CN1775274A - Cough-relieving sputum-resolving medicinal composition and preparing method - Google Patents
Cough-relieving sputum-resolving medicinal composition and preparing method Download PDFInfo
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Abstract
The present invention discloses a Chinese medicine composition for relieving cough and reducing sputum with obvious therapeutic effect. It is made up by using 8 Chinese medicinal materials of Huazhou pomelo rind, stemona root, poria, prepared pinellia tuber, cynanchum root, licorice and others through a certain preparation process.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition of relieving cough and resolving phlegm, relating in particular to a kind of is the Chinese patent medicine and preparation method thereof of the relieving cough and resolving phlegm that forms of feedstock production with the Chinese herbal medicine, belongs to the field of Chinese medicines.
Background technology
Interior warp " element is asked and coughed opinion " points out that " vital organs of the human body all make us coughing, and not merely lung also." back physicians from a family for generations family Zhang Jingyue reduce again " though cough demonstrate,prove many, pneumonopathy nothing but ".Lung qi is suitable to reduce to, and abnormal rising of lung-QI is cough with asthma then.Disorder of movement of QI, the dysfunction of the spleen, retention of water-damp in the body poly-wets into expectorant, phlegm resistance, disorder of QI movement, clear YANG failing to ascend, upward adverse flow of phlegm makes impairment of dispersing and descending function of the lung, QI rising in reverse order and be cough with asthma.
The traditional Chinese medical science thinks that the affection of exogenous wind-cold cough mainly is because the heresy of wind and cold is attacked human body by fur, mouth and nose, influence lung and defend, sluggishness of lung-QI is not declared, and respectful clearly making is not normal, sputum grows, obstructing airway influences the discrepancy of lung qi and causes clinical common cough, cough up white rare expectorant, very then with asthma, can be with cold and heat, exterior syndromes such as nasal obstruction watery nasal discharge.Be trouble if accompany damp, dampness hampering qi movement, spleen fortune is lost strong, and it is vexed breast gastral cavity painful abdominal mass then can to occur, and the expectoration amount is many etc.Except that dispersing wind-cold, must strengthen the cough-relieving of lung qi dispersing activating QI to eliminate phlegm in the treatment.
The Chinese patent medicine of the relieving cough and resolving phlegm of market sale at present is a lot, as fritillary-loquat liquid, JIZHI TANGJIANG, XIAOER ZHIKE TANGJIANG etc., these Chinese patent medicines for cough due to pathogenic wind-heat, cough caused by dryness-heat, expectorant heat syndrome cough breathe heavily, coughs such as liver-fire invading the lung cough or cough due to yin deficiency all have curative effect preferably, and are still all not ideal enough for cough due to wind and cold's curative effect.
Summary of the invention
Technical problem to be solved by this invention is to overcome the deficiencies in the prior art, provides a kind of and can effectively treat cough, and the pharmaceutical composition of good curative effect is especially arranged for the cough due to wind and cold.
Technical problem to be solved by this invention realizes by following technological approaches:
The pharmaceutical composition of relieving cough and resolving phlegm of the present invention, mainly make by following bulk drugs:
10～40 parts of Exocarpium Citri Grandises, 2～8 parts of the Radixs Stemonae, 2～5 parts in Poria, 2～5 parts of Rhizoma Pinelliae Preparata, 2～8 parts of Rhizoma Cynanchi Stauntoniis, 0.5～3 part in Radix Glycyrrhizae, 5～15 parts of Semen Armeniacae Amarums, 1～3 part of Fructus Schisandrae Chinensis.
Be preferably:
20～35 parts of Exocarpium Citri Grandises, 2～5 parts of the Radixs Stemonae, 2.5～4 parts in Poria, 2.5～4 parts of Rhizoma Pinelliae Preparata, 3～6 parts of Rhizoma Cynanchi Stauntoniis, 0.5～1.5 part in Radix Glycyrrhizae, 8～12 parts of Semen Armeniacae Amarums, 1.5～2.5 parts of Fructus Schisandrae Chinensis.
More preferably:
30 parts of Exocarpium Citri Grandises, 3 parts of the Radixs Stemonae, 3 parts in Poria, 3 parts of Rhizoma Pinelliae Preparata, 5 parts of Rhizoma Cynanchi Stauntoniis, 1 part in Radix Glycyrrhizae, 10 parts of Semen Armeniacae Amarums, 2 parts of Fructus Schisandrae Chinensis.
Pharmaceutical composition of the present invention is based on the differential diagnosis of diseases and the dialectical principle that combines of Chinese medicine asthma and cough, treating both the principal and secondary aspects of a disease, deficiency and excess is also controlled, and filters out the natural plant of removing dampness and eliminating phlegm, sending down the abnormal ascending QI cough-relieving, lung moistening antiinflammatory, according to the theory of Chinese medical science prescription, be prepared from according to certain weight proportion.
Modern pharmacology discovers that tangerine contained volatile oil has the stimulation phlegm-dispelling functions.The Rhizoma Pinelliae has the glucocorticoid effect, can increase the tonicity of blood vessel, alleviates hyperemia, reduces the permeability of blood capillary, suppresses leukocyte infiltration and engulfs reaction, reduces the release of various inflammatory factors.Semen Armeniacae Amarum KR-A and KR-B wherein has antiinflammatory action.Fructus Schisandrae Chinensis gomisinA wherein has antiinflammatory action, directly acts on macrophage, can suppress arachidonic free.Radix Glycyrrhizae also has the glucocorticoid effect, and wherein glycyrrhizin can suppress macrophage formation.
