CN1799583A - Medicine for treating cervical disease and its preparation method - Google Patents
Medicine for treating cervical disease and its preparation method Download PDFInfo
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Abstract
The invention discloses a medicament for treating cervical vertebra diseases and method for preparation, wherein the medicament is prepared from kudzu vine root, epimeddium, astragalus root, root of herbaceous peony, Chinese angelica root, Ligusticum wallichii, corydalis tuber, notoginseng, Chinese flowering quince, batryticated silkworm, licorice root, peach kernels, bark of peony root, pubescent angelica root and notopterygium root.
Description
Affiliated technical field
The present invention relates to a kind of preparation method for the treatment of medicine and this medicine of cervical spondylosis.
Background technology
Cervical spondylosis claims cervical spine syndrome again, is because cervical vertebra, intervertebral disc and muscles degenerative change on every side thereof cause meridians to check, and QI-blood circulation is not smooth, and cause neck shoulder arm pain, numbness, unable or dizzy, tinnitus, a series of condition of illness and sign such as damping off.Cervical spondylosis is a kind of commonly encountered diseases, frequently-occurring disease, is more common in the prime of life or crowd old and that bow for a long time and bend over one's desk working, and the male can betide any age more than the women, is many with the middle-aged and elderly people more than 40 years old, and sickness rate increases with the growth at age.According to statistics, 25% morbidity being arranged approximately among the crowd about 50 years old, 60 years old then was to be almost 100% in about 50%, 70 years old.This disease has the sickness rate height, and treatment time is long, characteristics such as recurrence very easily after the treatment.
Summary of the invention
The object of the present invention is to provide a kind of the have strong bone of dispelling wind collateral dredging, QI invigorating, activating blood circulation to dissipate blood stasis, promoting the circulation of QI to relieve pain, the treatment of cervical spondylopathy agent of symptom such as alleviate neck shoulder arm pain that cervical spondylosis causes, numbness, unable, movable unfavorable, dizziness and tinnitus, damping off.
Another object of the present invention provides the preparation method of this treatment of cervical spondylopathy agent.
The treatment of cervical spondylosis should be with the strong bone of Shujin, and benefiting QI for activating blood circulation, removing obstruction in the collateral to relieve pain are criterion.Solution of the present invention is based on motherland's medical science to cervical spondylosis and pathogenetic understanding of complication and Therapeutic Principle, with reference to the modern pharmacological research achievement, filters out the natural edible-plant medicine, by the theory of Chinese medical science prescription, skims the cream off milk.Radix Puerariae relieving muscles diaphoresis in the side, the dispelling wind collateral dredging, sending up the lucid YANG, through sick institute is the key medicine of stiff nape and back, so be monarch.Herba Epimedii claims Herba Epimedii again, and kidney invigorating and YANG supporting is arranged, strengthening the tendons and bones, the effect of expelling wind and removing dampness; Radix Astragali benefiting qi and raising yang is defended outer consolidating superficial resistance, more than two medicines be aided on the left and supported on the right, with being minister.Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Corydalis, Radix Notoginseng nourshing blood and promoting blood circulation, promoting the circulation of QI to relieve pain; The Radix Paeoniae Alba yin fluid astringing that nourishes blood, easing the affected liver to relieve pain; Fructus Chaenomelis, Bombyx Batryticatus expelling wind and removing dampness, relaxing muscles and tendons and activating QI and blood in the collateral, relieving convulsion eliminating stagnation are all adjuvant drug.The Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription is for making, and long memorial wind and removing obstruction in channels, QI invigorating are good for the merit of bone, blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain altogether.
For achieving the above object, the solution that the present invention adopts is:
Medicine of the present invention is made by following component: (consumption is a weight portion)
Radix Puerariae 53.4～267, Herba Epimedii 53.4～267, the Radix Astragali 133.5～453.9, the Radix Paeoniae Alba 133.5～453.9, Radix Angelicae Sinensis 53.4～267, Rhizoma Chuanxiong 26.7～213.6, Rhizoma Corydalis 53.4～267, Radix Notoginseng 13.35～133.5, Fructus Chaenomelis 53.4～267, Bombyx Batryticatus 53.4～267, Radix Glycyrrhizae 13.35～133.5, Semen Persicae 53.4～267, Cortex Moutan 80.1～400.5, Radix Angelicae Pubescentis 53.4～267, Rhizoma Et Radix Notopterygii 53.4～267.
The optimum weight of medicine of the present invention (part) proportioning is:
Radix Puerariae 178, Herba Epimedii 178, the Radix Astragali 296.7, the Radix Paeoniae Alba 296.7, Radix Angelicae Sinensis 178, Rhizoma Chuanxiong 118.7, Rhizoma Corydalis 178, Radix Notoginseng 59.3, Fructus Chaenomelis 178, Bombyx Batryticatus 178, Radix Glycyrrhizae 59.3, Semen Persicae 178, Cortex Moutan 237.3, Radix Angelicae Pubescentis 178, Rhizoma Et Radix Notopterygii 178.
