CN1814260A - Chinese medicine for treating blood stagnation disease - Google Patents
Chinese medicine for treating blood stagnation disease Download PDFInfo
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- CN1814260A CN1814260A CN 200510130075 CN200510130075A CN1814260A CN 1814260 A CN1814260 A CN 1814260A CN 200510130075 CN200510130075 CN 200510130075 CN 200510130075 A CN200510130075 A CN 200510130075A CN 1814260 A CN1814260 A CN 1814260A
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Abstract
The invention supplies a Chinese traditional medicine for curing blood sludging arthralgia that is made up from mastic, myrrh, Chinese clematis radix clematidis, safflower, red sage root, etc. It could be tablet to swallow. The invention also supplies the manufacture method for the medicine. It has good curing effect for blood sludging arthralgia. And it has little side effect.
Description
Technical field
The present invention relates to field of traditional Chinese, in particular to a kind of Chinese medicine for the treatment of blood stasis numbness and preparation method thereof.
Background technology
The traditional Chinese medical science thinks that rheumatismal basic pathogenesis is pathogen numbness resistance meridians, and QI-blood circulation is not smooth.Therefore, the resistance of blood stasis numbness is a rheumatismal important disease.
Rheumatism, rheumatoid arthritis are a kind of chronic autoimmune diseasees based on arthropathy, the traditional Chinese medical science is referred to as " insensitive impediment ", " severe and migratory arthralgia ", be commonly encountered diseases, the frequently-occurring disease of serious harm human health, be in, doctor trained in Western medicine a kind of refractory disease of generally acknowledging, be listed in clinical difficult miscellaneous diseases.This disease is called as " cancer that lives ".Relevant data according to calendar year 2001 degree " Chinese Medicine health annual report " shows that the China ill crowd of rheumatism in recent years is ascendant trend year by year.According to incompletely statistics, present stage of china has rheumatic osteoarthropathy patient people more than 200,000,000, and ratio is up to 17%.Wherein China's central plain area's sickness rate 15%, and northeast, northwest, extremely frigid zones and coastal rainy humid area, Eastern Europe and coastal island country sickness rate are up to 30%.And 8,200 ten thousand people that have of the comparatively serious basic disability of China, comparatively serious life can't be taken care of oneself substantially 1,100 ten thousand people.Rheumatism sickness rate in the world, proportion is lower slightly than China in developed country's populations such as America and Europe, roughly about 13%, but serious arthrosis patient is few unlike China, the whole world does not have rheumatic arthritis fully without any the continent and the border areas of a country, even the most hot national Brazilian sickness rate also is 1%.
Rheumatism pathogenic factor complexity, the ill cycle is long, is difficult for curing, and easily recurrence is that modern medicine is to rheumatismal common cognition.This class disease, modern medicine still do not have Therapeutic Method and effective better radical cure medicine preferably so far.The corticosteroids symptomatic treatment that doctor trained in Western medicine is commonly used is as meticortelone etc.Also have NSAID (non-steroidal anti-inflammatory drug) ibuprofen, diclofenac, indometacin etc., this type of poisonous side effect of medicine is big, and late result is dissatisfied.Though natural medicinal formulations Radix Tripterygii Wilfordii, Tripterygium hypoglaucum, sinomenine, Pa Fulin etc. have certain anti rheumatism action, and obvious toxic-side effects is all arranged.As Radix Tripterygii Wilfordii all there is infringement in systems such as the heart, liver, kidney, gastrointestinal, hemopoietic, reproduction, lymph, clinical toxic and side effects incidence rate is very high.
The prescription of treatment blood stasis numbness provided by the present invention is exactly to establish at blood stasis numbness resistance card.It consists of Olibanum, Myrrha, Radix Clematidis, Flos Carthami, Radix Salviae Miltiorrhizae, Radix Cyathulae, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Rhizoma Curcumae Longae, Rhizoma Cyperi, the Radix Astragali, and 11 flavor medicine compatibilities are played blood circulation promoting and blood stasis dispelling, the merit of dredging collateral to stop pain altogether.Confirm that through a large amount of clinical practices this medication effect is definite, take safety, and toxic and side effects is little.
Summary of the invention
The object of the present invention is to provide a kind of Chinese medicine for the treatment of blood stasis numbness, little, the taking convenience of determined curative effect, toxic and side effects of this Chinese medicine.
The present invention also provides this preparation method of Chinese medicine.
Chinese medicine of the present invention is prepared from by acceptable auxiliary on following weight parts proportion raw material and the pharmaceutics:
Olibanum or Olibanum (processed) 50-95 Radix Clematidis 140-220 Flos Carthami 95-145 Radix Salviae Miltiorrhizae 190-290
Myrrha or Myrrha (processed) 50-95 Radix Cyathulae 140-220 Rhizoma Chuanxiong 140-220 Radix Angelicae Sinensis 95-145
The Rhizoma Curcumae Longae 95-145 Rhizoma Cyperi or the prepared RHIZOMA CYPERI 115-175 Radix Astragali or Radix Astragali Preparata 140-220.
The weight portion proportion optimization of above-mentioned raw materials:
Olibanum or Olibanum (processed) 60-85 Radix Clematidis 150-200 Flos Carthami 105-135 Radix Salviae Miltiorrhizae 220-280
Myrrha or Myrrha (processed) 60-70 Radix Cyathulae 150-200 Rhizoma Chuanxiong 150-200 Radix Angelicae Sinensis 105-135
The Rhizoma Curcumae Longae 105-135 Rhizoma Cyperi or the prepared RHIZOMA CYPERI 115-175 Radix Astragali or Radix Astragali Preparata 150-200.
The weight portion proportioning of above-mentioned raw materials is also preferred:
Olibanum or Olibanum (processed) 65-80 Radix Clematidis 160-190 Flos Carthami 110-130 Radix Salviae Miltiorrhizae 230-260
Myrrha or Myrrha (processed) 65-80 Radix Cyathulae 160-190 Rhizoma Chuanxiong 160-190 Radix Angelicae Sinensis 110-130
The Rhizoma Curcumae Longae 110-130 Rhizoma Cyperi or the prepared RHIZOMA CYPERI 125-155 Radix Astragali or Radix Astragali Preparata 160-190.
The weight portion proportioning of above-mentioned raw materials is also preferred:
Olibanum or Olibanum (processed) 70-75 Radix Clematidis 175-185 Flos Carthami 115-125 Radix Salviae Miltiorrhizae 235-250
Myrrha or Myrrha (processed) 70-75 Radix Cyathulae 175-185 Rhizoma Chuanxiong 175-185 Radix Angelicae Sinensis 115-125
The Rhizoma Curcumae Longae 115-125 Rhizoma Cyperi or the prepared RHIZOMA CYPERI 135-150 Radix Astragali or Radix Astragali Preparata 175-185.
The weight portion proportioning of above-mentioned raw materials is also preferred:
Olibanum or Olibanum (processed) 50 Radix Clematidis 140 Flos Carthamis 145 Radix Salviae Miltiorrhizaes 190
Myrrha or Myrrha (processed) 95 Radix Cyathulaes 220 Rhizoma Chuanxiongs 220 Radix Angelicae Sinensis 95
Rhizoma Curcumae Longae 145 Rhizoma Cyperis or prepared RHIZOMA CYPERI 115 Radixs Astragali or Radix Astragali Preparata 140.
The weight portion proportioning of above-mentioned raw materials is also preferred:
Olibanum or Olibanum (processed) 95 Radix Clematidis 140 Flos Carthamis 95 Radix Salviae Miltiorrhizaes 190
Myrrha or Myrrha (processed) 90 Radix Cyathulaes 140 Rhizoma Chuanxiongs 140 Radix Angelicae Sinensis 95
Rhizoma Curcumae Longae 95 Rhizoma Cyperis or prepared RHIZOMA CYPERI 115 Radixs Astragali or Radix Astragali Preparata 140.
The weight portion proportioning of above-mentioned raw materials is also preferred:
Olibanum or Olibanum (processed) 72 Radix Clematidis 180 Flos Carthamis 120 Radix Salviae Miltiorrhizaes 240
Myrrha or Myrrha (processed) 72 Radix Cyathulaes 180 Rhizoma Chuanxiongs 180 Radix Angelicae Sinensis 120
Rhizoma Curcumae Longae 120 Rhizoma Cyperis or prepared RHIZOMA CYPERI 144 Radixs Astragali or Radix Astragali Preparata 180
Preparation of the present invention can be prepared into acceptable oral Pharmaceutical dosage forms on any pharmaceutics according to the common process of this area.Preferred tablet, granule, capsule, pellet or dispersible tablet.
Adjuvant among the present invention is an acceptable auxiliary on the pharmaceutics, comprises starch, dextrin, betacyclodextrin, magnesium stearate, Pulvis Talci, aspartame, stevioside, micropowder silica gel, microcrystalline Cellulose, cross-linked carboxymethyl cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose sodium, carboxymethyl starch sodium etc.Preferred betacyclodextrin, dextrin, microcrystalline Cellulose.
Tablet of the present invention can be made by the method for being prepared as follows:
Get Radix Salviae Miltiorrhizae, the Radix Astragali of Radix Cyathulae and half and half amount and pulverize sieving for standby; Remaining pharmacy decocts, merging filtrate, and the relative density that is evaporated to 50 ℃ of surveys is the clear paste of 1.18-1.22, and is standby.Qinghuo reagent and crude drug powder are granulated, and granulate adds auxiliary materials and mixing, tabletting; Perhaps wrap film-coat; Promptly.
Preparation of the present invention can be made micropill by the method for being prepared as follows:
1) get Rhizoma Chuanxiong, Rhizoma Cyperi, Rhizoma Curcumae Longae three flavors, extract volatile oil, standby, medicinal liquid, medicinal residues are standby;
2) get seven flavors such as Olibanum, Myrrha, Radix Clematidis, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, the Radix Astragali, Radix Cyathulae, decoct, add 1) medicinal residues and Flos Carthami, decoct collecting decoction and 1 again) medicinal liquid, and filtering, filtrate is condensed into fluid extract, adds ethanol, leaves standstill.Get supernatant, the relative density that decompression recycling ethanol is concentrated into 50 ℃ of surveys is the clear paste of 1.18-1.30;
3) press volatile oil: betacyclodextrin=1: 4-10, enclose 0.5-3 hour, get volatile oil clathrate compound, standby;
4) get 2) clear paste, add volatile oil clathrate compound and adjuvant, the preparation micropill; Perhaps with the micropill coating; Promptly.
Preparation of the present invention also can be made micropill by the method for being prepared as follows:
1) get Radix Angelicae Sinensis, Rhizoma Chuanxiong full dose, the Radix Astragali, Radix Salviae Miltiorrhizae half and half amount are pulverized, and sieve, and be standby.
2) get medical materials such as Olibanum, Myrrha, Radix Clematidis, Radix Cyathulae, Rhizoma Cyperi, Rhizoma Curcumae Longae full dose and remaining Radix Salviae Miltiorrhizae, the Radix Astragali, decoct twice.Add Flos Carthami when decocting for the second time, merge medicinal liquid, filter, the relative density that filtrate is concentrated into 50 ℃ of surveys is the clear paste of 1.18-1.30;
3) get 2) clear paste, add crude drug powder and adjuvant, the preparation micropill; Perhaps with the micropill coating; Promptly.
Preparation of the present invention can be made dispersible tablet by the method for being prepared as follows:
1) above-mentioned prescription medical material is decocted with water, the gained medical filtration, merging filtrate, filtrate is concentrated into fluid extract, and is standby;
2) getting above-mentioned clear paste adds ethanol and makes the alcohol amount of containing reach 50-80%.Above-mentioned medicinal liquid is stirred evenly, left standstill 12-36 hour, the best is 24 hours.Get supernatant, decompression recycling ethanol, the relative density that is concentrated into 50 ℃ of surveys is the clear paste of 1.18-1.30, and is standby;
3) get above-mentioned clear paste and add the proper auxiliary materials granulation, drying is made dispersible tablet, promptly.
Adjuvant described in the step 3) comprises that lactose, sucrose, dextrin, starch, low-substituted hydroxypropyl cellulose, carboxymethyl starch are received, in the microcrystalline Cellulose, 30 POVIDONE K 30 BP/USP 30, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, Pulvis Talci, magnesium stearate, micropowder silica gel, polyethylene glycol 6000, Macrogol 4000, essence, aspartame one or more mix and use.
Preparation of the present invention indication clinically is a blood circulation promoting and blood stasis dispelling, dredging collateral to stop pain.The numbness disease that is used for obstruction of collaterals by blood stasis, disease see that the muscle arthralgia is violent, are sensation of pricking more, and the position is fixing not to be moved, and the sore spot tenderness can have rhabdion or ecchymosis.
