CN1253168C - Chinese traditional medicine composition for treating chronic obstructive emphysema and preparation method thereof - Google Patents
Chinese traditional medicine composition for treating chronic obstructive emphysema and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to a medicinal composition for treating respiratory diseases, particularly to chronic obstructive pulmonary emphysema, and a preparation method thereof. The medicinal composition mainly contains the extract of milkvetch root, medicinal indianmulberry root, peach kernel and leech, and Japanese ardisia herb, epimedium herb or psoralea fruit and red sage root or epimedium can also be added to the raw material. The present invention has the functions of lung and kidney invigoration, blood circulation activation, blood stasis dissipation, combination in reinforcement and elimination and treatment of both the manifestation and the root cause of a disease so as to achieve the good effects of relieving inflammation, relieving cough, resolving phlegm and relieving asthma.
Description
Technical field
The invention belongs to pharmaceutical composition of treatment respiratory system disease and preparation method thereof, especially contain pharmaceutical composition of the Chinese medicine extract for the treatment of chronic obstructive emphysema and preparation method thereof.
Background technology
The common sympton of respiratory system disease has cough, excessive phlegm, often with inflammation.Chronic obstructive emphysema is a kind of serious respiratory system commonly encountered diseases, and its symptom is mainly and coughs, expectorant, breathe heavily, wheezing sound, breathe hard, and number of patients is many, because it slowly develops, has a strong impact on patient's work capacity and quality of life.Chronic obstructive emphysema is the lungs expansion and the excessively inflations of last bronchus distal portions eventually, causes lung tissue elastic force to weaken the general name that increases with volume.The dyspnea of its clinical manifestation for increasing the weight of gradually breathed hard after the activity, deficient QI being not enough to breathe, the scope of genus Chinese medicine " dyspnea due to deficiency ".The Therapeutic Method of present doctor trained in Western medicine Shang Wuhao, commercially available treatment chronic obstructive emphysema Chinese patent medicine is mainly based on improving inspiration by invigorating the kidney, relieving cough and resolving phlegm.Improving inspiration by invigorating the kidney asthma can not improving inspiration by invigorating kidney-QI occurs for suffering from a deficiency of the kidney when waiting disease, by the kidney invigorating treatment asthma.
Summary of the invention
The technical problem to be solved in the present invention is to overcome the deficiencies in the prior art, develops a kind of pharmaceutical composition for the treatment of the pure Chinese medicine of respiratory system disease, the curative effect of have antiinflammatory, cough-relieving, reduce phlegm, relievining asthma.Especially to the chronic obstructive emphysema disease of lung kidney two void, not only should have the invigorating the lung and the kidney function, i.e. tonifying the lung, function for tonifying kidney, and should have function of promoting blood circulation to disperse blood clots, so that by reinforcement and elimination in combination, treating both the principal and secondary aspects of a disease reaches good effect.
The technical problem to be solved in the present invention also comprises a kind of method for preparing the Chinese medicine composition of above-mentioned treatment respiratory system disease of research, is made into dosage modern preparation little, easy to use, this method favorable reproducibility, but suitability for industrialized production.
For addressing the above problem, the invention provides following technical solution.
A kind of pharmaceutical composition for the treatment of respiratory system disease is characterized in that it mainly being to be made by following bulk drugs: Radix Astragali 1-10 part, Radix Morindae Officinalis 1-6 part, Semen Persicae 1-4.5 part, Hirudo 1-5 part.Wherein crude drug preferably consumption be: Radix Astragali 3-8 part, Radix Morindae Officinalis 2-5 part, Semen Persicae 2-4 part, Hirudo 1-4 part.Wherein crude drug preferably consumption be: Radix Astragali 4-6 part, Radix Morindae Officinalis 3-4 part, Semen Persicae 3-4 part, Hirudo 2-3 part.
Aforementioned preparation of drug combination method comprises the following steps: 1) take by weighing each crude drug Radix Astragali, Radix Morindae Officinalis, Semen Persicae, Hirudo, standby; 2) the water intaking trematodiasis is ground into coarse powder, uses ethanol percolation, and the Hirudo medicinal residues that ethanol percolation is crossed are waited until processing, concentrates ethanol percolation liquid, gets extractum A, and is standby; 3) get the Semen Persicae alcohol reflux, concentrate ethanol extract, get extractum B, standby; 4) get the Radix Astragali, Radix Morindae Officinalis and 2) the Hirudo medicinal residues, use water extraction, in the water extract, add ethanol, making ethanol content is 50%～80%, remove ethanol after, the extractum C of water extract of the Radix Astragali, Radix Morindae Officinalis and Hirudo medicinal residues, standby; 5) above-mentioned extractum A, extractum B and extractum C are merged, drying makes the active component of pharmaceutical composition of the present invention.
Aforementioned pharmaceutical composition, wherein crude drug also has: Herba Epimedii or Fructus Psoraleae 1-6 part, Herba Ardisiae Japonicae 1-10 part.The consumption of each component is in the pharmaceutical composition preferably: Radix Astragali 3-8 part, Radix Morindae Officinalis 2-5 part, Semen Persicae 2-4 part, Hirudo 1-4 part, Herba Epimedii or Fructus Psoraleae 2-5 part, Herba Ardisiae Japonicae 2-8 part.Better the consumption of each component is in the pharmaceutical composition: Radix Astragali 4-6 part, Radix Morindae Officinalis 3-4 part, Semen Persicae 3-4 part, Hirudo 2-3 part, Herba Epimedii or Fructus Psoraleae 3-4 part, Herba Ardisiae Japonicae 3-6 part.
The preparation of drug combination method comprises the following steps preferably; 1) take by weighing each crude drug Radix Astragali, Radix Morindae Officinalis, Semen Persicae, Hirudo, Herba Epimedii or Fructus Psoraleae, Herba Ardisiae Japonicae, standby; 2) the water intaking trematodiasis is ground into coarse powder, uses ethanol percolation, and the Hirudo medicinal residues that ethanol percolation is crossed are waited until processing, concentrates ethanol percolation liquid, gets extractum A, and is standby; 3) get Semen Persicae and Herba Ardisiae Japonicae is used alcohol reflux, concentrate ethanol extract, extractum B, standby; 4) get the Radix Astragali, Radix Morindae Officinalis and 2) Hirudo medicinal residues and Herba Epimedii or Fructus Psoraleae, use water extraction, in the water extract, add ethanol, making ethanol content is 50%～80%, remove ethanol after, the extractum C of water extract, standby; 5) above-mentioned extractum A, extractum B and extractum C are merged, drying makes the active component of pharmaceutical composition of the present invention.
Aforementioned pharmaceutical composition, wherein crude drug also has: Herba Epimedii or Radix Salviae Miltiorrhizae 1-8 part.More the preparation method of suitable pharmaceutical compositions comprises the following steps: 1) take by weighing each crude drug Radix Astragali, Radix Morindae Officinalis, Semen Persicae, Hirudo, Herba Epimedii or Fructus Psoraleae, Herba Ardisiae Japonicae, Herba Epimedii or Radix Salviae Miltiorrhizae, standby; 2) Herba Epimedii or Radix Salviae Miltiorrhizae are measured reflux, extract, 2～4 times for 4～10 times with 90% ethanol, and each 1～3 hour, medicinal residues were waited until processing, merge ethanol extract, and decompression recycling ethanol gets extractum D, and is standby; 3) the water intaking trematodiasis is ground into coarse powder, with 50%～80% ethanol percolation, the Hirudo medicinal residues that ethanol percolation is crossed is waited until processing, and the decompression recycling ethanol percolate gets extractum A, and is standby; 4) get Semen Persicae, Herba Ardisiae Japonicae, measure reflux, extract, 2～4 times for 5～10 times with 50%～80% ethanol, each 1～3 hour, merge ethanol extract, decompression recycling ethanol gets extractum B, and is standby; 5) get the Radix Astragali, Radix Morindae Officinalis, Herba Epimedii or Fructus Psoraleae, 3) Hirudo medicinal residues, 2) Herba Epimedii or Radix Salviae Miltiorrhizae decoction dregs decoct with water 1～3 time, add 7～12 times in water at every turn, in aqueous extract, add ethanol and make ethanol content reach 50%～80%, post precipitation filters, concentrate ethanol liquid, get extractum C, standby; 6) above-mentioned extractum A, extractum B, extractum C and extractum D are merged, drying is mixed with pharmaceutically acceptable adjuvant.
