CN104645003A - Traditional Chinese medicine preparation for treating asthma and preparation method of traditional Chinese medicine preparation - Google Patents
Traditional Chinese medicine preparation for treating asthma and preparation method of traditional Chinese medicine preparation Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine preparation for treating asthma, belonging to the technical field of traditional Chinese medicines. The traditional Chinese medicine preparation is prepared from the following traditional Chinese medicinal materials: cuttlebone, lily flower, seaweed, rhubarb, clam shell, kelp, frog, aristolochia, gypsum, polygala tenuifolia, lumbricus, bupleurum, platycodon grandiflorum, folium eriobotryae, angelica sinensis, radixglehniae, indigo naturalis, peach seed, dried tangerine or orange peel, codonopsis pilosula and white sugar according to a traditional Chinese medicine preparation process. The traditional Chinese medicine preparation disclosed by the invention is obvious in effect of treating asthma and has the advantages of good curative effect and fast effectiveness, is capable of treating both symptoms and root causes and combining regulation and treatment, is difficult in reoccurrence and the like.
Description
Technical field
The present invention discloses a kind of Chinese medicine preparation for the treatment of asthma and preparation method thereof, belongs to the field of Chinese medicines.
Technical background
Asthma, also known as bronchial asthma, is participate in chronic airway inflammation illness by various kinds of cell (as eosinophilic granulocyte, mastocyte, T lymphocyte, neutrophilic granulocyte, human airway epithelial cells etc.) and cellular component.This chronic inflammatory disease causes the generation of airway hyperreactivity, the reversible airflow limitation that usual appearance is extensively changeable, and causing the symptoms such as the panting of recurrent exerbation, out of breath, uncomfortable in chest or cough, be everlasting night and (or) outbreak in morning, most of patients can spontaneous remissions or alleviate through treatment.
Asthma main pathogenesis is latent phlegm in body, meets inducement and triggering, make ascending or descending movement of vital Qi receive and pay out not normal caused by.Excess-dyspnea then stops up lung for pathogen, and gas loses a surname and falls; Eliminating the pathogens from the lung gas is exactly eliminating the pathogens from the lung row water, and expectorant water goes, and breathes heavily flat.Lung is the device of storage expectorant, the spleen being the source of producing phlegm.The spleen has the function to transport and transform nutrients, defeated water distribution liquid, and insufficiency of the spleen then retention of water-damp be stopped at pulmonary and can condense for expectorant, therefore spleen invigorating is with transmitting and distributing the fluids, stops the source of producing phlegm.The spleen being the foundation of acquired constitution, the strong then vigour foot of spleen, and sick body runback.The lung being the dominator of QI, the kidney being the root of QI.Asthma with the passing of time, sick dark and kidney, the kidney being the root of QI, instability of kidney-QI, loses and receives in taking the photograph, therefore exhales and inhale few more, and gas must not continue; The kidney warming makes kidney qi be sealed Tibetan, with supporing yang improving inspiration by invigorating kidney-QI.
The traditional Chinese medical science to the differentiation of symptoms and signs for classification of syndrome of asthma primarily of following several:
(1) asthma of cold-type type method for the treatment of: warming lung for dispelling cold, resolving phlegm and relieving asthma.
(2) asthma of heat type type method for the treatment of: reducing heat and dispersing lung-QI, eliminating phlegm and lowering adverse QI.
(3) deficiency of the lung type method for the treatment of: invigorating the lung and strengthening defensive QI, qi boosting calm panting.
(4) spleen-deficient method for the treatment of: invigorating the spleen for dissipating phlegm, lowering the adverse QI to relieve asthma.
(5) renal deficiency type method for the treatment of: improving inspiration by invigorating the kidney.
Inventor takes into account each typing, makes great efforts the Chinese medicine preparation of the new treatment asthma of exploitation.
Summary of the invention
The technical problem to be solved in the present invention is invention Chinese prescription and a set of preparation technology this prescription being made finished product preparation, makes the treatment of this finished product preparation to asthma have good effect.
For solving this technical problem, inventor studies intensively modern pharmaceutical technology meticulously, in conjunction with traditional medicine to the dialectical cognition of asthma and self clinical experience for many years, grope through clinical repeatedly practising and adjust, the Chinese prescription that final invention one is brand-new and its preparation technology, thus obtained Chinese medicine finished product preparation treatment asthma effect is very remarkable.This Chinese prescription is (with parts by weight):
Endoconcha Sepiae 22-34 part, Bulbus Lilii 19-31 part, Sargassum 16-28 part, Radix Et Rhizoma Rhei 8-20 part, Concha Meretricis Seu Cyclinae 12-28 part, Thallus Laminariae (Thallus Eckloniae) 14-29 part, Rana nigromaculata 21-35 part, Fructus Aristolochiae 9-19 part, Gypsum Fibrosum 8-18 part, Radix Polygalae 7-17 part, Pheretima 8-20 part, Radix Bupleuri 9-17 part, Fructus Citri tangerinae be 7-15 part, Folium Eriobotryae 10-22 part, Radix Angelicae Sinensis 9-21 part, Radix Glehniae 8-20 part, Indigo Naturalis 6-12 part, Semen Persicae 10-24 part, Pericarpium Citri Reticulatae 7-15 part, Radix Codonopsis 9-21 part, white sugar 18-32 part just.
Two that the optimize prescription proportionings with optimum therapeuticing effect are:
1: Endoconcha Sepiae 28 parts, Bulbus Lilii 25 parts, Sargassum 22 parts, Radix Et Rhizoma Rhei 14 parts, Concha Meretricis Seu Cyclinae 20 parts, Thallus Laminariae (Thallus Eckloniae) 21 parts, Rana nigromaculata 28 parts, Fructus Aristolochiae 14 parts, 13 parts, Gypsum Fibrosum, Radix Polygalae 12 parts, Pheretima 14 parts, Radix Bupleuri 13 parts, Fructus Citri tangerinae just 11 parts, Folium Eriobotryae 16 parts, Radix Angelicae Sinensis 15 parts, Radix Glehniae 14 parts, Indigo Naturalis 9 parts, 17 parts, Semen Persicae, Pericarpium Citri Reticulatae 11 parts, Radix Codonopsis 15 parts, white sugar 25 parts.