Confirm that through clinical experiment Chinese medicine preparation of the present invention has significant curative effect to blood stasis numbness of the present invention, and toxic and side effects is little, taking convenience.Concrete experimental data is as follows:
Test a blood stasis arthralgia eliminating granule pharmacodynamics test data
Test two blood stasis numbness capsule Pharmacodynamic test of active extract
Test two blood stasis arthralgia eliminating granule III phase clinical experiment final reports
Test three blood stasis numbness capsule III phase clinical experiment final reports
Blood stasis arthralgia eliminating granule pharmacodynamics test data
Summary: blood stasis arthralgia eliminating granule gastric infusion can obviously suppress carrageenin and cause rat paw edema, can obviously alleviate granuloma weight, reduces H
+Due to the abdominal cavity capillary permeability, reduce acetic acid induced mice writhing response number of times, prolong the mouse tail bleeding time, adjuvant arthritis is had obvious prophylactic treatment effect.
Purpose: the blood stasis arthralgia eliminating granule to the arthromyodynia of treatment obstruction of collaterals by blood stasis, has obtained satisfied curative effect in clinical practice for a long time, and pharmacodynamic experiment is mainly to its promoting blood circulation to remove obstruction in the collateral, and effects such as eliminating impediment pain relieving are studied.
Experiment material:
Tested medicine: the blood stasis arthralgia eliminating granule, the 3rd pharmaceutical factory provides by Benxi, lot number: 990201
Positive controls: FENGSHIBIKANG JIAONANG provides lot number by Chinese-foreign joint Jilin Hua Jia pharmaceutcal corporation, Ltd: 99010430.3g/ grain animal: rat Wista numbness kind, and white mice HM kind, Liaoning Province animal housing of medicine technical study institute provides.
The quality certification number: No. 003, the real moving word of the Liao Dynasty.
Experimental technique:
One, dish glue in diagonal angle causes the influence of big tree foot swelling.
40 of male rats, body weight 120～150g is divided into 5 groups at random, 10 every group, irritates stomach respectively and gives blood stasis arthralgia eliminating granule 4.64g/kg and 2.32g/kg (by the crude drug amount).Positive drug contrast FENGSHIBIKANG JIAONANG 0.16g/kg.Matched group waits the capacity normal saline.All irritate stomach every day and give once, 1 week of successive administration, last administration 30 ', before each rat foot subcutaneous injection 1% carrageenin 0.05ml causes inflammation, measures administration, 1,2,3,4,6 hour right back ankle joint Zhou Jing after the administration.Before causing inflammation with each rat, the difference of back ankle joint Zhou Jing is the swelling degree, calculates and respectively organizes swelling degree average and standard deviation, the results are shown in Table 1.
The influence of rat paw edema due to the table 1 blood stasis arthralgia eliminating granule diagonal angle dish glue
| Group | Dosage (g/kg) | Animal (only) | Rat paw edema degree (X ± SD, cm) (h) | ||||
| 1 | 2 | 3 | 4 | 6 | |||
| Contrast FENGSHIBIKANG blood stasis numbness blood stasis numbness | - 0.16 4.64 2.32 | 10 10 10 10 | 0.77±0.13 0.57±0.09** 0.55±0.08** 0.6±0.07* | 0.78±0.15 0.65±0.12* 0.63±0.09* 0.67±0.06* | 0.78±0.11 0.67±0.11* 0.65±0.10* 0.70±0.06* | 0.83±0.12 0.72±0.09** 0.70±0.10* 0.73±0.10* | 0.70±0.11 0.61±0.10** 0.57±0.11* 0.645±0.11* |
* compare with matched group P＜0.05 * * P＜0.01
Table 1 is the result show, blood stasis numbness can obviously suppress rat paw edema due to the carrageenin, and the obvious anti-inflammatory and anti effect is arranged.
Two, to the influence of granuloma induced by implantation of cotton pellets
32 of male rats, body weight 140～170g is divided into 4 groups at random, every group 8, through abdominal incision, (each cotton balls weighs 50 ± 1mg) autoclavings with two sterilization cotton balls under the sterile working, each adds ciprofloxacin ether light anaesthesia mg/0.1mg/, 50 ℃ of stove-dryings, and it is subcutaneous to implant rat both sides groin respectively, postoperative began gastric infusion the same day, once a day, and continuous 8 days, 1h after the last administration, the cervical vertebra dislocation is put to death, and gets cotton balls, it is roasting to constant weight to put 60 ℃ of baking boxs, weighs.Deduct the raw cotton ball weight, be the granuloma value.Respectively organize the granuloma weight differential, the results are shown in Table 2.
Table 2 blood stasis arthralgia eliminating granule is to the influence of granuloma induced by implantation of cotton pellets
| Group | Dosage (g/kg) | Number of animals (only) | The granuloma weight (X ± SD, mg) |
| Matched group FENGSHIBIKANG blood stasis arthralgia eliminating granule blood stasis arthralgia eliminating granule | - 0.16 4.64 2.32 | 8×2 8×2 8×2 8×2 | 45.79±24.18 31.13±11.82* 24.97±9.13* 29.64±11.88* |
* compare with matched group P＜0.05
Table 2 is the result show, the blood stasis arthralgia eliminating granule can obviously alleviate granuloma weight, and obvious antagonism connective tissue proliferation effect is arranged, and compares no significant difference with FENGSHIBIKANG.
Three, to the influence of abdominal cavity hair cell vascular permeability
40 of male white mouses, body weight 19～21g is divided into 4 groups at random, every group 10, every day gastric infusion once, successive administration 9 days, 1h after the last administration, the blue 0.1ml/10g of tail vein injection 1% ivens, the abdominal cavity only injects 0.7% glacial acetic acid 0.2ml/ immediately, sacrificed by decapitation after 20 minutes, lumbar injection 5ml normal saline is drawn peritoneal fluid, centrifugal 15 minutes, survey trap in the 599nm place, relatively each group difference the results are shown in Table 3.
Table 3 blood stasis arthralgia eliminating granule influences the abdominal cavity capillary permeability
| Group | Dosage (g/kg) | Number of animals (only) | Optical density (X ± SD, mg) |
| Matched group FENGSHIBIKANG blood stasis arthralgia eliminating granule blood stasis arthralgia eliminating granule | - 0.33 9.46 4.32 | 10 10 10 10 | 0.457±0.148 0.328±0.10* 0.243±0.949* 0.326±0.07* |
* compare with matched group P＜0.05
Table 3 result shows: the blood stasis arthralgia eliminating granule strengthens the abdominal cavity blood capillary general character due to the glacial acetic acid obvious inhibitory action.
Four, Dichlorodiphenyl Acetate causes the influence of pain
40 of male and female white mice, body weight 18～22g is divided into 4 groups at random, every group 10, every day gastric infusion once, successive administration 7 days, in 40 minutes each Mus lumbar injection 0.7% acetum 0.2ml/ of last administration only, immediately in the opening entry 20 minutes each mice turn round the body number of times, the results are shown in Table 4.
Table 4 blood stasis arthralgia eliminating granule is to the influence of mice acetic acid twisting reaction
| Group | Dosage (g/kg) | Number of animals (only) | The writhing response number of times (X ± SD) |
| Matched group FENGSHIBIKANG blood stasis arthralgia eliminating granule blood stasis arthralgia eliminating granule | - 0.33 946 4.32 | 10 10 10 10 | 26.0±7.29 16.8±9.0* 17.0±8.0* 18.2±6.7* |
* compare with matched group P＜0.05
Table 4 is the result show, what the blood stasis arthralgia eliminating granule can obviously reduce acetic acid induced mice abdominal pain turns round the body number of times, and obvious analgesic activity is arranged.
Five, to getting the influence in tail bleeding time
Select 18～22g mice for use, the male and female dual-purpose, be divided into 4 groups at random, continuous irrigation stomach seven days, after the last administration 30 minutes, cross-section in order to cutting respectively with mouse tail point 0.5cm place, blood flows out the back timing voluntarily, inhales to dehematize with filter paper every 15s and drips once, stops naturally until blood, calculate the bleeding time, gained data and matched group carry out significance test.
Table 5 blood stasis arthralgia eliminating granule is to the influence in mouse tail bleeding time
| Group | Dosage (g/kg) | Number of animals (only) | Bleeding time (X ± SD, min) |
| Saline control FENGSHIBIKANG blood stasis arthralgia eliminating granule blood stasis arthralgia eliminating granule | - 0.33 9.46 4.32 | 10 10 10 10 | 4.46±1.12 4.53±0.58 5.42±1.13* 5.07±0.74 |
* compare with matched group P＜0.05
Table 5 is the result show, blood stasis arthralgia eliminating granule 9.47g/kg can prolong the mouse tail bleeding time, and the effect of invigorating blood circulation of blood stasis arthralgia eliminating granule is described.
Six, to the effect of adjuvant arthritis
70 of male white rats, body weight 60～190g, divide 7 groups at random, every group 10, the complete matter agent of the right back sufficient subcutaneous injection Freudh ' s of every Mus 0.05ml causes inflammation, prophylactic treatment group gastric infusion immediately after causing inflammation, be administered once every day, and successive administration 21 days is before the survey administration, 3h after the administration, 18h, 5 days, 8 days, 12 days, 15 days, 18 days, two ankle joint Zhou Jing of 23 days, calculate the paw swelling of different time after the administration, the comparable group differences, secondary affection treatment group with cause beginning administration in scorching back 8 days, successive administration causes scorching back 29 days, measurement causes scorching back 8,12,15,18,21,23,26,29 days cause scorching ankle joint Zhou Jing to parapodum, be index with the swollen degree of left back foot, the comparable group differences, the results are shown in Table 6, table 7.
Table 6, table 7 is the result show, and blood stasis arthralgia eliminating granule prevention administration is to the primary affection of adjuvant arthritis, and secondary affection all has obvious inhibitory action, and the treatment administration has obvious inhibitory action to the adjuvant arthritis secondary affection.
Conclusion:
Above-mentioned pharmacodynamics test result of study shows: the blood stasis arthralgia eliminating granule has blood circulation promoting and blood stasis dispelling, the effect of dredging collateral to stop pain.
Table 6 blood stasis arthralgia eliminating granule prevention administration is to the influence in rat adjuvant joint
| Group | Dosage (g/kg) | Animal (only) | Cause scorching back different time swelling value (cm, X ± SD) | |||||||||
| 3h | 18h | 5h | 8d | 12d | 15d | 18d | 21d | 23d | ||||
| Cause scorching foot (left side) | Contrast FENGSHIBIKANG blood stasis arthralgia eliminating granule blood stasis arthralgia eliminating granule | - 0.16 4.64 2.32 | 10 10 10 10 | 0.59±0.13 0.62±0.17 0.60±0.14 0.58±0.16 | 0.89±0.16 0.90±0.20 0.88±0.15 0.94±0.19 | 0.87±0.12 0.65±0.18* 0.66±0.14* 0.80±0.15 | 1.03±0.13 0.74±0.19** 0.71±0.14 0.86±0.19* | 1.20±0.16 0.93±0.20** 0.93±0.23** 1.02±0.23* | 1.37±0.11 1.09±0.19** 1.08±0.24** 1.26±0.18 | 1.49±0.18 1.19±0.15** 1.18±0.24** 1.27±0.23 | 1.50±0.19 1.22±0.13** 1.21±0.19* 1.34±0.18 | 1.42±0.21 1.24±0.16 1.22±0.21* 1.32±0.15 |
| To parapodum (right side) | Contrast FENGSHIBIKANG blood stasis arthralgia eliminating granule blood stasis arthralgia eliminating granule | 0.16 4.64 2.32 | 10 10 10 10 | 0.09±0.08 0.09±0.07 0.05±0.05 0.07±0.07 | 0.21±0.12 0.13±0.10 0.16±0.14 0.11±0.06 | 0.68±0.18 0.48±0.17* 0.56±0.14 0.49±0.15 | 0.69±0.14 0.50±0.15* 0.55±00.12* 0.48±0.13* | 0.70±0.14 0.52±0.15* 0.57±0.11* 0.52±0.12* | 0.67±0.16 0.51±0.13* 0.55±0.09* 0.52±0.12* | |||
* compare with matched group P＜0.05 * * P＜0.01
Table 7 blood stasis arthralgia eliminating granule treatment administration is to the influence of adjuvant arthritis Secondary cases pathological changes
| Group | Dosage (g/kg) | Animal (only) | Cause scorching back different time swelling value (cm, X ± SD) | |||||||
| 8d | 12d | 15d | 18d | 21d | 23d | 26d | 29d | |||
| Matched group FENGSHIBIKANG blood stasis arthralgia eliminating granule blood stasis arthralgia eliminating granule | - 0.16 1.62 0.81 | 10 10 10 10 | 0.09±0.08 0.09±0.07 0.09±0.07 0.09±0.08 | 0.21±0.12 0.13±0.10 0.13±0.09 0.13±0.09 | 0.68±0.18 0.48±0.17* 0.49±0.14* 0.57±0.15 | 0.69±0.14 0.50±0.15* 0.51±0.13** 0.53±0.16* | 0.70±0.14 0.52±0.15* 0.54±0.11** 0.58±0.14 | 0.67±0.16 0.51±0.13* 0.55±0.08* 0.53±0.13 | 0.60±0.14 0.46±0.11* 0.56±0.07* 0.50±0.11 | 0.54±0.13 0.43±0.13 0.43±0.07* 0.45±0.10 |
* compare with matched group P＜0.05 * * P＜0.01
The capsular Pharmacodynamic test of active extract of blood stasis numbness
Summary: blood stasis numbness capsule gastric infusion can obviously suppress carrageenin and cause rat paw edema, can obviously alleviate granuloma weight, reduces H
+Due to the abdominal cavity capillary permeability, reduce acetic acid induced mice writhing response number of times, prolong the mouse tail bleeding time, adjuvant arthritis is had obvious prevention and therapeutical effect.