Described Exocarpium Citri Grandis is immaturity or the outer peel of maturescent drying of rutaceae Huazhou Fructus Citri grandis [Citrus grandis ' Tomentosa '] or Fructus Citri grandis [Citrus grandis (L.) Osbeck], the flavor of its hot perfume is the most mellow, to abundant expectoration breath with cough, the curative effect of stomachache due to hyperactive liver-QI attacking the stomach is better than other kinds Pericarpium Citri tangerinae.
The described Radix Stemonae is the sweet Radix Stemonae, and the method for its process of preparing Chinese medicine is as follows: get Radix Stemonae section, add the certain amount of boiling water molten with refined honey (Radix Stemonae section 100 jin with honey 12 jin 8 liang), mix thoroughly, vexed slightly, the mulse of waiting absorbs, putting pot interior slow fire stir-fry tack-free to little yellow is degree, takes out, and cools to get final product.
The used raw material of the present invention all can be buied from the Chinese medicine shop, and its specification meets national medical standard.
The compatibility foundation of medicine of the present invention: reuse that hot temperature is bitter dry, abnormal smells from the patient is mellow Huazhou is tangerine to be monarch, the stomach of being amusing of can regulating the flow of vital energy, but removing dampness and eliminating phlegm again, gas goes expectorant to disappear along then wet, but gas removes also spontaneous recovery of cough with asthma along expectorant.It is sliding to be aided with the hot Wen Erti of Rhizoma Pinelliae Preparata, and special removing dampness and eliminating phlegm of merit and middle preventing or arresting vomiting are good for the stomach to help dried tangerine peel to eliminate the phlegm; Rhizoma Cynanchi Stauntonii is hot sweet and warm, and phlegm and relieving cough under the special sending down the abnormal ascending QI of merit is minister to help the dried tangerine peel cough-relieving of regulating the flow of vital energy, the sending down the abnormal ascending QI cough-relieving but dried tangerine peel, the Rhizoma Pinelliae, the compatible regulating qi-flowing for strengthening spleen stomach of Rhizoma Cynanchi Stauntonii, removing dampness are eliminated the phlegm.Assistant flat and promoting diuresis with drugs of tasteless flavour with Poria, the spleen invigorating invigorating middle warmer, spleen is strong wetly to go then that damp-phlegm is difficult to give birth to, and reduces phlegm to help the damp eliminating of regulating the flow of vital energy of dried tangerine peel, the Rhizoma Pinelliae.The lung and the large intestine being interior-exteriorly related, Semen Armeniacae Amarum, the Radix Stemonae, bitter sweet and warm, relieving cough and asthma, loosening bowel to relieve constipation are to help the cough-relieving of the Rhizoma Cynanchi Stauntonii therapeutic method to keep the adverse QI flowing downwards, with merit tangerine, that Rhizoma Pinelliae compatibility strengthens the activating QI to eliminate phlegm cough-relieving; The trimethyl gallic acid temperature, but not only tonifying the lung and nourishing the kidney, but also can the arresting sweating arresting seminal emission, 5 have in loosing and receive mutually with above-mentioned all medicines in case the hot consumption gas that looses of above-mentioned all medicines.Make with Radix Glycyrrhizae (sweet flat) but not only nourishing the lung to arrest cough but also have and middle emergency, the same usefulness of the merit of coordinating the actions of various ingredients in a prescription and Fructus Schisandrae Chinensis, sour and sweet drugs can transforme into YIN is with the strong property of system said medicine suffering warm-dryness syndrome.
Above-mentioned all medicines share and play drying dampness to eliminate phlegm altogether, regulate the flow of vital energy and in, the function of sending down the abnormal ascending QI cough-relieving, can effectively treat wind, cold, expectorant, wet and the cough with copious phlegm or the yang deficiency cough with asthma that cause.
Aforementioned pharmaceutical compositions of the present invention adds various conventional adjuvant required when preparing different dosage form, for example disintegrating agent, lubricant, adhesive, excipient etc. are prepared into any oral formulations commonly used with the method for Chinese medicinal of routine, can be oral liquid, granule, soft extract, capsule etc. for example, be preferably oral liquid.
Another technical problem to be solved by this invention provides a kind of this preparation of drug combination method.
A kind of method of preparation aforementioned pharmaceutical compositions, step is as follows:
1) take by weighing each raw material by following weight portion proportioning:
10～40 parts of Exocarpium Citri Grandises, 2～8 parts of the Radixs Stemonae, 2～5 parts in Poria, 2～5 parts of Rhizoma Pinelliae Preparata, 2～8 parts of Rhizoma Cynanchi Stauntoniis, 0.5～3 part in Radix Glycyrrhizae, 5～15 parts of Semen Armeniacae Amarums, 1～3 part of Fructus Schisandrae Chinensis.
