CN101104035A - Medicine composition for treating hyperosteogeny disease and preparation method - Google Patents
Medicine composition for treating hyperosteogeny disease and preparation method Download PDFInfo
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- CN101104035A CN101104035A CNA2007102002035A CN200710200203A CN101104035A CN 101104035 A CN101104035 A CN 101104035A CN A2007102002035 A CNA2007102002035 A CN A2007102002035A CN 200710200203 A CN200710200203 A CN 200710200203A CN 101104035 A CN101104035 A CN 101104035A
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Abstract
The invention relates to a Chinese herbal preparation, namely, a drug compound for treating hyperosteogeny and the preparation method. The drug is prepared by the following weights of raw materials: 160-240g of radix rehmanniae preparata, 110-170g of shorthorned epimedium Herb (made from suet oil), 110-170g of caulis spatholobi, 110-170g of rhizoma cibotii, 110-170g of rhizoma drynariae (hot), 50-100g of Semen raphani (fried), 110-170g of songaria cynomorium Herb, 50-100g of fructus lycii and 50-100g of radix dipsaci. The preparation has the advantages of reasonable prescription, scientific preparation method, therapeutic treatment and low side effect. The total effective rate of the preparation can be achieved 92 percent after clinical experiments for three-hundred patients.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation, promptly treat the pharmaceutical composition and the preparation method of hyperosteogeny disease.
Background technology
In prior art, hyperosteogeny, cervical vertebra syndrome, bony spur, osteoporosis, rheumatic arthritis, lumbar muscle strain are a kind of common frdquently encountered diseases of harm middle-aged and elderly people, greatly endanger and influenced people's health and normal daily life work.The traditional Chinese medical science thinks that joint property diseases such as cervical spondylosis, hyperosteogeny, prolapse of lumbar intervertebral disc, tetanic property neck post inflammation, sciatica and scapulohumeral periarthritis are the immunodefiiciency inflammatory reactions of vertebrae tissue such as a kind of periosteum, bone liquid, cartilage, answer kidney tonifying to give birth to marrow in the treatment, relaxing muscles and tendons and activating QI and blood in the collateral it.The medicament categories of treatment hyperosteogeny disease is various, and curative effect is different.
Summary of the invention
The pharmaceutical composition and the preparation method that provide a kind of curative effect to treat hyperosteogeny disease reliably at disease is provided.
Technical solution of the present invention is: it is made a kind of pharmaceutical composition for the treatment of hyperosteogeny disease by the raw material of following weight: Radix Rehmanniae Preparata 160-240g, Herba Epimedii (Adeps caprae seu ovis system) 110-170g, Caulis Spatholobi 110-170g, Rhizoma Cibotii (processed with salt) 110-170g, Rhizoma Drynariae (scalding) 110-170g, Semen Raphani (stir-fry) 50-100g, Herba Cynomorii 110-170g, Fructus Lycii 50-100g and Radix Dipsaci 50-100g.
Can be mixed and made into tablet, capsule (soft capsule), granule, powder, pill, oral liquid or other conventional formulation by pharmaceutical carrier, additive or adjuvant commonly used in above-mentioned each medicinal raw material and the pharmacy.
Tabules: it makes 1000 by the raw material and the conventional pharmaceutic adjuvant of following weight: Radix Rehmanniae Preparata 208g, Herba Epimedii (Adeps caprae seu ovis system) 140g, Caulis Spatholobi 140g, Rhizoma Cibotii (processed with salt) 140g, Rhizoma Drynariae (scalding) 140g, Semen Raphani (stir-fry) 70g, Herba Cynomorii 140g, Fructus Lycii 70g and Radix Dipsaci 70g.Trade name: bone increases the sheet that disappears.
The Adeps caprae seu ovis system of Herba Epimedii is meant: get the Adeps caprae seu ovis heat fused, add Herba Epimedii, fry to even glossy getting final product with slow fire.
The Rhizoma Cibotii processed with salt is meant: gets clean Rhizoma Cibotii and adds the saline stirring, and vexed, put in the pot, with the slow fire heating, fry dried getting final product.
Rhizoma Drynariae scalds and is meant: get fluvial sand and put in the pot, after frying with high heat, add clean Rhizoma Drynariae, constantly stir, scald to cokled surface, hit unhairing and get final product.