Purpose: blood stasis numbness capsule is treated rheumatic in clinical practice for a long time, and rheumatoid arthritis has obtained satisfied curative effect, and pharmacodynamics test mainly to its blood circulation promoting and blood stasis dispelling, study by effects such as dredging collateral to stop pain, for clinical practice provides experimental basis.
Experiment material:
Tested medicine: blood stasis numbness capsule, the 3rd pharmaceutical factory provides by Benxi, 0.4g/ grain lot number: 990602
Positive control drug: FENGSHIBIKANG JIAONANG, pharmaceutcal corporation, Ltd provides lot number by magnificent osmanthus, Chinese-foreign joint Jilin: 9901043
Animal: rat Wistar kind, white mice HM kind, Liaoning Province medical industry academy animal housing provides, the quality certification number: No. 003, the real moving word of the Liao Dynasty.
Experimental technique:
1, on Carrageenan causes the influence of rat paw edema
40 of male white rats, body weight 120～150g is divided into 4 groups at random, 10 every group, irritates stomach respectively and gives blood stasis numbness capsule 2.95g/kg and 1.48g/kg; FENGSHIBIKANG JIAONANG 0.16g/kg; (dosage is converted by clinical people's consumption) matched group waits the capacity normal saline.All every day gastric infusion once, 1 week of successive administration, caused inflammation in rat ankle and foot subcutaneous injection carrageenin 0.05ml in 30 minutes after this administration, measure administration before, 1,2,3,4,6 hour metapedes ankle joint Zhou Jing after the administration.Before causing inflammation with each rat, the difference of back ankle joint Zhou Jing is the swelling degree, calculates and respectively organizes swelling degree average and standard deviation, and relatively each group difference the results are shown in Table 1.
The influence of rat paw edema due to the table 1 blood stasis numbness capsule diagonal angle dish glue
| Group | Dosage | Number of animals | Big paw swelling (X+SD, CM) | ||||
| 1 | 2 | 3 | 4 | 6 | |||
| Contrast FENGSHIBIKANG blood stasis numbness | - 0.16 2.95 1.8 | 10 10 10 10 | 0.705±0.13 0.565±0.09* 0.605±0.01* 0.635±0.09* | 0.780±0.15 0.65±0.119* 0.640±0.08* 0.650±0.06* | 0.775±0.10 0.665±0.10* 0.660±0.11* 0.675±0.05* | 0.835±0.12 0.750±0.085* 0.710±0.12* 0.700±0.05* | 0.695+0.11 0.610±0.10 0.600±0.11 0.625±0.09 |
* compare with matched group P＜0.05
Table 1 is the result show, rat paw edema has obvious inhibitory action due to the blood stasis numbness capsule on Carrageenan, and the effect of tool obvious anti-inflammatory and anti is described.
2, to the influence of granuloma induced by implantation of cotton pellets
32 of male rats, body weight 140～170g is divided into 4 groups at random, 8 every group, the ether light anaesthesia, through abdominal incision, (each cotton balls weighs 50 ± 1mg with two aseptic cotton balls under the sterile working, autoclaving, each adds ciprofloxacin 1mg/0.1ml, 50 ℃ of stove-dryings, it is subcutaneous to implant rat both sides groin respectively, and postoperative began gastric infusion the same day, once a day, continuous 8 days, last administration 1h, the cervical vertebra dislocation is put to death, get cotton balls, it is roasting to constant weight to put 60 ℃ of baking boxs, weighs.Deduct the raw cotton ball weight, be granuloma and weigh.Respectively organize the granuloma weight differential, the results are shown in Table 2.
Table 2 blood stasis numbness capsule is to the influence of granuloma induced by implantation of cotton pellets
| Group | Dosage (g/kg) | Animal (only) | The granuloma weight (X ± SD) |
| Contrast FENGSHIBIKANG blood stasis numbness | 0.16 2.95 1.48 | 8×2 8×2 8×2 8×2 | 45.79±24.18 31.13±11.82* 26.59±9.57* 32.78±7.59* |
Compare with matched group P＜0.05
Table 2 shows that blood stasis numbness capsule can obviously alleviate the swollen weight of meat, and obvious antagonism connective tissue proliferation effect is arranged.
3, to the influence of abdominal cavity capillary permeability
40 of male white mouses, body weight 19 ~ 22g are divided into 4 groups at random, every day gastric infusion once, successive administration 9 days, 1h after the last administration, the blue 0.1ml/10g of tail vein injection 1% ivens, lumbar injection 0.7% glacial acetic acid immediately, 0.2ml/ only, sacrificed by decapitation after 20 minutes, lumbar injection 5ml normal saline, draw peritoneal fluid, centrifugal 15 minutes, survey trap in the 590nm place, relatively each group difference the results are shown in Table 3.
The influence of table 3 blood stasis numbness capsule abdominal cavity capillary permeability
| Group | Dosage (g/kg) | Animal (only) | Optical density (X ± SD) |
| Contrast FENGSHIBIKANG blood stasis numbness | 0.16 2.95 1.48 | 10 10 10 10 | 0.457±0.148 0.387±0.105* 0.238±0.109* 0.313±0.07* |
* compare with matched group P＜0.05
Table 3 result shows that blood stasis numbness capsule strengthens the abdominal cavity capillary permeability due to the glacial acetic acid obvious inhibitory action.
4, to the influence in mouse tail bleeding time
Select 40 of body weight 18～22g white mice, the male and female dual-purpose, be divided into 4 groups at random, continuous irrigation stomach seven days, after last perfusion 30 minutes, cross-section in order to cutting respectively with mouse tail point 0.5cm place, blood flows out the back timing voluntarily, every 15 seconds with filter low inhale to dehematize drip once, stop naturally until blood, calculate the bleeding time, gained data and matched group carry out significance test.
Table 4 blood stasis numbness capsule is to the influence in mouse tail bleeding time
| Group | Dosage (g/kg) | Animal (only) | Bleeding time (min) |
| Contrast FENGSHIBIKANG blood stasis health | 0.33 5.9 2.95 | 10 10 10 10 | 4.46±1.12 5.03±0.8* 6.53±2.79* 5.20±0.94* |
* P＜0.05 matched group relatively
The visible blood stasis numbness of table 4 result capsule has obvious prolongation effect to the mouse tail bleeding time, shows the effect of invigorating blood circulation of blood stasis numbness capsule.
5, Dichlorodiphenyl Acetate causes the influence of pain
40 of female white mice, body weight 18～22g is divided into 4 groups at random, every group 10, every day gastric infusion once, successive administration 7 days, last administration pneumoretroperitoneum is injected 0.7% acetum 0.2ml/ only, immediately in the opening entry 20 minutes each mice turn round the body number of times, the results are shown in Table 5.
Table 5 blood stasis numbness capsule is to the influence of mice acetic acid twisting reaction
| Group | Dosage (g/kg) | Number of animals (only) | The writhing response number of times (X ± SD) |
| Matched group FENGSHIBIKANG blood stasis arthralgia eliminating granule blood stasis arthralgia eliminating granule | - 0.33 5.9 2.95 | 10 10 10 10 | 26.0±7.29 16.8±9.0** 17.1±6.75** 17.5±5.7** |
Compare with matched group * P＜0.01
Table 5 is the result show, what blood stasis numbness capsule can obviously reduce white mice abdominal pain due to the acetic acid turns round the body number of times, and very significant analgesia role is arranged.
6, to the influence of adjuvant arthritis
70 of male white rats, body weight 60～190g, divide 7 groups at random, every group 10, the complete matter agent of the right back sufficient subcutaneous injection Freudh ' s of every Mus 0.05ml causes inflammation, prophylactic treatment group gastric infusion immediately after causing inflammation, be administered once every day, successive administration 21 days, before the survey administration, 3h after the administration, 18h, 5 days, 8 days, 12 days, 15 days, 18 days, two ankle joint Zhou Jing of 23 days, the paw swelling of different time after the calculating administration, the comparable group differences, secondary affection treatment group with cause beginning administration in scorching back 8 days, successive administration causes scorching back 29 days, measurement causes scorching back 8,12,15,18,21,23,26,29 days cause scorching ankle joint Zhou Jing to parapodum, with the swollen degree of left back foot is index, comparable group differences, table 6 between the result, table 7.
Table 6, table 7 result show that blood stasis numbness capsule prevention administration is to the primary affection of adjuvant arthritis, and secondary affection all has obvious inhibitory action, and the treatment administration has obvious inhibitory action to the adjuvant arthritis secondary affection.
Conclusion:
Above-mentioned pharmacodynamics test result of study shows: blood stasis numbness capsule has blood circulation promoting and blood stasis dispelling, the effect of dredging collateral to stop pain.
Table 6 blood stasis numbness capsule prevention administration is to the influence in rat adjuvant joint
| Group | Dosage (g/kg) | Animal (only) | Cause scorching back different time swelling value (cm, X ± SD) | |||||||||
| 3h | 18h | 5h | 8d | 12d | 15d | 18d | 21d | 23d | ||||
| Cause scorching foot (left side) | Contrast FENGSHIBIKANG blood stasis numbness capsule blood stasis numbness capsule | - 0.16 2.95 1.48 | 10 10 10 10 | 0.59±0.13 0.62±0.17 0.69±0.11 0.65±0.15 | 0.89±0.16 0.90±0.20 0.87±0.11 0.89±0.16 | 0.87±0.12 0.65±0.18* 0.89±0.10 0.81±0.15 | 1.03±0.13 0.74±0.19** 0.71±0.14** 0.75±0.19* | 1.20±0.16 0.93±0.20** 0.91±0.11** 0.96±0.10* | 1.37±0.11 1.09±0.19** 1.01±0.12** 1.12±0.07 | 1.49±0.18 1.19±0.15** 1.28±0.11** 1.17±0.04* | 1.50±0.19 1.22±0.13** 1.23±0.12* 1.21±0.06* | 1.42±0.21 1.24±0.16 1.15±0.11* 1.26±0.07 |
| To parapodum (right side) | Contrast FENGSHIBIKANG blood stasis numbness capsule blood stasis numbness capsule | 0.16 2.95 1.48 | 10 10 10 10 | 0.09±0.08 0.09±0.07 0.08±0.07 0.05±0.05 | 0.21±0.12 0.10±0.09* 0.15±0.07 0.13±0.06 | 0.68±0.18 0.46±0.17* 0.51±0.18 0.50±0.09 | 0.69±0.14 0.50±0.24* 0.54±0.13* 0.53±0.07* | 0.70±0.14 0.53±0.19* 0.51±0.16* 0.56±0.13* | 0.67±0.16 0.53±0.11* 0.55±0.13* 0.53±0.11* | |||
* compare with matched group P＜0.05 * * P＜0.01
The administration of table 7 blood stasis numbness capsule for treating is to the influence of adjuvant arthritis Secondary cases pathological changes
| Group | Dosage (g/kg) | Animal (only) | Cause scorching back different time swelling value (cm, X ± SD) | |||||||
| 8d | 12d | 15d | 18d | 21d | 23d | 26d | 29d | |||
| Matched group FENGSHIBIKANG blood stasis arthralgia eliminating granule blood stasis arthralgia eliminating granule | - 0.16 2.95 1.48 | 10 10 10 10 | 0.09±0.08 0.09±0.08 0.09±0.07 0.09±0.09 | 0.21±0.12 0.13±0.10 0.13±0.04 0.13±0.09 | 0.68±0.18 0.48±0.17* 0.49±0.11* 0.53±0.10 | 0.69±0.14 0.50±0.15* 0.51±0.07* 0.53±0.07 | 0.70±0.14 0.52±0.15* 0.55±0.06* 0.53±0.07 | 0.67±.0.16 0.51±0.13* 0.56±0.07* 0.53±0.08 | 0.60±0.14 0.46±0.11* 0.55±0.06 0.54±0.08 | 0.54±0.13 0.43±0.13 0.45±0.06 0.45±0.07 |
* compare with matched group P＜0.05
Blood stasis numbness capsule III phase clinical experiment final report
Blood stasis numbness capsule is one of sick serial medicine of national three kind new medicine numbness, and for Chinese Chinese medicine and pharmacy is understood rheumatism association cipher prescription, Liver and kidney two deficiency syndrome in the treatment traditional Chinese medical science rheumatism are waited.This medicine is chosen as national essential drugs, and Chinese medicine protection kind and " medical insurance " medication by national requirements, need that this medicine is carried out clinical efficacy and revalue, and carry out safety and investigate, and the spy carries out III phase clinical experiment.Can the tissue whole nation 12 tame hospitals of rheumatism association carry out open clinical observation by Chinese Chinese medicine and pharmacy,, observe patient's 383 examples altogether from April in August, 2000 to calendar year 2001, test group 296 examples wherein, matched group 87 examples now are reported as follows the result.