2: Endoconcha Sepiae 30 parts, Bulbus Lilii 26 parts, Sargassum 21 parts, Radix Et Rhizoma Rhei 12 parts, Concha Meretricis Seu Cyclinae 21 parts, Thallus Laminariae (Thallus Eckloniae) 20 parts, Rana nigromaculata 29 parts, Fructus Aristolochiae 16 parts, 12 parts, Gypsum Fibrosum, Radix Polygalae 13 parts, Pheretima 13 parts, Radix Bupleuri 12 parts, Fructus Citri tangerinae just 10 parts, Folium Eriobotryae 17 parts, Radix Angelicae Sinensis 16 parts, Radix Glehniae 13 parts, Indigo Naturalis 8 parts, 15 parts, Semen Persicae, Pericarpium Citri Reticulatae 12 parts, Radix Codonopsis 16 parts, white sugar 27 parts.
By above-mentioned Chinese prescription, the production technology being processed into finished product preparation is:
A, take each raw medicinal material in Chinese prescription ratio of the present invention;
B, by Rana nigromaculata, Endoconcha Sepiae dry, pulverize levigate mistake 120 mesh sieve, obtain fine powder 1, for subsequent use;
C, by Concha Meretricis Seu Cyclinae, pulverize, levigate mistake 120 mesh sieve, obtain fine powder 2, for subsequent use;
D, by Bulbus Lilii, Sargassum, Radix Et Rhizoma Rhei, Thallus Laminariae (Thallus Eckloniae), Fructus Aristolochiae, Gypsum Fibrosum, Radix Polygalae, Pheretima, Radix Bupleuri, Fructus Citri tangerinae just, Folium Eriobotryae, Radix Angelicae Sinensis, Radix Glehniae, Indigo Naturalis, Semen Persicae, Pericarpium Citri Reticulatae, Radix Codonopsis, the medical materials such as white sugar, pulverize respectively, add the purified water of 6-12 times of weight, backflow decocts 1-4 hour, filter, the purified water of initial medical material 4-8 times weight is added in filtering residue, backflow decoction 2 times, each 1-3 hour, filter, merging filtrate, carry out concentrating under reduced pressure, until the relative density of mixed liquor is 1.30-1.35(65 DEG C of survey) time stop concentrated, proceed vacuum drying, obtain dry extract, pulverize levigate, cross 120 mesh sieves, be fine powder 3,
E, just fine powder 1, fine powder 2, fine powder 3 mix homogeneously, obtain this Chinese medicine composition effective ingredient powder;
F, in above-mentioned Chinese medicine composition effective ingredient powder, add suitable adjuvant, make clinical required dosage form, as dosage forms such as tablet, pill, capsule, powder, granules with Chinese medicine preparation conventional formulation technique.
The character feature of the present invention's Chinese crude drug used and source effect:
Endoconcha Sepiae: this product is the dry inner shell of Sepiidae animal sepiella maindroni de Rochebrune or golden cuttlefish.Salty in the mouth, puckery, warm in nature; Return spleen, kidney channel; Astringing to arrest bleeding, relieving leukorrhea by astringents, antacid, sore.
Bulbus Lilii: this product is the dry meat scale leaf of liliaceous plant tiger lily, Bulbus Lilii or Lilium tenuifolium.Sweet in the mouth, cold in nature; GUIXIN, lung meridian; Nourishing YIN and moistening the lung, clearing away heart-fire for tranquillization.
Sargassum: this product is the dry frond of Sargassaceae plant Sargassum or Sargassum fusiforme (Harv.) Setch.Bitter in the mouth, salty, cold in nature; Return liver, stomach, kidney channel; Hard masses softening and resolving, expectorant, diuretic.
Radix Et Rhizoma Rhei: this product is the dry root and rhizome of polygonum rheum palmatum, Rheum tanguticum or Rheum officinale.Bitter in the mouth, cold in nature; Return spleen, stomach, large intestine, liver, pericardium channel; Purging heat and dredging bowels, removing pathogenic heat from blood and toxic substance from the body, eliminating blood stasis and inducing menstruation.
Concha Meretricis Seu Cyclinae: this product is the shell of Veneridae animal Conch Meretricis seu Cyclinae or Concha Meretricis Seu Cyclinae.Bitter in the mouth, salty, cold in nature; Return lung, kidney, stomach warp; Removing heat-phlegm, hard masses softening and resolving, relieving gastric hyperacidity to alleviate stomachache.
Thallus Laminariae (Thallus Eckloniae): this product is the dry thallus of Laminariaceae plant Thallus Laminariae (Thallus Eckloniae) or Alariaceae plant Thallus Laminariae (Thallus Eckloniae) (goose palm dish).Salty in the mouth, cold in nature; Return liver, stomach, kidney channel; Hard masses softening and resolving, expectorant, diuretic.
Rana nigromaculata: be the entirety of ranid Rana nigromaculata or Rana Plancyi etc.Sweet in the mouth, cool in nature; Return lung, spleen, urinary bladder channel; Inducing diuresis to remove edema, heat-clearing and toxic substances removing, tonify deficiency.
Fructus Aristolochiae: this product is the dry mature fruit of aristolochiaceae plant Aristolochia contorta or Fructus Aristolochiae.Bitter in the mouth, cold nature; Return lung, large intestine channel; Lung heat clearing sending down the abnormal ascending QI, relieving cough and asthma, bowel relieving disappears hemorrhoid.
Gypsum Fibrosum: this product is Sulfates mineral anhydrite race Gypsum Fibrosum, main containing hydrous calcium sulfate (CaSO42H2O), after excavating, removing silt and assorted stone.Sweet in the mouth, pungent, property Great Cold; Attach to the lung and stomach meridians; Clearing away heat-fire, relieving restlessness is quenched the thirst.