The present invention treats the pharmaceutical composition of the pure Chinese medicine of respiratory system disease, by invigorating the lung and the kidney and blood circulation promoting and blood stasis dispelling, and reinforcement and elimination in combination, the excellent results of reach antiinflammatory, cough-relieving, reduce phlegm, relievining asthma.Especially to the chronic obstructive emphysema disease of lung kidney two void, not only having the invigorating the lung and the kidney function is tonifying the lung, function for tonifying kidney, and has function of promoting blood circulation to disperse blood clots, and by reinforcement and elimination in combination, treating both the principal and secondary aspects of a disease reaches good therapeutic effect.The present invention prepares the method for the Chinese medicine composition of above-mentioned treatment respiratory system disease, is made into dosage modern preparation little, easy to use, this method favorable reproducibility, but suitability for industrialized production.
The common sympton of respiratory system disease has cough, excessive phlegm, often with inflammation.Chronic obstructive emphysema is a kind of serious respiratory system commonly encountered diseases, and this disease is prolonged illness, and lung, spleen, renal function deficiency are arranged on the whole, for causing moving major reason of then breathing hard, the real pulmonary ventilation function deficiency that belongs to, the pulmonary circulatory function obstacle causes, and treatment is when vital energy benefiting and the kidney invigorating, blood circulation promoting and blood stasis dispelling.In the pharmaceutical composition of the present invention: Radix Astragali QI invigorating, the Radix Morindae Officinalis the kidney invigorating, Semen Persicae and Hirudo are drug for invigorating blood circulation and eliminating stasis.In the pharmaceutical composition of the present invention, the Herba Ardisiae Japonicae that relieving cough and resolving phlegm is relievingd asthma be can add again, the Herba Epimedii or the Fructus Psoraleae of the kidney invigorating are all with Radix Morindae Officinalis; The Radix Salviae Miltiorrhizae or the Herba Epimedii that perhaps add blood circulation promoting and blood stasis dispelling again.But both vital energy benefiting and the kidney invigorating of prescription of the present invention, the blood circulation promoting and blood stasis dispelling of holding concurrently again, clinical efficacy significantly improves.
The part pharmacological experiment data of pharmaceutical composition of the present invention are as follows.
One, pharmaceutical composition of the present invention suppresses the test of white mice auricle edema
Experimental result (seeing Table 1); Adopt the scorching method of white mice auricle caused by dimethylbenzene xylene, give mice lavage pharmaceutical composition 26.4,13.2 of the present invention and 6.6g crude drug/kg, the result shows: the auricle swelling degree of drug regimen object height of the present invention, middle treated animal and model control group relatively all have remarkable reduction (P＜0.05); Swelling suppresses percentage rate and all can reach more than 59.0% after the administration.Prompting this product has tangible antiinflammation.
Laboratory animal: regular grade KM kind white mice, body weight 18～22g, ♀ ♂ has concurrently, purchases in animal cultivation field, Green Dragon mountain, Jiangning the quality certification number: SCXK (Soviet Union) 2002-0018.
Experimental drug: pharmaceutical composition of the present invention (dry extract); 6.72g crude drug/g, lot number 020305, pharmaceutical preparation research department in Jiangsu Prov. Research Inst. Traditional Chinese Medical provides; Aspirin enteric-coated tablets (aspirin): 25mg/ sheet, lot number 20010702, Nanjing second pharmaceutical factory.
Experimental technique: get 50 of mices, weigh, be divided into 5 groups at random, 10 every group, ♀ ♂ has concurrently, is respectively model group (distilled water 20ml/kg), the high, medium and low dosage group of aspirin matched group (0.2g/kg) pharmaceutical composition of the present invention (26.4,13.2 and the 6.6g crude drug/kg).To be made into isometric(al) gastric infusion behind the variable concentrations for the reagent product, dosage is 20ml/kg, 1h with dimethylbenzene 0.02ml/ only is coated with respectively by group at white mice auris dextra tow sides after the administration, left side ear compares, and puts to death animal behind the 15min, and ears are cut (punch method) with the position homalographic, weigh respectively, with left and right sides auricle weight difference is the swelling degree, calculates and respectively organizes the swelling degree, obtains inhibitory rate of intumesce (%) by following formula.Each administration group and model control group are carried out the t-inspection statistics and are handled.
Table 1, pharmaceutical composition xylol of the present invention cause the influence (x ± s) of white mice swelling of auricle
| Group | Dosage (g/kg) | Number of animals (only) | Auris dextra heavy (mg) | Left side ear heavy (mg) | Swelling degree (mg) | Suppression ratio (%) |
| Dosage group low dose group in the model group aspirin group high dose group | 25 0.2 26.4 13.2 6.6 | 10 10 10 10 10 | 43.6±6.5 28.0±4.5 30.3±5.1 31.7±6.9 31.4±4.9 | 24.4±2.4 24.4±2.6 25.0±2.9 25.0±2.9 23.5±4.1 | 19.2±6.3 3.6±3.5*** 5.5±4.8*** 6.7±5.4*** 7.9±4.9*** | / 81.3 71.4 64.8 59.0 |
Annotate: compare *: p＜0.001 with model control group.
Experimental technique list of references: Ministry of Public Health bureau of drug policy ﹠ administration. study of tcm new drug guide (pharmacy pharmacology's toxicology): 176～177: Li Yikui etc. herbal pharmacology experimental methodology (front page). Shanghai: the 1991:299 of Shanghai science tech publishing house～300.
Two, pharmaceutical composition of the present invention suppresses the test of rat granuloma
Experimental result (seeing Table 2): behind rat filling stomach pharmaceutical composition 26.4,13.2 of the present invention and 6.6g crude drug/kg, adopt rat chronic inflammatory disease agar granuloma method to test.The result shows that the granuloma weight in wet base of administration treated animal compares with model control group, and remarkable reduction (P＜0.05～0.01) is all arranged, and suppression ratio is greater than 25.4%.The pharmaceutical composition of the present invention that the stomach doses is irritated in prompting has tangible antiinflammatory action to rat chronic inflammation agar granuloma.
Laboratory animal: regular grade SD rat, ♂, body weight 140～170g purchases in animal cultivation field, Green Dragon mountain, Jiangning, the quality certification number: SCXK (Soviet Union) 2002-0018.
Experimental drug: pharmaceutical composition of the present invention (dry extract): contain crude drug 6.72g crude drug/g, lot number 020305, preparation research chamber, Jiangsu Prov. Research Inst. Traditional Chinese Medical provides; Aspirin enteric-coated tablets (aspirin): 25mg/ sheet, lot number 20010702, Nanjing second pharmaceutical factory; Agar: lot number 980424, Nat'l Pharmaceutical ﹠ Biological Products Control Institute.
Experimental technique: the preparation of rat granuloma model: male white rat back midline is got 2.0 * 2.0cm area depilation, sterilization, subcutaneous injection 2% agar (55 ℃ of water bath heat preservations) 2ml, protruding spherical enclosed mass immediately after the injection.The next day get 50 above-mentioned granuloma model rat, ♂, divide 5 groups at random, every group 10, be respectively model control group (ig distilled water 10ml/kg), positive drug aspirin group (0.1g/kg), high, medium and low three the dosage groups of pharmaceutical composition of the present invention (13.2,6.6 and the 3.3g crude drug/kg).After will being made into respective concentration for the reagent product, each treated animal is irritated stomach (ig) administration, and dosage is 10ml/kg.Every day, ig was 1 time, and successive administration 7 days is observed animal activity situation and granuloma every day and changed, take off vertebra execution rat in 1 hour behind the last medicine, cut off granulation position skin, peel off the granuloma agar block, take by weighing weight in wet base, each administration group and model control group are organized a t-inspection statistics and are handled.Granuloma suppression ratio (%) is pressed routine formula and is calculated:
Table 2, pharmaceutical composition of the present invention are to the granulomatous influence of rat chronic inflammatory disease agar (x ± s)
| Group | Dosage (g/Kg) | Number of animals (only) | Granuloma weight in wet base (g) | Suppression ratio (%) |
| Dosage group low dose group in the model control group aspirin group high dose group | 10 0.1 13.2 12.5 6.25 | 10 10 10 10 10 | 3.19±0.80 2.40±0.85 * 2.23±0.58 ** 2.31±0.63 * 2.37±0.70 * | / 34.6 58.5 35.0 25.4 |
Annotate: compare *: P＜0.05, * * with model control group; P＜0.01.
Experimental technique list of references: Ministry of Public Health bureau of drug policy ﹠ administration. study of tcm new drug guide (pharmacy pharmacology's toxicology): 94～95,203～204; Li Yikui etc. herbal pharmacology experimental methodology (front page). Shanghai: the 1991:303 of Shanghai science tech publishing house～305; Qi Chen etc. the herbal pharmacology research methodology. Beijing: People's Health Publisher, 1993:366～369.