General material
One, case source: this group is totally 383 examples, inpatient's 183 examples wherein, outpatient's 200 examples.
Two, sex: two groups of patient's sex ratios see Table 1
Table 1 liang group patient sex ratio
| Group | The example number | Male N (%) | Women N (%) |
| The test group matched group | 296 87 | 139(47) 35(40) | 157(53) 52(60) |
Test group and matched group compare: X
2=1.228 P＞0.05
Two groups of patients there was no significant difference on sex distributes is described, has comparability.
Three, two groups of patient ages distribute relatively, see Table 2
Table 2 liang group patient age distribution comparison (year)
| Group | The example number | ≤30 N(％) | 31~40 N(％) | 41~50 N(％) | 51~65 N(％) | Mean age X ± S |
| The test group matched group | 296 87 | 31(10.5) 7(8) | 44(14.9) 8(9) | 78(26.4) 34(39) | 143(49.38) 38(44) | 43.79±13.36 45.64±11.02 |
Test group and matched group compare: X
2=7.654 P＞0.05
Two groups of patients there was no significant difference in age distribution is described, has comparability.
Four, two groups of patient's courses of disease relatively see Table 3
The table 3 liang group patient course of disease relatively
| Group | The example number | ≤ 6 months N (%) | Half a year ~ N (%) | 2 years ~ N (%) | 5 years ~ N (%) | 10 years ~ N (%) | Average course of disease X ± S |
| The experimental group matched group | 296 87 | 50(17) 8(9) | 80(27) 18(21) | 79(27) 28(32) | 46(16) 20(23) | 41(14) 13(15) | 3.72±4.17 4.79±5.33 |
Test group and matched group compare: X
2=6.633 P＞0.05
Illustrate that two groups of patients relatively go up there was no significant difference in the course of disease, have comparability.
Five, the sick kind distributes relatively, sees Table 4
The sick kind of table 4 distributes relatively
| Group | The example number | RA N(％) | AS N(％) | gout N(％) | OA N(％) |
| The test group matched group | 296 87 | 97(33) 27(31) | 34(11) 8(9) | 21(7) 14(16) | 144(49) 39(44) |
Test group and matched group compare: X
2=5.254 P＞0.05
Two groups of patients there was no significant difference on the disease kind distributes is described, has comparability.
Six, syndrome degree: two groups of patient's syndrome degree relatively see Table 5
Table 5 liang group patient syndrome degree relatively
| Group | The example number | Slight N (%) | Moderate N (%) | Severe N (%) |
| The test group matched group | 296 87 | 24(8) 13(15) | 158(53) 41(47) | 114(39) 33(38) |
Test group and matched group compare: X
2=1.61 P＞0.05
Two groups of patients there was no significant difference on the syndrome degree is described, has comparability.
Test method
One. diagnostic criteria
(1) syndrome of static blood blocking collaterals
The muscle arthralgia is violent, is twinge more, and the position is fixing not to be moved, and local swelling can have scleroma or ecchymosis, and purplish tongue has ecchymosis, white and thin fur, stringy and hesitant pulse.
(2) Western medicine diagnose standard
According to the therapeutic efficiency of blood stasis numbness (capsule, granule), select sick kind of following doctor trained in Western medicine to carry out clinical observation.
1. knee osteoarthritis diagnostic criteria (adopting Americanism damp disease association standard)
Most of date gonalgias since (1) one month;
(2) the X line shows edge, joint hyperosteogeny;
(3) (transparent, viscosity reduces OA synovial membrane liquid more, WBC＞2100/ml);
(4) person that can not look into the synovial fluid, the age must 〉=40 years old;
(5) morning deadlock≤30min;
(6) snap sound is arranged during joint motion.
It is all diagnosable to satisfy (1) (2) or (1) (3) (5) (6) or (1) (4) (5) (6) person
2. rheumatoid arthritis (RA) diagnostic criteria (Americanism damp disease association revision diagnostic criteria in 1987)
(1) morning deadlock at least 1 hour, continued at least 6 weeks.
(2) 3 or the arthroncus more than 3 continued at least 6 weeks.
(3) carpal joint, metacarpophalangeal joints or 6 weeks of nearly articulations digitorum manus swelling or more than.
(4) symmetry arthroncus.
(5) the X line of hands changes.
(6) rheumatoid nodules.
(7) the rheumatoid factor positive.
In above-mentioned 7, have 4 or above person and can be diagnosed as RA.
3. ankylosing spondylitis diagnostic criteria (the New York standard of revision in 1984)
(1) clinical criteria
1. low back pain continues at least 3 months, can alleviate after the activity, has a rest not have and improves
2. lumbar vertebra is at the limitation of activity of vertical and horizontal plane
3. the thorax mobility be lower than corresponding age, property others
(2) radiology standard
3～4 grades of bilateral sacroiliitis 〉=2 grade or one-sided sacroiliitises
Make a definite diagnosis: meet radiology standard and 1 above clinical criteria.
4. gout diagnostic criteria (Holmes 1985)
(1) in the leukocyte of synovial bursa hydrops, urate crystal is arranged;
(2) in suction of tophus pin or the biopsy urate crystal is arranged;
(3) do not find special urate crystal, but hyperuricemia is arranged, typical acute arthritis is shown effect and the asymptomatic intermission, and treatment has specially good effect person to colchicine.
Two. test case standard
(1) case is included standard in
1. meet above-mentioned tcm syndrome standard and certain Western medicine diagnose person, all can include the object of observation in.
2. the age is between 18 ~ 65 years old.
(2) case is got rid of and the rejecting standard
1. do not meet and include standard person in.
2. gestation or women breast-feeding their children, serious primary diseases such as allergic constitution or this medicine allergy sufferers merged is had the inclination, cerebrovascular, liver, kidney, hemopoietic system, psychotic.
3. not medication in accordance with regulations can't be judged the infull person of curative effect or data.
Three. observational technique
(1) medicine
1. test drug: blood stasis numbness capsule, blood stasis arthralgia eliminating granule, specification: granule is the 10g/ bag; Capsule is 0.25g, and being produced by Benxi, Liaoning Province the 3rd pharmaceutical factory provides.
2. contrast medicine: ZHENGQINGFENGTONGNING PIAN, specification are the 20mg/ sheet, produce (authentication code: ZZ-5365 defends in Hunan the accurate word 1992 of medicine No. 023069) by Zhengqing Pharmaceutical Group Corp., Ltd., Hunan Prov., and Benxi the 3rd pharmaceutical factory provides.
(2) test method
1. the object of observation is for being in hospital and the out-patient.
2. grouping: adopt contrast method at random, case is pressed Capsules group: groups of grains: matched group distributes, and ratio is 3: 3: 1.
3. medication: Capsules group, each 4,3 times on the one; Groups of grains, each 1 bag, 3 times on the one; Matched group, 2 of first clothes, 3 times on the one, having no adverse reaction after the week adds to each 3, three times on the one.
4. course of treatment: rheumatoid arthritis and ankylosing spondylitis, be 2 months the course of treatment; Gout, knee osteoarthritis course of treatment is 1 month.
Four. observation index
(1) safety observation
1. general health check-up project
2. blood, urine, just routine examination
3. electrocardiogram, liver, kidney function test
(2) health giving quality observation
1. symptom grade scale:
1. arthralgia:
0 minute: do not have
1 minute: mild pain, can stand, do not influence sleep.
2 minutes: moderate pain, inertia be pain also.
3 minutes: pain was difficult to stand, and influences function.
2. arthroncus:
0 minute: do not have
1 minute: mild swelling, near bone mark was clear.
2 minutes: swelling was equal with near bone mark.
3 minutes: obviously swelling, bone mark was unclear.
3. articular pain:
0 minute: do not have.
1 minute: weight at the edge, joint or when touching ligament, patient claimed that pain is arranged.
2 minutes: weight patient claimed that pain is arranged, and frowns discomfort, and activity is slightly limited.
3 minutes: the severe tenderness, pressing slightly promptly has pain and shrinks back, and passive activity is seriously limited.
4. morning deadlock:
0 minute: do not have.
1 minute: morning stiff time＜30 minute.
2 minutes: morning stiff time 〉=30 minute,＜60 minutes.
3 minutes: morning stiff time 〉=60 minute.
5. function of joint:
0 minute: function was normal.
1 minute: slightly limited, can be engaged in normal activity.
2 minutes: obviously limited, life can be taken care of oneself, but can not be engaged in general activity.
3 minutes: the movable function forfeiture, can't take care of oneself.
6. pain is fixing does not move:
0 minute: do not have
1 minute: have
7. joint sting:
0 minute: do not have
1 minute: have
8. purplish tongue has ecchymosis:
0 minute: do not have
1 minute: have
The mild symptoms major punishment is fixed:
Slightly: integration＜5 minute
Moderate: integration 6～10 minutes
Severe: integration＞10 minute
(2) both hands grip: all write down the numerical value (mmHg) that is reached before and after the treatment.
(3) picture of the tongue pulse condition observation.
(4) laboratory indexes observation: ESR, CRP, RF, blood uric acid.
(5) untoward reaction observation:, itemized record with the relevant untoward reaction of curative possibility.
The symptom efficacy determination:
Control: reduce to 0 fen person through the treatment symptom integral.
Produce effects: reduce by 2 fens persons through the treatment symptom integral.
Effectively: reduce by 1 fen person through the treatment symptom integral.
Five. traditional Chinese medical science disease curative effect determinate standard (according to new Chinese medicine clinical guidance principle standard)
Clinic control: treat the back symptom and disappear substantially, symptom was promptly divided 0～1 fen.
Produce effects: treat the back symptom and be clearly better, symptom is promptly divided decline 〉=2/3
Effectively: treat the back doing well,improving, symptom is promptly divided decline 〉=1/3.
Invalid: as not reach effective standard.
Six. the curative effect of treatment rheumatism sexually transmitted disease (STD) in the curative effect of disease standard (with reference to new drug (Western medicine) clinical guidance principle)
Evaluation criteria.
Clinical remission: symptom, sign disappear, and the laboratory leading indicator is recovered or be approaching normal.
Produce effects: symptom, sign disappear substantially, and the laboratory leading indicator is obviously improved, decline degree 〉=50%.
Effectively: symptom, sign alleviate, and the laboratory leading indicator also has improvement.
Invalid: symptom, sign and laboratory leading indicator do not have improvement.
Annotate: laboratory indexes computational methods erythrocyte sedimentation rate, c reactive protein, numeral-normal value before the numeral-treatment back numeral/treatment before the treatment; 〉=two dilution factors of rheumatoid factor decline
Result of the test
One, total effects analysis: two groups of clinical total effectses of patient relatively see Table 6
Table 6 liang group patient clinical efficacy relatively
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | The above rate N of produce effects (%) | Total effective rate N (%) |
| The test group matched group | 296 87 | 45(15.2) 7(8) | 112(37.8) 24(27.6) | 104(35.1) 34(39) | 25(8.4) 22(25) | 147(49.7) 31(35.6) | 271(91.6) 65(75) |
Annotate: * total effective rate=clinic control rate+obvious effective rate+effective percentage
Test group and matched group compare: u=3.710 P＜0.001
Two, symptom curative effect
1, two groups of patient's arthralgia treatment front and back curative effects relatively see Table 7.