Radix Polygalae: this product is the dry root of milk wort Radix Polygalae or ovum leaf Radix Polygalae.Bitter in the mouth, pungent, warm in nature; GUIXIN, kidney, lung meridian; To calm the nerves Fructus Alpiniae Oxyphyllae, eliminate the phlegm, detumescence.
Pheretima: this product is the dry body of Ju Yin section animal Pheretima aspergillum, popular Pheretimatschiliensis, power simulation or the blind Pheretimatschiliensis of comb.Salty in the mouth, cold in nature; Return liver, spleen, urinary bladder channel; Heat clearing away is calmed the frightened, and dredging collateral, relievings asthma, diuresis.
Radix Bupleuri: this product is the dry root of umbelliferae bupleurum or Radix Bupeuri Scorzonerfolii..Bitter in the mouth, cold nature; Return liver, gallbladder meridian; Reconciling superficies and interior, soothing the liver, yang invigorating.
Fructus Citri tangerinae is just: this product is the dry root of Campanulaceae Radix Platycodonis.Bitter in the mouth, pungent, property is put down; Return lung meridian; Lung qi dispersing, sore-throat relieving, eliminates the phlegm, evacuation of pus.
Folium Eriobotryae: this product is the dried leaves of rosaceous plant Folium Eriobotryae.Bitter in the mouth, cold nature; Attach to the lung and stomach meridians; Clearing away lung-heat to relieve cough, stopping nausea and vomiting by lowering the adverse flow of QI.
Radix Angelicae Sinensis: this product is the dry root of umbelliferae angelica.Sweet in the mouth, pungent, warm in nature; Return liver, the heart, spleen channel; Enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.
Radix Glehniae: this product is the dry root of samphire glehnia littoralis.Sweet in the mouth, micro-hardship, cold nature; Attach to the lung and stomach meridians; Nourishing YIN and clearing away lung-heat, reinforcing stomach reg fluid.
Indigo Naturalis: this product is acanthaceous vegetable acanthaceous indigo, the leaf of polygonaceae plant polygonum tinctorium ait. or cruciferae isatis or stem and leaf be through processing obtained dried powder or agglomerate.Salty in the mouth, cold in nature; Return Liver Channel; Heat-clearing and toxic substances removing, removing heat from blood, arresting convulsion.
Semen Persicae: this product is the dry mature seed of rosaceous plant Fructus Persicae or Prunus davidiana.Bitter in the mouth, sweet, property is put down; GUIXIN, liver, large intestine channel; Blood circulation promoting and blood stasis dispelling, loosening bowel to relieve constipation.
Pericarpium Citri Reticulatae: be the mature peel of rutaceae orange and variety thereof.Bitter in the mouth, pungent, warm in nature; Return lung, spleen channel; Regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.
Radix Codonopsis: the dry root that this product is Campanulaceae Radix Codonopsis, element spends Radix Codonopsis (RADIX CODONOPSIS PILOSULAE from Northwest of China) or radix codonpsis tangshen.Sweet in the mouth, property is put down; Return spleen, lung meridian; Invigorating the spleen and replenishing QI, spleen invigorating lung benefiting.
White sugar: be the stem juice of grass Caulis Sacchari sinensis, through refining creamy white crystals body.Sweet in the mouth, property is put down; Return spleen, lung meridian; With middle emergency, promote the production of body fluid and moisturize.
The side of Chinese prescription of the present invention separates:
This Chinese prescription is with Endoconcha Sepiae, Bulbus Lilii, Sargassum, Concha Meretricis Seu Cyclinae, Rana nigromaculata, Thallus Laminariae (Thallus Eckloniae) for monarch drug, astringing to arrest bleeding, nourishing YIN and moistening the lung, expectorant diuretic, removing heat-phlegm, inducing diuresis to remove edema; With Radix Et Rhizoma Rhei, Fructus Aristolochiae, Folium Eriobotryae, Semen Persicae, white sugar, Fructus Citri tangerinae just for ministerial drug, removing pathogenic heat from blood and toxic substance from the body, relieving cough and asthma, clearing away lung-heat to relieve cough, blood circulation promoting and blood stasis dispelling, promote the production of body fluid moisturize, lung qi dispersing sore-throat relieving; With Gypsum Fibrosum, Pheretima, Radix Polygalae, Indigo Naturalis, Radix Glehniae for adjuvant drug, clearing away heat-fire, dredging collateral are relievingd asthma, eliminating phlegm for diminishing swelling, removing toxic substances removing heat from blood; With Radix Bupleuri, Radix Angelicae Sinensis, Pericarpium Citri Reticulatae, Radix Codonopsis for making medicine, reconciling superficies and interior, enrich blood invigorate blood circulation, drying dampness to eliminate phlegm, invigorating the spleen and replenishing QI; The all medicines of monarch coordinate, and synergism, jointly reaches the effects such as nourishing YIN and moistening the lung, removing heat-phlegm, removing pathogenic heat from blood and toxic substance from the body, relieving cough and asthma, eliminating phlegm for diminishing swelling, reconciling superficies and interior, invigorating the spleen and replenishing QI, have very significant therapeutic effect to asthma.
Compared with prior art, Chinese medicine preparation of the present invention has the treatment advantage such as good effect, instant effect, treating both the principal and secondary aspects of a disease, medical treatment combination, not easily recurrence, and it also has, and preparation technology is easy, preparation efficacy stability, curative effect individual variation are little, be easy to technical advantages such as applying.