Above-mentioned each component is made medicine production method of the present invention is:
1, earlier the Radix Paeoniae Alba, Radix Notoginseng, Cortex Moutan are ground into fine powder, sieve mixing;
2, the water that Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Angelicae Pubescentis, Rhizoma Et Radix Notopterygii is added the twelvefold amount, distillating extracting oil;
3, get the cycloheptaamylose of volatile oil weight octuple amount, the water that adds six times of amounts is made suspension, grinds with colloid mill, the alcoholic solution that adds volatile oil grinds and makes clathrate, cold preservation, filtration, the clathrate cold drying, the fine powder mixing made from the above-mentioned Radix Paeoniae Alba, Radix Notoginseng, Cortex Moutan;
4, the medicinal residues after the four flavor distillations such as Radix Puerariae, the Radix Astragali, Semen Persicae, Radix Glycyrrhizae and Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Angelicae Pubescentis, Rhizoma Et Radix Notopterygii decoct with water twice, the water that adds for the first time ten times of amounts, decocted 2 hours, the water that adds for the second time the octuple amount, decocted 1.5 hours, medicinal liquids after the four flavor distillations such as twice decocting liquid and Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Angelicae Pubescentis, Rhizoma Et Radix Notopterygii merge, and filter, and filtrate vacuum concentration to relative density is the thick paste of 1.28～1.30 (50 ℃ of surveys);
5, four flavors such as all the other Herba Epimedii extract three times, 70% alcohol reflux 2 hours that adds for the first time the octuple amount, for the second time with 60% alcohol reflux that all adds six times of amounts for the third time 1.5 hours, three times extracting solution merges, filter, behind the filtrate recycling ethanol, vacuum concentration to relative density is the thick paste of 1.28～1.30 (50 ℃ of surveys);
6, above-mentioned two kinds of thick pastes are merged, every 100g thick paste adds the 15g refined honey, and with the Radix Paeoniae Alba, Radix Notoginseng, Cortex Moutan fine powder and clathrate mixing pill, cold drying is with the mixture coating of Pulvis Talci-iron oxide red, with the insect wax polishing, promptly.
Medicine of the present invention has the strong bone of dispelling wind collateral dredging, QI invigorating, activating blood circulation to dissipate blood stasis, promoting the circulation of QI to relieve pain, the effect of symptom such as alleviate neck shoulder arm pain that cervical spondylosis causes, numbness, unable, movable unfavorable, dizziness and tinnitus, damping off.
Clinical drug of the present invention uses the result to show that following advantage is arranged:
1, the present invention need not decoct, and taking convenience meets state food health legislation regulation.
2, to select the natural edible-plant medicine for use be raw material in the present invention, and each component meets the pharmaceutical control law regulation.Utilize the comprehensive function treatment cervical spondylosis of various Chinese medicines, no chemical addition agent, nontoxic to human body.
3, therapeutic effect of the present invention is obvious, and can alleviate or eliminate other complication significantly.
For showing the safety of medicine of the present invention, the invention will be further described below by acute toxicity test in mice, maximum dosage-feeding test and rat long term toxicity test.
One, medicine acute toxicity test in mice of the present invention
1, test objective: according to the acute toxicity test requirement of " specification requirement of new Chinese medicine pharmacological toxicology research ", by measuring LD
50, weigh the animal acute toxicity reaction of drug oral administration of the present invention.
2, test material:
(1) be subjected to the reagent thing: the plain ball of medicine of the present invention is provided lot number: 041210 by Zhangzhou Yi'an Pharmaceutical Co., Ltd..Plain ball fine powder after crushed, per 1 gram is equivalent to total medical material 2.67g, in the plain ball prescription, feeds intake and yield calculating according to the actual of this batch, in per 1000 grams, contains cyclodextrin 45.8g, refined honey 84g.Face with preceding and with distilled water dry powder is mixed with the suspension oral gavage of debita spissitudo, concentration is respectively: 1.16g crude drug/ml, 0.928g crude drug/ml, 0.742g crude drug/ml, 0.594g crude drug/ml, 0.475g crude drug/ml.
(2) Kunming mouse, body weight 18-22g, male and female half and half are provided by Jiangxi Medical College's Experimental Animal Center, the quality certification number: 021-96-02.Air conditioner surroundings is raised a week, the beginning formal test.22 ± 2 ℃ of receptacle temperature, natural lighting is freely drunk water.
3, test method:
50 mices are divided into five groups at random by body weight, every group of 10 animals, male and female half and half.Give a dosage, from low to high, be respectively: 46.40g crude drug/kg, 37.12g crude drug/kg, 29.70g crude drug/kg, 23.76g crude drug/kg, 19.01g crude drug/kg for every group by 0.8 times of spacing.Animal fasting (can't help water) is 15 hours before the administration, feeds at twice and gives, and in each administration about morning 9:00 and about afternoon 5:00 1 time, administration adopts not capacity such as isoconcentration to irritate the stomach method, and the filling gastric capacity is 40.0ml/Kg.Observed for 1 week immediately and subsequently after the perfusion, activity, behavior and the death condition of mice respectively organized in record, and 1 week back execution animal performs an autopsy on sb, and observes the change of each main organs.Data are carried out statistical procedures, with Bliss computing method LD
50
4, result of the test:
Observation in the administration same day and 1 week does not thereafter have animal dead, and feed, water inlet, activity, drainage, breathing etc. also take place unusual.Put to death the back postmortem, perusal, all no abnormal changes of important organ such as the heart of each dosage group mice, lung, liver,kidney,spleen, stomach, small intestinal.The results are shown in following table 1.