Semen Raphani is fried and is meant: get clean Semen Raphani, put in the heat pot, frying extremely with slow fire, little heaving gets final product.
Preparation method: Rhizoma Cibotii, the Herba Epimedii of getting ormal weight are ground into fine powder, sieve; Seven flavors such as remaining Radix Rehmanniae Preparata, decoct with water secondary, each 1.5 hours, gradation filters, merging filtrate, filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.35 (60-70 a ℃), be mixed with above-mentioned powder, dry, pulverize, system granule, drying, tabletting, sugar coating or film-coat, promptly.
Get orthopaedics principal agent Rhizoma Drynariae in the side: bitter, warm.Return kidney, Liver Channel, energy the kidney invigorating bone strengthening, continue and hinder pain relieving, invigorate blood circulation, stop blooding, control suffer from a deficiency of the kidney chronic diarrhea and lumbago, diseases such as rheumatic arthralgia.Caulis Spatholobi is mended with flesh and blood, blood and is not lost strong muscle, the not empty then nourishing muscle and tendon of blood.Icariine has the body of increasing non-specific immunity, can improve cytophagous phagocytic activity, promotes LT effect.Assistant with the Rhizoma Cibotii invigorating the liver and kidney, remove rheumatism, strong waist foot and the kidney invigorating to the marrow, prevention joint muscles and bones is strong.The spring is stayed in the Radix Rehmanniae Preparata skin care, draws the panacea for comprehensive cure.Semen Raphani, hot, sweet, flat, return lung, spleen, stomach warp, help digestion to remove and expand lowering the adverse-rising QI to resolve phlegm.All medicine compatibilities, really can kidney tonifying give birth to marrow and be first, bone strengthening marrow it, " Gu the liver nourishing muscle and tendon is auxilliary ", relaxing muscles and tendons and activating QI and blood in the collateral, analgesia attached it, be ideal orthopaedics good medicine.
Function with cure mainly: the liver and the kidney tonifying, invigorate blood circulation.Be used for the bone matrix hyperplasia such as waist kneecap joint aches due to Liver and kidney two void.
Advantage of the present invention is: be pure Chinese medicinal preparation, and reasonable recipe, the method for making science, drug effect is definite, and toxic and side effects is little.Through 300 routine patient's clinical trials, total effective rate 92%.
Below in conjunction with embodiment and experimental example the present invention is described in further detail.
The specific embodiment
Embodiment 1
Bone increases the sheet that disappears: raw material and conventional pharmaceutic adjuvant by following weight are made 1000: Radix Rehmanniae Preparata 208g, Herba Epimedii (Adeps caprae seu ovis system) 140g, Caulis Spatholobi 140g, Rhizoma Cibotii (processed with salt) 140g, Rhizoma Drynariae (scalding) 140g, Semen Raphani (stir-fry) 70g, Herba Cynomorii 140g, Fructus Lycii 70g and Radix Dipsaci 70g.
Embodiment 2
Preparation method: raw material: see embodiment 1.Rhizoma Cibotii, the Herba Epimedii of getting ormal weight are ground into fine powder, sieve; Seven flavors such as remaining Radix Rehmanniae Preparata, decoct with water secondary, each 1.5 hours, gradation filters, merging filtrate, filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.35 (60-70 a ℃), be mixed with above-mentioned powder, dry, pulverize, system granule, drying, tabletting, sugar coating or film-coat, promptly.
Experimental example 1: bone increases the sheet acute toxicity test in mice that disappears
Summary: increase the sheet suspension 20g/kg (being equivalent to the 32g crude drug) that disappears with bone, give the mouse stomach administration twice on the one, none dead and generation toxic reaction of mice is 25.6g medicated powder/kg so record oral this medicine maximum tolerated dose of mice in 7 days, is equivalent to 320 times of clinical consumption.
Test objective: according to the maximum tolerance determination method under " new drug research guide " acute toxicity item, increase when disappearing sheet LD50 can't measuring bone, we have carried out maximum tolerance determination to this medicine.
