 minutes, then will mix medical fluid twice It closes and decoction is made, take after the meal in two times.

Clinical case of the invention:

Patient's Mr. Lin, female 72 years old, aching pain in waist and back recurrent exerbation 2 years, knot with tinnitus, night lower limb, the soft knee acid of shin, Occasionally have a do not feel like eating, defecate often dilute soft, it is tired after fatiguability, check: ordinary circumstance can, for lumbar vertebrae without obvious tenderness, joint is living Dynamic normal, pale tongue, tongue fur be thin, print with teeth, and small and wiry pulse is slow, and Chinese medicine is given in lumbar spine bmd detection prompt osteoporosis, treatment Composition, is taken after the meal in two times by daily 1 dose, treats two weeks, and aching pain in waist and back is substantially reduced, and lower limb cramp number is reduced, greatly Just it can shape, treat 3 months, soreness of waist and knee joint is alleviated, and night knots without lower limb, and appetite is normal, and stool is normal, and tinnitus obviously subtracts Gently, without other malaise symptoms.Continue medication 3 months, for body without malaise symptoms, diet, stool are normal, lumbar spine bmd detection compared with It is significantly improved before treatment, duration of medication is reacted without discomfort.

Chen, female, 68 years old, soreness of waist and knee joint 1 year, occasionally there was lower limb cramp at night, and appetite is not good enough, and stool is even dilute soft, walking half Hour after soreness and weakness of waist and knees it is out of strength, check: ordinary circumstance can, for waist and knee joints without tenderness, joint motion is normal, pale tongue, tongue fur it is thin it is white, have Tooth print, small and wiry pulse, lumbar spine bmd detection prompt osteoporosis treat and give Chinese medicine composition, and daily 1 dose, in two times It takes after the meal, treats two weeks, soreness of waist and knee joint, lower limb cramp symptom are obviously improved, and are treated 3 months, uncomfortable symptom is basic Alleviate.Continue medication 3 months, body significantly improves before relatively treating without discomfort, lumbar spine bmd detection.The nontoxic secondary work of duration of medication With generation.

Poplar, female, 62 years old, aching pain in waist and back 3 months, Shen Ti Of-thin was weak, and night lower limb knot, long row fatiguability, do not feel like eating, Loose stool checks lumbar vertebrae without tenderness, and joint motion is normal, and pale tongue is fat, thin white, the with teeth print of tongue fur, veins string, lumbar spine bmd detection prompt Osteoporosis, treatment give Chinese medicine composition, daily 1 dose, take after the meal in two times, treat two weeks, soreness of waist and knee joint, under Limb cramp, appetite, loose stool symptom are obviously improved, and are treated 3 months, uncomfortable symptom is alleviated substantially.Continue medication 3 months, body Body significantly improves before relatively treating without malaise symptoms, lumbar spine bmd detection.Have no toxic side effect generation during medication.

Beneficial effects of the present invention are discussed below with reference to specific experimentation:

One, material

1. experimental animal

6 monthly age cleaning grade female sd inbred rats 40, are provided by Shanghai Slac Experimental Animal Co., Ltd., and experiment is dynamic Object credit number: SCXK (Shanghai) 2007-0005, quality certification number: 2007000530078.In Fujian Institute of Traditional Chinese Medicine's ratio It is raised compared with Medical experimental center, medical experiment animal environment facility is cleaning grade [quality certification number: SYXK (Fujian) 2009- 000]。

2. experimental drug

Present composition composition: crude drug is purchased by pharmaceuticals, Fujian Province.

Rat oral gavage amount calculation method:

People 50Kg:122 ÷ 50=2.44g/kg/ days

Rat oral gavage amount: 2.44 × 6.25 times=15g/kg

122g ÷ 81.33ml=1.5g/ml

Constant volume is to 81.33ml, raw drug content 1.5g/ml after one traditional Chinese medicine decocting.

I.e. rat oral gavage amount is 1ml/100g rat body weight.

10 doses of invention formula Chinese medicine medicine materical crude slice 1220g are added into distilled water immersion 30min by Chinese medicine tradition decocting method, are boiled 30min pours out medical fluid, and the dregs of a decoction add 5 times of distilled water, then boil 20min, pour out medical fluid, mixes 2 medical fluids and filters, is concentrated into 813.0ml (1.5g crude drug/ml), packing, saves backup in 4 DEG C of refrigerators.

3. reagent

The production of Allan sodium phosphate piece (Fosamax) Hangzhou Mo Shadong pharmaceutical Co. Ltd, specification: 70mg/ piece；Caltrate D favour The production of family name pharmaceutical Co. Ltd, specification: 600mg/ piece；Elisa kit (TSZ company, the U.S.), Elisa kit (U.S. TSZ Company), pvdf membrane (Invitrogen company)；Primary antibody (Abcam company)；(Thermo Scientific is public for ECL luminescence reagent Department).