Table 1 medicine acute toxicity test in mice of the present invention result
| Dosage (the g crude drug/kg) | Log10 dose | Number of animals (only) | Dead animal number (only) | Mortality rate (%) | Probit (Y) | LD 50And fiducial limit |
| 46.40 | 1.6665 | 10 | 0 | 0 | - | |
| 37.12 | 1.5696 | 10 | 0 | 0 | - | |
| 29.70 | 1.4728 | 10 | 0 | 0 | - | Can not survey |
| 23.76 | 1.3758 | 10 | 0 | 0 | - | |
| 19.01 | 1.2890 | 10 | 0 | 0 | - |
5, conclusion (of pressure testing):
Medicine of the present invention is not measured LD under the dosage of this experimental design
50, should change and do the maximum dosage-feeding test.
Two, medicine maximum dosage-feeding test of the present invention
1, test objective:
According to the acute toxicity test requirement of " new Chinese medicine pharmacological toxicology research specification requirement ", do not measure LD being tried thing
50The time, should do the maximum dosage-feeding test.After promptly once giving animal subject with Cmax, maximum administration volume, observed continuously 7-14 days, animal does not produce death, thinks that then this is tried the LD of thing to certain certain route of administration of animal
50Greater than a certain numerical value (g crude drug/kg).This experiment is intended to measure medicine mice maximum dosage-feeding of the present invention.
2, test material:
(1) be subjected to the reagent thing: the plain ball of medicine of the present invention is provided lot number: 041210 by Zhangzhou Yi'an Pharmaceutical Co., Ltd..Plain ball fine powder after crushed, per 1 gram is equivalent to total medical material 2.67g, in the plain ball prescription, feeds intake and yield calculating according to the actual of this batch, in per 1000 grams, contains cyclodextrin 45.8g, refined honey 84g.Adult's consumption: one time 18 ball, 3.1g, a twice-daily, oral.Face with preceding and with distilled water dry powder is mixed with the suspension oral gavage of Cmax, concentration is: 1.29g crude drug/ml, this moment the mouse stomach device just in time can smoke and medicinal liquid even.
(2) Kunming mouse, 40, body weight 18-22g, male and female half and half are provided by Shanghai Slac Experimental Animal Co., Ltd., the quality certification number: SCXK (Shanghai) 2003-0003.Animal is bought the back back and raised five days at the Jiangxi College of Traditional Chinese Medicine Animal Lab., the beginning formal test.22 ± 2 ℃ of receptacle temperature, ad lib is freely drunk water.
3, test method:
40 mices are divided into administration group and matched group at random by body weight respectively, every group of 20 animals, male and female half and half.It is 103.26g crude drug/kg that administration group mice is given drug dose of the present invention.The animal fasting be can't help water 15 hours before the administration, fed at twice and gave, and in each administration about morning 9:00 and about afternoon 5:00 1 time, irritating the gastric capacity mice is the 40ml/kg body weight, and matched group is irritated the distilled water of capacity such as stomach.Observed immediately and subsequently 14 days after the perfusion, observe and record animal dead situation.
4, result of the test:
Reach after the perfusion and observe subsequently in 14 days, do not have animal dead, the feed of two treated animals, water inlet, activity, drainage, breathing etc. also take place unusual.Put to death the back postmortem, perusal, all no abnormal changes of important organ such as the heart of two groups of mices, lung, liver,kidney,spleen, stomach, small intestinal.
5, conclusion (of pressure testing):
Gavage the logical ball of benefit for mice one twice-daily, dosage is 103.26g crude drug/kg, observes 14 days, does not see animal dead, so think the LD of medicine mouse stomach approach of the present invention
50Greater than 103.26g crude drug/kg.With the equivalent of animals and human beings relatively, this dosage is equivalent to clinical 1 day therapeutic dose (501.80 times of 14.41g crude drug/70kg) respectively.
Three, medicine rat long term toxicity test of the present invention
1, test objective:
The toxic reaction of observing animal-use drug and producing, the symptom that at first occurs during poisoning, relevant organizing after internal organs structure and changing function situation and the drug withdrawal and the development and the recovery situation of functional lesion are for clinical experimental study provides the safety reference.
2, EXPERIMENTAL DESIGN:
According to " specification requirement of new Chinese medicine pharmacological toxicology research ", get 180 of 60～110g healthy rats, ♀ ♂ half and half, be divided into four groups of basic, normal, high dosage group of medicine of the present invention and blank groups at random, irritate respectively stomach (ig) give medicine 3.22g crude drug/kg of the present invention, 6.44g crude drug/kg, 12.88g medicated powder/kg (be equivalent to clinical usual amounts 15.69 times, 31.39 times, 62.77 times) and etc. the capacity distilled water, irritate gastric capacity 10.0ml/kg, once a day, continuous six months.Take by weighing body weight weekly once during the administration and after the drug withdrawal, weekly according to corresponding increase feedstuff of body weight and dose, situations such as the outward appearance sign of observation every day and record rat, behavioral activity, diet, feces are then taken out single cage if any toxic reaction to raise primary part observation.Find death or moribund animals postmortem in time.10 rats of every group of execution in three months after the administration, after the administration after the last administration in six months work in 24 hours kill 2/3 rat, two weeks lived and kill remaining rat after the drug withdrawal, carry out comprehensively, careful system's postmortem, the organ emphasis that notes abnormalities carries out histopathologic examination, core, liver, spleen, lung, kidney, the adrenal gland, thymus, brain, the uterus, ovary, testis and epididymis are weighed, calculate organ coefficient, and with the heart, liver, spleen, lung, kidney, esophagus, stomach, duodenum, ileum, large intestine, the uterus, ovary, vagina, bladder, testis, epididymis, prostate, brain, hypophysis, thyroid, thymus, the adrenal gland, lymph nodes etc. are also fixed with 10% formalin, paraffin embedding, the HE microscopy; Measure hematology's (hemoglobin, red blood cell count(RBC), numeration of leukocyte, leukocyte differential count, reticulocyte count, clotting time) and blood biochemical simultaneously respectively and learn (GPT, GOT, CR, BUN, GLU, CHOL etc.) index.The residue rat continue to be raised two to four weeks, carries out above-mentioned observation and detection equally, with understand rat during administration toxic reaction and drug withdrawal after recovery and development in a period of time.