Experiment material
Medicine: it is the preparation that nine flavor Chinese medicines such as Radix Rehmanniae Preparata, Rhizoma Cibotii, Herba Epimedii, Rhizoma Drynariae are formed that bone increases the sheet that disappears.Provide by Tonghua Zhenghe Pharmaceutical Industry Co., Ltd., remove sugar-coat during test, grind, be made into the desired concn medicinal liquid, use for gastric infusion with distilled water.
Animal: Kunming mouse, body weight 18-20g, male and female half and half, animal housing provides by the institute for drug control, Jilin Province.The animal quality certification number: 10-1008
Experimental technique
1, median lethal dose(LD 50) LD50 measures: get 20 of mices, body weight 18-20g male and female half and half, after breeding observing 1 day is no abnormal, fasting be can't help water 12 hours, increase disappear sheet 20% concentration with bone next day, the maximum stomach 40ml/kg that irritates, 20g/kg (being equivalent to crude drug in whole 12.8g) gives the disposable filling stomach of mice, observes to have or not animal dead in 48 hours and toxic reaction takes place.
All are tried none dead and generation toxic reaction of mice to the result in 48 hours.
2, maximum tolerance determination: get 20 of mices, body weight 18-20g male and female half and half, fasting be can't help water 12 hours, increased the sheet Cmax 20% that disappears by bone next day and gave mouse stomach, the each 0.4ml of every Mus, administration is 2 times in 1 day, each dosing interval 6 hours, and its 2 times are irritated the stomach total amount is 0.8ml, this dosage is equivalent to 25.6 medicated powder/kg, be equivalent to clinical 320 times of being, observed 7 days continuously after the administration, observe activity, hair color, feed and the death condition of animal.
3, result: the movable minimizing behind the animals administer, be rest state, recover normal activity behind the 30min, to observe continuously 7, all are tried mice, and none is dead and toxic reaction takes place, and the mice hair color, that food ration, two just reaches active situation is all no abnormal.Experiment finishes the back and puts to death mice, the no abnormal variations of internal organs such as the heart of perusal animal, liver, spleen, lung, kidney.
Brief summary: the chmice acute toxicity test is the result show, it is very little that bone increases the sheet oral toxicity that disappears, and fails to measure LD
50, when giving the mice maximum tolerated dose, there are not obvious poisoning symptom and dead the generation, so be limited to the administration volume, recording the oral bone of mice, to increase the sheet maximum tolerated dose that disappears be 25.6g medicated powder/kg, this concentration is equivalent to 320 times of clinical consumption.Illustrate that it is that a kind of toxicity is very little that bone increases the sheet that disappears, and takes the big medicine of safety range.(material preservation place: pharmacological room of Changchun Traditional Chinese Medical College)
Experimental example 2: bone increases the sheet treatment cervical spondylosis 300 routine clinical experiment reports that disappear
(1), physical data
This ordinary circumstance of organizing 400 routine people (outpatient service and inpatient) sees table 1-table 4 for details
1, sex
The table 1 liang comparison that the group sex distributes
| n | The man | The woman | X 2 | P | |
| Observation group's matched group | 300 100 | 168 65 | 132 35 | 0.744 | ＞0.05 |
As can be seen from Table 1, two groups of comparisons that sex distributes are through X
2P＞0.05 is handled in check, illustrates that it is balanced comparable that two groups of sexes distribute.
2, the age
The comparison of table 2 liang group age distribution
| n | 30- | 40- | 50- | X 2 | P | |
| Observation group's matched group | 300 100 | 47 14 | 126 39 | 127 47 | 1.215 | ＞0.05 |
As can be seen from Table 2, the comparison of two groups of age distribution is through X
2P＞0.05 is handled in check, illustrates that two groups of age distribution are balanced comparable.
3, pathology
The table 3 liang comparison (year) that the group course of disease distributes
| n | ≤1 | ≤3 | ≤5 | ＞5 | X 2 | P | |
| Observation group's matched group | 300 100 | 67 16 | 85 32 | 93 37 | 55 15 | 1.436 | ＞0.05 |
As can be seen from Table 3, the comparison of two groups of age distribution is through X
2P＞0.05 is handled in check, illustrates that it is balanced comparable that two groups of courses of disease distribute.