4. instrument

Discovery Wi Dual-energy X-rays absorptionmetry (Hologic company, the U.S.), universal testing machine AGIC-20KN (Japanese Shimadzu Corporation), (U.S. Protein simple FluorChem M is public for multicolor fluorescence/chemiluminescence imaging work station Department), detection of nucleic acids instrument 2100 (Agilent company, the U.S.).

Two, method

1. grouping

Select the healthy 6 monthly age SD female rats 40 of cleaning grade, be randomly divided into 4 groups: Caltrate D group, inventive formulation group, Sham-operation group, removal ovary osteoporosis model group.Every group 10.

2, the modeling of osteoporosis model rat and administration

Selection SD rat 40, modeling method row bilateral oophorectomy, the specific steps are as follows: with 2% yellow Jackets 40mg/kg intraperitoneal injection of anesthesia, operative site cropping disinfection, takes abdomen median incision about 2cm, into after abdominal cavity, it is seen that rat Y The uterus of shape, after the spy of uterus bilateral and left and right end ovary, row ligation resection, by stomach wall layer-by-layer suture.Postoperative 3 days continuous Intramuscular injection penicillin prevention infection (80,000 units/only).Sham-operation group is in addition to the ligation excision of non-row ovary, remaining step and operation group It is identical.In the treatment of beginning stomach-filling in postoperative 30 days, 6.25 times of the weight clinic doses such as rat dosage is.

Specific as follows: Alendronate sodium group stomach-filling amount is 8.2mg/kg, once a week；Caltrate D dosage is 0.126g/ (kgd), stomach-filling in afternoon；Inventive formulation 10ml/kg, morning stomach-filling；Sham-operation group and model group are often only given physiological saline 10ml/kg.Groups of animals in temperature 25C, relative humidity 70-80%, is divulged information, under the environment of illumination abundance, and generic word is given Expect that word is supported, free water is move freely.

3. materials

It draws materials respectively after being administered 12 weeks, every group 10.After 10% chloral hydrate anesthesia, by abdominal aortic blood, then Take bilateral tibial and lumbar vertebra.After taken whole blood is stored at room temperature Ih, it is centrifuged lOmin through 3000rmp, takes serum, -80 DEG C of preservations. Right side shin bone is fixed with 4% neutral paraformaldehyde, and left tibias is wrapped up with physiological saline gauze, be stored in after sealed bag sealing- 20 DEG C, for detecting bone density and biomethanics.Lumbar vertebra directly freezes in -80 DEG C of refrigerators.

4, detection method

4.1 Bone mineral density

Left tibias bone densitometry is carried out using Dual-energy X-rays absorptionmetry.

The detection of 4.2 bone biomechanicals

All left tibias are returned to room temperature after taking out in -20 DEG C of low temperature refrigerators, and keep physiological saline wet.It is multiple Shin bone is placed on universal testing machine by Wen Hou using three-point bending method, support span 20mm, is reinforcing with shin bone midpoint Point, pressure-loaded speed 1mm/min, until fracture of tibia, load and deformation trace load-deflection curve by computer.It surveys Shin bone internal diameter, outer diameter are measured, biomechanical is obtained by computer record analysis: maximum load and maximum stress.

4.3 serum BALP and PICP detection

Using Elisa kit, takes enzyme to be coated with plate, be fixed on frame, standard sample wells, instrument connection and blank is respectively set Control wells add standard items 50ul in gauge orifice；After 40ul sample diluting liquid is added in instrument connection, 10ul rat blood serum is added Sample；Blank well is not loaded.After sample-adding, is incubated with 37 DEG C of postposition of sealing plate film sealing plate, take sealing plate film off after 30 minutes, discard liquid Body, drying.It concentrated cleaning solution board-washing 5 times after 20 times being diluted, pats dry.Then 50 μ l of enzyme marking reagent, blank well is added in every hole Except.Continue 37 DEG C of incubation 30min, board-washing 5 times.50 μ l of color developing agent A is first added in every hole later, adds 50 μ l of color developing agent B, 37 DEG C are protected from light colour developing 15 minutes.Terminate liquid 50ul is added to terminate reaction (blue is vertical at this time turns yellow), last 450nm wavelength measurement is each The absorbance in hole.