Three, pharmaceutical composition mice cough-relieving test of the present invention (ammonia spraying method)
Experimental result (seeing Table 3): behind mouse stomach pharmaceutical composition 26.4,13.2 of the present invention and 6.6g crude drug/kg, adopt the strong aqua ammonia nebulization to carry out the cough-relieving test, the result shows: drug regimen object height of the present invention, middle amount group are compared with model control group, all can prolong cough latent period (P＜0.05～0.001); The cough number of times also obviously reduces (P＜0.01～0.001) in 2 minutes.Results suggest drug composition oral administration of the present invention can obviously prolong cough latent period and reduce the cough number of times, and mice is had tangible antitussive action.
Laboratory animal: regular grade KM kind white mice, body weight 18～22g, ♀ ♂ has concurrently, purchases in animal cultivation field, Green Dragon mountain, Jiangning the quality certification number; SCXK (Soviet Union) 2002-0018.
Experimental drug, equipment: pharmaceutical composition of the present invention (dry extract): contain crude drug 6.72g/g, lot number 020305, preparation research chamber, Jiangsu Prov. Research Inst. Traditional Chinese Medical provides; Pentoxyverine citrate sheet (carbetapentane citrate): every contains pentoxyverine citrate 25mg, lot number 020118-2, Suzhou medicine Group Co.,Ltd; 1.4S-888 type soniclizer: Chinese-foreign joint Dao Fen Electronics Co., Ltd. produces.
Experimental technique: get 50 of mices, weigh, be divided into 5 groups at random, 10 every group, ♀ ♂ has concurrently, is respectively model group (distilled water 20ml/kg), positive drug carbetapentane citrate matched group (0.05g/kg) and the high, medium and low dosage group of pharmaceutical composition of the present invention (26.4,13.2 and the 6.6g crude drug/kg).After will being made into respective concentration for the reagent product, each treated animal is irritated stomach (ig) administration, dosage is 20ml/kg, each Mus has placed respectively and has covered in the active box behind the administration 1h, spray in the active box after the strong aqua ammonia atomizing with same intensity with soniclizer, spray after 15 seconds, observe animal cough latent period (after sucking the ammonia aerosol to the required time that takes place to cough be incubation period) immediately, and the cough number of times in the note spirit 2 minutes, each administration group and model control group are organized a t-test statistics processing.
Table 3, pharmaceutical composition of the present invention to the influence of mice antitussive action (x ± s, n=10)
| Group | Dosage (g/Kg) | Cough latent period (S) | Cough number of times/2 minute |
| Dosage group low dose group in the model control group carbetapentane citrate group high dose group | 20 0.05 26.4 13.2 6.6 | 22.0±9.4 40.8±20.3 * 52.4±20.7 *** 48.6±32.8 * 30.7±13.5 | 36.7±10.9 13.0±7.4 *** 15.5±11.3 *** 21.7±11.5 ** 25.9±17.3 |
Annotate: compare * with model control group; P＜0.05, * *: P＜0.01, * * *: P＜0.001.
Experimental technique list of references: Ministry of Public Health bureau of drug policy ﹠ administration. study of tcm new drug guide (pharmacy pharmacology's toxicology): 73; Li Yikui etc. herbal pharmacology experimental methodology (front page). Shanghai: the 1991:424 of Shanghai science tech publishing house; 3 Qi Chens etc. the herbal pharmacology research methodology. Beijing: People's Health Publisher, 1993:636.
Four, pharmaceutical composition Cavia porcellus cough-relieving test of the present invention (citric acid nebulization)
Experimental result (seeing Table 4): behind Cavia porcellus filling stomach pharmaceutical composition 13.2,6.6 of the present invention and 3.3g crude drug/kg, adopt the citric acid nebulization to carry out the cough-relieving test, the result shows: the cough number of times obviously reduces (P＜0.001) in 5 minutes; The cough-relieving rate reaches more than 220%.Point out pharmaceutical composition of the present invention to have tangible antitussive effect.
Laboratory animal: Cavia porcellus, ♀ ♂ has concurrently, and body weight 220～250g purchases in animal cultivation field, Green Dragon mountain, Jiangning, the quality certification number: SCXK (Soviet Union) 2002-004.
Experimental drug, equipment: pharmaceutical composition of the present invention (dry extract): contain crude drug 6.72g/g, lot number 020305, preparation research chamber, Jiangsu Prov. Research Inst. Traditional Chinese Medical provides; Pentoxyverine citrate sheet (carbetapentane citrate): every contains pentoxyverine citrate 25mg, lot number 020118-2, Suzhou medicine Group Co.,Ltd; 1.4S-888 type soniclizer: Chinese-foreign joint Dao Fen Electronics Co., Ltd..
Experimental technique: choose body weight 220～250g Cavia porcellus, ♀ ♂ has concurrently, divide 5 groups at random, every group 10, model control group is irritated stomach (distilled water 10ml/kg), positive drug carbetapentane citrate matched group (0.025/kg), high, medium and low three the dosage groups of pharmaceutical composition of the present invention and is irritated stomach (13.2,6.6 and the 3.3g crude drug/kg) respectively.After will being made into respective concentration for the reagent product, each treated animal is irritated stomach (ig) administration, and dosage is 10ml/kg.Behind the administration 1h, placed respectively and covered in the active box, sprayed into 18% citric acid aerosol with soniclizer with the same intensity atomizing, sprayed after 15 seconds, observed 5 minutes animal cough number of times immediately, each administration group and model control group are organized a t-inspection statistics and are handled.Press public examination and calculate cough-relieving rate (%)
Table 4, pharmaceutical composition of the present invention to the influence of mice antitussive action (x ± s, n=10)
| Group | Dosage (g/Kg) | Cough number of times/5 minute | Relative cough-relieving rate (%) |
| Dosage group low dose group in the model control group carbetapentane citrate group high dose group | 10 0.05 16.4 13.2 6.6 | 31.1±11.1 7.4±2.3 *** 11.1±5.6 *** 12.7±6.3 *** 14.1±7.4 *** | / 420 280 245 220 |
Annotate: compare with model control group,
* *: P＜0.001.
Experimental technique list of references: Ministry of Public Health bureau of drug policy ﹠ administration, study of tcm new drug guide (pharmacy pharmacology's toxicology): 73; Li Yikui etc. herbal pharmacology experimental methodology (front page). Shanghai: the 1991:426 of Shanghai science tech publishing house; Qi Chen etc. the herbal pharmacology research methodology. Beijing: the People's Health Publisher, 1993:
Five, pharmaceutical composition mice expectorant test of the present invention (phenol red expelling phlegm method)
Experimental result (seeing Table 5): behind mouse stomach pharmaceutical composition 26.4,13.2 of the present invention and 6.6g crude drug/kg, adopt phenol red expelling phlegm method, with the phenol red excretion amount of spectrophotometric determination (OD value), the result shows: each administration group of pharmaceutical composition of the present invention is compared with model control group, can obviously increase respiratory mucosa and discharge phenol red amount (P＜0.001); Trachea expectoration increment rate reaches more than 188%.Results suggest pharmaceutical composition of the present invention has significant phlegm-dispelling functions.
Laboratory animal: regular grade KM kind white mice, body weight 23～28g, ♀ ♂ has concurrently, purchases in animal cultivation field, Green Dragon mountain, Jiangning the quality certification number: SCXK (Soviet Union) 2002-0018.
Experimental drug: pharmaceutical composition of the present invention (dry extract): contain crude drug 6.72g/g, lot number 020305, the Jiangsu Prov. Research Inst. Traditional Chinese Medical Drug Manufacturing Room provide; Compound Radix Glycyrrhizae mixture: lot number 20010325, Nanjing second pharmaceutical factory.