4, tcm syndrome
The comparison of disease integration before table 4 liang group is treated
| n | X±S | t | P | |
| Observation group's matched group | 300 100 | 34.85±6.18 32.48±7.03 | 07677 | ＞0.05 |
As can be seen from Table 4, two groups of comparisons for the treatment of preceding disease integration through t check analysis P＞0.05, illustrate that the preceding syndrome integration of two groups of patient treatments is balanced comparable.
(2), test method
1, the clinical trial employing is parallel at random, and the double blind control method is carried out
2, experimental animal
Bone increases the sheet that disappears: oral 1 time 6,3 times on the 1st.Tonghua just provides with Pharmaceutical
The contrast medicine: GUCIPING PIAN, oral 1 time 6,3 times on the 1st.
In observing treatment, ban use of other drug with therapeutical effect.
3, the course of treatment this test course of treatment was 3 weeks
(3) observed and recorded of testing data
1, all cases are conscientiously filled up a form all by such scheme, can not arbitrarily alter case history, and various laboratory datas all should record, and need be bonded at initial report on the medical history record.
2, note observing whether the untoward reaction generation is arranged,, should give discriminating, handle, and carry out record as abnormal symptom and sign.
(4), result of the test
1, curative effect determinate standard
(1) clinical recovery: pain, numbness or symptom, sign integration such as dizzy reduce 〉=95%, and the X line shows normal.
(2) produce effects: pain, numbness or symptom, sign integration such as dizzy reduce 〉=70%,＜95%, and the X line shows and is clearly better.
(3) effective: produce effects: pain, numbness or symptom, sign integration such as dizzy reduce 〉=30%,＜70%, and the demonstration of X line is clearly better.
(4) invalid: produce effects: pain, numbness or symptom, sign integration less than 30% such as dizzy, X line show not have and change.
(5) result of the test and efficacy analysis
This observes 400 routine patients, and result of the test and efficacy analysis see Table 5-table 6
Table 5 liang group treatment efficient comparison (%)
| n | Clinical recovery | Produce effects | Invalid | u | p | |
| Observation group's matched group | 300 100 | 42(14.00) 11(11.00) | 76(25.33)158(52.67) 17(17.00)60(60.00) | 24(8.00) 12(12.00) | 0.7854 | ＞0.05 |
As can be seen from Table 5, it is 14.00% that bone increases the sheet treatment cervical spondylosis clinical recovery rate that disappears, and obvious effective rate is 25.33%, effective percentage is 52.67%, and inefficiency is 8.00%, and matched group clinical drug rate is 11.00%, obvious effective rate is 17.00%, and effective percentage is 60.00%, inefficiency 12.00.Two groups of total effectses are through the Ridit Treatment Analysis, u=0.7854, p＞0.05 liang group curative effect there was no significant difference.
It is the same with the matched group medicine to tcm symptom that bone increases the sheet that disappears, and there was no significant difference p＞0.05 of comparing between p＜0.01 or p＜0.05, two group of improving is in various degree all arranged.
The comparison (%) that X line place changes before and after the table 6 liang group treatment
| n | Normally | Be clearly better | Take a turn for the better | Do not have and change | u | p | |
| Observation group's matched group | 300 100 | 42(14.00) 11(11.00) | 78(26.00) 18(18.00) | 155(51.67) 58(58.00) | 25(8.33) 13(13.00) | 0.6752 | ＞0.05 |
Taking bone as can be seen from Table 6 increases the sheet that disappears X-ray film is recovered is 14.00% normally, what be clearly better is 26.00%, transfer 51.67% to well, do not have and to change into 8.33%, taking control drug, the X line is recovered is 11.00% normally, and what be clearly better is 58.00%, unaltered is 13.00%, relatively analyze u=0.6752, p＞0.05 liang group curative effect there was no significant difference for two groups through Ridit.
(6), discuss
Cervical spondylosis is clinical middle commonly encountered diseases, frequently-occurring disease, has the long and numerous and diverse characteristics of symptom of the course of disease.Have a strong impact on people's orthobiosis and routine work.It is the active drug of effectively treating cervical spondylosis, cervical vertebra syndrome, proliferative cervical spondylosis that bone increases the sheet that disappears.