Detailed description of the invention
Embodiment 1: produce granule by Chinese prescription optimum ratio 1 of the present invention and optimal processing parameter
A, take Endoconcha Sepiae 2800g, Bulbus Lilii 2500g, Sargassum 2200g, Radix Et Rhizoma Rhei 1400g, Concha Meretricis Seu Cyclinae 2000g, Thallus Laminariae (Thallus Eckloniae) 2100g, Rana nigromaculata 2800g, Fructus Aristolochiae 1400g, Gypsum Fibrosum 1300g, Radix Polygalae 1200g, Pheretima 1400g, Radix Bupleuri 1300g, Fructus Citri tangerinae just 1100g, Folium Eriobotryae 1600g, Radix Angelicae Sinensis 1500g, Radix Glehniae 1400g, Indigo Naturalis 900g, Semen Persicae 1700g, Pericarpium Citri Reticulatae 1100g, Radix Codonopsis 1500g, white sugar 2500g in Chinese prescription ratio of the present invention;
B, by Rana nigromaculata, Endoconcha Sepiae dry, pulverize levigate mistake 120 mesh sieve, obtain fine powder 1, for subsequent use;
C, by Concha Meretricis Seu Cyclinae, pulverize, levigate mistake 120 mesh sieve, obtain fine powder 2, for subsequent use;
D, by Bulbus Lilii, Sargassum, Radix Et Rhizoma Rhei, Thallus Laminariae (Thallus Eckloniae), Fructus Aristolochiae, Gypsum Fibrosum, Radix Polygalae, Pheretima, Radix Bupleuri, Fructus Citri tangerinae just, Folium Eriobotryae, Radix Angelicae Sinensis, Radix Glehniae, Indigo Naturalis, Semen Persicae, Pericarpium Citri Reticulatae, Radix Codonopsis, the medical materials such as white sugar, pulverize respectively, add the purified water of 9 times of weight, backflow decoction 2 hours, filter, the purified water of initial medical material 7 times of weight is added in filtering residue, backflow decoction 2 times, each 1.5 hours, filter, merging filtrate, carry out concentrating under reduced pressure, until the relative density of mixed liquor is 1.30-1.35(65 DEG C of survey) time stop concentrated, proceed vacuum drying, obtain dry extract, pulverize levigate, cross 120 mesh sieves, be fine powder 3,
E, just fine powder 1, fine powder 2, fine powder 3 mix homogeneously, obtain this Chinese medicine composition effective ingredient powder;
F, in above-mentioned Chinese medicine composition effective ingredient powder, add suitable adjuvant, make granule, specification with Chinese medicine preparation conventional formulation technique: amount to 0.375g crude drug/g granule.
Embodiment 2: produce granule by Chinese prescription optimum ratio 2 of the present invention and optimal processing parameter
A, take Endoconcha Sepiae 3000g, Bulbus Lilii 2600g, Sargassum 2100g, Radix Et Rhizoma Rhei 1200g, Concha Meretricis Seu Cyclinae 2100g, Thallus Laminariae (Thallus Eckloniae) 2000g, Rana nigromaculata 2900g, Fructus Aristolochiae 1600g, Gypsum Fibrosum 1200g, Radix Polygalae 1300g, Pheretima 1300g, Radix Bupleuri 1200g, Fructus Citri tangerinae just 1000g, Folium Eriobotryae 1700g, Radix Angelicae Sinensis 1600g, Radix Glehniae 1300g, Indigo Naturalis 800g, Semen Persicae 1500g, Pericarpium Citri Reticulatae 1200g, Radix Codonopsis 1600g, white sugar 2700g in Chinese prescription ratio of the present invention;
B, by Rana nigromaculata, Endoconcha Sepiae dry, pulverize levigate mistake 120 mesh sieve, obtain fine powder 1, for subsequent use;
C, by Concha Meretricis Seu Cyclinae, pulverize, levigate mistake 120 mesh sieve, obtain fine powder 2, for subsequent use;
D, by Bulbus Lilii, Sargassum, Radix Et Rhizoma Rhei, Thallus Laminariae (Thallus Eckloniae), Fructus Aristolochiae, Gypsum Fibrosum, Radix Polygalae, Pheretima, Radix Bupleuri, Fructus Citri tangerinae just, Folium Eriobotryae, Radix Angelicae Sinensis, Radix Glehniae, Indigo Naturalis, Semen Persicae, Pericarpium Citri Reticulatae, Radix Codonopsis, the medical materials such as white sugar, pulverize respectively, add the purified water of 9 times of weight, backflow decoction 2 hours, filter, the purified water of initial medical material 7 times of weight is added in filtering residue, backflow decoction 2 times, each 1.5 hours, filter, merging filtrate, carry out concentrating under reduced pressure, until the relative density of mixed liquor is 1.30-1.35(65 DEG C of survey) time stop concentrated, proceed vacuum drying, obtain dry extract, pulverize levigate, cross 120 mesh sieves, be fine powder 3,
E, just fine powder 1, fine powder 2, fine powder 3 mix homogeneously, obtain this Chinese medicine composition effective ingredient powder;
F, in above-mentioned Chinese medicine composition effective ingredient powder, add suitable adjuvant, make granule, specification with Chinese medicine preparation conventional formulation technique: amount to 0.375g crude drug/g granule.
Embodiment 3: produce granule by Chinese prescription scope maximum proportioning of the present invention and optimal processing parameter
A, take Endoconcha Sepiae 3400g, Bulbus Lilii 3100g, Sargassum 2800g, Radix Et Rhizoma Rhei 2000g, Concha Meretricis Seu Cyclinae 2800g, Thallus Laminariae (Thallus Eckloniae) 2900g, Rana nigromaculata 3500g, Fructus Aristolochiae 1900g, Gypsum Fibrosum 1800g, Radix Polygalae 1700g, Pheretima 2000g, Radix Bupleuri 1700g, Fructus Citri tangerinae just 1500g, Folium Eriobotryae 2200g, Radix Angelicae Sinensis 2100g, Radix Glehniae 2000g, Indigo Naturalis 1200g, Semen Persicae 2400g, Pericarpium Citri Reticulatae 1500g, Radix Codonopsis 2100g, white sugar 3200g in Chinese prescription ratio of the present invention;
B, by Rana nigromaculata, Endoconcha Sepiae dry, pulverize levigate mistake 120 mesh sieve, obtain fine powder 1, for subsequent use;
C, by Concha Meretricis Seu Cyclinae, pulverize, levigate mistake 120 mesh sieve, obtain fine powder 2, for subsequent use;
D, by Bulbus Lilii, Sargassum, Radix Et Rhizoma Rhei, Thallus Laminariae (Thallus Eckloniae), Fructus Aristolochiae, Gypsum Fibrosum, Radix Polygalae, Pheretima, Radix Bupleuri, Fructus Citri tangerinae just, Folium Eriobotryae, Radix Angelicae Sinensis, Radix Glehniae, Indigo Naturalis, Semen Persicae, Pericarpium Citri Reticulatae, Radix Codonopsis, the medical materials such as white sugar, pulverize respectively, add the purified water of 9 times of weight, backflow decoction 2 hours, filter, the purified water of initial medical material 7 times of weight is added in filtering residue, backflow decoction 2 times, each 1.5 hours, filter, merging filtrate, carry out concentrating under reduced pressure, until the relative density of mixed liquor is 1.30-1.35(65 DEG C of survey) time stop concentrated, proceed vacuum drying, obtain dry extract, pulverize levigate, cross 120 mesh sieves, be fine powder 3,
E, just fine powder 1, fine powder 2, fine powder 3 mix homogeneously, obtain this Chinese medicine composition effective ingredient powder;
F, in above-mentioned Chinese medicine composition effective ingredient powder, add suitable adjuvant, make granule, specification with Chinese medicine preparation conventional formulation technique: amount to 0.375g crude drug/g granule.