Experimental technique: get 50 of mices, fasting be can't help weighing more than the water 16h, be divided into 5 groups at random, every group 10, ♀ ♂ has concurrently, is respectively model group (distilled water 20ml/kg), positive drug licorice mixture matched group (20ml/kg) and the high, medium and low dosage group of pharmaceutical composition of the present invention (26.4,13.2 and the 6.6g crude drug/kg).Dosage is 20ml/kg, 0.5h lumbar injection 2.5% phenol red normal saline 0.5ml behind the gastric infusion, injection back 0.5h takes off neck and puts to death, lie on the back and be fixed on the operation plate, cut off neck center skin, separate trachea, under larynx, No. 7 pin syringe needles are carefully inserted about 0.3cm in the trachea, after fixing with the silk thread ligation, draw 5%NaHCO3 solution 1ml with the 1ml syringe, by syringe needle lavation respiratory tract 3 times (not stopping) back and forth at every turn, irrigating solution is injected a test tube, draw 5%NaHCO3 solution 1ml again, as above lavation 2 times again, shared washing liquid 3ml takes out and washes 9 times, 3 times washing liquids is merged put in the test tube, the placement certain hour is used, make contamination precipitation, get the transparent red liquid of supernatant and survey the OD value with 545nm752 type ultraviolet-uisible spectrophotometer colorimetric, each administration group and model control group are carried out the t-inspection statistics and are handled.Trachea expectoration increment rate is calculated as follows:
Table 5, pharmaceutical composition of the present invention to the influence of mice phlegm-dispelling functions (x ± s, n=10)
| Group | Dosage (g/Kg) | The phenol red excretion amount of trachea (OD) | Expectoration increment rate (%) |
| Dosage group low dose group in the model control group licorice mixture group high dose group | 20 20 26.4 13.2 6.6 | 0.26±0.04 0.87±0.08 *** 0.66±0.23 *** 0.64±0.17 *** 0.49±0.18 *** | / 335 254 246 188 |
Annotate: compare with model control group,
* *: P＜0.001.
Experimental technique list of references: Ministry of Public Health bureau of drug policy ﹠ administration. study of tcm new drug guide (pharmacy pharmacology's toxicology): 73; Li Yikui etc. herbal pharmacology experimental methodology (front page). Shanghai: the 1991:430 of Shanghai science tech publishing house; Qi Chen etc. the herbal pharmacology research methodology. Beijing: People's Health Publisher, 1993:642.
Six, the pharmaceutical composition Cavia porcellus of the present invention test of relievining asthma
Experimental result (seeing Table 6): behind Cavia porcellus filling stomach pharmaceutical composition 13.2,6.6 of the present invention and 3.3g crude drug/kg, adopt medicine to draw the method for breathing heavily, pharmaceutical composition of the present invention draws to breathe heavily to compare with model control group incubation period all significant prolongation (P＜0.01); Self compares (P＜0.05) before and after the administration; The number of animals that asthma is twitched after the administration also obviously reduces.The result shows: drug composition oral administration of the present invention can obviously prolong to draw breathes heavily incubation period, reduces the number of animals that asthma is twitched, and Cavia porcellus is had obvious antiasthmatic effect.
Laboratory animal: Cavia porcellus, ♀ ♂ has concurrently, and body weight 230～260g purchases in animal cultivation field, Green Dragon mountain, Jiangning, the quality certification number: SCXK (Soviet Union) 2002-004.
Experimental drug, equipment: pharmaceutical composition of the present invention (dry extract): 6.72g crude drug/g, lot number 020305, preparation research chamber, Jiangsu Prov. Research Inst. Traditional Chinese Medical provides; Aminophylline injection: every 2ml includes aminophylline 0.25g, lot number 010710, Changzhou Lanling Pharmaceutical Co., Ltd.; 4 histamine phosphate injs; Every 1ml includes 1mg, lot number 010311, Shanghai the tenth pharmaceutical factory; Acecoline: 100mg/ props up, the import packing; Cause and breathe heavily agent: the 5mg histamine phosphate adds the 1g acecoline is made into 100ml with distilled water mixed liquor (facing the time spent preparation); S-888 type soniclizer: Chinese-foreign joint Dao Fen Electronics Co., Ltd..
Experimental technique: trial test: choose body weight 230～260g Cavia porcellus, insert respectively in the animal activity case of lid, spray into to cause with same intensity with soniclizer and breathe heavily agent (containing 1mg/ml acecoline and 0.05mg/ml histamine phosphate) and accurately sprayed for 15 seconds, animal after sucking above medicinal liquid through certain incubation period, produce asthma reaction, what produce asthma reaction in 60 seconds be responsive animal, above 60 second the person be insensitive person, do not select for use in advance." asthma " reaction and judgement is a standard to breathe heavily the absorption tic.The next day get preliminary election " asthma " Cavia porcellus, ♀ ♂ has concurrently, divide 5 groups at random, every group 10, model control group ig distilled water 10ml/kg, positive drug group lumbar injection aminophylline 0.125g/kg (1ml/kg), high, medium and low three the dosage groups of pharmaceutical composition of the present invention are irritated stomach 13.2,6.6 and 3.3g crude drug/kg respectively, and dosage is 10ml/kg.After the administration 30 minutes, the similarity condition when putting into above-mentioned sprayer unit by preliminary election respectively sprays into respectively to cause breathes heavily agent.Record spraying begins to the time that symptom occurs (with breathe heavily absorption twitch be as the criterion) as latent time, observe 3 minutes (180 seconds), do not have and breathe heavily the absorption tiqueur and draw and breathe heavily incubation period with calculating in 180 seconds.Each administration group and model control group are organized a t-inspection statistics and are handled.
Table 6 pharmaceutical composition of the present invention to the influence of Cavia porcellus antiasthmatic effect (x ± s, n=10)
| Group | Dosage (g/Kg) | Before the administration | After the administration | ||
| Draw and breathe heavily incubation period (s) | Twitch number of animals | Draw and breathe heavily incubation period (s) | Twitch number of animals (only) | ||
| Dosage group low dose group in the model control group aminophylline group high dose group | 10.0 0.2 13.2 6.6 3.3 | 40.8±8.9 43.7±11.5 41.4±12.5 43.8±15.5 43.0±13.6 | 10/10 10/10 10/10 10/10 10/10 | 41.5±9.3 115.8±49.5 ***▲▲ 63.7±20.3 **▲ 60.2±16.5 **▲ 57.3±11.5 **▲ | 10/10 0/10 2/10 4/10 4/10 |
Annotate: compare * *: P＜0.01, * * *: P＜0.001 with model control group; Self compares before and after the administration, ▲: P＜0.05, ▲ ▲: P＜0.01.
Experimental technique list of references: Ministry of Public Health bureau of drug policy ﹠ administration. study of tcm new drug guide (pharmacy pharmacology's toxicology): 73; Li Yikui etc. herbal pharmacology experimental methodology (front page). Shanghai: the 1991:443 of Shanghai science tech publishing house～444; Qi Chen etc. the herbal pharmacology research methodology. Beijing: People's Health Publisher, 1993:649～651.
Seven, pharmaceutical composition acute toxicity test in mice report of the present invention
Experimental result: tangible toxic reaction is not seen in drug composition oral administration of the present invention, can't measure median lethal dose(LD 50) (LD50) according to a conventional method.The maximum dosage-feeding of white mice gastric infusion on the one is 345.6g crude drug/kg, and this dosage is intended 576 times of clinical people's consumption for pharmaceutical composition of the present invention, does not see the overt toxicity reaction.After the administration first time in 0.5～1 hour; white mice is movable to be reduced; but rap cage and have the reaction of new line; the basic normal activity that recovers behind the 4h, most animals lies prostrate down after the administration for the second time, the movable minimizing; most animals comes into play behind the 1h; movable normal behind the 2h, do not see other untoward reaction, there is not animal dead yet.It mainly may be the excessive discomfort that causes of dosage that the activity of animal reduces.It is 24.9 ± 2.0g that one Zhou Houfu weighs.After putting to death the dissection animal, its main organs there is no tangible abnormality.The maximum dosage-feeding of mice lavage administration is 345.6g crude drug/kg, and this dosage is intended 576 times (the normal adult average weight is pressed 60kg and calculated, and takes the 36g crude drug every day) of clinical people's consumption for pharmaceutical composition of the present invention.
Laboratory animal: cleaning level KM kind white mice, body weight 18～20g, ♀ ♂ half and half purchases the Shanghai Experimental Animal Center in the Chinese Academy of Sciences, qualified number: No. the 99004th, the moving pipe of middle section (Shanghai);
Experimental drug: pharmaceutical composition of the present invention (dry powder) contains raw medicinal herbs 6.72g/g, lot number: 020305, provide by the TCM Preparation Room of the court.
Experimental technique: trial test: get each 5 of the above white mice ♀ ♂ of fasting 16h, press the dosage (the maximum stomach amount of irritating) of 0.4ml/10g with containing crude drug 4.32g/ml pharmaceutical composition of the present invention (this concentration is the Cmax that No. 12 irrigation stomach devices can aspirate) test liquid, gastric infusion is 2 times in the 6h, total dosage is 345.6g crude drug/kg, observed 7 days continuously, the result does not have animal dead, can't measure LD50 routinely, measures so carry out maximum dosage-feeding.