The detection of 4.4OPG, RNAKL protein expression

Extract gross protein from lumbar vertebrae bone and its cells, ultraviolet spectrophotometry photometric determination protein concentration, poly- third Acrylamide gel electrophoresis.Glue is turned after electrophoresis to impregnate 15min in liquid in electricity, the clip pvdf membrane equal with gel area and two Filter paper is equally soaked in electricity and turns 10min in liquid.Porous gasket is impregnated with after electricity turns liquid, electric rotary device, sequence are as follows: anode are installed (red), porous gasket, filter paper, pvdf membrane, gel, filter paper, porous gasket, cathode (black).Electric carryover sequence: 110v is set 1.5h.Pvdf membrane is placed in confining liquid later, room temperature jog 2h or 4 DEG C are overnight.Film is washed with TBST solution, adds primary antibody, secondary antibody, Wash film.Finally using super quick ECL chemical luminescence reagent kit and with gel imaging system testing result.

5, statistics

Data analysis is carried out using 17.0 software of SPSS, is compared using t inspection, P < 0.05 indicates statistically significant.

Three, result

1. bone density compares between group

Inventive formulation group bone density highest in 4 groups, bone density is obviously higher than sham-operation group, Caltrate D group and mould Type group, statistical difference very significant (compared with Caltrate D group t=2.4867, p < 0.023, the t=compared with sham-operation group 3.3499, p < 0.01, the t=5.5133 compared with model group, p < 0.000).It is shown in Table 1.

Table 1, each group bone density value compare (g/cm²)

Note: compared with inventive formulation group, " * " indicates that p < 0.05, " * * * " indicate p < 0.000.

2, bone biomechanical compares between group

Inventive formulation group breaking point maximum load is significantly higher than model group (t=2.4469, p < 0.05)；

Inventive formulation group breaking point maximum stress is significantly higher than model group (t=2.3521, p < 0.05).It is shown in Table 2.

Table 2, each group rat fracture point load, stress and strain are compared

Note: compared with inventive formulation group, " * " indicates p < 0.05.

3, serum BALP and PICP compare between group

Each group rat type I Procollagen C propetide (PICP), serum bone alkaline phosphatase (BALP) concentration compare, the present invention Formula group BALP concentration is apparently higher than model group (t=3.6435, p < 0.01)；

Inventive formulation group PICP concentration is significantly lower than model group (t=4.0491, p < 0.001).It is shown in Table 3.

Table 3, each group serum BALP, PICP level compare

Note: compared with inventive formulation group, " * * " indicates that p < 0.01, " * * * " indicate p < 0.001.4, OPG between group, RNAKL protein expression compares

Inventive formulation group OPG protein concentration is apparently higher than model group (t=2.1359, p < 0.05)；

Inventive formulation group RNAKL protein concentration is significantly lower than model group (t=3.2168, p < 0.01).It is shown in Table 4.

Table 4, each group OPG, RNAKL protein expression level compare

Note: compared with inventive formulation group, " * " indicates that p < 0.05, " * * " indicate p < 0.01.

Conclusion

Above-mentioned zoopery proves: inventive formulation can be improved the protein expression level of OPG gene, reduce RNAKL base The protein expression level of cause reduces I type Procollagen C propetide (PICP) level, improves serum bone alkaline phosphatase (BALP) water It is flat, the bone density of osteoporosis model rat is significantly improved, while the maximum of bone breaking point for being significantly enhanced rat model carries Lotus and maximum stress improve the intensity of bone.

Claims (2)

1. a kind of Chinese medicine composition for treating primary osteoporosis, which is characterized in that Chinese medicine composition according to mass parts by Following components composition: 6 parts~15 parts of radix paeoniae rubra, 6 parts~12 parts of cortex moutan, 10 parts~15 parts of Poria cocos, 3 parts~10 parts of Rhizoma Chuanxiong, prolong recklessly 3 parts~10 parts of rope, 3 parts~9 parts of safflower, 10 parts~15 parts of the rhizome of davallia, 5 parts~15 parts of Rhizoma Atractylodis Macrocephalae, 9 parts~15 parts of teasel, dried orange peel 3 Part~10 parts, 10 parts~20 parts of the fruit of glossy privet, 3 parts~10 parts of Radix Glycyrrhizae.

2. the Chinese medicine composition for the treatment of primary osteoporosis according to claim 1, which is characterized in that further Ground, the Chinese medicine composition are composed of the following components according to mass parts: 10 parts of radix paeoniae rubra, 10 parts of cortex moutan, 12 parts of Poria cocos, Rhizoma Chuanxiong 10 Part, 10 parts of rhizoma corydalis, 9 parts of safflower, 15 parts of the rhizome of davallia, 8 parts of Rhizoma Atractylodis Macrocephalae, 15 parts of teasel, 5 parts of dried orange peel, 15 parts of the fruit of glossy privet, Radix Glycyrrhizae 3 Part.