Embodiment 4: produce granule by Chinese prescription stated range minimum proportioning of the present invention and optimal processing parameter
A, take Endoconcha Sepiae 2200g, Bulbus Lilii 1900g, Sargassum 1600g, Radix Et Rhizoma Rhei 800g, Concha Meretricis Seu Cyclinae 1200g, Thallus Laminariae (Thallus Eckloniae) 1400g, Rana nigromaculata 2100g, Fructus Aristolochiae 900g, Gypsum Fibrosum 800g, Radix Polygalae 700g, Pheretima 800g, Radix Bupleuri 900g, Fructus Citri tangerinae just 700g, Folium Eriobotryae 1000g, Radix Angelicae Sinensis 900g, Radix Glehniae 800g, Indigo Naturalis 600g, Semen Persicae 1000g, Pericarpium Citri Reticulatae 700g, Radix Codonopsis 900g, white sugar 1800g in Chinese prescription ratio of the present invention;
B, by Rana nigromaculata, Endoconcha Sepiae dry, pulverize levigate mistake 120 mesh sieve, obtain fine powder 1, for subsequent use;
C, by Concha Meretricis Seu Cyclinae, pulverize, levigate mistake 120 mesh sieve, obtain fine powder 2, for subsequent use;
D, by Bulbus Lilii, Sargassum, Radix Et Rhizoma Rhei, Thallus Laminariae (Thallus Eckloniae), Fructus Aristolochiae, Gypsum Fibrosum, Radix Polygalae, Pheretima, Radix Bupleuri, Fructus Citri tangerinae just, Folium Eriobotryae, Radix Angelicae Sinensis, Radix Glehniae, Indigo Naturalis, Semen Persicae, Pericarpium Citri Reticulatae, Radix Codonopsis, the medical materials such as white sugar, pulverize respectively, add the purified water of 9 times of weight, backflow decoction 2 hours, filter, the purified water of initial medical material 7 times of weight is added in filtering residue, backflow decoction 2 times, each 1.5 hours, filter, merging filtrate, carry out concentrating under reduced pressure, until the relative density of mixed liquor is 1.30-1.35(65 DEG C of survey) time stop concentrated, proceed vacuum drying, obtain dry extract, pulverize levigate, cross 120 mesh sieves, be fine powder 3,
E, just fine powder 1, fine powder 2, fine powder 3 mix homogeneously, obtain this Chinese medicine composition effective ingredient powder;
F, in above-mentioned Chinese medicine composition effective ingredient powder, add suitable adjuvant, make granule, specification with Chinese medicine preparation conventional formulation technique: amount to 0.375g crude drug/g granule.
Embodiment 5: produce granule by arbitrary value proportioning within the scope of Chinese prescription of the present invention and optimal processing parameter
A, take Endoconcha Sepiae 2200g, Bulbus Lilii 3100g, Sargassum 1600g, Radix Et Rhizoma Rhei 2000g, Concha Meretricis Seu Cyclinae 1200g, Thallus Laminariae (Thallus Eckloniae) 2900g, Rana nigromaculata 2100g, Fructus Aristolochiae 1900g, Gypsum Fibrosum 800g, Radix Polygalae 1700g, Pheretima 800g, Radix Bupleuri 1700g, Fructus Citri tangerinae just 700g, Folium Eriobotryae 2200g, Radix Angelicae Sinensis 900g, Radix Glehniae 2000g, Indigo Naturalis 600g, Semen Persicae 2400g, Pericarpium Citri Reticulatae 700g, Radix Codonopsis 2100g, white sugar 1800g in Chinese prescription ratio of the present invention;
B, by Rana nigromaculata, Endoconcha Sepiae dry, pulverize levigate mistake 120 mesh sieve, obtain fine powder 1, for subsequent use;
C, by Concha Meretricis Seu Cyclinae, pulverize, levigate mistake 120 mesh sieve, obtain fine powder 2, for subsequent use;
D, by Bulbus Lilii, Sargassum, Radix Et Rhizoma Rhei, Thallus Laminariae (Thallus Eckloniae), Fructus Aristolochiae, Gypsum Fibrosum, Radix Polygalae, Pheretima, Radix Bupleuri, Fructus Citri tangerinae just, Folium Eriobotryae, Radix Angelicae Sinensis, Radix Glehniae, Indigo Naturalis, Semen Persicae, Pericarpium Citri Reticulatae, Radix Codonopsis, the medical materials such as white sugar, pulverize respectively, add the purified water of 9 times of weight, backflow decoction 2 hours, filter, the purified water of initial medical material 7 times of weight is added in filtering residue, backflow decoction 2 times, each 1.5 hours, filter, merging filtrate, carry out concentrating under reduced pressure, until the relative density of mixed liquor is 1.30-1.35(65 DEG C of survey) time stop concentrated, proceed vacuum drying, obtain dry extract, pulverize levigate, cross 120 mesh sieves, be fine powder 3,
E, just fine powder 1, fine powder 2, fine powder 3 mix homogeneously, obtain this Chinese medicine composition effective ingredient powder;
F, in above-mentioned Chinese medicine composition effective ingredient powder, add suitable adjuvant, make granule, specification with Chinese medicine preparation conventional formulation technique: amount to 0.375g crude drug/g granule.