Curative effect relatively before and after the table 7 liang group patient arthralgia treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 294 87 | 96(32.7) 13(14.9) | 59(20.1) 30(34.5) | 125(42.5) 25(28.7) | 14(4.8) 19(21.8) |
Test group and matched group compare: u=2.763 P＜0.01
Illustrate: test group is being better than matched group aspect the arthralgia curative effect.
2, two groups of patient's arthroncus treatment front and back curative effects relatively see Table 8.
Curative effect relatively before and after the table 8 liang group patient arthroncus treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 238 73 | 84(35.3) 10(13.7) | 69(29.0) 22(30.19) | 63(26.5) 21(28.7) | 22(9.2) 20(27.5) |
Test group and matched group compare: U=3.694 P＜0.001
Illustrate: test group is being better than matched group aspect the arthroncus curative effect.
3, two groups of patient's articular pain treatment front and back curative effects relatively see Table 9.
Curative effect relatively before and after the table 9 liang group patient articular pain treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 289 73 | 84(25.3) 10(12.2) | 52(18.0) 21(25.6) | 102(35.3) 14(17.4) | 62(21.4) 37(45.1) |
Test group and matched group compare: U=3.043 P＜0.01
Illustrate: test group is being better than matched group aspect the articular pain curative effect.
4, two groups of patient's joint function disturbance treatment front and back curative effects relatively see Table 10.
Curative effect relatively before and after the table 10 liang group patient joint function disturbance treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 275 69 | 70(25.5) 8(11.6) | 39(14.2) 16(23.1) | 85(30.9) 14(20.2) | 81(29.4) 31(44.9) |
Test group and matched group compare, U=2.189 P＜0.05
Illustrate: test group is being better than matched group aspect the joint function disturbance curative effect.
5, stiff treatment in morning front and back, two groups of patient joints curative effect relatively sees Table 11.
Curative effect relatively before and after the table 11 liang stiff treatment in group patient joint morning
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 79 29 | 17(21.5) 9(31.1) | 19(24.1) 3(10.4) | 27(34.2) 5(17.2) | 16(20.2) 12(41.3) |
Test group and matched group compare, U=1.215 P＞0.05
Illustrate: test group is compared there was no significant difference with matched group aspect the deadlock in the joint morning.
6, two groups of patient's joint sting treatment front and back disappearance rate relatively see Table 12.
Table 12 liang group patient joint sting disappearance rate relatively
| Group | The example number | N before the treatment | Treatment back N | Disappearance rate N (%) |
| The test group matched group | 86 18 | 59 12 | 8 3 | 51(86.4) 9(75.0) |
Test group and matched group compare, X
2=0.996 P＞0.05
Illustrate: test group is being compared there was no significant difference with matched group aspect the joint sting curative effect.
Three, the curative effect of the two groups of different sick kind treatment of patient front and back relatively.
1. curative effect relatively sees Table 13 before and after the two category rheumatic arthritis patient treatments.
Curative effect relatively before and after the table 13 liang category rheumatic arthritis patient treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate (%) |
| The test group matched group | 97 27 | 19(19.65) 1(3.7) | 34(35.1) 5(18.5) | 39(40.2) 14(51.8) | 5(5.1) 7(26) | 94.8 74 |
Test group and matched group compare, and Ridit analyzes: U=3.382 P＜0.001
Illustrate: test group and matched group curative effect relatively have significant differences.
2. two groups of osteoarthritis patient treatment front and back curative effects relatively see Table 14.
Curative effect relatively before and after the table 14 liang group osteoarthritis patient treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate (%) |
| The test group matched group | 144 53 | 22(15.3) 9(16.9) | 49(34.0) 5(9.4) | 51(35.4) 22(41.5) | 22(15.34) 17(32.1) | 84.7 67.9 |
Test group and matched group compare, and Ridit analyzes: U=3.059 P＜0.01
Illustrate: test group and treatment of control group osteoarthritis curative effect relatively have significant difference.
3. two groups of patients with ankylosing spondylitis treatment front and back curative effects relatively see Table 15
Curative effect relatively before and after the table 15 liang group patients with ankylosing spondylitis treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate (%) |
| The test group matched group | 34 6 | 4(15.0) 0 | 17(15.0) 1(17.0) | 11(62.0) 3(50.0) | 2(8.0) 2(33.0) | (92.0) (67.0) |
Test group and matched group compare, U=1.997 P＜0.05
Illustrate: test group and matched group relatively have significant difference.
4. two groups of patient with gout treatment front and back curative effects relatively see Table 16
Curative effect relatively before and after the table 16 liang group patient with gout treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate (%) |
| The test group matched group | 38 14 | 7(18.4) 1(7.1) | 11(28.9) 4(28.6) | 15(39.5) 5(35.7) | 5(13.2) 4(28.6) | 86.8 71.4 |
Test group and matched group compare, U=1.187 P＞0.05
Illustrate: test group and matched group be there was no significant difference relatively.
Four, the two groups of main laboratory indexes treatment of patient front and back curative effects relatively.
1. curative effect relatively sees Table 17 before and after the erythrocyte sedimentation rate treatment
Curative effect compares X ± S before and after the treatment of table 17 erythrocyte sedimentation rate
| The sick kind | Group | The example number | Before the treatment | After the treatment | P |
| RA AS | Test group matched group test group matched group | 91 15 34 8 | 39.21±15.02 40.31±15.02 43.29±22.35 19.33±7.99 | 13.74±10.15 24.30±13.23 18.47±11.49 16.5±5.6 | ＜0.01 ＜0.05 ＜0.01 ＞0.05 |
Illustrate before and after the test group self significant difference is relatively arranged; Compare RA before and after the matched group self significant difference is arranged.
2.C curative effect relatively sees Table 18 before and after the reactive protein treatment.
Curative effect relatively before and after the treatment of table 18 c reactive protein
| Group | The example number | Before the treatment | After the treatment | Negative conversion rate (%) | P | ||
| Negative | Positive | Negative | Positive | ||||
| The test group matched group | 100 45 | 75 28 | 25 17 | 93 37 | 7 8 | 72.0 52.9 | ＜0.05 ＞0.05 |
Illustrate: significant difference is relatively arranged before and after the test group self; Relatively there is not very significant difference before and after the matched group self.
3. curative effect relatively sees Table 19 before and after the treatment of rheumatoid arthritis patients rheumatoid factor.
Curative effect relatively before and after the treatment of table 19 rheumatoid factor
| Group | The example number | Before the treatment | After the treatment | Negative conversion rate (%) | P | ||
| Negative | Positive | Negative | Positive | ||||
| The test group matched group | 93 25 | 13 3 | 80 22 | 59 8 | 34 18 | 57.5 22.7 | ＞0.05 ＞0.05 |
Illustrate: compare there was no significant difference before and after the test group self; Compare there was no significant difference before and after the matched group self.
4. curative effect relatively sees Table 20 before and after the treatment of patient with gout blood uric acid.
Curative effect compares X ± S before and after the treatment of table 20 patient with gout blood uric acid
| Group | The example number | Before the treatment | After the treatment | P |
| The test group matched group | 38 14 | 595.5±69.1 535.25±34.06 | 357.8±24.2 428.1±45.12 | ＜0.01 ＞0.05 |
Illustrate: significant difference is relatively arranged before and after the test group self; Compare there was no significant difference before and after the matched group self.
Safety detects
In clinical trial, whole experimenters have been carried out the safety detection, the results are shown in Table 21.
Table 21 experimental group patient safety detects
| Project | The example number | Before the treatment | After the treatment | ||
| Normally | Unusually | Normally | Unusually | ||
| Routine blood test routine urinalysis stool routine examination GPT BUN Cr electrocardiogram | 232 232 232 232 232 232 232 | 228 221 232 232 232 232 206 | 4 11 0 0 0 0 26 | 232 227 232 232 232 232 211 | 1 6 0 0 0 0 21 |
Untoward reaction
Individual patient has slight gastrointestinal reaction, takes a turn for the better behind symptomatic treatment, all can adhere to treatment.
Discuss
Blood stasis is the pathological product of body under the pathogenic factor effect, can be used as the cause of disease again and acts on human body.The reason of its formation has internal and external factor, and exopathogen numbness resistance skin, joint, muscle arteries and veins etc. are located, and QI-blood circulation does not freely cause blood stasis and stagnates; Rheumatism mostly is the chronic course of disease, does not with the passing of time heal, and visceral dysfunction is then given birth in the blood stasis.Blood stasis numbness resistance outstanding behaviours is that pain of joint muscle is violent or acupuncture sample pain is arranged, and painful area is fixed, local swelling or scleroma is arranged, and dark tongue quality has the ecchymosis petechia more, stringy pulse or puckery.The traditional Chinese medical science thinks that rheumatismal basic pathogenesis is pathogen numbness resistance meridians, and QI-blood circulation is not smooth, so the resistance of blood stasis numbness is a rheumatismal important syndrome.Any period with disease can appear in this syndrome, sees with middle and advanced stage especially more, is common in rheumatisms such as rheumatoid arthritis, ankylosing spondylitis, gout, osteoarthritis.Blood stasis numbness capsule is made up of ten several kinds of Chinese medicinal materials such as Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Rhizoma Curcumae Longae, Flos Carthamis, cures mainly the blood stasis numbness resistance card in the traditional Chinese medical science rheumatism.Modern pharmacological research thinks that blood circulation promoting medicine has stronger anticoagulation, anti-thrombosis function; Reduce plasma fibrin source content, and tangible anti-fibrosis effect is arranged, the part medicine has the immunosuppressive action of pair cell and body fluid.Many bibliographical informations are arranged, and rheumatisant's microcirculation and hemorheology show tangible hypercoagulability.Activating blood circulation to dissipate blood stasis and dredge the collateral is the rheumatismal basic rule of treatment of treatment.
This research is according to traditional Chinese medical science treating different diseases with the same therapeutic principle and debates disease and the dialectical principle that combines, carry out blood stasis numbness capsule for treating rheumatoid arthritis, ankylosing spondylitis, gout, osteoarthritis and belong to the clinical observation on the therapeutic effect of blood stasis numbness resistance syndrome, result of the test is as follows: 1, two groups of total effectses are compared: test group 296 examples, above 147 examples of produce effects, obvious effective rate is 49.7%; Total effective rate is 91.6%.Matched group 87 examples, obvious effective rate are 35.6%; Total effective rate is 75%; Two groups of medicine total effectses are compared (P＜0.001).Significant differences is arranged.2, each symptom curative effect relatively: test group is being compared significant difference with matched group aspect treatment arthralgia, arthroncus, articular pain, the joint function disturbance.3. curative effect of disease relatively: treatment RA total effective rate is 94.8%, has compared significant difference with matched group; Treatment AS total effective rate is 92%, and treatment Gout total effective rate is 86.8%; Treatment knee osteoarthritis total effective rate is 84.7%, with matched group significant difference is arranged more all.4. to the influence of main laboratory indexes: test group treatment back ESR, CRP, RF, blood uric acid all have decline, and significant difference is relatively all arranged except that RF before and after the treatment.5. security inspection: blood stasis numbness capsule is except that small number of patients has slight gastrointestinal reaction, and no obvious adverse reaction all has no adverse effects to the heart, liver, kidney, hemogram etc.
More than explanation blood stasis numbness capsule has the effect of blood circulation promoting and blood stasis dispelling, removing obstruction in the collateral to relieve pain really, in present oral dose, course of treatment scope, drug safety, can be applicable to rheumatismal any period, no matter be all can alleviate the joint symptom as main medicine or ancillary drug treatment, especially to there being the handicapped patient in joint that certain mitigation is arranged, can be used as the treatment rheumatism and belong to one of choice drug of Yuxuebi capsule.
Test unit:
Guang-amen Hospital, China Traditional Chinese Medicine Instl
Shanghai brilliance hospital
Shanghai City institute of traditional Chinese medicine
Henan rheumatism hospital
Luoyang bonesetting hospital
The Beijing Jishuitan Hospital
Hospital Attached to Liaoning Inst. of Traditional Chinese Medicine
Gansu Provincial Hospital of Traditional Chinese Medicine
Tangshan City institute of traditional Chinese medicine
The Provincial Medicine Research Institute, Gansu
466 hospitals of Beijing air force
Benxi Hospital of Traditional Chinese Medicine
Blood stasis arthralgia eliminating granule III phase clinical experiment final report
The blood stasis arthralgia eliminating granule is one of sick serial medicine of national three kind new medicine numbness, and for Chinese Chinese medicine and pharmacy is understood rheumatism association cipher prescription, Liver and kidney two deficiency syndrome in the treatment traditional Chinese medical science rheumatism are waited.This medicine is chosen as national essential drugs, and Chinese medicine protection kind and " medical insurance " medication by national requirements, need that this medicine is carried out clinical efficacy and revalue, and carry out safety and investigate, and the spy carries out III phase clinical experiment.From April in August, 2000 to calendar year 2001, can the tissue whole nation 12 tame hospitals of rheumatism association carry out open clinical observation by Chinese Chinese medicine and pharmacy, observe patient's 378 examples altogether, test group 291 examples wherein, matched group 87 examples now are reported as follows the result.