2) with dried tangerine peel, Semen Armeniacae Amarum steam distillation, collect distillate, medicinal residues decoct with water secondary with the Radix Stemonae, Poria, Rhizoma Pinelliae Preparata, Rhizoma Cynanchi Stauntonii, Radix Glycyrrhizae and Fructus Schisandrae Chinensis, each 2 hours, filter merging filtrate, being concentrated into relative density is the clear paste of 1.25～1.35 (80～85 ℃), adding ethanol, to make the percent by volume of the alcohol amount of containing be 50%～90%, leaves standstill, and gets supernatant, reclaim ethanol and be concentrated into the clear paste that relative density is 1.18～1.20 (80～85 ℃), stir after adding correctives, antiseptic, mixing filters, put cold, add the water standardize solution, stir evenly, promptly.
In the above-mentioned preparation method, step 2 wherein) in clear paste, add in alcoholic acid amount be preferably clear paste percent by volume 75%～80%.
Usage and consumption: oral, a 10～20ml, one day three times.
Further describe beneficial effect of the present invention by the following examples, it should be understood that these embodiment only are used for the purpose of illustration, never limit protection scope of the present invention.
The specific embodiment
The preparation of [embodiment 1] oral liquid
Take by weighing each raw material:
Exocarpium Citri Grandis 300g, sweet Radix Stemonae 30g, Poria 30g, Rhizoma Pinelliae Preparata 30g, Rhizoma Cynanchi Stauntonii 50g, Radix Glycyrrhizae 10g, Semen Armeniacae Amarum 100g, Fructus Schisandrae Chinensis 20g.
With Exocarpium Citri Grandis, the Semen Armeniacae Amarum steam distillation is collected distillate 65ml, Six-elements such as medicinal residues and all the other sweet Radixs Stemonae, add the decocting in water secondary, each 2 hours, filter, merging filtrate, being concentrated into relative density is the clear paste of 1.25～1.35 (80～85 ℃), adds ethanol and makes that to contain alcohol amount be 78%, leaves standstill 24 hours, get supernatant, reclaim ethanol and be concentrated into the clear paste that relative density is 1.18～1.20 (80～85 ℃), with sucrose 400g, Mel 100g, sodium benzoate 3g, ethyl hydroxybenzoate 0.3g stirs and makes dissolving, add above-mentioned distillate, mixing filters, and puts cold, perfuming sugar and Mentholum are an amount of, add water to 1000ml, stir evenly, promptly.
The preparation of [embodiment 2] oral liquid
Take by weighing each raw material:
Exocarpium Citri Grandis 120g, Radix Stemonae 20g, Poria 20g, Rhizoma Pinelliae Preparata 20g, Rhizoma Cynanchi Stauntonii 20g, Radix Glycyrrhizae 6g, Semen Armeniacae Amarum 50g, Fructus Schisandrae Chinensis 10g.
Exocarpium Citri Grandis, the Semen Armeniacae Amarum steam distillation is collected distillate 50ml, Six-elements such as medicinal residues and all the other Radixs Stemonae, add the decocting in water secondary, each 2 hours, filter, merging filtrate, being concentrated into relative density is the clear paste of 1.25～1.35 (80～85 ℃), adds ethanol and makes that to contain alcohol amount be 60%, leaves standstill 24 hours, get supernatant, reclaim ethanol and be concentrated into the clear paste that relative density is 1.18～1.20 (80～85 ℃), with sucrose 400g, Mel 100g, sodium benzoate 3g, ethyl hydroxybenzoate 0.3g stirs and makes dissolving, add above-mentioned distillate, mixing filters, and puts cold, perfuming sugar and Mentholum are an amount of, add water to 1000ml, stir evenly, promptly.
The preparation of [embodiment 3] oral liquid
Take by weighing each raw material: Exocarpium Citri Grandis 400g, sweet Radix Stemonae 75g, Poria 50g, Rhizoma Pinelliae Preparata 50g, Rhizoma Cynanchi Stauntonii 75g, Radix Glycyrrhizae 25g, Semen Armeniacae Amarum 140g, Fructus Schisandrae Chinensis 25g.
Exocarpium Citri Grandis, the Semen Armeniacae Amarum steam distillation is collected distillate 80ml, Six-elements such as medicinal residues and all the other sweet Radixs Stemonae, add the decocting in water secondary, each 2 hours, filter, merging filtrate, being concentrated into relative density is the clear paste of 1.25～1.35 (80～85 ℃), adds ethanol and makes that to contain alcohol amount be 85%, leaves standstill 24 hours, get supernatant, reclaim ethanol and be concentrated into the clear paste that relative density is 1.18～1.20 (80～85 ℃), with sucrose 400g, Mel 100g, sodium benzoate 3g, ethyl hydroxybenzoate 0.3g stirs and makes dissolving, add above-mentioned distillate, mixing filters, and puts cold, perfuming sugar and Mentholum are an amount of, add water to 1000ml, stir evenly, promptly.
[test example 1] pharmaceutical composition of the present invention causes the antiinflammatory action test of rat paw inflammatory swelling to the injection Ovum Gallus domesticus album
One, test material
1, for the reagent thing: the oral liquid that the embodiment of the invention 1 is prepared is divided into high, medium and low three dosage groups.
2, positive control medicine: ZHIKE CHUANBEI PIPA LU (the lot number D06004 of Guangzhou Pangaoshou Pharmaceutical Co., Ltd)
3, other material: normal saline, Ovum Gallus domesticus album (10%).
Two, test equipment: rat paw volume determination instrument.