Embodiment 6: the toxicity test of Chinese medicine preparation of the present invention
(1) acute toxicity test
1, tested medicine: the granule manufactured by embodiment of the present invention 1-5, adds purified water and is modulated into magma, for subsequent use.
2, experimental animal: Kunming mouse, body weight 20g ± 4g, male and female half and half, female mice is all without pregnant.
3, to mouse stomach Chinese medicine granules of the present invention, when given low reaches 647.2g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 2 hours recover normal, Continuous Observation 7 days after administration, none animal dead, its overall health of patients, diet, take the photograph water, urine and body weight increase all normal.
4, result of the test shows: the maximum dosage-feeding of mouse stomach granule of the present invention is 647.2g crude drug/kg/d(LD
50> 647.2g crude drug/kg).Chinese medicine preparation clinical application every day total amount of the present invention is 0.25g crude drug/kg/d; By weighing machine, the dosis tolerata of mouse stomach granule of the present invention is 2588.8 times of clinical patient.Point out this medicine acute toxicity extremely low, clinical drug safety.
(2) long term toxicity test
1, test objective: the toxic reaction of viewing test animal after long-term edible Chinese medicine preparation of the present invention, assesses the basic security of Chinese medicine preparation of the present invention.
2, test material:
(1) animal: select adult healthy SD rat 180, original body mass 221 ± 11g, male and female half and half, female rats is all without pregnant.
(2) medicine: the granule manufactured by embodiment of the present invention 1-5, adds purified water and is modulated into magma, for subsequent use.Per weight dosage is by 20 times of calculating (clinical application amount foundation Pharmacopoeia of the People's Republic of China version in 2010) of clinical application amount, and dosage is 5.0g crude drug/kg/d.
3, test method
(1) 180 SD rats are divided into 6 groups, often organize 30, male and female half and half.Experimental animal male and female sub-cage rearing, 5, every cage, quantitative feeding (every cage 1350-1500g/ week), normal feedstuff is experimental mouse full-valence pellet feed, freely drinks water.Experimental temperature (22 ± 2) DEG C, humidity 60%-80%.The natural lighting light and shade cycle.After SD rat is bought, under this laboratory rearing condition, adapt to 2 weeks, observe general behavior performance.Test pre-test animal ingestion amount, selects qualified rat.
(2) medication
With the magma of the made granule modulation of embodiment 1-5, respectively to wherein 5 groups of SD rat oral gavages administration, every day 2 times, each volume is 0.2ml/10g body weight, successive administration 26 weeks.Remaining one group is matched group, by same method gavage normal saline.Experimental animal is weighed weekly 1 time, according to body weight change adjustment dosage.24h after administration in the 13rd week, often organize execution 10, male and female half and half, observe and detect indices; Remaining continuation administration was observed to 26 weeks, and 24h after last 1 administration, often organizes and put to death 10 again, male and female half and half, observe and detect indices; Remaining 10 are carried out 8 week convalescent period and observe.
(3) test item and the time
General inspection: the general status observing animal every day, as the mental status, dynamic response, behavioral activity, the change of dietary amount, defecation situation, eyes and duct secretions, hair color, cleannes etc.Body weight change situation and food ration measure weekly 1 time.
Hematological examination: after administration, the 13rd, 26 week and drug withdrawal recover the end of term (the 34th week) and detect following index respectively: packed cell volume (HCT), red blood cell count(RBC) (RBC), content of hemoglobin (HGB), numeration of leukocyte (WBC), lymphocyte comparative counting (LY), platelet count (PLT), neutrophilic granulocyte comparative counting (NE), mononuclear cell comparative counting (Mon) and clotting time (CT).
Blood parameters check: after administration the 13rd, 26 week and drug withdrawal recovery the end of term (the 34th week) detect following index respectively: alanine aminotransferase (ALT), alkali phosphatase (AST), Lomefloxacin aspartate injection (AST), total bilirubin (TB), albumin (ALB), gross protein (TP), blood glucose (GLU), blood urea nitrogen (BUN), T-CHOL (TC), creatinine (Crea), uric acid (UA), blood sodium (Na
+), blood potassium (K
+), blood calcium (Ca
+) and β
2-microglobulin.
Urinate biochemical and urine routine: after administration, the 13rd, 26 week and drug withdrawal recover the end of term (the 34th week) each survey 1 time.Animal metabolism cage list cage is raised and is collected 24h urine, overnight fasting before test, detects urine bilirubin (BIL), glucose (GLU), ketoboidies (KET), protein, pH value, urobilinogen (URO), urine is occulted blood (BLO), nitrite (NIT), proportion and leukocyte (WBC); Quantitative determination of radioimmunoassay urine β
2-MG(renal tubular function obstacle sensitive indicator).
System postmortem and histopathologic examination: macroscopy is carried out to each internal organs, the organs such as heart, liver, lungs, kidney, spleen, brain, adrenal gland, thymus, thyroid, pancreas, uterus, ovary, testis, prostate are taken out and weighs, calculate organ coefficient (organ weights/body weight).With light microscopic, histological examination is carried out to above-mentioned internal organs and spinal cord, thymus, bladder, bone marrow (breastbone), duodenum, stomach, ileum, pancreas, hypophysis cerebri, optic nerve, lymph node, coton and rectal etc.
4, result of the test
The all rats of overview all do not show any abnormal conditions; Hematological examination, blood parameters inspection, urinate biochemical, urine routine, system postmortem and histopathologic examination, indices, compared with control animals, does not all have obvious difference.Therefore, Chinese medicine granules of the present invention to SD rat without any toxic action, in view of 20 times of ratios of its behaviour dose, so can infer that to take be safe to this granule for patient.