Maximum dosage-feeding determination test: choose 20 of healthy mices, ♀ ♂ half and half, body weight 19.6 ± 1.0g, use behind the about 16h of fasting (can't help water) and contain the maximum dosage-feeding gastric infusion of the pharmaceutical composition test liquid of the present invention of crude drug amount 4.32g/ml by 0.4ml/10g, administration is 2 times in the 6h, total dosage is 345.6g crude drug/kg, and white mice is normally raised (25 ± 0.5 ℃ of room temperatures after the administration; Relative humidity 55～60%), activity, fur, diet, the feces of observing animal have or not abnormal change, and observe and have or not poisoning symptom and death (if death is arranged, then dissecting and pathological examination), observe a week continuously.One Zhou Houfu weighs, and puts to death animal and dissects, and the observation heart, liver, spleen, lung, kidney, adrenal gland, thymus, brain, tongue, stomach, intestinal, bladder, gonad main organs such as (uterus, ovary or testis and epididymises) have or not ANOMALOUS VARIATIONS.
Experimental technique list of references: Ministry of Public Health bureau of drug policy ﹠ administration. study of tcm new drug guide (pharmacy pharmacology's toxicology): 203～204
Eight, medicine composite for curing chronic obstructive emphysema 61 routine clinical experiments of the present invention
(30 examples are organized in treatment to 30 couples of patients of medicine composite for curing chronic obstructive emphysema insufficiency of QI of the lung and kidney disease of the present invention, matched group 31 examples) 30 days courses of treatment, treatment group as a result shows control rate 63.3%, total effective rate 93.3%, curative effect obviously is better than matched group, and learning by statistics to handle has significant differences (P＜0.01).To cough, the curative effect of expectorant, a symptom such as breathe heavily, breathe hard, the treatment group effect of coughing, cough up phlegm, breathe hard is better, all is better than matched group, antiasthmatic effect takes second place, but is excellent than matched group also.Statistical procedures has significant difference (P＜0.01).Change that treatment group white and greasy fur is most of to be improved before and after the sign, the pulse condition stringy and tense pulse is controlled the rear section and is transferred normal pulse to, and sputum is sticking in vain, transfers to rare after controlling mostly or does not have expectorant.Experiment a surname check: blood, routine urinalysis, hepatic and renal function inspection, and except that increasing the treatment shield, small part patient neutrophilic granulocyte recovers normal surplus having no significant change, after lung function part patient controls improvement is arranged, Electrocardioscopy is controlled the back nothing and is obviously changed.
The case choice criteria
Chinese medical discrimination typing and foundation thereof: " new Chinese medicine treatment chronic bronchitis clinical research guideline " (in May, 2002 version) chronic pulmonary heart disease (version in 1993) and obstructive emphysema clinical diagnosis standard (trying) syndrome of qi deficiency of lung and kidney in 1973 of formulating by Ministry of Public Health: symptoms including cough, pant, breathe hard, activity postemphasis or small amount of foam expectorant, waist soreness, weak or aversion to cold and cold limbs, pale tongue, white and thin fur, deep-thready pulse.
The Western medicine diagnose standard: the obstructive emphysema clinical diagnosis can be with reference to medical history, sign, X ray examination and pulmonary function test etc. are comprehensive to be judged, tentatively be divided into light, in, weigh three degree.
Table 7, diagnostic criteria
| The calibration project | Slightly | Moderate | Severe | |
| Medical history | 1. medical history 2. such as chronic bronchitis is breathed hard | It is slight when work is arranged | Slight work or movable slightly back were obviously when calmness was arranged | It is obvious when calmness is arranged |
| Sign | 1. 5. 7. lung liver circle 8. base of lung mobilities of heart circle 6. hear sounds (apical region of heart) of thorax shape 2. percussion repercussion 3. breath sounds, 4. apex beats (position) | Intercostal slightly broadening slightly strengthens slightly to weaken and does not normally have under the 6th costal margin of change more than the 4.0CM | Move slightly to dwindle in intercostal space broadening enhancing weakens and weaken 3.1-4.0CM under the 7th costal margin | Typical case's tubbiness obviously strengthens or box-note obviously weaken move on to obviously dwindle under the sword or be difficult for kowtowing obviously weaken and remote the 8th costal margin under below the 3.0CM |
| The X line | 1. diaphragm limitation of movement diaphragm low level 2. pulmonary vascular markingses that flatten manage that 3. pulmonary belb, 4. lung fields are bright reads to strengthen the change that changes 5. podiods when deeply breathing, cardiothoracic ratio | 2.0-1.5CM diaphragm is positioned at 11 aft ribs or intercostal changes not significantly accidental obvious 0.45-0.4 | 1.4-0.6CM the peripheral branch of 11 aft ribs or intercostal is very thin medium 0.39-0.35 is arranged | 0.5CM-motionless 12 aft ribs are following very thin sparse more common slight or unchanged below 0.34 |
| 1. maximal voluntary ventilation | 61-80％ | 41-60％ | Below 40% | |
| Pulmonary function | (accounting for predicted value percentage ratio) be 3. residual volume/total lung capacity ratio 4. maximal expiratory flow-volume curves (MEUF) of first second timed vital capacity (accounting for vital capacity percentage ratio) 2. | Compare before and after the 60-50% 40-50% treatment | 50-40％ 50-60％ | Below 40% more than 60% |
By stages emophysematous
The first phase, asymptomatic stage, patient's no conscious sympton, physical examination, C-XF and pulmonary ventilation function are measured all no abnormal discovery, only find to have when pathologic finding emphysema therefore to belong to the subclinical stage.
The second phase, i.e. dysfunction of ventilation phase: the patient has ictal or the persistence dyspnea.Chronic cough, fatigue and weak, physical examination and chest X-ray have the emphysema performance, and lung function tests shows dysfunction of ventilation, and residual volume increases.Though can make the early stage emphysema that belong to of emphysema diagnosis when clinical symptoms and sign occurring, enter the second phase.
The third phase, the hypoxemia phase: except that above-mentioned symptom, inappetence can also occur, lose weight, weakness, cyanosis, partial pressure of oxygen reduces when having a rest or moving.
The fourth phase, the carbon dioxide retention phase: occur drowsiness, disturbance of consciousness.Partial pressure of carbon dioxide raises.
The fifth phase, the pulmonary heart disease phase: be divided into compensatory phase and compensatory phase of mistake, heart failure can appear in the later stage.
The division of severity extent
Cough:
Slightly (+): be interrupted cough daytime, do not influence orthobiosis and work.
Moderate (++): symptom is between slight (+) and severe (+++).
Severe (+++): the frequent or apasm of coughing of cough round the clock, influence is had a rest and sleep.
Cough up phlegm:
Gently (+): the 10-50ml that coughs up phlegm round the clock, or the 5-25ml that coughs up phlegm in night and early morning.
In (++): the 51-100ml that coughs up phlegm round the clock, or the 26-50ml that coughs up phlegm in night and early morning.
Heavy (+++): cough up phlegm more than the 100ml round the clock, or night and early morning cough up phlegm more than the 50ml.
Pant:
Slightly (+): the idol of panting has outbreak, and degree is light, does not influence sleep activity.
Moderate (++): the state of an illness is between slight (+) and severe (+++).
Severe (+++): pant obviously, can not put down for sleeping in, influence sleep and movable.
Heavy breathing toot sound:
Gently (+): idol is heard, or in cough, the back of deeply breathing occurs.
In (++): be dispersed in.
Heavy (+++): be abound with.
Breathe hard (respiratory insufficiency clinical criteria):
I level (slightly): feel dyspnea during the moderate work, slight cyanosis.
II level (moderate): feel dyspnea during gentle activity, the moderate cyanosis.
III level (severe): feel dyspnea during tranquillization, the severe cyanosis.
Table 8, arteries and veins blood gas grade scale
| Project | Slightly | Moderate | Severe |
| PaO 2 SaO 2 PaCO 2 | ＞50MMHG ＞80％ ＜50MMHG | 30-50MMHG 60-80％ 50-70MMHG | ＜30MMHG ＜60％ ＞70MMHG |
Clinical severity extent is judged: cough during treatment, expectorant, breathe heavily, wheezing sound, breathe hard in five, any one enough severe person is a severe; Enough moderate persons are moderate; All not enough severe and moderate person are slight in four.
Observation index: safety observation, respectively look into once during the treatment beginning and when finishing the course of treatment.General health check-up project: body temperature, breathing, heart rate, blood pressure etc.Blood, urine, just routine test.Electrocardiogram, liver, kidney function test.Health giving quality is observed: tcm symptom (comprise and cough, expectorant, breathe heavily, wheezing, breathe hard) sign (cardiopulmonary sign, pulmonary rale and tongue, arteries and veins are observed); Pulmonary function (PEF); Chest X-ray; Expectorant is cultivated and phlegm cytology checking; Arterial blood gas analysis; Blood examination; Superoxide dismutase is checked (SOD); Examination of nail fold microcirculation.