3, test material and method:
(1) be subjected to the reagent thing: the plain ball of medicine of the present invention is provided lot number: 041210 by Zhangzhou Yi'an Pharmaceutical Co., Ltd..Plain ball fine powder after crushed, per 1 gram is equivalent to total medical material 2.67g, in the plain ball prescription, feeds intake and yield calculating according to the actual of this batch, in per 1000 grams, contains cyclodextrin 45.8g, refined honey 84g.Adult's consumption: one time 18 ball, 3.1g, a twice-daily, oral.
Be subjected to the preparation of reagent thing:
High concentration: accurately take by weighing medicated powder 50g, slowly add distilled water, do not stop to stir, at last to 900ml, 0.556g medicated powder/ml, i.e. 1.288g crude drug/ml;
Middle concentration: get high concentration medicine 400ml, slowly add distilled water, do not stop to stir, at last to 800ml, 0.278g medicated powder/ml, i.e. 0.644g crude drug/ml;
Low concentration: concentration medicine 300ml in getting, slowly add distilled water, do not stop to stir, at last to 600ml, 0.139g medicated powder/ml, i.e. 0.322g crude drug/ml.
(2) administration capacity: the 10ml/kg body weight, once a day.
(3) experimental animal: rat, the SD strain, body weight 60～110g is provided by Shanghai Slac Experimental Animal Co., Ltd., the quality certification number: SCXK (Shanghai) 2003-0003.Animal is bought the back back and raised seven days at the Jiangxi College of Traditional Chinese Medicine Animal Lab., the beginning formal test.22 ± 2 ℃ of receptacle temperature, ad lib is freely drunk water.
(4) date processing: adopt the SPSS statistical software to carry out statistical disposition, variance is neat with check heterogeneity of variance Dunnett T with LSD
3Check.
4, result of the test:
Ordinary circumstance: behavioral activity, diet, secretions, respiratory system, blood circulation, central nervous system etc. during administration are all normal for blank group rat, and hair color is smooth next to the shin, phenomenons such as no Folium Pini, the back of a bow, diarrhoea, body weight normal growth; The low dose group rat shows no obvious abnormalities at aspects such as diet, drinking-water, activity, hair, breathing, drainages, and the body weight normal growth does not relatively have evident difference with the blank group; Middle dosage group rat is showing no obvious abnormalities hair smoothing, body weight normal growth aspect diet, activity, the drainage; High dose group rat feces volume is more, and estimation is relevant with filling stomach high concentration medicine, and its activity, hair, diet, breathing etc. are normal, the body weight normal growth, and concrete outcome sees the following form.
Table 2 medicine of the present invention is to the influence of male rat body weight gain (before the administration～the 3rd week) (X ± S)
| Group | Number of animals (only) | Before the administration | First week | Second week | The 3rd week |
| Blank group | 22 | 91.00±12.11 | 136.00±16.08 | 172.77±18.78 | 196.73±20.45 |
| Low dose group | 22 | 92.05±11.84 | 128.00±16.76 | 163.59±18.64 | 205.82±27.73 |
| Middle dosage group | 22 | 90.73±10.53 | 130.91±15.84 | 172.45±21.86 | 204.50±24.54 |
| High dose group | 22 | 91.41±11.83 | 128.09±13.25 | 154.32±16.38 | 191.77±18.14 |
Table 3 medicine of the present invention is to the influence of male rat body weight gain (around～the 5th week) (X ± S)
| Group | Number of animals (only) | Around | The 5th week |
| Blank group | 22 | 221.55±19.62 | 243.36±24.81 |
| Low dose group | 22 | 232.77±23.33 | 246.36±21.25 |
| Middle dosage group | 22 | 225.36±28.57 | 246.68±31.57 |
| High dose group | 21 | 240.71±25.24 | 254.14±28.53 |
Annotate: high dose group has a rat to choke to death because of irritating the stomach high concentration medicine.
Table 4 medicine of the present invention is to the influence of female rats body weight gain (before the administration～the 3rd week) (X ± S)
| Group | Number of animals (only) | Before the administration | First week | Second week | The 3rd week |
| Blank group | 22 | 79.50±9.66 | 120.73±12.63 | 154.50±15.69 | 172.55±13.797 |
| Low dose group | 22 | 80.41±9.10 | 116.45±9.11 | 149.18±13.23 | 178.23±17.848 |
| Middle dosage group | 22 | 77.91±9.70 | 113.50±13.60 | 146.14±12.50 | 175.50±12.420 |
| High dose group | 22 | 79.73±9.95 | 116.59±14.02 | 145.45±15.27 | 169.73±14.377 |
Table 5 medicine of the present invention is to the influence of female rats body weight gain (around～the 5th week) (X ± S)
| Group | Number of animals (only) | Around | The 5th week |
| Blank group | 22 | 191.95±12.85 | 213.32±14.94 |
| Low dose group | 22 | 193.82±17.48 | 209.32±23.95 |
| Middle dosage group | 22 | 193.09±14.35 | 213.64±14.16 |
| High dose group | 21 | 190.57±18.51 | 209.19±19.23 |
Annotate: high dose group has a rat to choke to death because of irritating the stomach high concentration medicine.