Embodiment 7: animal model in asthma is tested
1, basic document
Experimental animal: male SD rat, 40, body weight: 200 ± 15g, is provided by Shanghai City Experimental Animal Center.
Egg protein: Sigma Co., USA's product (lot number: 20141629).
Pertussis vaccine: Qingdao institute of biological products produces (lot number: 20141011).
The granule 1 of the embodiment of the present invention 1, embodiment 2 preparation, specification: amount to 0.375g crude drug/g granule.
Rat IFN-γ ELISA test kit and IL-5ELISA test kit, purchased from American Sigma company.
Eotaxin EL ISA test kit, purchased from American Sigma company.
2, test grouping
SD rat is divided into 4 groups at random, often organizes 10, be numbered respectively: matched group, asthmatic model group, treat 1 group, treat 2 groups.
3, modeling method
(1), matched group: 1d adopts normal saline 1ml to replace antigen to carry out lumbar injection sensitization to rat, excites, 2h before exciting, normal saline 2ml gavage, every day 1 time, each 30min, continuous 10d after 15d with normal saline atomization.
(2), asthmatic model group: 1d with 1ml modeling liquid (containing OVA100mg, aluminium hydroxide dry powder 100mg and deactivation bordetella pertussis 6 × 10
9individual) lumbar injection sensitization, after 15d, rat is placed in self-control atomization box (30cm × 30cm × 30cm) and excites with 10g/L OVA solution ultrasonic atomizatio, 2h before exciting, normal saline 2ml gavage, 1 time/d, 30min/ time, there is dysphoria, exaggerated respiration, quickening with rat in 10d altogether, to nod breathing, cough, hear and wheezing sound, in asthma sample, mouth week cyanosis, bradykinesia etc. show as successful animal model.
(3), treatment group: 2h before exciting, two treatment groups adopt the embodiment of the present invention 1 and the granule Chinese medicine prepared by embodiment 2 respectively, are dissolved in water, are configured to magma, and take 2ml solution (5.0g crude drug/kg) gavage, all the other are with asthmatic model group.
4, Indexs measure
Eosinophil count detection method: modeling 25d, every rats by intraperitoneal injection 0.2ml heparin sodium, extracts eyeball and gets blood and be about 3ml and put in anticoagulant tube, with the centrifugal 5min of 2000r/min, get blood plasma cytokine to be measured.Take a morsel whole blood smear, with Jim Sha dyeing, makes Eos counting (eosinophilic granulocyte).
IL-5, the detection of IFN-γ and Eotaxin: undertaken by the explanation of test kit, in the ELISA Plate of anti-IL-5 monoclony antibody bag quilt, add the standard substance (100 μ L/ hole) of specimen and variable concentrations, room temperature (20-25 DEG C) hatches 120min, wash plate 4 times, anti-IL-5 monoclony antibody (the 100 μ L/ hole) room temperature adding enzyme labelling incubates 60min, washes plate 4 times, adds substrate working solution, lucifuge room temperature 10-30min, add stop buffer, mixing, by microplate reader densitometric value in 5min, drawing standard curve, finds specimen concentration.IFN-γ and Eotaxin illustrates by EL ISA test kit and carries out.
5, statistical procedures
Measurement data adopts (
± S) represent, compare between group and adopt χ
2inspection, all data all adopt the process of SPSS12.0 statistical software.
6, result of the test
(1) Chinese medicine composition of the present invention in the rat blood of bronchial asthma Eos counting and preclinical impact as shown in table 1:
Table 1 Chinese medicine composition is on Eos counting and preclinical impact in the rat blood of bronchial asthma
Note: compared with model group, * P<0.05.
As can be seen from table 1, the eosinophilic granulocyte of model group significantly rises relative to matched group, and through the treatment for the treatment of by Chinese herbs group, the eosinophilic granulocyte of rat significantly reduces, P<0.05, has comparability.Relative to model group, treatment by Chinese herbs group can incubation period of significant prolongation bronchial asthma, and P<0.05, has comparability.
(2), the impact (pg/mL) expressed experimental rat model of asthma IL-5, IFN-γ and Eotaxin of Chinese medicine composition is as shown in table 2:
The impact that table 2 Chinese medicine composition is expressed experimental rat model of asthma IL-5, IFN-γ and Eotaxin
Note: compared with model group, * P<0.05.
As can be seen from table 2, in asthmatic model group serum, IFN-γ level reduces, IL-5 and Eotaxin level raises, and after Chinese medicine preparation is intervened, significantly can raise IFN-γ level in experimental rat model of asthma serum, reduces IL-5 and Eotaxin level.
Embodiment 8
The clinical trial of Chinese medicine preparation of the present invention
1, physical data
The patient of this clinical trial provides by certain the People's Hospital of city Pneumology Department, amount to 180 people, wherein male 90 people, age 18-56 year, female 90 people, age 18-59 year, all patients all meet the Western medicine diagnose standard (belonging to the catabasis) of bronchial asthma; Meet tcm syndrome standard simultaneously.
2, test drug
Contrast medicine: salmeterol powders for inhalation, authentication code: H20090241, manufacturing enterprise: Glaxo Operations UK Limited.
Investigational agent: show the granule that the excellent embodiment of the present invention 2 is produced in animal model test, specification: amount to 0.375g crude drug/g granule.
3, the standard of curative effect evaluation
Cure: all symptoms of asthma disappear completely, and make a definite diagnosis through doctor and return to one's perfect health;
Effective: asthma partial symptoms disappears or takes a turn for the better, or attack times reduces, duration of seizure shortens;
Invalid: all symptoms of asthma are without any improvement, even more serious.
4, result of the test (see table 3)
Table 3 logging table
5, conclusion
Result of the test shows, and test group cure rate is significantly higher than matched group (high 3.1 times), and total effective rate is higher than matched group 24.5 percentage points.Therefore, on clinical efficacy compared with prior art, Chinese medicine preparation of the present invention has very significant technical advantage, achieves creationary breakthrough.
