CN102526546A - Chinese medicinal composition and preparation and preparation method thereof - Google Patents
Chinese medicinal composition and preparation and preparation method thereof Download PDFInfo
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- CN102526546A CN102526546A CN2012100006865A CN201210000686A CN102526546A CN 102526546 A CN102526546 A CN 102526546A CN 2012100006865 A CN2012100006865 A CN 2012100006865A CN 201210000686 A CN201210000686 A CN 201210000686A CN 102526546 A CN102526546 A CN 102526546A
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Abstract
The invention discloses a Chinese medicinal composition. The disclosed Chinese medicinal composition consists of the raw material active ingredients in parts by weight: 9-15 parts of lily, 9-15 parts of earthworm, 9-15 parts of cicada shell, 9-15 parts of garter snake, 9-15 parts of siberian cocklour fruit, 9-15 parts of common ducksmeat herb, 9-15 parts of magnolia flower, 9-15 parts of rice kernel, 3-9 parts of white mustard seed, 3-9 parts of dark plum fruit and 3-9 parts of liquoric root. The invention further discloses a preparation method and a preparation of the Chinese medicinal composition. As proved by clinical experiments and pharmacological experiments performed by an applicant, the Chinese medicinal composition has a remarkable effect on the prevention and control of pollinosis.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, particularly a kind of have a Chinese medicine composition of preventing and treating the pollinosis effect, belongs to field of medicaments.
Background technology
Pollinosis; Claiming pollen hypersensitivity again, is a kind of general day by day disease in Australia with Europe, has statistics to show; Per 3 philtrums of living in Australia just have an anaphylactic disease patient; To the middle-aged and elderly people each age group generation is arranged all from neonate, do not have obvious gender tendency, but the heritability tendency obviously.Scholar of European Section even prediction, by 2015, half the European can suffer from least a anaphylaxis.Live among the overseas Chinese, pollinosis patient is also more and more, although there is not definite statistics, ratio is not less than 1/5th.
Patient's allergic constitution is depended in the generation of pollinosis on the one hand, is modern's life style on the other hand.Contain high protein, high caloric diets such as a large amount of seafood, eggs, meat products like feed, it is hyperfunction that the result causes producing in the body ability of antibody, thereby when running into antigen such as pollen, allergy just takes place more easily.Because of the extensive application of atmospheric pollution, water pollution and food additive, new anaphylactogen gets into people's life again and again, causes human body to contact more antigenic substance on the other hand, impels the human allergic disease that takes place.Pollinosis possibly produce chronic disease like active treatment not, develops complications, and such as asthma, chronic pneumonia, chronic rhinitis, conjunctivitis etc. will be even slight also can the reducing quality of life of pollinosis will threaten people's life under the serious situation.
Normally used to the treatment of pollinosis at present is the oral anti-allergy medicine; Like chlorphenamine (DIMETINDEN; Commodity are called FENISTIL) tablet or liquor, An Ertai (ATARAX) etc., but this type of oral medicine has certain sedation; Can cause hypohypnosis, the danger of the driving accident that causes driving a vehicle is arranged.Can take desensitization treatment (Hyposensibilisierung) to serious Allergic Rhinitis, this treatment is implemented in the autumn and winter season of non-irritated phase usually.The success rate of desensitization treatment is 50%.But, in the world anaphylaxis is not still had the radical cure way at present, above-mentioned therapy be basically suit the medicine to the illness not to because of, some drugs is taken for a long time also has some side effect.Desensitization treatment is to because of therapy in theory, and also oversize because of taking (2-3), patient are difficult for adhering to that the actual therapeutic effect is unsatisfactory.
Therefore, at present drug world still lack a kind of general effectively, the medicine of treatment pollinosis that toxic and side effects is little.
Summary of the invention
Defective to prior art; Applicant's pleasantly surprised discovery in a large amount of medicine exploration experiments has notable therapeutic effect by the Chinese medicine that Bulbus Lilii, Pheretima, Periostracum Cicadae, Zaocys, Fructus Xanthii, Herba Spirodelae, Flos Magnoliae, Semen Coicis, Fructus Mume, Semen Sinapis Albae, Radix Glycyrrhizae etc. are compounded to form for preventing and treating pollinosis; Therefore the invention provides a kind of Chinese medicine composition, it is remarkable that it is used to prevent and treat the pollinosis effect, and side effect is little; Can take for a long time; For the generation that prevents and treats pollinosis, and prevention has dual function by the various complication that pollinosis causes; And said Chinese medicine composition dose is little, taking convenience, and can guarantee medicine stability and effect preferably.Its production technology is simple, production cost is low, implementation is strong, is easy to large-scale industrial production.