For showing the drug effect of medicine of the present invention, the invention will be further described below by the test of pesticide effectiveness.
Medicine effect test of the present invention
One, test material
1, experimental animal:
Kunming mouse, 18-22g, Jiangxi Medical College's Experimental Animal Center provides, the quality certification number: 021-9602.Provide the quality certification number by Shanghai Slac Experimental Animal Co., Ltd.: SCXK (Shanghai) 2003-0003.
2, medicine and reagent:
(1) the plain ball of medicine of the present invention fine powder after crushed, per 1 gram is equivalent to total medical material 2.67g, in the plain ball prescription, feeds intake and yield calculating according to the actual of this batch, in per 1000 grams, contains cyclodextrin 45.8g, refined honey 84g.The clinical plan consumption of people is: an oral 3.1g, and a twice-daily, 21 days is a course of treatment.Provide lot number by Zhangzhou Yi'an Pharmaceutical Co., Ltd.: 041210.
The used dosage of mice is: low dosage is behaved clinical plan with 3 times of dosage, i.e. 0.27g medicated powder/kg, 0.63g crude drug/Kg
In dosage behave clinical plan with 10 times of dosage, i.e. 0.9g medicated powder/kg, 2.1g crude drug/Kg
High dose is behaved clinical plan with 30 times of dosage, i.e. 2.7g medicated powder/kg, 6.3g crude drug/Kg
(2) glacial acetic acid: 500ml/ bottle, AR, Zhuzhou nine divisions of China in remote antiquity chemical reagent factory, lot number: 990114.0.6% acetic acid: get the 0.6ml glacial acetic acid and add normal saline to 100ml.
(3) positive drug: JINGFUKANG KELI, every bag of 5g, a twice-daily, one time one to two bag, boiled water is taken after mixing it with water, Chengde JingFuKang pharmacy Group Co.,Ltd, lot number: 040922.Mice dosage is 3.0g granule/kg.
(4) dimethylbenzene: CA, Hubei University chemical plant, lot number: 960818
(5) prednisone: the 5mg*100 sheet, Xianju, Zhejiang pharmaceutical Co. Ltd produces, lot number 020502;
3, administration capacity: mice 20ml/kg.
4, statistical disposition: adopt the SPSS statistical software to carry out statistical disposition, variance is neat with the LSD check, and is uneven with Dunnett T3 check.
Two, test method and result
(1) to the influence of mice analgesic activity
1, writhing method
(1) test objective: adopt mouse peritoneal injected chemical medicine, calculate the Mus number and the number of times of mouse writhing reaction, observe the analgesic activity of medicine.
(2) test method and result:
A. animal grouping: animal is divided into 6 groups at random, and 10 every group, the basic, normal, high dosage group of medicine promptly of the present invention, JINGFUKANG group, model group and matched group.
B. observation index: model group and matched group give distilled water, other each groups are all irritated stomach and are given relative medicine 20ml/kg, successive administration seven days, after the last administration 60 minutes, remove the matched group intraperitoneal injection of saline, the equal lumbar injection 0.6% acetic acid 0.2ml of each Mus, observe respectively to organize in 10 minutes and writhing response (abdominal part indent, stretching, extension hind leg, buttocks are raised) mice number of elements occurs, behind injection acetic acid to mice (incubation period time of body appears turning round the first time, do not calculate by 600 seconds if occurred in 10 minutes), every mouse writhing reaction times the results are shown in following table 6.
Table 6 medicine of the present invention is to the influence of mice analgesic activity (X ± S)
| Group | Number of animals (only) | Dosage | Body Mus number (only) appears turning round | Turn round body number of times (inferior) | Incubation period |
| The blank group | 10 | Distilled water 20ml/kg | 0 | 0.00±0.00 | 600.00±0.00 |
| Model group | 10 | Distilled water 20ml/kg | 10 △△△ | 17.40±6.02 △△△ | 315.80±61.54 △△△ |
| Low dose group | 10 | 0.63g crude drug/kg | 9 | 6.80±4.98 | 395.70±105.27 ▲ |
| Middle dosage group | 10 | 2.7g crude drug/kg | 6 | 3.20±3.15 ▲▲ | 517.40±76.66 ▲▲ |
| High dose group | 10 | 6.3g crude drug/kg | 5 ▲ | 2.30±3.26 ▲▲ | 511.80±106.23 ▲▲ |
| JINGFUKANG | 10 | 3.0g granule/kg | 9 | 8.30±7.24 | 340.30±135.16 |
Compare with the blank group,
△ △ △P＜0.001; Compare with model group,
▲P＜0.05,
▲ ▲P＜0.01,
▲ ▲ ▲P＜0.001.
As can be seen from the above table, lumbar injection 0.6% glacial acetic acid can cause mice and pain reaction occurs.Writhing response all appears in the model group mice, the number of times showed increased, illustrate that modeling is successful, the middle and high dosage of medicine of the present invention all can obviously reduce the mouse writhing reaction times, reduce the Mus number of writhing response, prolong incubation period, medicine low dosage of the present invention all can prolong incubation period, illustrates that it has certain analgesic effect.