Clinical trial is adopted by single blind method of contrast at random, and observation treatment group, each 30 example of matched group are observed 60 examples altogether in 1: 1 ratio.All case is selected outpatient service and inpatient, the strict control of outpatient variable factor.
The test medication: oral pharmaceutical composition of the present invention is organized in treatment, and each four, three times on the one, (providing) by Jiangsu Province academy of traditional Chinese medicine Pharmacology Lab, the oral FEIQIZHONG PIAN of matched group (contain chemical medicine clenbuterol, the Zhenjiang pharmaceutical factory of traditional Chinese medicine produces), each four, three times on the one, equal 30 days is a course of treatment.Period in a medicine is refused to obey other antibiotics and relieving cough and eliminating sputum anti-asthmatic.
Curative effect judging standard and according to (clinical research guideline 2002 version----of press new Chinese medicine lung qi deficient syndrome is tried)
Clinical recovery: the clinical symptoms of insufficiency of lung-QI, sign disappear or basic the disappearance, and the disease integration reduces＞=95%
Produce effects: clinical symptoms, the sign of insufficiency of lung-QI are obviously improved, and the disease integration reduces＞=70%
Effectively: clinical symptoms, the sign of insufficiency of lung-QI all take a favorable turn, and the disease integration reduces＞=30%
Invalid: the clinical symptoms of insufficiency of lung-QI, sign do not have obvious improvement, even increase the weight of, the disease integration reduces less than 30%
Annotate: the disease integration is pressed the nimodipine method.
Individual event symptom curative effect judging standard (clinical research guideline 2002 version----of pressing the new Chinese medicine chronic bronchitis is tentative)
Clinic control: cough, expectorant, the symptom of breathing heavily, breathe hard disappears the slight person of pulmonary's wheezing sound substantially.
Produce effects: cough, expectorant, the symptom of breathing heavily, breathe hard is clearly better (+++---+), pulmonary's wheezing sound alleviates.
Effectively: cough, expectorant, the symptom of breathing heavily, breathe hard take a turn for the better (+++---++, or +++---+), pulmonary's wheezing sound alleviates.
Invalid: cough, expectorant, the symptom of breathing heavily, breathe hard do not have change, or alleviate not obvious, and symptom and the wheezing sound person of increasing the weight of.
Therapeutic outcome
Two groups of case comprehensive therapeutic effects: pharmaceutical composition of the present invention and FEIQIZHONG PIAN, to cough, expectorant, the comprehensive therapeutic effect branch of breathing heavily, breathe hard face the control rate, show the control rate, total effective rate, curative effect average rank have significant difference (seeing Table 9) through rank test
Table 9, two groups of case comprehensive therapeutic effects are analyzed
| Group | The example number | Face control | Produce effects | Take a turn for the better | Invalid | Show control rate % | Effective percentage % | The curative effect average rank | Rank test Uc P |
| Treatment group matched group | 30 31 | 7 3 | 12 3 | 9 19 | 2 6 | 63.3 19.4 | 93.3 80.6 | 2.8 2.09 | 3.15＜0.05 |
Relatively treatment group of two groups of curative effects curative effect is better than matched group
Notes: invalid volume one-level, take a turn for the better and compile secondary, produce effects is compiled three grades, faces the control-register level Four, down together.
Individual event symptom curative effect: (seeing Table 10)
Table 10, two groups of patient's individual event symptoms and therapeutic effect
| Symptom | Group | The example number | Face control | Produce effects | Take a turn for the better | Invalid | Show control rate % | Effective percentage % | The curative effect average rank | Rank test | Uc P |
| Cough | Treatment group matched group | 28 28 | 13 6 | 6 2 | 7 14 | 2 6 | 67.8 28.6 | 92.8 78.6 | 3.07 2.28 | 2.68 | ＜0.05 |
| Cough up phlegm | Treatment group matched group | 28 26 | 11 4 | 9 2 | 6 10 | 2 10 | 71.4 23.1 | 92.9 61.5 | 3.04 2.0 | 3.38 | ＜0.05 |
| Asthma | Treatment group matched group | 23 13 | 6 5 | 4 0 | 11 0 | 2 8 | 43.5 38.5 | 91.3 38.5 | 2.61 2.15 | 4.94 | ＜0.05 |
| Breathe hard | Treatment group matched group | 30 31 | 7 4 | 10 2 | 11 18 | 2 7 | 56.5 19.4 | 93.3 77.4 | 2.73 2.09 | 2.79 | ＜0.05 |
Treatment group antitussive, remove expectorant, relieving asthma, the improvement of breathing hard all is better than matched group
In addition, there are data to show that curative effect is better than old group with young group of curative effect; The course of disease is optimum with 2-5 with interior person's curative effect.
The specific embodiment
The used medical material of the present invention is commercially available.The Radix Astragali is leguminous plant Radix Astagali Astragalus membranaceus (Fisch.) Bge.var.mongholicus (Bge.) Hsiao, or the dry root of Radix Astragali Astragalus membranaceus (Fisch.) Bge..Radix Morindae Officinalis is the dry root of Maguireothamnus speciosus Radix Morindae Officinalis Morinda officinalis How.Herba Epimedii is the dry aerial parts of Berberidaceae plant Herba Epimedii Epimedium brevicornum Maxim., arrow leaf Herba Epimedii Epimedium sagittatum (Sieb.Et Zucc.) Maxim., pubescence Herba Epimedii Epimedium pubescens Maxim., Epimedium wushanense Epimedium wushanense T.S.Ying or Herba Epimedii Epimedium koreanum Nakai.Radix Salviae Miltiorrhizae is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae Salviamiltiorrhiza Bge..Semen Persicae is the dry mature seed of rosaceous plant peach Prunus persica (L.) Batsch or mountain peach Prunus davidiana (Carr.) Franch.Hirudo is the dry body of Hirudinidae animal whitmania Whitmania pigra, Hirudo Hirudo nipponica Whitman or Folium Salicis Babylonicae Hirudo Whitmania acranulata Whitman.Herba Ardisiae Japonicae is the dry Herb of Myrsinacea plant Herba Ardisiae Japonicae Ardisia japonica (Thunb.) BL..
Pharmaceutical combination preparation of the present invention can be made various dosage forms, comprises tablet, capsule, suspensoid, electuary.Preferably tablet, capsule.Wherein filler can be selected lactose, microcrystalline Cellulose, dextrin, starch, calcium phosphate etc. for use; Disintegrating agent can be selected hyprolose, carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose etc. for use; Also optional binding agent, wetting agent and the lubricant of adding.
Embodiment 1
Prescription: the Radix Astragali 10 gram Radix Morindae Officinaliss 6 gram Herba Epimedii 6 gram Radix Salviae Miltiorrhizaes 8 gram Semen Persicaes 4.5 gram Hirudos 5 gram Herba Ardisiae Japonicaes 10 grams.By the prescription weighting raw materials, standby.
1) Radix Salviae Miltiorrhizae is measured reflux, extract, 4 times for 10 times with 90% ethanol, each 3 hours, merge ethanol extract, decompression recycling ethanol gets the tanshinol extracted extract, and is standby;
2) the water intaking trematodiasis is ground into coarse powder, uses 80% ethanol percolation, and the decompression recycling ethanol percolate gets Hirudo percolation cream, and is standby;
3) get Semen Persicae, Herba Ardisiae Japonicae, measure reflux, extract, 4 times for 8 times with 80% ethanol respectively, each 4 hours, merge described Semen Persicae ethanol extract and described Herba Ardisiae Japonicae ethanol extract, decompression recycling ethanol gets alcohol-extracted extracts such as Semen Persicae, and is standby;
4) get the Radix Astragali, Radix Morindae Officinalis, Herba Epimedii and described Hirudo medicinal residues, described Radix Salviae Miltiorrhizae decoction dregs and decoct with water 4 times, add 12 times in water at every turn, adding ethanol, to make ethanol content be 80%, and post precipitation filters, and reclaims ethanol, the water extracted immersing pastes such as the Radix Astragali, standby;
5) merge the water extracted immersing pastes such as the alcohol extraction extractum such as described tanshinol extracted extract, described Hirudo percolation extractum, described Semen Persicae and the Radix Astragali, spray drying adds conventional adjuvant dry granulation, encapsulated in, every heavy 0.35 gram.Every day three times, each four.