Three, laboratory animal: SPF level male SD rat (Zhongshan University's Experimental Animal Center provides, Guangdong probatio inspectionem pecuoarem word 2003A064)
Four, test method and result
Get 50 of SPF level male SD rats, be divided into 5 groups after weighing at random, be respectively the normal saline matched group, ZHIKE CHUANBEI PIPA LU group (5.4ml/kg), for reagent thing low dose group (2.7ml/kg), for dosage group (5.4ml/kg) in the reagent thing, for reagent object height dosage group (10.8ml/kg), each administration group is gastric infusion (15ml/kg) according to dosage, matched group is given isopyknic normal saline, make a labelling at every rat hindleg sole of the foot place, adopt rat paw volume determination instrument to measure its volume as causing scorching preceding normal volume.1h behind the filling stomach, the 10% Ovum Gallus domesticus album 0.1ml that under the sterile working, newly prepares in every right back sufficient plantar subcutaneous injection of rat.Adopt rat paw volume determination instrument mensuration to cause inflammation front and back different time rat paw volume-variation, respectively at causing inflammation back 10min, 30min, 1h, 2h, 3h, 4h, 5h mensuration swelling degree, consequently the volumetrical difference of the inflammation sufficient sole of the foot in front and back is as the swelling degree.
Result's (seeing Table 1) is seen in test.
The about thing of table 1 the present invention to rat paw injection egg disappear the influence that causes inflammatory swelling (x ± s, n=10)
| Group | Dosage ml/kg | Different time change in volume (unit: ml) after the injection egg disappears | |||||
| 10min | 30min | 1h | 2h | 3h | 5h | ||
| Physiological saline group cough-relieving fritillary and loquat cough mixture control group supplies reagent thing high dose group for the about thing low dose group of examination for dosage group in the reagent thing | / 5.4 2.7 5.4 10.8 | 0.63±0.19 0.51±0.15 0.51±0.15 0.41±0.26 0.49±0.12 | 0.77±0.28 0.75±0.12 0.66±0.17 0.45±0.21 *## 0.61±0.16 *## | 0.72±0.23 0.62±0.08 0.58±0.16 * 0.41±0.21 **# 0.49±0.18 *# | 0.78±0.23 0.59±0.11 * 0.42±0.13 **## 0.36±0.16 **## 0.38±0.14 **## | 0.64±0.14 0.49±0.15 * 0.40±0.14 ** 0.32±0.11 **# 0.29±0.18 **# | 0.41±0.11 0.29±0.10 * 0.25±0.18 * 0.17±0.10 **# 0.17±0.16 ** |
Annotate: * is with respect to blank group p＜0.05, and * * is with respect to blank group p＜0.01,
# is with respect to ZHIKE CHUANBEI PIPA LU matched group p＜0.05, and ## is with respect to ZHIKE CHUANBEI PIPA LU matched group p＜0.01
The result shows:
With the blank group relatively, (2.7ml/kg, 5.4ml/kg 10.8ml/kg) all can eliminate inflammatory swelling due to the rat paw injection Ovum Gallus domesticus album with ZHIKE CHUANBEI PIPA LU (5.4ml/kg) for the basic, normal, high dosage group of reagent thing.For dosage in the reagent thing and high dose group half an hour and after each observed time all show the antiinflammatory effect, low dosage then one hour and after demonstrate the antiinflammatory effect.ZHIKE CHUANBEI PIPA LU then demonstrates the antiinflammatory effect after reaching in two hours.
The dose concentration that the ZHIKE CHUANBEI PIPA LU group is got is suitable with the middle dosage (5.4ml/kg) that supplies the reagent thing, all is equivalent to into the human oral maximal dose.Both compare, and all show the antiinflammatory effect better than the ZHIKE CHUANBEI PIPA LU group (p＜0.05 or p＜0.01) for reagent object height dosage group when reaching low dose group at two hours between half an hour and three hours.Therefore under this experiment condition, good than the ZHIKE CHUANBEI PIPA LU group for the antiinflammation of reagent thing.Antiinflammatory effect for the reagent thing has certain dose-effect relationship, and dosage is high more, and produce effects is fast more.
[test example 2] medicine of the present invention is to the resolve phlegm effect test of mice
One, test material
1, for the reagent thing; The oral liquid that the embodiment of the invention 2 is prepared is divided into high, medium and low three dosage groups.
2, positive control medicine: ZHIKE CHUANBEI PIPA LU (the lot number D06004 of Guangzhou Pangaoshou Pharmaceutical Co., Ltd).
3, other reagent: phenol red, sodium hydroxide, normal saline.
Two, test equipment: 721 type spectrophotometers (Shanghai the 3rd analytical tool factory)
Three, laboratory animal: the SPF Kunming mouse (is economized Experimental Animal Center credit number is provided: SCXK (Guangdong) the word 2004AO19 that checks and affirm in 2003-0002 Guangdong.
Four, test method and result
1, the drafting of standard phenol Monas cuspurpureus Went line: accurately take by weighing the phenol red of 0.1g with analytical balance, add among normal saline and the sodium hydroxide mixed solution 100ml (sodium hydroxide 5ml wherein, normal saline 95ml), being mixed with 1ml, to contain 1000 μ g phenol red, dilute 100 times, get the phenol red of 10 μ g/ml, be diluted to every milliliter then in proportion in turn and contain phenol red 1,2,3,4,5,6 μ g, with spectrophotometric instrumentation OD value.With phenol red dosage is abscissa, and the OD value is a vertical coordinate, and each intersection point is linked to be straight line, according to measured OD value, can find the phenol red excretion amount of each Mus from standard curve.