General material
One, case source: this group is totally 378 examples, inpatient's 129 examples wherein, outpatient's 249 examples.
Two, sex: two groups of patient's sex ratios see Table 1
Table 1 liang group patient sex ratio
| Group | The example number | Male N (%) | Women N (%) |
| The test group matched group | 291 87 | 112(38.0) 35(40.0) | 179(62.0) 52(60.0) |
Test group and matched group compare: X
2=3.841 P＞0.05
Two groups of patients there was no significant difference on sex distributes is described, has comparability.
Three, two groups of patient ages distribute relatively, see Table 2
Table 2 liang group patient age distribution comparison (year)
| Group | The example number | ≤30 N(％) | 31~40 N(％) | 41~50 N(％) | 51~65 N(％) | Mean age X ± S |
| The test group matched group | 291 87 | 20(7.0) 7(8.0) | 37(13.0) 8(9.0) | 78(27.0) 34(39.0) | 156(53.08) 38(44.0) | 47.19±11.56 45.64±11.02 |
Test group and matched group compare: X
2=5.519 P＞0.05
Two groups of patients there was no significant difference in age distribution is described, has comparability.
Four, two groups of patient's courses of disease relatively see Table 3
The table 3 liang group patient course of disease relatively
| Group | The example number | ≤ 6 months N (%) | Half a year ~ N (%) | 2 years ~ N (%) | 5 years ~ N (%) | 10 years ~ N (%) | Average course of disease X ± S |
| The experimental group matched group | 291 87 | 41(14.0) 8(9.0) | 60(21.0) 18(21.0) | 71(24.0) 28(3.0) | 57(20.0) 20(23.0) | 62(21.0) 13(15.0) | 5.52±5.84 4.79±5.33 |
Test group and matched group compare: X
2=4.534 P＞0.05
Illustrate that two groups of patients relatively go up there was no significant difference in the course of disease, have comparability.
Five, the sick kind distributes relatively, sees Table 4
The sick kind of table 4 distributes relatively
| Group | The example number | RA N(％) | AS N(％) | gout N(％) | OA N(％) |
| The test group matched group | 291 87 | 103(35.2) 27(31.0) | 26(8.91) 8(9.0) | 34(12.0) 14(16.0) | 128(43.9) 39(44.0) |
Test group and matched group compare: X
2=2.582 P＞0.05
Two groups of patients there was no significant difference on the disease kind distributes is described, has comparability.
Six, syndrome degree: two groups of patient's syndrome degree relatively see Table 5
Table 5 liang group patient syndrome degree relatively
| Group | The example number | Slight N (%) | Moderate N (%) | Severe N (%) |
| The test group matched group | 291 87 | 30(10.08) 13(15.0) | 152(52.0) 41(47.0) | 109(38.0) 33(38.0) |
Test group and matched group compare: X
2=1.61 P＞0.05
Two groups of patients there was no significant difference on the syndrome degree is described, has comparability.
Test method
One. diagnostic criteria
(1) syndrome of static blood blocking collaterals
The muscle arthralgia is violent, is twinge more, and the position is fixing not to be moved, and local swelling can have scleroma or ecchymosis, and purplish tongue has ecchymosis, white and thin fur, stringy and hesitant pulse.
(2) Western medicine diagnose standard
According to the therapeutic efficiency of blood stasis numbness (capsule, granule), select sick kind of following doctor trained in Western medicine to carry out clinical observation.
1. knee osteoarthritis diagnostic criteria (adopting Americanism damp disease association standard)
Most of date gonalgias since (1) one month;
(2) the X line shows edge, joint hyperosteogeny;
(3) (transparent, viscosity reduces OA synovial membrane liquid more, WBC＞2100/ml);
(4) person that can not look into the synovial fluid, the age must 〉=40 years old;
(5) morning deadlock≤30min;
(6) snap sound is arranged during joint motion.
It is all diagnosable to satisfy (1) (2) or (1) (3) (5) (6) or (1) (4) (5) (6) person
2. rheumatoid arthritis (RA) diagnostic criteria (Americanism damp disease association revision diagnostic criteria in 1987)
(1) morning deadlock at least 1 hour, continued at least 6 weeks.
(2) 3 or the arthroncus more than 3 continued at least 6 weeks.
(3) carpal joint, metacarpophalangeal joints or 6 weeks of nearly articulations digitorum manus swelling or more than.
(4) symmetry arthroncus.
(5) the X line of hands changes.
(6) rheumatoid nodules.
(7) the rheumatoid factor positive.
In above-mentioned 7, have 4 or above person and can be diagnosed as RA.
3. ankylosing spondylitis diagnostic criteria (the New York standard of revision in 1984)
(1) clinical criteria
1. low back pain continues at least 3 months, can alleviate after the activity, has a rest not have and improves
2. lumbar vertebra is at the limitation of activity of vertical and horizontal plane
3. the thorax mobility be lower than corresponding age, property others
(2) radiology standard
3～4 grades of bilateral sacroiliitis 〉=2 grade or one-sided sacroiliitises
Make a definite diagnosis: meet radiology standard and 1 above clinical criteria.
4. gout diagnostic criteria (Holmes 1985)
(1) in the leukocyte of synovial bursa hydrops, urate crystal is arranged;
(2) in suction of tophus pin or the biopsy urate crystal is arranged;
(3) do not find special urate crystal, but hyperuricemia is arranged, typical acute arthritis is shown effect and the asymptomatic intermission, and treatment has specially good effect person to colchicine.
Two. test case standard
(1) case is included standard in
1. meet above-mentioned tcm syndrome standard and certain Western medicine diagnose person, all can include the object of observation in.
2. the age is between 18 ~ 65 years old.
(2) case is got rid of and the rejecting standard
1. do not meet and include standard person in.
2. gestation or women breast-feeding their children, allergic constitution or this medicine allergy sufferers merged is had the inclination, cerebrovascular, liver,
Serious primary disease such as kidney, hemopoietic system, the psychotic.
3. not medication in accordance with regulations can't be judged the infull person of curative effect or data.
Three. observational technique
(1) medicine
1. test drug: blood stasis arthralgia eliminating granule, blood stasis numbness capsule, specification: granule is the 10g/ bag; Capsule is 0.25g, and being produced by Benxi, Liaoning Province the 3rd pharmaceutical factory provides.
2. contrast medicine: ZHENGQINGFENGTONGNING PIAN, specification are the 20mg/ sheet, produce (authentication code: ZZ-5365 defends in Hunan the accurate word 1992 of medicine No. 023069) by Zhengqing Pharmaceutical Group Corp., Ltd., Hunan Prov., and Benxi the 3rd pharmaceutical factory provides.
(2) test method
1. the object of observation is for being in hospital and the out-patient.
2. grouping: adopt contrast method at random, case is pressed Capsules group: groups of grains: matched group distributes, and ratio is 3: 3: 1.
3. medication: Capsules group, each 4,3 times on the one; Groups of grains, each 1 bag, 3 times on the one; Matched group, 2 of first clothes, 3 times on the one, having no adverse reaction after the week adds to each 3, three times on the one.
4. course of treatment: rheumatoid arthritis and ankylosing spondylitis, be 2 months the course of treatment; Gout, knee osteoarthritis course of treatment is 1 month.
Four. observation index
(1) safety observation
1. general health check-up project
2. blood, urine, just routine examination
3. electrocardiogram, liver, kidney function test
(2) health giving quality observation
1. symptom grade scale:
1. arthralgia:
0 minute: do not have
1 minute: mild pain, can stand, do not influence sleep.
2 minutes: moderate pain, inertia be pain also.
3 minutes: pain was difficult to stand, and influences function.
2. arthroncus:
0 minute: do not have
1 minute: mild swelling, near bone mark was clear.
2 minutes: swelling was equal with near bone mark.
3 minutes: obviously swelling, bone mark was unclear.
3. articular pain:
0 minute: do not have.
1 minute: weight at the edge, joint or when touching ligament, patient claimed that pain is arranged.
2 minutes: weight patient claimed that pain is arranged, and frowns discomfort, and activity is slightly limited.
3 minutes: the severe tenderness, pressing slightly promptly has pain and shrinks back, and passive activity is seriously limited.
4. morning deadlock:
0 minute: do not have.
1 minute: morning stiff time＜30 minute.
2 minutes: morning stiff time 〉=30 minute,＜60 minutes.
3 minutes: morning stiff time 〉=60 minute.
5. function of joint:
0 minute: function was normal.
1 minute: slightly limited, can be engaged in normal activity.
2 minutes: obviously limited, life can be taken care of oneself, but can not be engaged in general activity.
3 minutes: the movable function forfeiture, can't take care of oneself.
6. pain is fixing does not move:
0 minute: do not have
1 minute: have
7. joint sting:
0 minute: do not have
1 minute: have
8. purplish tongue has ecchymosis:
0 minute: do not have
1 minute: have
The mild symptoms major punishment is fixed:
Slightly: integration＜5 minute
Moderate: integration 6～10 minutes
Severe: integration＞10 minute
(2) both hands grip: all write down the numerical value (mmHg) that is reached before and after the treatment.
(3) picture of the tongue pulse condition observation.
(4) laboratory indexes observation: ESR, CRP, RF, blood uric acid.
(5) untoward reaction observation:, itemized record with the relevant untoward reaction of curative possibility.The symptom efficacy determination:
Control: reduce to 0 fen person through the treatment symptom integral.
Produce effects: reduce by 2 fens persons through the treatment symptom integral.
Effectively: reduce by 1 fen person through the treatment symptom integral.
Five. traditional Chinese medical science disease curative effect determinate standard (according to new Chinese medicine clinical guidance principle standard)
Clinic control: treat the back symptom and disappear substantially, symptom was promptly divided 0～1 fen.
Produce effects: treat the back symptom and be clearly better, symptom is promptly divided decline 〉=2/3
Effectively: treat the back doing well,improving, symptom is promptly divided decline 〉=1/3.
Invalid: as not reach effective standard.
Six. the curative effect of treatment rheumatism sexually transmitted disease (STD) in the curative effect of disease standard (with reference to new drug (Western medicine) clinical guidance principle)
Evaluation criteria.
Clinical remission: symptom, sign disappear, and the laboratory leading indicator is recovered or be approaching normal.
Produce effects: symptom, sign disappear substantially, and the laboratory leading indicator is obviously improved, decline degree 〉=50%.
Effectively: symptom, sign alleviate, and the laboratory leading indicator also has improvement.
Invalid: symptom, sign and laboratory leading indicator do not have improvement.
Annotate: laboratory indexes computational methods erythrocyte sedimentation rate, c reactive protein, numeral-normal value before the numeral-treatment back numeral/treatment before the treatment; 〉=two dilution factors of rheumatoid factor decline
Result of the test
One, total effects analysis: two groups of clinical total effectses of patient relatively see Table 6
Table 6 liang group patient clinical efficacy relatively
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | The above rate N of produce effects (%) | Total effective rate (%) |
| The test group matched group | 291 87 | 48(16.5) 7(8.0) | 88(30) 24(27.6) | 107(37.7) 34(39.0) | 48(164) 22(25.0) | 136(46.8) 31(35.6) | (84.0) (75) |
Annotate: * total effective rate=clinic control rate+obvious effective rate+effective percentage
Test group and matched group compare: u=2.2780 P＜0.05
Two, symptom curative effect
1, two groups of patient's arthralgia treatment front and back curative effects relatively see Table 7.
Curative effect relatively before and after the table 7 liang group patient arthralgia treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 103 87 | 55(18.9) 13(14.9) | 112(38.5) 30(34.5) | 91(31.1) 25(28.7) | 33(11.3) 19(21.8) |
Test group and matched group compare: u=2.312 P＜0.05
Illustrate: test group is being better than matched group aspect the arthralgia curative effect.
2, two groups of patient's arthroncus treatment front and back curative effects relatively see Table 8.
Curative effect relatively before and after the table 8 liang group patient arthroncus treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 254 73 | 51(20.0) 10(13.7) | 75(29.5) 22(30.1) | 60(23.6) 21(28.7) | 68(26.7) 20(27.5) |
Test group and matched group compare: U=0.854 P＞0.05
Illustrate: test group compares there was no significant difference with matched group aspect the arthroncus curative effect.