Embodiment 2
Prescription: the Radix Astragali 1 gram Radix Morindae Officinalis 1 gram Herba Epimedii 1 gram Radix Salviae Miltiorrhizae 1 gram Semen Persicae 1 gram Hirudo 1 gram Herba Ardisiae Japonicae 1 gram.By the prescription weighting raw materials, standby.
1) Radix Salviae Miltiorrhizae is measured reflux, extract, 2 times for 4 times with 90% ethanol, each 0.5 hour, merge ethanol extract, decompression recycling ethanol gets the tanshinol extracted extract, and is standby;
2) the water intaking trematodiasis is ground into coarse powder, uses 50% ethanol percolation, and the decompression recycling ethanol percolate gets Hirudo percolation cream, and is standby;
3) get Semen Persicae, Herba Ardisiae Japonicae, measure reflux, extract, 2 times for 8 times with 50% ethanol respectively, each 1 hour, merge described Semen Persicae ethanol extract and described Herba Ardisiae Japonicae ethanol extract, decompression recycling ethanol gets alcohol-extracted extracts such as Semen Persicae, and is standby;
4) get the Radix Astragali, Radix Morindae Officinalis, Herba Epimedii and described Hirudo medicinal residues, described Radix Salviae Miltiorrhizae decoction dregs and decoct with water 2 times, add 6 times in water at every turn, adding ethanol, to make ethanol content be 50%, and post precipitation filters, and reclaims ethanol, the water extracted immersing pastes such as the Radix Astragali, standby;
5) merge the water extracted immersing pastes such as the alcohol extraction extractum such as described tanshinol extracted extract, described Hirudo percolation extractum, described Semen Persicae and the Radix Astragali, spray drying, dry granulation, encapsulated in, every heavy 0.35 gram.Every day three times, each four.
Embodiment 3
Prescription: the Radix Astragali 8 gram Radix Morindae Officinaliss 5 gram Herba Epimedii 5 gram Radix Salviae Miltiorrhizaes 7 gram Semen Persicaes 4 gram Hirudos 4 gram Herba Ardisiae Japonicaes 8 grams.By the prescription weighting raw materials, standby.
1) Radix Salviae Miltiorrhizae is measured reflux, extract, 4 times for 10 times with 90% ethanol, and each 3 hours, merge ethanol extract, decompression recycling ethanol gets the tanshinol extracted extract, and is standby;
2) the water intaking trematodiasis is ground into coarse powder, uses 80% ethanol percolation, and the decompression recycling ethanol percolate gets Hirudo percolation cream, and is standby;
3) get Semen Persicae, Herba Ardisiae Japonicae, measure reflux, extract, 4 times for 10 times with 80% ethanol respectively, each 1 hour, merge described Semen Persicae ethanol extract and described Herba Ardisiae Japonicae ethanol extract, decompression recycling ethanol gets alcohol-extracted extracts such as Semen Persicae, and is standby;
4) get the Radix Astragali, Radix Morindae Officinalis, Herba Epimedii and described Hirudo medicinal residues, described Radix Salviae Miltiorrhizae decoction dregs and decoct with water 3 times, add 7 times in water at every turn, adding ethanol, to make ethanol content be 80%, and post precipitation filters, and reclaims ethanol, the water extracted immersing pastes such as the Radix Astragali, standby;
5) merge the water extracted immersing pastes such as the alcohol extraction extractum such as described tanshinol extracted extract, described Hirudo percolation extractum, described Semen Persicae and the Radix Astragali, conventional wet granulation after the drying, divides the bag of packing into.
Embodiment 4
Prescription: the Radix Astragali 2 gram Radix Morindae Officinaliss 2 gram Herba Epimedii 2 gram Radix Salviae Miltiorrhizaes 6 gram Semen Persicaes 2 gram Hirudos 1 gram Herba Ardisiae Japonicae 2 grams.By the prescription weighting raw materials, standby.
1) Radix Salviae Miltiorrhizae is measured reflux, extract, 3 times for 5 times with 90% ethanol, and each 1 hour, merge ethanol extract, decompression recycling ethanol gets the tanshinol extracted extract, and is standby;
2) the water intaking trematodiasis is ground into coarse powder, uses 60% ethanol percolation, and the decompression recycling ethanol percolate gets Hirudo percolation cream, and is standby;
3) get Semen Persicae, Herba Ardisiae Japonicae, measure reflux, extract, 3 times for 7 times with 60% ethanol respectively, each 1 hour, merge described Semen Persicae ethanol extract and described Herba Ardisiae Japonicae ethanol extract, decompression recycling ethanol gets alcohol-extracted extracts such as Semen Persicae, and is standby;
4) get the Radix Astragali, Radix Morindae Officinalis, Herba Epimedii and described Hirudo medicinal residues, described Radix Salviae Miltiorrhizae decoction dregs and decoct with water 2 times, add 9 times in water at every turn, adding ethanol, to make ethanol content be 60%, and post precipitation filters, and reclaims ethanol, the water extracted immersing pastes such as the Radix Astragali, standby;
5) merge the water extracted immersing pastes such as the alcohol extraction extractum such as described tanshinol extracted extract, described Hirudo percolation extractum, described Semen Persicae and the Radix Astragali, add conventional adjuvant wet granulation, encapsulated in, every heavy 0.35 gram.Every day three times, each four.
Embodiment 5
Prescription: the Radix Astragali 7 gram Radix Morindae Officinaliss 4 gram Herba Epimedii 5 gram Radix Salviae Miltiorrhizaes 2 gram Semen Persicaes 4 gram Hirudos 4 gram Herba Ardisiae Japonicaes 8 grams.By the prescription weighting raw materials, standby.
1) Radix Salviae Miltiorrhizae is measured reflux, extract, 3 times for 9 times with 90% ethanol, and each 1 hour, merge ethanol extract, decompression recycling ethanol gets the tanshinol extracted extract, and is standby;
2) the water intaking trematodiasis is ground into coarse powder, uses 75% ethanol percolation, and the decompression recycling ethanol percolate gets Hirudo percolation cream, and is standby;
3) get Semen Persicae, Herba Ardisiae Japonicae, measure reflux, extract, 4 times for 9 times with 70% ethanol respectively, each 1 hour, merge described Semen Persicae ethanol extract and described Herba Ardisiae Japonicae ethanol extract, decompression recycling ethanol gets alcohol-extracted extracts such as Semen Persicae, and is standby;
4) get the Radix Astragali, Radix Morindae Officinalis, Herba Epimedii and described Hirudo medicinal residues, described Radix Salviae Miltiorrhizae decoction dregs and decoct with water 3 times, add 8 times in water at every turn, adding ethanol, to make ethanol content be 70%, and post precipitation filters, and reclaims ethanol, the water extracted immersing pastes such as the Radix Astragali, standby;
5) merge the water extracted immersing pastes such as the alcohol extraction extractum such as described tanshinol extracted extract, described Hirudo percolation extractum, described Semen Persicae and the Radix Astragali, vacuum drying adds conventional adjuvant to granulate, tabletting, every heavy 0.35 gram.
Embodiment 6
Prescription: the Radix Astragali 3 gram Radix Morindae Officinaliss 2 gram Herba Epimedii 2 gram Semen Persicaes 2 gram Hirudos 1 gram Herba Ardisiae Japonicae 2 grams.By the prescription weighting raw materials, standby.
1) the water intaking trematodiasis is ground into coarse powder, uses 75% ethanol percolation, and the decompression recycling ethanol percolate gets Hirudo percolation cream, and is standby;
2) get Semen Persicae, Herba Ardisiae Japonicae, measure reflux, extract, 2 times for 8 times with 60% ethanol respectively, each 1 hour, merge described Semen Persicae ethanol extract and described Herba Ardisiae Japonicae ethanol extract, decompression recycling ethanol gets alcohol-extracted extracts such as Semen Persicae, and is standby;
3) get the Radix Astragali, Radix Morindae Officinalis, Herba Epimedii and described Hirudo medicinal residues and decoct with water 3 times, add 10 times in water at every turn, adding ethanol, to make ethanol content be 60%, and post precipitation filters, and reclaims ethanol, the water extracted immersing pastes such as the Radix Astragali, standby;
4) merge the water extracted immersing pastes such as the alcohol extraction extractum such as described Hirudo percolation extractum, described Semen Persicae and the Radix Astragali, vacuum drying adds conventional adjuvant to granulate, tabletting, every heavy 0.35 gram.Every day three times, each four.
Embodiment 7
Prescription: the Radix Astragali 6 gram Radix Morindae Officinaliss 4 gram Herba Epimedii 4 gram Semen Persicaes 4 gram Hirudos 2 gram Herba Ardisiae Japonicaes 6 grams.By the prescription weighting raw materials, standby.