For realizing the foregoing invention purpose, the present invention realizes with following technical scheme:
A kind of Chinese medicine composition, effective ingredient is processed by following materials based on weight: 9～15 parts of Bulbus Liliies, 9～15 parts of Pheretimas, 9～15 parts of Periostracum Cicadaes, 9～15 parts of Zaocyss, 9～15 parts of Fructus Xanthii, 9～15 parts in Herba Spirodelae, 9～15 parts of Flos Magnoliaes, 9～15 parts of Semen Coicis, 3～9 parts of Semen Sinapis Albaes, 3～9 parts of Fructus Mumes, 3～9 parts in Radix Glycyrrhizae.
As is known to the person skilled in the art; Actual acting in medicine is the chemical constituent that these compositions contain; Therefore described each above-mentioned raw material can also be the extract of these compositions; Comprise water extract and/or extractive with organic solvent, consider drug safety and prepare needs, preferably its water extract easily.
Chinese medicine composition of the present invention both can use separately, in order to take conveniently, improved the local flavor and the mouthfeel of medicine, and preferably pharmaceutical preparation comprises that Chinese medicine composition of the present invention and pharmaceutically acceptable preparing carriers form.Yet, it should be noted that the present invention also can use Chinese medicine composition separately, for example adopt following method that Chinese medicine composition is processed crude drug for use:
According to described parts by weight, adopt suitable water or organic solvent to extract each raw material, preferably water extracts, and gets final product pulverizing mix homogeneously behind each raw extract combination drying then.
As stated; In the present invention; Described Chinese medicine composition normally is prepared into pharmaceutical preparation, and wherein said pharmaceutically acceptable carrier is to be used for useful in preparing drug formulations adjunct ingredient commonly used, includes but not limited to one or more the mixture in diluent, lubricant, binding agent, disintegrating agent, sweeting agent, stabilizing agent, the antiseptic etc.; To different preparation types, selecting different carriers is conspicuous as adjuvant to those skilled in the art.
Wherein, above-mentioned carrier, its consumption and usage, kind are fully open pharmaceutically.For example described diluent includes but not limited to lactose, starch, microcrystalline Cellulose, mannitol etc.; Described lubricant includes but not limited to magnesium stearate, Pulvis Talci etc.; Described binding agent includes but not limited to polyethylene pyrrole Lip river alkane ketone, hydroxypropyl cellulose etc.; Described disintegrating agent includes but not limited to carboxymethyl cellulose, acetic acid carboxyl Starch Sodium, polyvinylpolypyrrolidone etc.; Described sweeting agent comprises but is not limited to sucrose, fructose, Sorbitol etc.; Described stabilizing agent comprises but is not limited to sodium carboxymethyl cellulose, cyclodextrin, xanthan gum etc.; Described antiseptic includes but not limited to potassium sorbate, Nipagin ester etc.
Based on above-mentioned adjuvant and other common adjuvants of this area; Can Chinese medicine composition of the present invention be prepared as the different drug dosage form, include but not limited to powder, tablet, granule, capsule, soft capsule, spray etc., preferred; In order to prepare conveniently; Use simply, described pharmaceutical preparation is granule, can adopt following method to prepare:
1) get Fructus Xanthii, Herba Spirodelae, Flos Magnoliae, the Semen Sinapis Albae of said parts by weight, soak reflux then, collect volatile oil, volatile oil adds microcrystalline Cellulose, mix homogeneously, volatile oil figuration powder; The medicinal liquid filtered while hot, filtrating merges, and must filtrate 1;
2) get Bulbus Lilii, Pheretima, Periostracum Cicadae, Zaocys, Semen Coicis, Fructus Mume, the Radix Glycyrrhizae of said parts by weight, decocte with water, collecting decoction filters, and must filtrate 2;
3) merging filtrate 1 and filtrating 2 concentrate with the organic solvent filtration, reclaim organic solvent, are condensed into thick paste, and drying under reduced pressure is pulverized, and adds the volatile oil figuration powder and the adjuvant of step 1) then, and mixing is processed granule, drying, and granulate, packing promptly gets.
Wherein, used method for concentration and drying means are any available method in this area, for example adopt vacuum concentration or room temperature concentrating under reduced pressure, for example adopt spray drying or lyophilization.
Wherein, will filtrate and the isolating method of residue can be any available method in this area, for example filter or centrifugation method.
Wherein, preferred, said step 1) was soaked 0.5～1 hour, reflux 2～3 times, each 1～3 hour; Preferably, said step 2) decocte with water twice, 0.5～2 hour for the first time, 1～3 hour for the second time; Preferably, the used organic solvent of said step 3) is an ethanol; Preferably, the concentrated condition of said step 3) is 1.08～1.28 for being concentrated into relative density, adds ethanol and makes that to contain the alcohol amount be 50～70%.