3, two groups of patient's articular pain treatment front and back curative effects relatively see Table 9.
Curative effect relatively before and after the table 9 liang group patient articular pain treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 283 82 | 48(17.1) 10(12.2) | 84(29.7) 21(25.6) | 75(26.5) 14(17.4) | 76(26.8) 37(45.1) |
Test group and matched group compare: U=2.338 P＞0.05
Illustrate: test group compares there was no significant difference with matched group aspect the articular pain curative effect.
4, two groups of patient's joint function disturbance treatment front and back curative effects relatively see Table 10.
Curative effect relatively before and after the table 10 liang group patient joint function disturbance treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 241 69 | 42(17.4) 8(11.6) | 47(19.5) 16(23.1) | 46(19.1) 14(20.2) | 106(44) 31(44.9) |
Test group and matched group compare, U=0.4539 P＞0.05
Test group compares there was no significant difference with matched group aspect the joint function disturbance curative effect.
5, stiff treatment in morning front and back, two groups of patient joints curative effect relatively sees Table 11.
Curative effect relatively before and after the table 11 liang stiff treatment in group patient joint morning
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) |
| The test group matched group | 89 41 | 31(34.9) 10(24.4) | 15(16.9) 4(9.8) | 25(28.0) 7(17.0) | 18(20.2) 12(29.3) |
Test group and matched group compare, U=1.215 P＞0.05
Illustrate: test group is compared there was no significant difference with matched group aspect the deadlock in the joint morning.
6, two groups of patient's joint sting treatment front and back disappearance rate relatively see Table 12.
Table 12 liang group patient joint sting disappearance rate relatively
| Group | The example number | N before the treatment | Treatment back N | Disappearance rate N (%) |
| The test group matched group | 103 31 | 85 25 | 31 14 | 54(63.52) 11(44.00) |
Test group and matched group compare, X
2=1.19 P＞0.05
Illustrate: test group is being compared there was no significant difference with matched group aspect the joint sting curative effect.
Three, the curative effect of the two groups of different sick kind treatment of patient front and back relatively.
1. curative effect relatively sees Table 13 before and after the two category rheumatic arthritis patient treatments.
Curative effect relatively before and after the table 13 liang category rheumatic arthritis patient treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate (%) |
| The test group matched group | 93 27 | 10(10.8) 1(3.7) | 21(22.6) 5(18.5) | 45(48.3) 14(51.8) | 17(18.3) 7(26.0) | 81.7 74.0 |
Test group and matched group compare, U=1.124 P＞0.05
Illustrate: test group and matched group curative effect be there was no significant difference relatively.
2. two groups of patients with ankylosing spondylitis treatment front and back curative effects relatively see Table 14
Curative effect relatively before and after the table 14 liang group patients with ankylosing spondylitis treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate (%) |
| The test group matched group | 26 6 | 3(11.0) 0 | 7(28.0) 1(17.0) | 11(62.0) 3(50.0) | 2(8.0) 2(33.0) | 32(92.0) 6(67.0) |
Test group and matched group compare, U=1.323 P＞0.05
Illustrate: test group and matched group be there was no significant difference relatively.
3. two groups of patient with gout treatment front and back curative effects relatively see Table 15
Curative effect relatively before and after the table 15 liang group patient with gout treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate (%) |
| The test group matched group | 34 14 | 2(5.9) 1(7.1) | 7(20.6) 4(28.6) | 17(50.0) 5(35.7) | 8(23.52) 4(28.6) | 76.5 71.4 |
Test group and matched group compare, U=3.229 P＜0.01
Illustrate: test group and matched group relatively have significant difference.
4. two groups of osteoarthritis patient treatment front and back curative effects relatively see Table 16.
Curative effect relatively before and after the table 16 liang group osteoarthritis patient treatment
| Group | The example number | Clinic control N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate (%) |
| The test group matched group | 128 39 | 25 (19.3) 2(5.1) | 38(29.6) 8(20.5) | 49(38.14) 15(38.5) | 18(14.0) 14(38.5) | 86.0 64.1 |
Test group and matched group compare, and Ridit analyzes: U=3.229 P＜0.05
Illustrate: test group and treatment of control group osteoarthritis curative effect relatively have significant difference.
Four, the two groups of main laboratory indexes treatment of patient front and back curative effects relatively.
1. curative effect relatively sees Table 17 before and after the erythrocyte sedimentation rate treatment
Curative effect compares X ± S before and after the treatment of table 17 erythrocyte sedimentation rate
| The sick kind | Group | The example number | Before the treatment | After the treatment | P |
| RA AS | Test group matched group test group matched group | 83 15 26 8 | 45.43±16.03 40.31±15.02 33.47±28.47 19.33±7.99 | 25.65±15.25 24.30±13.23 20.19±18.49 16.5±5.6 | ＜0.05 ＜0.05 ＞0.05 ＞0.05 |
Illustrate before and after the test group self significant difference is relatively arranged; Compare RA before and after the matched group self significant difference is arranged.
2.C curative effect relatively sees Table 18 before and after the reactive protein treatment.
Curative effect relatively before and after the treatment of table 18 c reactive protein
| Group | The example number | Before the treatment | After the treatment | Negative conversion rate (%) | P | ||
| Negative | Positive | Negative | Positive | ||||
| The test group matched group | 148 45 | 87 28 | 61 17 | 131 37 | 17 8 | 72.1 52.9 | ＜0.05 ＞0.05 |
Illustrate: significant difference is relatively arranged before and after the test group self; Relatively there is not very significant difference before and after the matched group self.
3. curative effect relatively sees Table 19 before and after the treatment of rheumatoid arthritis patients rheumatoid factor.
Curative effect relatively before and after the treatment of table 19 rheumatoid factor
| Group | The example number | Before the treatment | After the treatment | Negative conversion rate (%) | P | ||
| Negative | Positive | Negative | Positive | ||||
| The test group matched group | 89 25 | 18 3 | 71 22 | 35 8 | 38 18 | 23.9 22.7 | ＞0.05 ＞0.05 |
Illustrate: compare there was no significant difference before and after the test group self; Compare there was no significant difference before and after the matched group self.
4. curative effect relatively sees Table 20 before and after the treatment of patient with gout blood uric acid.
Curative effect compares X ± S before and after the treatment of table 20 patient with gout blood uric acid
| Group | The example number | Before the treatment | After the treatment | P |
| The test group matched group | 34 14 | 530.12±44.44 535.25±34.06 | 398.21± 59.07 428.1±45.12 | ＜0.01 ＞0.05 |
Illustrate: significant difference is relatively arranged before and after the test group self; Compare there was no significant difference before and after the matched group self.
Safety detects
In clinical trial, whole experimenters have been carried out the safety detection, the results are shown in Table 21.
Table 20 experimental group patient safety detects
| Project | The example number | Before the treatment | After the treatment | ||
| Normally | Unusually | Normally | Unusually | ||
| Routine blood test routine urinalysis stool routine examination GPT BUN Cr electrocardiogram | 282 282 282 282 282 282 281 | 281 278 282 282 282 282 276 | 1 4 0 0 0 0 5 | 280 282 282 282 282 282 278 | 2 0 0 0 0 0 3 |
Untoward reaction
Hyper-menorrhea appears in 1 example; Gastrointestinal symptom appears in 5 examples, all can adhere to treatment.
Discuss
Blood stasis is the pathological product of body under the pathogenic factor effect, can be used as the cause of disease again and acts on human body.The reason of its formation has internal and external factor, and exopathogen numbness resistance skin, joint, muscle arteries and veins etc. are located, and QI-blood circulation does not freely cause blood stasis and stagnates; Rheumatism mostly is the chronic course of disease, does not with the passing of time heal, and visceral dysfunction is then given birth in the blood stasis.Blood stasis numbness resistance outstanding behaviours is that pain of joint muscle is violent or acupuncture sample pain is arranged, and painful area is fixed, local swelling or scleroma is arranged, and dark tongue quality has the ecchymosis petechia more, stringy pulse or puckery.The traditional Chinese medical science thinks that rheumatismal basic pathogenesis is pathogen numbness resistance meridians, and QI-blood circulation is not smooth, so the resistance of blood stasis numbness is a rheumatismal important syndrome.Any period with disease can appear in this syndrome, sees with middle and advanced stage especially more, is common in rheumatisms such as rheumatoid arthritis, ankylosing spondylitis, gout, osteoarthritis.The blood stasis arthralgia eliminating granule is made up of ten several kinds of Chinese medicinal materials such as Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Rhizoma Curcumae Longae, Flos Carthamis, cures mainly the blood stasis numbness resistance card in the traditional Chinese medical science rheumatism.Modern pharmacological research thinks that blood circulation promoting medicine has stronger anticoagulation, anti-thrombosis function; Reduce plasma fibrin source content, and tangible anti-fibrosis effect is arranged, the part medicine has the immunosuppressive action of pair cell and body fluid.Many bibliographical informations are arranged, and rheumatisant's microcirculation and hemorheology show tangible hypercoagulability.Activating blood circulation to dissipate blood stasis and dredge the collateral is the rheumatismal basic rule of treatment of treatment.
This research is according to traditional Chinese medical science treating different diseases with the same therapeutic principle and debates disease and the dialectical principle that combines, carry out blood stasis numbness capsule for treating rheumatoid arthritis, ankylosing spondylitis, gout, osteoarthritis and belong to the clinical observation on the therapeutic effect of blood stasis numbness resistance syndrome, result of the test is as follows: 1, two groups of total effectses are compared: test group 291 examples, above 136 examples of produce effects, obvious effective rate is 46.8%; Total effective rate is 84%.Matched group 87 examples, obvious effective rate are 35.6%; Total effective rate is 75%; Two groups of medicine total effectses are compared (P＜0.05).Significant difference is arranged.2, each symptom curative effect relatively: test group is being compared significant difference with matched group aspect the treatment arthralgia; There was no significant difference is compared with matched group in arthroncus, articular pain, joint function disturbance aspect.3. curative effect of disease relatively: treatment RA total effective rate is 81.7%, and treatment AS total effective rate is 89%, compares there was no significant difference with matched group; Treatment Gout total effective rate is 76.5%; Treatment knee osteoarthritis total effective rate is 86%, with matched group significant difference is arranged more all.4. to the influence of main laboratory indexes: test group treatment back ESR, CRP, RF, blood uric acid all have decline, and significant difference is relatively all arranged except that RF before and after the treatment; There was no significant difference before and after the treatment of control group.5. security inspection: blood stasis arthralgia eliminating granule small number of patients has slight gastrointestinal reaction, and 1 example has hyper-menorrhea, but all can tolerate treatment, and surplus no obvious adverse reaction all has no adverse effects to the heart, liver, kidney, hemogram etc.
More than explanation blood stasis arthralgia eliminating granule has the effect of blood circulation promoting and blood stasis dispelling, removing obstruction in the collateral to relieve pain really, in present oral dose, course of treatment scope, drug safety, can be applicable to rheumatismal any period, no matter be all can alleviate the joint symptom as main medicine or ancillary drug treatment, especially to there being the handicapped patient in joint that certain mitigation is arranged, can be used as the treatment rheumatism and belong to one of choice drug of Yuxuebi capsule.
Test unit:
Guang-amen Hospital, China Traditional Chinese Medicine Instl
Shanghai brilliance hospital
Shanghai City institute of traditional Chinese medicine
Henan rheumatism hospital
Luoyang bonesetting hospital
The Beijing Jishuitan Hospital
Hospital Attached to Liaoning Inst. of Traditional Chinese Medicine
Gansu Provincial Hospital of Traditional Chinese Medicine
Tangshan City institute of traditional Chinese medicine
The Provincial Medicine Research Institute, Gansu
466 hospitals of Beijing air force
Benxi Hospital of Traditional Chinese Medicine
The specific embodiment
Embodiment 1
Olibanum or Olibanum (processed) 72 Radix Clematidis 180 Flos Carthamis 120 Radix Salviae Miltiorrhizaes 240
Myrrha or Myrrha (processed) 72 Radix Cyathulaes 180 Rhizoma Chuanxiongs 180 Radix Angelicae Sinensis 120
Rhizoma Curcumae Longae 120 Rhizoma Cyperis or prepared RHIZOMA CYPERI 144 Radixs Astragali or Radix Astragali Preparata 180.
Make Chinese medicine preparation according to a conventional method.
Embodiment 2
Olibanum or Olibanum (processed) 50 Radix Clematidis 140 Flos Carthamis 145 Radix Salviae Miltiorrhizaes 190
Myrrha or Myrrha (processed) 95 Radix Cyathulaes 220 Rhizoma Chuanxiongs 220 Radix Angelicae Sinensis 95
Rhizoma Curcumae Longae 145 Rhizoma Cyperis or prepared RHIZOMA CYPERI 115 Radixs Astragali or Radix Astragali Preparata 140.