2, hot plate method
(1) test objective: adopt thermostimulation, observe mice and give time of licking metapedes behind the different pharmaceutical, as the index of the analgesic effect of weighing medicine.
(2) test method and result:
A. animal grouping: animal is divided into 5 groups at random, and 14 every group, the basic, normal, high dosage group of medicine promptly of the present invention, JINGFUKANG KELI group, blank group.
B. observation index: 90 of female mices, water bath with thermostatic control is adjusted to 55 ± 0.5 ℃, the contact water surface at the bottom of the metal dish, the heating back is as thermostimulation, certainly drop into hot plate to the pain threshold of the time of metapedes occurring licking with stopwatch record mice as this Mus, is qualified with pain threshold in second at 5-30, sieve totally 70 of mices, carry out random packet by its pain threshold, it is the same to divide into groups, matched group gives distilled water, and other are respectively organized equal vagina and give relative medicine 20ml/kg, and be administered once every day, continuous 7 days, after the last administration 30,60,120, surveyed the mice pain threshold respectively in 240 minutes, and calculated its threshold of pain and improve percentage rate, the formula calculating down of threshold of pain raising rate.The results are shown in Table 7, table 8 and Fig. 1.
Table 7 medicine of the present invention causes the influence (X ± S) of pain effect to the mice hot plate method
| Group | Number of animals (only) | Dosage | Before the administration (S) | Different time licks sufficient incubation period (s) after the administration | |||
| 30min | 60min | 120min | 240min | ||||
| The blank group | 14 | Distilled water 20ml/kg | 16.11±2.6 8 | 17.28±4.73 | 17.21±4.35 | 16.85±3.91 | 17.64±3.54 |
| Low dose group | 14 | 0.63g crude drug/kg | 16.21±2.8 1 | 21.50±6.22 ▲ | 23.57±4.60 ▲ | 24.50±4.87 ▲ | 22.57±4.07 ▲ |
| Middle dosage group | 14 | 2.7g crude drug/kg | 16.28±2.9 7 | 22.42±5.13 ▲ | 22.00±4.13 ▲ | 23.21±3.49 ▲ | 24.14±4.18 ▲ |
| High dose group | 14 | 6.3g crude drug/kg | 16.35±3.0 0 | 21.57±6.27 ▲ | 24.21±5.96 ▲ | 24.07±4.32 ▲ | 24.85±4.41 ▲ |
| JINGFUKANG | 14 | 3.0g granule/kg | 16.39±3.0 7 | 22.50±5.28 ▲ | 22.64±5.18 ▲ | 24.92±4.26 ▲ | 25.64±3.93 ▲ |
Compare with the normal saline group,
▲P＜0.05,
▲ ▲P＜0.01.
Table 8 medicine of the present invention is carried the influence (X ± S) of rate to the mice hot plate method threshold of pain
| Group | Number of animals (only) | 30min(％) | 60min(％) | 120min(％) | 240min(％) |
| The blank group | 14 | 7.26 | 6.83 | 4.59 | 9.50 |
| Low dose group | 14 | 32.63 | 45.40 | 51.14 | 39.24 |
| Middle dosage group | 14 | 37.71 | 35.14 | 42.57 | 48.28 |
| High dose group | 14 | 31.93 | 48.07 | 47.22 | 51.99 |
| JINGFUKANG | 14 | 37.28 | 38.47 | 52.42 | 56.82 |
Can find out from table 7, table 8 and Fig. 1, basic, normal, high dosage group of medicine of the present invention and JINGFUKANG KELI just can obviously improve the mice pain threshold in 30 minutes after administration, also acted in the time of 60,90,120 minutes obviously, pointing out medicine of the present invention that hot plate is caused the pain mice has significant analgesia role.
(2) antiinflammatory action
1, auricle edema method
(1) test objective: give medicine by being coated with again after dimethylbenzene causes inflammatory model, weigh the antiinflammatory action of medicine by the weight difference that compares two ears to Mice Auricle.
(2) test method and result:
A. animal grouping: animal is divided into 5 groups at random, and 12 every group, the basic, normal, high dosage group of medicine promptly of the present invention, JINGFUKANG KELI group and matched group.
B. observation index: matched group gives distilled water, other each groups are all irritated stomach and are given relative medicine 20ml/kg, successive administration seven days, last after 60 minutes left auricle be coated with 100% dimethylbenzene 0.02ml/ only, after 4 hours, mice is pulled cervical vertebra put to death, cut two ears along the auricle baseline, lay round auricle at same position respectively with the straight card punch of 8mm, balance is weighed; Every Mus left side auricle deducts the auris dextra sheet and heavily is the swelling degree.The results are shown in Table 9.
Table 9 medicine of the present invention is to the influence of mice auricle swelling (X ± S)
| Group | Number of animals (only) | Dosage | Left side ear heavy (mg) | Auris dextra heavy (mg) | The swelling degree |
| The blank group | 12 | Distilled water 20ml/kg | 11.15±2.43 | 7.47±0.78 | 3.75±1.92 |
| The JINGFUKANG KELI group | 12 | 3.0g granule/kg | 8.24±0.81 ▲ | 6.97±0.74 | 1.23±0.52 ▲ |
| Medicine low dose group of the present invention | 12 | 0.63g crude drug/kg | 8.72±1.34 | 7.40±0.57 | 1.32±0.90 ▲ |
| Dosage group in the medicine of the present invention | 12 | 2.7 crude drug/kg | 8.39±0.60 ▲ | 7.18±0.43 | 1.20±0.63 ▲ |
| Medicine high dose group of the present invention | 12 | 6.3 crude drug/kg | 8.95±1.06 | 7.57±0.44 | 1.47±0.92 ▲ |
Compare with the blank group,
▲P＜0.05,
▲ ▲P＜0.01,
▲ ▲ ▲P＜0.001.