2, test procedure: get 50 of SPF kunming mices, male and female half and half, weigh respectively, be divided into 5 groups at random by body weight, and calculate dosage according to body weight, each administration group is gastric infusion (20ml/kg) according to dosage, matched group is given isopyknic physiological water, after irritating stomach 30min, the phenol red 0.1ml of lumbar injection (5mg)/10g injects phenol red back 30min, put to death animal, peel off the trachea surrounding tissue, cut one section trachea to the trachea bifurcation, put into the test tube that fills the 1.9ml normal saline from thyroid cartilage, add 0.1ml (or 1-2 drips) sodium hydroxide again, flushing liquor is collected in flushing, divides wide photometer with 721 types, wavelength 546nm surveys the OD value, the reference standard curve draws corresponding phenol red content (μ g/ml), and each group compares.
Result of the test sees Table 2.
Table 2 is respectively organized (the x ± s) of phenol red content mean and standard error behind the mice irrigation of trachea
| Grouping | Every group of example number | Dose concentration (ml/kg) | Phenol red content behind the irrigation of trachea (μ g/ml) |
| Normal saline group ZHIKE CHUANBEI PIPA LU group supplies reagent object height dosage group for reagent thing low dose group for dosage group in the reagent thing | 10 10 10 10 10 | -- 7.8ml/kg 7.8ml/kg 15.6ml/kg 20ml/kg | 1.168±0.296 2.873±1.139* 3.936±1.446*△ 4.705±1.615*# 5.567±1.150*# |
Annotate: * compares p＜0.01 with the normal saline group; # compares p＜0.05 with the Bulbus Fritillariae Cirrhosae group; △ compares p＞0.05 for the Bulbus Fritillariae Cirrhosae group;
Compare with the normal saline matched group for reagent thing and each dosage group of ZHIKE CHUANBEI PIPA LU group (7.8ml/kg, 15.6ml/kg, 20ml/kg), equal p＜0.01, notable statistics difference is arranged, be Bulbus Fritillariae Cirrhosae, supply the reagent thing can obviously increase the phenol red excretion amount of mice trachea section, have resolve phlegm effect.
For the reagent object height, in, low dose group all has significant resolve phlegm effect (with normal saline comparison p＜0.01 with positive control drug ZHIKE CHUANBEI PIPA LU group; The dosage that the ZHIKE CHUANBEI PIPA LU group is got is equivalent to the low dose group (7.8ml/kg) for the reagent thing, is into the maximal dose of human oral, compares p＞0.05, no difference of science of statistics for reagent thing low dose group with the ZHIKE CHUANBEI PIPA LU group; Resolve phlegm effect and ZHIKE CHUANBEI PIPA LU (7.8ml/kg) that the low dosage (7.8ml/kg) that supplies the reagent thing is described are suitable.
For between each group of reagent thing, resolve phlegm effect is certain dose-effect relationship.For the middle and high dosage group of reagent thing (15.6ml/kg, 20ml/kg) compare with ZHIKE CHUANBEI PIPA LU group (7.8ml/kg) that there were significant differences (with middle dosage than p＜0.05, with high dose than p＜0.01=; Prompting is along with drug dose increases, and is good more for the effect of reagent thing.
[test example 3] medicine of the present invention stimulates the antitussive action of mice to sulfur dioxide
One, test material
1, for the reagent thing; The oral liquid that the embodiment of the invention 3 is prepared is divided into high, medium and low three dosage groups.
2, positive control medicine: ZHIKE CHUANBEI PIPA LU (the lot number D06004 of Guangzhou Pangaoshou Pharmaceutical Co., Ltd)
3, other reagent: concentrated sulphuric acid (Guangzhou chemistry examination factory, lot number 20030902-3), sodium sulfite (Guangzhou Chemical Reagent Factory lot number 20020903-2).
Two, test equipment: sulfur dioxide gas preparation facilities (according to the document self-control)
Three, laboratory animal: NIH mice (Zhongshan University's Experimental Animal Center provides Guangdong probatio inspectionem pecuoarem word 2003A064).
Four, experimental technique and result
1, the preparation of sulfur dioxide gas: with 250ml side mouth flask, the side mouth connects balloon with rubber tube, contains sodium sulfite in the bottle, and flask is adorned a burette beyond the Great Wall, in put concentrated sulphuric acid, open the piston on the burette, after concentrated sulphuric acid drips, in bottle, produce sulfur dioxide gas, gas is stored in the balloon, clamp with mosquito forceps, during application, draw 10ml with syringe.
2, experimental procedure: get 50 of NIH mices, male and female half and half, be divided into 5 groups at random, weigh respectively and calculate dosage, the administration group is pressed the confession reagent thing that 0.02ml/g gives prepared and diluted, the blank group is pressed 0.02ml/g and is irritated normal saline, positive controls is pressed the fritillary-loquat solution that 0.02ml/g gives prepared and diluted, behind the 1h mice is put into the wide mouthed bottle of 2000ml, inject sulfur dioxide 10ml, observe the incubation period (beginning to the required time of cough takes place by injection sulfur dioxide is incubation period) of mouse cough, the results are shown in Table 3.