Preparation method is as follows: Radix Salviae Miltiorrhizae, the Radix Astragali of getting Radix Cyathulae and half and half amount are pulverized, and it is standby to cross 100 mesh sieves; Get eight flavors such as Radix Salviae Miltiorrhizae, the Radix Astragali half and half amount and Olibanum and decoct twice, add 8 times of amounts of water for the first time to decoct 2 hours; Add for the second time 6 times of amounts of water and decocted 1 hour, merging filtrate, filtrate decompression is concentrated into the clear paste of relative density 1.18-1.22 (50 ℃), and is standby.Qinghuo reagent and crude drug powder are granulated, and granulate adds carboxymethyl starch sodium and magnesium stearate mixing, tabletting, and the bag film-coat, promptly.。
Embodiment 3
Olibanum or Olibanum (processed) 95 Radix Clematidis 140 Flos Carthamis 95 Radix Salviae Miltiorrhizaes 190
Myrrha or Myrrha (processed) 90 Radix Cyathulaes 140 Rhizoma Chuanxiongs 140 Radix Angelicae Sinensis 95
Rhizoma Curcumae Longae 95 Rhizoma Cyperis or prepared RHIZOMA CYPERI 115 Radixs Astragali or Radix Astragali Preparata 140
Preparation method is as follows:
1) get Rhizoma Chuanxiong, Rhizoma Cyperi, Rhizoma Wenyujin Concisum three flavors, extract volatile oil, standby, medicinal liquid, medicinal residues are standby.
2) get seven flavors such as Olibanum, Myrrha, Radix Clematidis, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, the Radix Astragali, Radix Cyathulae, decoct twice, decoct for the second time simultaneously, add 1 medicinal residues, medicinal liquid and Flos Carthami simply, collecting decoction filters, filtrate is condensed into fluid extract, adds 3 times of amounts of ethanol, leaves standstill and makes precipitation in 12 hours.Get supernatant, reclaim ethanol and be concentrated into the clear paste that relative density is 1.10-1.30 (50 ℃).
3) press volatile oil: betacyclodextrin=1: 4-10, colloid milling enclose 0.5-3 hour, drying gets volatile oil clathrate compound, and is standby.
4) be end powder with the adjuvant, get its clear paste, add volatile oil clathrate compound, the preparation micropill, the coating filled capsules, promptly.
Embodiment 4
Olibanum or Olibanum (processed) 75 Radix Clematidis 170 Flos Carthamis 130 Radix Salviae Miltiorrhizaes 230
Myrrha or Myrrha (processed) 80 Radix Cyathulaes 160 Rhizoma Chuanxiongs 180 Radix Angelicae Sinensis 100
Rhizoma Curcumae Longae 105 Rhizoma Cyperis or prepared RHIZOMA CYPERI 120 Radixs Astragali or Radix Astragali Preparata 190.
Preparation method is as follows:
1) get Radix Angelicae Sinensis, Rhizoma Chuanxiong full dose, the Radix Astragali, Radix Salviae Miltiorrhizae half and half amount are pulverized, and cross 100 mesh sieves, and be standby.
2) get 8 flavors such as Olibanum, Myrrha, Radix Clematidis, Radix Cyathulae, Rhizoma Cyperi, Rhizoma Wenyujin Concisum full dose and remaining Radix Salviae Miltiorrhizae, the Radix Astragali, decoct twice.Add Flos Carthami when decocting for the second time, merge medicinal liquid, filter, filtrate is concentrated into the clear paste that relative density is 1.10-1.30 (50 ℃).
3) be end powder with adjuvant and crude drug powder, get its clear paste, the preparation micropill, the coating filled capsules, promptly.
Embodiment 5
Olibanum or Olibanum (processed) 87 Radix Clematidis 140 Flos Carthamis 145 Radix Salviae Miltiorrhizaes 200
Myrrha or Myrrha (processed) 70 Radix Cyathulaes 220 Rhizoma Chuanxiongs 150 Radix Angelicae Sinensis 105
Rhizoma Curcumae Longae 110 Rhizoma Cyperis or prepared RHIZOMA CYPERI 160 Radixs Astragali or Radix Astragali Preparata 180.
Preparation method is as follows:
1) above-mentioned prescription medical material is decocted with water 2-3 time, each 1-2 hour, the gained medical filtration, merging filtrate, filtrate is concentrated into the clear paste that relative density is 1.10-1.20 (80 ℃), and is standby.
2) get above-mentioned clear paste and add ethanol and make and contain alcohol amount and reach 50-80%, the best is 65%.Above-mentioned medicinal liquid is stirred evenly, left standstill 12-36 hour, the best is 24 hours.Get supernatant, decompression recycling ethanol is concentrated into relative density and is the clear paste of 1.20-1.30 (80 ℃), and is standby.
3) with above-mentioned clear paste and lactose and starch mixing, to granulate, drying is made dispersible tablet, promptly.
Claims (18)
1. Chinese medicine for the treatment of blood stasis numbness is characterized in that it is prepared from by acceptable auxiliary on following weight parts proportion raw material and the pharmaceutics:
Olibanum 50-95 Radix Clematidis 140-220 Flos Carthami 95-145 Radix Salviae Miltiorrhizae 190-290
Myrrha 50-95 Radix Cyathulae 140-220 Rhizoma Chuanxiong 140-220 Radix Angelicae Sinensis 95-145
Rhizoma Curcumae Longae 95-145 Rhizoma Cyperi 115-175 Radix Astragali 140-220.
2. Chinese medicine according to claim 1 is characterized in that the weight portion of raw material is:
Olibanum 60-85 Radix Clematidis 150-200 Flos Carthami 105-135 Radix Salviae Miltiorrhizae 220-280
Myrrha 60-70 Radix Cyathulae 150-200 Rhizoma Chuanxiong 150-200 Radix Angelicae Sinensis 105-135
Rhizoma Curcumae Longae 105-135 Rhizoma Cyperi 115-175 Radix Astragali 150-200.
3. Chinese medicine according to claim 1 is characterized in that the weight portion of raw material is:
Olibanum 65-80 Radix Clematidis 160-190 Flos Carthami 110-130 Radix Salviae Miltiorrhizae 230-260
Myrrha 65-80 Radix Cyathulae 160-190 Rhizoma Chuanxiong 160-190 Radix Angelicae Sinensis 110-130
Rhizoma Curcumae Longae 110-130 Rhizoma Cyperi 125-155 Radix Astragali 160-190.
4. Chinese medicine according to claim 1 is characterized in that the weight portion of raw material is:
Olibanum 70-75 Radix Clematidis 175-185 Flos Carthami 115-125 Radix Salviae Miltiorrhizae 235-250
Myrrha 70-75 Radix Cyathulae 175-185 Rhizoma Chuanxiong 175-185 Radix Angelicae Sinensis 115-125
Rhizoma Curcumae Longae 115-125 Rhizoma Cyperi 135-150 Radix Astragali 175-185.
5. Chinese medicine according to claim 1 is characterized in that the weight portion of raw material is:
Olibanum 50 Radix Clematidis 140 Flos Carthamis 145 Radix Salviae Miltiorrhizaes 190
Myrrha 95 Radix Cyathulaes 220 Rhizoma Chuanxiongs 220 Radix Angelicae Sinensis 95
Rhizoma Curcumae Longae 145 Rhizoma Cyperis 115 Radixs Astragali 140.
6. Chinese medicine according to claim 1 is characterized in that the weight portion of raw material is:
Olibanum 95 Radix Clematidis 140 Flos Carthamis 95 Radix Salviae Miltiorrhizaes 190
Myrrha 90 Radix Cyathulaes 140 Rhizoma Chuanxiongs 140 Radix Angelicae Sinensis 95
Rhizoma Curcumae Longae 95 Rhizoma Cyperis 115 Radixs Astragali 140.
7. Chinese medicine according to claim 1 is characterized in that the weight portion of raw material is:
Olibanum 72 Radix Clematidis 180 Flos Carthamis 120 Radix Salviae Miltiorrhizaes 240
Myrrha 72 Radix Cyathulaes 180 Rhizoma Chuanxiongs 180 Radix Angelicae Sinensis 120
Rhizoma Curcumae Longae 120 Rhizoma Cyperis 144 Radixs Astragali 180.
8. according to the arbitrary described Chinese medicine of claim 1-7, it is characterized in that: Olibanum wherein is an Olibanum (processed).
9. according to the arbitrary described Chinese medicine of claim 1-7, it is characterized in that: Myrrha wherein is a Myrrha (processed).
10. according to the arbitrary described Chinese medicine of claim 1-7, it is characterized in that: Rhizoma Cyperi wherein is a prepared RHIZOMA CYPERI.
11. according to the arbitrary described Chinese medicine of claim 1-7, it is characterized in that: the Radix Astragali wherein is a Radix Astragali Preparata.
12. according to the arbitrary described Chinese medicine of claim 1-7, it is characterized in that: this Chinese medicine is tablet, granule, capsule, micropill or dispersible tablet.
13. preparation method of Chinese medicine according to claim 12, the Radix Salviae Miltiorrhizae, the Radix Astragali that it is characterized in that comprising the following steps: to get Radix Cyathulae and half and half amount are pulverized sieving for standby; Remaining medical material decocts, and merging filtrate is evaporated to the clear paste of the relative density 1.18-1.22 of 50 ℃ of surveys, and is standby; Qinghuo reagent and crude drug powder are granulated, and granulate adds auxiliary materials and mixing, tabletting, and coating, promptly.
14. preparation method of Chinese medicine according to claim 12 is characterized in that comprising the following steps:
1) get Rhizoma Chuanxiong, Rhizoma Cyperi, Rhizoma Curcumae Longae three flavors, extract volatile oil, standby, medicinal liquid, medicinal residues are standby;
2) get seven flavors such as Olibanum, Myrrha, Radix Clematidis, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, the Radix Astragali, Radix Cyathulae, decoct, add 1) medicinal residues and Flos Carthami, decoct again, the medicinal liquid of collecting decoction and extraction volatile oil filters, and filtrate is condensed into fluid extract, adds ethanol, leaves standstill.Get supernatant, the relative density that decompression recycling ethanol is concentrated into 50 ℃ of surveys is the clear paste of 1.18-1.30;
3) press volatile oil: betacyclodextrin=1: 4-10, enclose 0.5-3 hour, get volatile oil clathrate compound, standby;
4) get 2) clear paste, add volatile oil clathrate compound and adjuvant, the preparation micropill; Perhaps, promptly with the micropill coating.
15. preparation method of Chinese medicine according to claim 12 is characterized in that comprising the following steps:
1) get Radix Angelicae Sinensis, Rhizoma Chuanxiong full dose, the Radix Astragali, Radix Salviae Miltiorrhizae half and half amount are pulverized, and sieve, and be standby;
2) get medical materials such as Olibanum, Myrrha, Radix Clematidis, Radix Cyathulae, Rhizoma Cyperi, Rhizoma Curcumae Longae full dose and remaining Radix Salviae Miltiorrhizae, the Radix Astragali, decoct twice.Add Flos Carthami when decocting for the second time, merge medicinal liquid, filter, the relative density that filtrate is concentrated into 50 ℃ of surveys is the clear paste of 1.18-1.30;
3) get 2) clear paste, add crude drug powder and adjuvant, the preparation micropill, filled capsules; Perhaps, will recharge capsule behind the micropill coating.
16. preparation method of Chinese medicine according to claim 12 is characterized in that:
1) above-mentioned medical material is decocted with water, the gained medical filtration, merging filtrate, filtrate is concentrated into fluid extract, and is standby;
2) getting above-mentioned clear paste adds ethanol and makes the alcohol amount of containing reach 50-80%.Above-mentioned medicinal liquid is stirred evenly, left standstill 12-36 hour; Get supernatant, decompression recycling ethanol, the relative density that is concentrated into 50 ℃ of surveys is the clear paste of 1.18-1.30, and is standby;
3) get above-mentioned clear paste and add proper auxiliary materials, granulate, drying is made dispersible tablet.
17. the described preparation method of Chinese medicine of claim 16 is characterized in that: step 2) in time of repose be 24 hours.
18. the described preparation method of Chinese medicine of claim 16 is characterized in that: adjuvant described in the step 3) is that lactose, sucrose, dextrin, starch, low-substituted hydroxypropyl cellulose, carboxymethyl starch are received, in the microcrystalline Cellulose, 30 POVIDONE K 30 BP/USP 30, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, Pulvis Talci, magnesium stearate, micropowder silica gel, polyethylene glycol 6000, Macrogol 4000, essence, aspartame one or more.
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