Through the clinical observation finding, the clinical recovery rate that bone increases the sheet treatment cervical spondylosis that disappears is 14.00%, obvious effective rate is 25.33%, effective percentage is 17.00%, total effective rate is 92.00%, and matched group clinical drug cure rate is 11.00%, obvious effective rate 17.00%, effective percentage is 60.00%, and total effective rate is 88.00%.Two groups of general curative effects are through Ridit Treatment Analysis p＞0.05, there was no significant difference.Bone increase disappear sheet to tcm symptom all have in various degree improve p＜0.01 or p＜0.05, compare no significance difference p＞0.05 with matched group.Bone increases the sheet that disappears, and X-ray film is recovered is 14.00% normally, and being clearly better is 26.00%, transfers 51.67% to well, does not have and changes into 8.33%.Compare there was no significant difference p＞0.05 with matched group.
Aspect safety observation, to find to take bone and increase the sheet that disappears blood, urine, just conventional, liver, renal function and Electrocardiographic abnormal change p＞0.05 do not occur in the middle of the observation process life influenced p＞0.05.The clinical use that this medicine is described is safe.In sum, the clinical efficacy that bone increases the sheet treatment cervical spondylosis that disappears is satisfied, and clinical obvious adverse reaction safe in utilization, convenient, no.
Claims (4)
1. pharmaceutical composition for the treatment of hyperosteogeny disease is characterized in that it is made by the raw material of following weight: Radix Rehmanniae Preparata 160-240g, Herba Epimedii (Adeps caprae seu ovis system) 110-170g, Caulis Spatholobi 110-170g, Rhizoma Cibotii (processed with salt) 110-170g, Rhizoma Drynariae (scalding) 110-170g, Semen Raphani (stir-fry) 50-100g, Herba Cynomorii 110-170g, Fructus Lycii 50-100g and Radix Dipsaci 50-100g.
2. according to the pharmaceutical composition of the described treatment hyperosteogeny disease of claim 1, it is characterized in that it being tablet, capsule, granule, oral liquid or pill.
3. according to the pharmaceutical composition of claim 1 or 2 described treatment hyperosteogeny diseases, it is characterized in that it makes 1000 by the raw material and the conventional pharmaceutic adjuvant of following weight: Radix Rehmanniae Preparata 208g, Herba Epimedii (Adeps caprae seu ovis system) 140g, Caulis Spatholobi 140g, Rhizoma Cibotii (processed with salt) 140g, Rhizoma Drynariae (scalding) 140g, Semen Raphani (stir-fry) 70g, Herba Cynomorii 140g, Fructus Lycii 70g and Radix Dipsaci 70g.
4. the preparation of drug combination method of a treatment hyperosteogeny disease as claimed in claim 3, it is characterized in that step is as follows: Rhizoma Cibotii, Herba Epimedii are ground into fine powder, sieve; Seven flavors such as remaining Radix Rehmanniae Preparata, decoct with water secondary, each 1.5 hours, gradation filters, merging filtrate, filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.35 (60-70 a ℃), be mixed with above-mentioned powder, dry, pulverize, system granule, drying, tabletting, sugar coating or film-coat, promptly.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101337014B (en) * | 2008-08-11 | 2011-06-01 | 李翠华 | Traditional Chinese medicine patch for treating internal and external injury |
| CN104940426A (en) * | 2015-07-19 | 2015-09-30 | 吉林省正和药业集团股份有限公司 | Preparation method and application of osteoproliferation removal tablets |
| CN107412429A (en) * | 2017-09-11 | 2017-12-01 | 江西华太药业有限公司 | A kind of bone increases capsule for eliminating and preparation method |
-
2007
- 2007-02-13 CN CNA2007102002035A patent/CN101104035A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101337014B (en) * | 2008-08-11 | 2011-06-01 | 李翠华 | Traditional Chinese medicine patch for treating internal and external injury |
| CN104940426A (en) * | 2015-07-19 | 2015-09-30 | 吉林省正和药业集团股份有限公司 | Preparation method and application of osteoproliferation removal tablets |
| CN107412429A (en) * | 2017-09-11 | 2017-12-01 | 江西华太药业有限公司 | A kind of bone increases capsule for eliminating and preparation method |
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Open date: 20080116 |