Adopt said method and preparation condition thereof, the most effectively guaranteed the effect of extraction and the stability of product, and made production technology simple, reduced production cost.
Further, on the basis of the above, the invention also discloses above-mentioned Chinese medicine composition and prevent and treat the purposes in the pollinosis medicine in preparation.Chinese medicine composition of the present invention can be used to prepare the drug desensitization of the medicine of preventing and treating pollinosis, especially pollen hypersensitivity and/or allergic rhinitis.As is known to the person skilled in the art; When the treatment anaphylactic disease; The usage that drug combination is arranged usually, therefore with the present invention and other Claritin drug combination to play comprehensive antiallergic, it is conspicuous stoping the effect of multiple sensitization chemical mediator release.
Treatment mechanism of the present invention is: Chinese medicines such as Pheretima, Periostracum Cicadae, Zaocys, Fructus Xanthii, Herba Spirodelae, Flos Magnoliae, Fructus Mume, Radix Glycyrrhizae have anti-allergic effects.Concrete mechanism is that Pheretima has antihistamine effect; Periostracum Cicadae can reduce the reflex myotonia reaction, reduce striate tonicity, and neuroganglion is had slight blocking effect; Radix Glycyrrhizae has inflammation-inhibiting, the anti-allergic effects of similar adrenocortical hormone and mineralocorticoid.Semen Sinapis Albae has the central antitussive effect, and bronchial mucosa is had protective effect; Flos Magnoliae has antiallergic and antiinflammation; Fructus Xanthii has antiinflammatory and antibacterial; Fructus Mume has the effect of relieving cough and moistening lung, and Semen Coicis has antibacterial repercussive effect etc.Chinese medicine composition of the present invention has fully combined modern's dietary habit characteristics and natural environment characteristics, and part antiallergic Chinese medicine characteristic, and the Chinese medicinal granule of preventing and treating the pollinosis effect that prescription forms has reliable curative effect, has higher safety simultaneously.
Usage and dosage of the present invention is: boiled water is taken after mixing it with water, one time 10～20 gram (1～3 bag), every day 1～3 time, 1～3 month course of treatment.According to the practical situation of different cases, can adjust accordingly.
Clinical trial shows that the present invention has the lung moistening clearing away phlegm, the effect of dispelling wind for relieving itching.Be used to prevent and treat paroxysmal rhinocnesmus, seriality sneeze, a large amount of snivel, the nasal obstruction that pollinosis (pollen hypersensitivity) causes; Ear, eye, bottleneck throat gargalesthesia and headache etc. also can be arranged, and improve the breathing heavily of allergic asthma, suppress, symptom such as cough has notable therapeutic effect.
The specific embodiment
In following embodiment; The invention provides the finished product preparation of described Chinese medicine composition; It will be understood by those skilled in the art that adopting other adjuvants is conspicuous with the dosage form that Chinese medicine composition is prepared into other accordingly, still belongs to protection scope of the present invention.
Embodiment 1
Composition of raw materials: Bulbus Lilii 1200 Pheretimas 1200 Periostracum Cicadaes 1000 Zaocyss 1000 Fructus Xanthii 1000 Herba Spirodelaes 1000 Flos Magnoliaes 1000 Semen Coicis 1500 Fructus Mumes 600 Semen Sinapis Albaes 600 Radix Glycyrrhizaes 600
Method for making: get Fructus Xanthii, Herba Spirodelae, Flos Magnoliae, Semen Sinapis Albae 4 flavor medicines, add 8 times of water yields and soaked 0.5 hour, reflux 3 hours is collected volatile oil, adds an amount of microcrystalline Cellulose, mix homogeneously.The medicinal liquid filtered while hot, filtrating merges, and adds 8 times of water yields, must dilute filtrating; Other gets Bulbus Lilii, Pheretima, Periostracum Cicadae, Zaocys, Semen Coicis, Fructus Mume, Radix Glycyrrhizae 7 flavor Chinese medicines, adds 8 times of water yields, decocts 0.5 hour, adds 12 times of amounts of water for the second time, decocts 2 hours; Merge twice decocting liquid and dilution filtrating, filter, being concentrated into relative density is 1.18 (25 ℃), adds ethanol and makes that to contain the alcohol amount be 60%, places 24 hours; Filter, filtrate recycling ethanol, being concentrated into density is the clear paste of 1.35 (60 ℃), vacuum drying is pulverized; Get dry extract, merge the volatile oil microcrystalline Cellulose, add soluble starch 108 grams, xylitol 18 grams, aspartame 10 grams; Mixing is processed granule, and drying is processed 1000 grams, promptly gets.