As can be seen from the above table, basic, normal, high dosage of medicine of the present invention and JINGFUKANG KELI have the mice auricle swelling degree and obviously alleviate effect, illustrate that medicine xylol induced mice auricle inflammation of the present invention has inhibitory action.
2, cotton ball granular swelling
(1) test objective: give medicine by implanting again after cotton balls causes inflammatory model, weigh the antiinflammatory action of medicine by the weight difference that compares cotton balls to mice.
(2) test method and result:
A. animal grouping: animal is divided into 6 groups at random, and 10 every group, the basic, normal, high dosage group of medicine promptly of the present invention, prednisone group, JINGFUKANG KELI group and matched group.
B. observation index: under aseptic condition, the heavy aseptic cotton balls of 5mg is implanted each one of oxter, both sides behind the etherization, sew up wound, matched group gives distilled water, and other each groups are all irritated stomach and given relative medicine 20ml/kg, once a day, successive administration ten days, put to death mice after 60 minutes after the last administration, peel off the ball granulation and claim its weight in wet base, baking was weighed after 2 hours in 80 ℃ of baking boxs, be dry weight, the results are shown in following table 10.
Table 10 medicine of the present invention is to the influence of mice granuloma induced by implantation of cotton pellets (X ± S)
| Group | Number of animals (only) | Dosage | Weight in wet base (mg) | Suppression ratio (%) | Dry weight (mg) | Suppression ratio (%) |
| The blank group | 10 | Distilled water 20ml/kg | 97.79±10.01 | 19.00±3.81 | ||
| The JINGFUKANG KELI group | 10 | 3.0g granule/kg | 83.15±7.95 ▲▲▲ | 14.94 | 14.55±1.45 ▲▲ | 23.42 |
| Low dose group | 10 | 0.63g crude drug/kg | 93.66±7.17 | 4.22 | 16.86±1.58 | 11.26 |
| Middle dosage group | 10 | 2.7g crude drug/kg | 82.51±5.87 ▲▲▲ | 15.63 | 14.32±1.36 ▲▲ | 24.63 |
| High dose group | 10 | 6.3g crude drug/kg | 81.22±9.10 ▲▲▲ | 16.94 | 13.94±1.52 ▲▲ | 26.63 |
| The prednisone group | 10 | 100mg/kg | 77.12±7.70 ▲▲▲ | 21.14 | 13.65±1.93 ▲▲ | 28.16 |
Compare with the blank group,
▲P＜0.05,
▲ ▲P＜0.01,
▲ ▲ ▲P＜0.001.
As can be seen from the above table, except that medicine low dose group of the present invention, other each group is wet to the mice granuloma induced by implantation of cotton pellets, dry weight all has and obviously alleviates effect, illustrates that middle and high three the dosage groups of medicine of the present invention, JINGFUKANG KELI group and prednisone group have the obvious suppression effect to inflammation.
Description of drawings
The invention will be further described below in conjunction with drawings and Examples.
Fig. 1 is medicine of the present invention causes the pain effect to the mice hot plate method influence
The specific embodiment
Embodiment
Take by weighing raw material (gram) by following proportioning:
Radix Puerariae 178, Herba Epimedii 178, the Radix Astragali 296.7, the Radix Paeoniae Alba 296.7, Radix Angelicae Sinensis 178, Rhizoma Chuanxiong 118.7, Rhizoma Corydalis 178, Radix Notoginseng 59.3, Fructus Chaenomelis 178, Bombyx Batryticatus 178, Radix Glycyrrhizae 59.3, Semen Persicae 178, Cortex Moutan 237.3, Radix Angelicae Pubescentis 178, Rhizoma Et Radix Notopterygii 178.
Production method is as follows:
Earlier the Radix Paeoniae Alba, Radix Notoginseng, Cortex Moutan are ground into fine powder, sieve mixing; The water that again Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Angelicae Pubescentis, Rhizoma Et Radix Notopterygii is added the twelvefold amount, distillating extracting oil; Get the cycloheptaamylose of volatile oil weight octuple amount, the water that adds six times of amounts is made suspension, grinds with colloid mill, the alcoholic solution that adds volatile oil grinds and makes clathrate, cold preservation, filtration, the clathrate cold drying, the fine powder mixing made from the above-mentioned Radix Paeoniae Alba, Radix Notoginseng, Cortex Moutan; Medicinal residues after the four flavor distillations such as Radix Puerariae, the Radix Astragali, Semen Persicae, Radix Glycyrrhizae and Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Angelicae Pubescentis, Rhizoma Et Radix Notopterygii decoct with water twice, the water that adds for the first time ten times of amounts, decocted 2 hours, the water that adds for the second time the octuple amount, decocted 1.5 hours, medicinal liquids after the four flavor distillations such as twice decocting liquid and Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Angelicae Pubescentis, Rhizoma Et Radix Notopterygii merge, and filter, and filtrate vacuum concentration to relative density is the thick paste of 1.28～1.30 (50 ℃ of surveys); Four flavors such as all the other Herba Epimedii extract three times, 70% alcohol reflux 2 hours that adds for the first time the octuple amount, for the second time with 60% alcohol reflux that all adds six times of amounts for the third time 1.5 hours, three times extracting solution merges, filter, behind the filtrate recycling ethanol, vacuum concentration to relative density is the thick paste of 1.28～1.30 (50 ℃ of surveys); Above-mentioned two kinds of thick pastes are merged, and every 100g thick paste adds the 15g refined honey, with the Radix Paeoniae Alba, Radix Notoginseng, Cortex Moutan fine powder and clathrate mixing pill, cold drying, with the mixture coating of Pulvis Talci-iron oxide red, with the insect wax polishing, makes 1000 balls, promptly.