Table 3 medicine of the present invention stimulates the antitussive action (x ± s) of mice to sulfur dioxide
| Grouping | The example number | Dose concentration (ml/kg) | Cough latent period (unit: s) |
| Normal saline group ZHIKE CHUANBEI PIPA LU group supplies reagent object height dosage group for reagent thing low dose group for dosage group in the reagent thing | 10 10 10 10 10 | --- 7.8ml/kg 7.8ml/kg 15.6ml/kg 20ml/kg | 13.1±3.88 23±3.97* 24.5±5.02*△ 29.3±7.29*# 51.4±12.99*# |
Annotate: * compares p＜0.01 with the normal saline group; # compares p＜0.05 with the Bulbus Fritillariae Cirrhosae group; △ compares p＞0.05 with the Bulbus Fritillariae Cirrhosae group;
The result shows, compare with the normal saline matched group for reagent thing and each dosage group of ZHIKE CHUANBEI PIPA LU group (7.8ml/kg, 15.6ml/kg, 20ml/kg), all there is notable statistics difference p＜0.01, promptly has significant cough-relieving effect for reagent thing, ZHIKE CHUANBEI PIPA LU.
All have significant cough-relieving effect for each group of reagent thing and positive control drug ZHIKE CHUANBEI PIPA LU group and (compare p＜0.01 with normal saline; The dosage that the ZHIKE CHUANBEI PIPA LU group is got is equivalent to the low dose group (7.8ml/kg) for the reagent thing, is into the maximal dose of human oral, compares p＞0.05, no difference of science of statistics for reagent thing low dose group with the ZHIKE CHUANBEI PIPA LU group; Cough-relieving effect and ZHIKE CHUANBEI PIPA LU (7.8ml/kg) that the low dosage (7.8ml/kg) that supplies the reagent thing is described are suitable.
For between each group of reagent thing, the cough-relieving effect is certain dose-effect relationship.For the middle and high dosage group of reagent thing (15.6ml/kg, 20ml/kg) compare with ZHIKE CHUANBEI PIPA LU group (7.8ml/kg) that there were significant differences (with middle dosage than p＜0.05, with high dose than p＜0.01=; Prompting is along with drug dose increases, and is good more for the cough-relieving effect effect of reagent thing.
From above experimental result as can be seen, medicine of the present invention can alleviate the swelling degree of rat paw, increase the phenol red excretion amount of mice trachea section, prolong the incubation period of mouse cough, have tangible antiinflammatory, reduce phlegm and antitussive action, reduce phlegm and antitussive action suitable with ZHIKE CHUANBEI PIPA LU, the effect of antiinflammatory is better than ZHIKE CHUANBEI PIPA LU.
The clinical observation on the therapeutic effect test of [test example 4] pharmaceutical composition of the present invention
One, physical data
1. clinical data
All cases derive from the patient of department of Chinese medicine outpatient service.Observe 70 examples altogether, be divided into two groups at random.50 examples are organized in treatment, male 21 examples, women 29 examples; 18～70 years old age, average 50.4 ± 11.3 years old; The course of disease 2～9 days, average 4.3 ± 2.1 days; Simple wind-cold type 27 examples, wind and cold folder wet type 23 examples.Matched group 20 examples, male 8 examples, women 12 examples; 19～68 years old age, average 50.1 ± 10.8 years old; The course of disease 3～7 days, average 4.0 ± 1.1 days; Simple wind-cold type 11 examples, wind and cold folder wet type 9 examples.Two groups of patient's sexes, age, course of disease typings there are no significant difference has comparability.
2. diagnose and the typing standard
Wind-cold type cough: cough, thin and whitish sputum.Can be with nasal obstruction, snivel, itching throat, joint is ached, aversion to cold, or heating is arranged, thin white fur of tongue, floating and tense pulse.
The cough of wind and cold folder wet type: the symptom of wind-cold type cough is simultaneously white with the expectoration color, rare or thick, and nose heave body is tired, and is uncomfortable in chest indigestion and loss of appetite, white and greasy fur, floating-rolling pulse.
3. case exclusion standard
(1) cough, symptom such as cough up phlegm is caused by following disease: pulmonary tuberculosis, bronchiectasis, bronchial asthma, lung abscess, cardiac insufficiency etc.
(2) be associated with cardiovascular and cerebrovascular vessel, liver, the serious primary disease of kidney system, psychotic.
(3) age is less than 18 years old or greater than 70 years old person.
(4) do not meet the case inclusion criteria; Not medication or add in accordance with regulations with other relieving cough and resolving phlegm medicines; Or the infull person of clinical data.
4, mild symptoms weight classification score standard
(1) cough
Do not have (-): 0 minute. slight (+): cough is arranged, do not influence orthobiosis and, work, 2 minutes; Moderate (++): between slight and severe, 4 minutes; Severe (+++): the frequent or paroxysmal of cough is round the clock choked and is coughed, and influences work and rest, 6 minutes.
(2) nothing (-) of coughing up phlegm, 0 minute; Amount few (+): the 10-50mL that coughs up phlegm every day, 2 minutes; In the amount (++): the 51-100M1 that coughs up phlegm every day, 4 minutes; Measure many (+++): cough up phlegm more than the 100mL 6 fens every day.