1) the water intaking trematodiasis is ground into coarse powder, uses 70% ethanol percolation, and the decompression recycling ethanol percolate gets Hirudo percolation cream, and is standby;
2) get Semen Persicae, Herba Ardisiae Japonicae, measure reflux, extract, 2 times for 5 times with 60% ethanol respectively, each 1 hour, merge described Semen Persicae ethanol extract and described Herba Ardisiae Japonicae ethanol extract, decompression recycling ethanol gets alcohol-extracted extracts such as Semen Persicae, and is standby;
3) get the Radix Astragali, Radix Morindae Officinalis, Herba Epimedii and described Hirudo medicinal residues and decoct with water 3 times, add 9 times in water at every turn, adding ethanol, to make ethanol content be 70%, and post precipitation filters, and reclaims ethanol, the water extracted immersing pastes such as the Radix Astragali, standby;
4) merge the water extracted immersing pastes such as the alcohol extraction extractum such as described Hirudo percolation extractum, described Semen Persicae and the Radix Astragali, constant pressure and dry adds conventional adjuvant to granulate, encapsulated in, every heavy 0.35 gram.
Embodiment 8
Prescription: the Radix Astragali 10 gram Radix Morindae Officinaliss 6 gram Semen Persicaes 4.5 gram Hirudos 5 grams.By the prescription weighting raw materials, standby.
1) the water intaking trematodiasis is ground into coarse powder, uses 80% ethanol percolation, and the decompression recycling ethanol percolate gets Hirudo percolation cream, and is standby;
2) get Semen Persicae and measure reflux, extract, 4 times for 8 times with 80% ethanol, each 4 hours, merge ethanol extract, decompression recycling ethanol gets the Semen Persicae alcohol-extracted extract, and is standby;
3) get the Radix Astragali, Radix Morindae Officinalis and described Hirudo medicinal residues and decoct with water 4 times, add 12 times in water at every turn, adding ethanol, to make ethanol content be 80%, and post precipitation filters, and reclaims ethanol, the water extracted immersing pastes such as the Radix Astragali, standby;
4) merge the water extracted immersing pastes such as the alcohol extraction extractum such as described Hirudo percolation extractum, described Semen Persicae and the Radix Astragali, spray drying adds conventional adjuvant dry granulation, and is encapsulated.
Claims (10)
1, a kind of pharmaceutical composition for the treatment of chronic obstructive emphysema is characterized in that it mainly being to be made by following bulk drugs: Radix Astragali 1-10 part, Radix Morindae Officinalis 1-6 part, Semen Persicae 1-4.5 part, Hirudo 1-5 part.
2, the pharmaceutical composition of claim 1, wherein the consumption of crude drug is: Radix Astragali 3-8 part, Radix Morindae Officinalis 2-5 part, Semen Persicae 2-4 part, Hirudo 1-4 part.
3, the pharmaceutical composition of claim 2, wherein the consumption of crude drug is: Radix Astragali 4-6 part, Radix Morindae Officinalis 3-4 part, Semen Persicae 3-4 part, Hirudo 2-3 part.
4, the preparation of drug combination method of one of claim 1～3 comprises the following steps:
1) take by weighing each crude drug Radix Astragali, Radix Morindae Officinalis, Semen Persicae, Hirudo, standby;
2) the water intaking trematodiasis is ground into coarse powder, uses ethanol percolation, and the Hirudo medicinal residues that ethanol percolation is crossed are waited until processing, concentrates ethanol percolation liquid, gets extractum A, and is standby;
3) get the Semen Persicae alcohol reflux, concentrate ethanol extract, get extractum B, standby;
4) get the Radix Astragali, Radix Morindae Officinalis and 2) the Hirudo medicinal residues, use water extraction, in the water extract, add ethanol, making ethanol content is 50%～80%, remove ethanol after, the extractum C of water extract of the Radix Astragali, Radix Morindae Officinalis and Hirudo medicinal residues, standby;
5) above-mentioned extractum A, extractum B and extractum C are merged, drying makes the active component of pharmaceutical composition of the present invention.
5, the pharmaceutical composition of claim 1, wherein crude drug also has: Herba Epimedii or Fructus Psoraleae 1-6 part, Herba Ardisiae Japonicae 1-10 part.
6, the pharmaceutical composition of claim 5, wherein the consumption of each crude drug is: Radix Astragali 3-8 part, Radix Morindae Officinalis 2-5 part, Semen Persicae 2-4 part, Hirudo 1-4 part, Herba Epimedii or Fructus Psoraleae 2-5 part, Herba Ardisiae Japonicae 2-8 part.
7, the pharmaceutical composition of claim 6, wherein the consumption of each crude drug is: Radix Astragali 4-6 part, Radix Morindae Officinalis 3-4 part, Semen Persicae 3-4 part, Hirudo 2-3 part, Herba Epimedii or Fructus Psoraleae 3-4 part, Herba Ardisiae Japonicae 3-6 part.
8, one of claim 5～7 preparation of drug combination method comprises the following steps:
1) take by weighing each crude drug Radix Astragali, Radix Morindae Officinalis, Semen Persicae, Hirudo, Herba Epimedii or Fructus Psoraleae, Herba Ardisiae Japonicae, standby;
2) the water intaking trematodiasis is ground into coarse powder, uses ethanol percolation, and the Hirudo medicinal residues that ethanol percolation is crossed are waited until processing, concentrates ethanol percolation liquid, gets extractum A, and is standby;
3) get Semen Persicae and Herba Ardisiae Japonicae is used alcohol reflux, concentrate ethanol extract, extractum B, standby;
4) get the Radix Astragali, Radix Morindae Officinalis and 2) Hirudo medicinal residues and Herba Epimedii or Fructus Psoraleae, use water extraction, in the water extract, add ethanol, making ethanol content is 50%～80%, remove ethanol after, the extractum C of water extract, standby;
5) above-mentioned extractum A, extractum B and extractum C are merged, drying makes the active component of pharmaceutical composition of the present invention.
9, the pharmaceutical composition of claim 5, wherein crude drug also has: Herba Epimedii or Radix Salviae Miltiorrhizae 1-8 part.
10, the preparation of drug combination method of claim 9 comprises the following steps:
1) take by weighing each crude drug Radix Astragali, Radix Morindae Officinalis, Semen Persicae, Hirudo, Herba Epimedii or Fructus Psoraleae, Herba Ardisiae Japonicae, Herba Epimedii or Radix Salviae Miltiorrhizae, standby;
2) Herba Epimedii or Radix Salviae Miltiorrhizae are measured reflux, extract, 2～4 times for 4～10 times with 90% ethanol, and each 1～3 hour, medicinal residues were waited until processing, merge ethanol extract, and decompression recycling ethanol gets extractum D, and is standby;
3) the water intaking trematodiasis is ground into coarse powder, with 50%～80% ethanol percolation, the Hirudo medicinal residues that ethanol percolation is crossed is waited until processing, and the decompression recycling ethanol percolate gets extractum A, and is standby;
4) get Semen Persicae, Herba Ardisiae Japonicae, measure reflux, extract, 2～4 times for 5～10 times with 50%～80% ethanol, each 1～3 hour, merge ethanol extract, decompression recycling ethanol gets extractum B, and is standby;
5) get the Radix Astragali, Radix Morindae Officinalis, Herba Epimedii or Fructus Psoraleae, 3) Hirudo medicinal residues, 2) Herba Epimedii or Radix Salviae Miltiorrhizae decoction dregs decoct with water 1～3 time, add 7～12 times in water at every turn, in aqueous extract, add ethanol and make ethanol content reach 50%～80%, post precipitation filters, concentrate ethanol liquid, get extractum C, standby;
6) above-mentioned extractum A, extractum B, extractum C and extractum D are merged, drying is mixed with pharmaceutically acceptable adjuvant.
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| CN101530493B (en) * | 2009-04-16 | 2011-08-17 | 天津中医药大学第二附属医院 | Medicament combination for curing respiratory diseases and application thereof |
| CN103191255B (en) * | 2013-05-02 | 2014-10-01 | 上海市普陀区中心医院 | Traditional Chinese medicinal composition for treating chronic airway inflammation |
| CN103768384B (en) * | 2014-02-20 | 2016-04-13 | 吕莉 | One treats emophysematous Chinese medicine composition and preparation method thereof |
| CN105250700A (en) * | 2015-11-04 | 2016-01-20 | 陈春芬 | Traditional Chinese medicine for treating chronic obstructive emphysema and preparation method thereof |
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