Usage and consumption: oral.One twice-daily, one time 18 ball.
Claims (3)
1, a kind of medicine for the treatment of cervical spondylosis is characterized in that it is the medicament of being made by the following weight proportion raw material: (consumption is a weight portion)
Radix Puerariae 53.4～267, Herba Epimedii 53.4～267, the Radix Astragali 133.5～453.9, the Radix Paeoniae Alba 133.5～453.9, Radix Angelicae Sinensis 53.4～267, Rhizoma Chuanxiong 26.7～213.6, Rhizoma Corydalis 53.4～267, Radix Notoginseng 13.35～133.5, Fructus Chaenomelis 53.4～267, Bombyx Batryticatus 53.4～267, Radix Glycyrrhizae 13.35～133.5, Semen Persicae 53.4～267, Cortex Moutan 80.1～400.5, Radix Angelicae Pubescentis 53.4～267, Rhizoma Et Radix Notopterygii 53.4～267.
2, the medicine of treatment cervical spondylosis according to claim 1 is characterized in that the weight proportion of each raw material is: (consumption is a weight portion)
Radix Puerariae 178, Herba Epimedii 178, the Radix Astragali 296.7, the Radix Paeoniae Alba 296.7, Radix Angelicae Sinensis 178, Rhizoma Chuanxiong 118.7, Rhizoma Corydalis 178, Radix Notoginseng 59.3, Fructus Chaenomelis 178, Bombyx Batryticatus 178, Radix Glycyrrhizae 59.3, Semen Persicae 178, Cortex Moutan 237.3, Radix Angelicae Pubescentis 178, Rhizoma Et Radix Notopterygii 178.
3, the preparation method of the medicine of treatment cervical spondylosis according to claim 1 and 2 is characterized in that earlier the Radix Paeoniae Alba, Radix Notoginseng, Cortex Moutan being ground into fine powder, sieves mixing; Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Angelicae Pubescentis, Rhizoma Et Radix Notopterygii are added the water of twelvefold amount, distillating extracting oil; Get the cycloheptaamylose of volatile oil weight octuple amount, the water that adds six times of amounts is made suspension, grinds with colloid mill, the alcoholic solution that adds volatile oil grinds and makes clathrate, cold preservation, filtration, the clathrate cold drying, the fine powder mixing made from the above-mentioned Radix Paeoniae Alba, Radix Notoginseng, Cortex Moutan; Medicinal residues after the four flavor distillations such as Radix Puerariae, the Radix Astragali, Semen Persicae, Radix Glycyrrhizae and Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Angelicae Pubescentis, Rhizoma Et Radix Notopterygii decoct with water twice, the water that adds for the first time ten times of amounts, decocted 2 hours, the water that adds for the second time the octuple amount, decocted 1.5 hours, medicinal liquids after the four flavor distillations such as twice decocting liquid and Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Angelicae Pubescentis, Rhizoma Et Radix Notopterygii merge, and filter, and filtrate vacuum concentration to relative density is the thick paste of 1.28～1.30 (50 ℃ of surveys); Four flavors such as all the other Herba Epimedii extract three times, 70% alcohol reflux 2 hours that adds for the first time the octuple amount, for the second time with 60% alcohol reflux that all adds six times of amounts for the third time 1.5 hours, three times extracting solution merges, filter, behind the filtrate recycling ethanol, vacuum concentration to relative density is the thick paste of 1.28～1.30 (50 ℃ of surveys); Above-mentioned two kinds of thick pastes are merged, and every 100g thick paste adds the 15g refined honey, and with the Radix Paeoniae Alba, Radix Notoginseng, Cortex Moutan fine powder and clathrate mixing pill, cold drying is with the mixture coating of Pulvis Talci-iron oxide red, with the insect wax polishing.
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| CNB2005101131044A CN100425255C (en) | 2005-10-13 | 2005-10-13 | Medicine for treating cervical disease and its preparation method |
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|---|---|---|---|
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| CN101574501B (en) * | 2009-06-17 | 2011-08-17 | 于海燕 | Sanchi and combined spicebush root paste used for preventing and treating cervical spondylosis |
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| CN100376585C (en) * | 1997-08-21 | 2008-03-26 | 通用电气公司 | Blocked mercaptosilane coupling agents for filled rubber |
| CN1236629A (en) * | 1998-05-22 | 1999-12-01 | 邵章祥 | Medicine for treating cervical vertebra disease and its preparing process |
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| CN101574501B (en) * | 2009-06-17 | 2011-08-17 | 于海燕 | Sanchi and combined spicebush root paste used for preventing and treating cervical spondylosis |
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