(3) asthma does not have (-), 0 minute; Slightly (+): idol occurs, and degree is light, does not influence sleep or movable, 2 minutes; Moderate (++): between slight and severe.
5, curative effect judging standard
Recovery from illness: cough, cough up phlegm the asthma complete obiteration.
Produce effects: cough, to cough up phlegm, asthma symptom is clearly better, two differential (as 6 minutes-2 minutes) of individual event integration decline.
Effectively: cough, to cough up phlegm, asthma symptom take a favorable turn, one differential (as 4 minutes-2 minutes) of individual event integration decline.
Invalid: each symptom does not all have improvement or increases the weight of.
6, untoward reaction record
Main observe whether Drug therapy causes nausea, vomits, untoward reaction such as diarrhoea, dizzy, erythra, then write down its appearance and persistent period, the extent of reaction, treatment measures if having.
Two, treatment and observational technique
The treatment group is taken the prepared oral liquid of the embodiment of the invention 1, and one time 2 (20ml), every day three times, warm water delivery service was taken seven days continuously.The matched group SHEDAN CHENPI YE, one time 2 (20ml), every day three times, warm water delivery service was taken seven days continuously.Viewing duration does not use other related drugs or treatment means.Before treatment, treat the 3rd day, the 7th day to cough, cough up phlegm, symptom variation such as asthma, picture of the tongue, pulse condition carry out observed and recorded, carry out conventional chest X-ray examination before the treatment, get rid of other pulmonary disease.
Three, statistical method
Date processing carries out with SPSS10 software, and enumeration data is shown data x with R * C
2Check.(x ± s) expression, check with independent sample t between two groups by significance test with mean ± standard deviation for measurement data result.
Four, result
Cough has good therapeutical effect to medicine of the present invention to affection of exogenous wind-cold (or folder wet) type, and especially to the cough of light, moderate, the clinical efficacy of coughing up phlegm outstanding (see Table 4, table 5), and the therapeutic effect of treatment group obviously is better than matched group (seeing Table 6):
The Drug therapy of the present invention curative effect relatively (table 4) of coughing in various degree
| The example number | The treatment group | Total effective rate | ||||
| Recovery from illness | Produce effects | Effectively | Invalid | |||
| Slight moderate severe | 10 32 8 | 9 17 1 | 0 10 2 | 0 4 4 | 1 2 1 | 90％ 93.75％ 87.5％ |
The Drug therapy of the present invention curative effect relatively (table 5) of coughing up phlegm in various degree
| The example number | The treatment group | Total effective rate | ||||
| Recovery from illness | Produce effects | Effectively | Invalid | |||
| Slight moderate severe | 9 31 10 | 9 19 1 | 0 8 3 | 0 3 4 | 0 1 2 | 100％ 96.77％ 80％ |
Drug therapy cough symptom curative effect of the present invention is (table 6) relatively
| Symptom | The example number | The treatment group | Total effective rate | The example number | Matched group | Total effective rate | ||||||
| Recovery from illness | Produce effects | Effectively | Invalid | Recovery from illness | Produce effects | Effectively | Invalid | |||||
| Cough and expectoration | 50 50 | 27 29 | 12 11 | 7 7 | 4 3 | 92％ 94％ | 20 20 | 6 7 | 4 5 | 4 3 | 6 5 | 70％ 75％ |
Annotate: cough between two groups relatively, P＜0.05 (0.027), relatively, there is the significance meaning P＜0.05 (0.038) between two groups of expectorations.
2. in observing therapeutic process, do not find any untoward reaction and toxic and side effects.
Conclusion (of pressure testing):
Show by above observation on Clinical Application, medicine of the present invention has good preventing phlegm from forming and stopping coughing effect to wind and cold (or folder is wet) type exogenous cough, its curative effect will obviously be better than positive control medicine SHEDAN CHENPI YE, observes in the therapeutic process and does not find untoward reaction and toxic and side effects, clinical drug safety.
Claims (10)
1, a kind of pharmaceutical composition of relieving cough and resolving phlegm, mainly make by following bulk drugs:
10～40 parts of Exocarpium Citri Grandises, 2～8 parts of the Radixs Stemonae, 2～5 parts in Poria, 2～5 parts of Rhizoma Pinelliae Preparata, 2～8 parts of Rhizoma Cynanchi Stauntoniis, 0.5～3 part in Radix Glycyrrhizae, 5～15 parts of Semen Armeniacae Amarums, 1～3 part of Fructus Schisandrae Chinensis.
2, according to the described pharmaceutical composition of claim 1, it is characterized in that the weight portion of each crude drug is: 20～35 parts of Exocarpium Citri Grandises, 2～5 parts of the Radixs Stemonae, 2.5～4 parts in Poria, 2.5～4 parts of Rhizoma Pinelliae Preparata, 3～6 parts of Rhizoma Cynanchi Stauntoniis, 0.5～1.5 part in Radix Glycyrrhizae, 8～12 parts of Semen Armeniacae Amarums, 1.5～2.5 parts of Fructus Schisandrae Chinensis.
3, according to the described pharmaceutical composition of claim 2, it is characterized in that the weight portion of each crude drug is: 30 parts of Exocarpium Citri Grandises, 3 parts of the Radixs Stemonae, 3 parts in Poria, 3 parts of Rhizoma Pinelliae Preparata, 5 parts of Rhizoma Cynanchi Stauntoniis, 1 part in Radix Glycyrrhizae, 10 parts of Semen Armeniacae Amarums, 2 parts of Fructus Schisandrae Chinensis.