Claims (5)
1. treat a Chinese medicine preparation for asthma, it is characterized in that being made up of the raw material of following weight portion: Endoconcha Sepiae 22-34 part, Bulbus Lilii 19-31 part, Sargassum 16-28 part, Radix Et Rhizoma Rhei 8-20 part, Concha Meretricis Seu Cyclinae 12-28 part, Thallus Laminariae (Thallus Eckloniae) 14-29 part, Rana nigromaculata 21-35 part, Fructus Aristolochiae 9-19 part, Gypsum Fibrosum 8-18 part, Radix Polygalae 7-17 part, Pheretima 8-20 part, Radix Bupleuri 9-17 part, Fructus Citri tangerinae be 7-15 part, Folium Eriobotryae 10-22 part, Radix Angelicae Sinensis 9-21 part, Radix Glehniae 8-20 part, Indigo Naturalis 6-12 part, Semen Persicae 10-24 part, Pericarpium Citri Reticulatae 7-15 part, Radix Codonopsis 9-21 part, white sugar 18-32 part just.
2. the Chinese medicine preparation for the treatment of asthma as claimed in claim 1, is characterized in that being made up of the raw material of following weight portion: Endoconcha Sepiae 28 parts, Bulbus Lilii 25 parts, Sargassum 22 parts, Radix Et Rhizoma Rhei 14 parts, Concha Meretricis Seu Cyclinae 20 parts, Thallus Laminariae (Thallus Eckloniae) 21 parts, Rana nigromaculata 28 parts, Fructus Aristolochiae 14 parts, 13 parts, Gypsum Fibrosum, Radix Polygalae 12 parts, Pheretima 14 parts, Radix Bupleuri 13 parts, Fructus Citri tangerinae just 11 parts, Folium Eriobotryae 16 parts, Radix Angelicae Sinensis 15 parts, Radix Glehniae 14 parts, Indigo Naturalis 9 parts, 17 parts, Semen Persicae, Pericarpium Citri Reticulatae 11 parts, Radix Codonopsis 15 parts, white sugar 25 parts.
3. the Chinese medicine preparation for the treatment of asthma as claimed in claim 1, is characterized in that being made up of the raw material of following weight portion: Endoconcha Sepiae 30 parts, Bulbus Lilii 26 parts, Sargassum 21 parts, Radix Et Rhizoma Rhei 12 parts, Concha Meretricis Seu Cyclinae 21 parts, Thallus Laminariae (Thallus Eckloniae) 20 parts, Rana nigromaculata 29 parts, Fructus Aristolochiae 16 parts, 12 parts, Gypsum Fibrosum, Radix Polygalae 13 parts, Pheretima 13 parts, Radix Bupleuri 12 parts, Fructus Citri tangerinae just 10 parts, Folium Eriobotryae 17 parts, Radix Angelicae Sinensis 16 parts, Radix Glehniae 13 parts, Indigo Naturalis 8 parts, 15 parts, Semen Persicae, Pericarpium Citri Reticulatae 12 parts, Radix Codonopsis 16 parts, white sugar 27 parts.
4. prepare a method for the Chinese medicine preparation for the treatment of asthma as claimed in claim 1, it is characterized in that comprising following processing step:
A, take each raw medicinal material in Chinese prescription ratio of the present invention;
B, by Rana nigromaculata, Endoconcha Sepiae dry, pulverize levigate mistake 120 mesh sieve, obtain fine powder 1, for subsequent use;
C, by Concha Meretricis Seu Cyclinae, pulverize, levigate mistake 120 mesh sieve, obtain fine powder 2, for subsequent use;
D, by Bulbus Lilii, Sargassum, Radix Et Rhizoma Rhei, Thallus Laminariae (Thallus Eckloniae), Fructus Aristolochiae, Gypsum Fibrosum, Radix Polygalae, Pheretima, Radix Bupleuri, Fructus Citri tangerinae just, Folium Eriobotryae, Radix Angelicae Sinensis, Radix Glehniae, Indigo Naturalis, Semen Persicae, Pericarpium Citri Reticulatae, Radix Codonopsis, the medical materials such as white sugar, pulverize respectively, add the purified water of 6-12 times of weight, backflow decocts 1-4 hour, filter, the purified water of initial medical material 4-8 times weight is added in filtering residue, backflow decoction 2 times, each 1-3 hour, filter, merging filtrate, carry out concentrating under reduced pressure, until the relative density 65 DEG C of mixed liquor is surveyed as stopping during 1.30-1.35 concentrated, proceed vacuum drying, obtain dry extract, pulverize levigate, cross 120 mesh sieves, be fine powder 3,
E, just fine powder 1, fine powder 2, fine powder 3 mix homogeneously, obtain this Chinese medicine composition effective ingredient powder;
F, in above-mentioned Chinese medicine composition effective ingredient powder, add suitable adjuvant, make clinical required dosage form with Chinese medicine preparation conventional formulation technique.
5. the Chinese medicine preparation for the treatment of asthma as claimed in claim 1, is characterized in that: described Chinese medicine preparation is tablet, pill, capsule, powder or granule.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105561010A (en) * | 2016-02-19 | 2016-05-11 | 覃淑兰 | Chinese herbal preparation for treating asthma and preparing method thereof |
| CN105617356A (en) * | 2016-01-29 | 2016-06-01 | 程潜 | Medicine for treating asthma |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104288477A (en) * | 2014-10-29 | 2015-01-21 | 王丽丽 | Traditional Chinese medicine preparation curing infantile asthma |
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2015
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104288477A (en) * | 2014-10-29 | 2015-01-21 | 王丽丽 | Traditional Chinese medicine preparation curing infantile asthma |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105617356A (en) * | 2016-01-29 | 2016-06-01 | 程潜 | Medicine for treating asthma |
| CN105561010A (en) * | 2016-02-19 | 2016-05-11 | 覃淑兰 | Chinese herbal preparation for treating asthma and preparing method thereof |
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Application publication date: 20150527 |