4, according to the described pharmaceutical composition of claim 1, it is characterized in that: the described Radix Stemonae is the sweet Radix Stemonae.
5, according to the described pharmaceutical composition of claim 1, it is characterized in that: add various conventional adjuvant required when preparing different dosage form, be prepared into oral liquid, granule, soft extract or capsule with method of Chinese medicinal.
6, according to the described pharmaceutical composition of claim 5, it is characterized in that: described preparation is an oral liquid.
7, prepare the method for claim 1 pharmaceutical composition, step is as follows:
1) take by weighing each raw material by following weight portion proportioning:
10～40 parts of Exocarpium Citri Grandises, 2～8 parts of the Radixs Stemonae, 2～5 parts in Poria, 2～5 parts of Rhizoma Pinelliae Preparata, 2～8 parts of Rhizoma Cynanchi Stauntoniis, 0.5～3 part in Radix Glycyrrhizae, 5～15 parts of Semen Armeniacae Amarums, 1～3 part of Fructus Schisandrae Chinensis.
2) with Exocarpium Citri Grandis, the Semen Armeniacae Amarum steam distillation, collect distillate, the medicinal residues and the Radix Stemonae, Poria, Rhizoma Pinelliae Preparata, Rhizoma Cynanchi Stauntonii, Radix Glycyrrhizae and Fructus Schisandrae Chinensis decoct with water secondary together, each 2 hours, filter, merging filtrate, being concentrated into relative density is 1.25～1.35, and temperature is 80～85 ℃ a clear paste, and adding ethanol, to make the percent by volume of the alcohol amount of containing be 50%～90%, leave standstill, get supernatant, reclaiming ethanol and being concentrated into relative density is 1.18～1.20, temperature is 80～85 ℃ a clear paste, adds correctives, stir after the antiseptic, mixing, filter, put coldly, add the water standardize solution, stir evenly, promptly.
8, in accordance with the method for claim 7, it is characterized in that: step 2) in to add alcoholic acid amount in clear paste be that to make the percent by volume that contains the alcohol amount be 75%～80%.
9, the purposes of any pharmaceutical composition of claim 1～6 in preparation treatment flu, bronchitis, pharyngolaryngitis medicine.
10, the purposes of any pharmaceutical composition of claim 1～6 in medicine is coughed, coughed up phlegm, pants in the preparation treatment.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200510007651 CN1775274A (en) | 2005-02-07 | 2005-02-07 | Cough-relieving sputum-resolving medicinal composition and preparing method |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200510007651 CN1775274A (en) | 2005-02-07 | 2005-02-07 | Cough-relieving sputum-resolving medicinal composition and preparing method |
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| CN1775274A true CN1775274A (en) | 2006-05-24 |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101181563B (en) * | 2006-06-16 | 2011-03-16 | 贵州益佰制药股份有限公司 | Chrysoidine productive cough preparations as well as preparation method and mass control method |
| CN102380075A (en) * | 2011-11-17 | 2012-03-21 | 路良宇 | Chinese medicine for treating child respiratory system infection and inflammation |
| CN101717692B (en) * | 2009-12-02 | 2012-08-29 | 中国科学院西北高原生物研究所 | Artemisia rutifolia essential oil and extraction process and application thereof |
| CN105727104A (en) * | 2016-03-10 | 2016-07-06 | 广西天天乐药业股份有限公司 | Medicine composition with effects of diminishing inflammation and relieving cough and method for preparing medicine composition |
| CN107296928A (en) * | 2017-06-30 | 2017-10-27 | 成都恒凌科技有限公司 | A kind of paste and application thereof |
| CN107441434A (en) * | 2017-06-30 | 2017-12-08 | 成都恒凌科技有限公司 | A kind of granule and application thereof |
| CN107468982A (en) * | 2017-06-30 | 2017-12-15 | 成都恒凌科技有限公司 | A kind of oral liquid and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101181563B (en) * | 2006-06-16 | 2011-03-16 | 贵州益佰制药股份有限公司 | Chrysoidine productive cough preparations as well as preparation method and mass control method |
| CN101717692B (en) * | 2009-12-02 | 2012-08-29 | 中国科学院西北高原生物研究所 | Artemisia rutifolia essential oil and extraction process and application thereof |
| CN102380075A (en) * | 2011-11-17 | 2012-03-21 | 路良宇 | Chinese medicine for treating child respiratory system infection and inflammation |
| CN102380075B (en) * | 2011-11-17 | 2013-03-13 | 路良宇 | Chinese medicine for treating child respiratory system infection and inflammation |
| CN105727104A (en) * | 2016-03-10 | 2016-07-06 | 广西天天乐药业股份有限公司 | Medicine composition with effects of diminishing inflammation and relieving cough and method for preparing medicine composition |
| CN107296928A (en) * | 2017-06-30 | 2017-10-27 | 成都恒凌科技有限公司 | A kind of paste and application thereof |
| CN107441434A (en) * | 2017-06-30 | 2017-12-08 | 成都恒凌科技有限公司 | A kind of granule and application thereof |
| CN107468982A (en) * | 2017-06-30 | 2017-12-15 | 成都恒凌科技有限公司 | A kind of oral liquid and application thereof |
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