Embodiment 2
Composition of raw materials: Bulbus Lilii 1200 Pheretimas 1200 Periostracum Cicadaes 1000 Zaocyss 1000 Fructus Xanthii 1000 Herba Spirodelaes 1000 Flos Magnoliaes 1000 Semen Coicis 1500 Fructus Mumes 600 Semen Sinapis Albaes 600 Radix Glycyrrhizaes 600
Method for making: get Fructus Xanthii, Herba Spirodelae, Flos Magnoliae, Semen Sinapis Albae 4 flavor medicines, add 10 times of water yields and soaked 1 hour, reflux 3 hours is collected volatile oil, adds an amount of microcrystalline Cellulose, mix homogeneously.The medicinal liquid filtered while hot, filtrating merges, and adds 8 times of water yields, must dilute filtrating; Other get Bulbus Lilii, Pheretima, Periostracum Cicadae, Zaocys, Semen Coicis, Fructus Mume,, Radix Glycyrrhizae 7 flavor Chinese medicines, add 10 times of water yields, decocted 1 hour, add 12 times of amounts of water the second time, decocted 3 hours; Merge twice decocting liquid and dilution filtrating, filter, being concentrated into relative density is 1.10 (25 ℃), adds ethanol and makes that to contain the alcohol amount be 50%, places 24 hours; Filter, filtrate recycling ethanol, being concentrated into density is the clear paste of 1.30 (50 ℃), vacuum drying is pulverized; Get dry extract, merge the volatile oil microcrystalline Cellulose, but add dextrin 108 grams, xylitol 18 grams, sweet foline 12 grams; Mixing is processed granule, and drying is processed 1000 grams, promptly gets.
Embodiment 3
Composition of raw materials: Bulbus Lilii 900 Pheretimas 900 Periostracum Cicadaes 900 Zaocyss 900 Fructus Xanthii 900 Herba Spirodelaes 900 Flos Magnoliaes 900 Semen Coicis 900 Fructus Mumes 300 Semen Sinapis Albaes 300 Radix Glycyrrhizaes 300
Method for making: get Fructus Xanthii, Herba Spirodelae, Flos Magnoliae, Semen Sinapis Albae 4 flavor medicines, add 10 times of water yields and soaked 1.5 hours, reflux 3 hours is collected volatile oil, adds an amount of microcrystalline Cellulose, mix homogeneously.The medicinal liquid filtered while hot, filtrating merges, and adds 8 times of water yields, must dilute filtrating; Other get Bulbus Lilii, Pheretima, Periostracum Cicadae, Zaocys, Semen Coicis, Fructus Mume,, Radix Glycyrrhizae 7 flavor Chinese medicines, add 10 times of water yields, decocted 1 hour, add 8 times of amounts of water the second time, decocted 3 hours; Merge twice decocting liquid and dilution filtrating, filter, being concentrated into relative density is 1.10 (25 ℃), adds ethanol and makes that to contain the alcohol amount be 50%, places 24 hours; Filter, filtrate recycling ethanol, being concentrated into density is the clear paste of 1.30 (50 ℃), vacuum drying is pulverized; Get dry extract, merge the volatile oil microcrystalline Cellulose, but add dextrin 95 grams, xylitol 15 grams, sweet foline 12 grams; Mixing is processed granule, and drying is processed 1000 grams, promptly gets.
Embodiment 4
Composition of raw materials: Bulbus Lilii 1500 Pheretimas 1500 Periostracum Cicadaes 1500 Zaocyss 1500 Fructus Xanthii 1500 Herba Spirodelaes 1500 Flos Magnoliaes 1500 Semen Coicis 1500 Fructus Mumes 900 Semen Sinapis Albaes 900 Radix Glycyrrhizaes 900
Method for making: get Fructus Xanthii, Herba Spirodelae, Flos Magnoliae, Semen Sinapis Albae 4 flavor medicines, add 15 times of water yields and soaked 1 hour, reflux 3 hours is collected volatile oil, adds an amount of microcrystalline Cellulose, mix homogeneously.The medicinal liquid filtered while hot, filtrating merges, and adds 10 times of water yields, must dilute filtrating; Other get Bulbus Lilii, Pheretima, Periostracum Cicadae, Zaocys, Semen Coicis, Fructus Mume,, Radix Glycyrrhizae 7 flavor Chinese medicines, add 10 times of water yields, decocted 1 hour, add 12 times of amounts of water the second time, decocted 3 hours; Merge twice decocting liquid and dilution filtrating, filter, being concentrated into relative density is 1.10 (25 ℃), adds ethanol and makes that to contain the alcohol amount be 50%, places 24 hours; Filter, filtrate recycling ethanol, being concentrated into density is the clear paste of 1.30 (50 ℃), vacuum drying is pulverized; Get dry extract, merge the volatile oil microcrystalline Cellulose, but add dextrin 120 grams, xylitol 24 grams, sweet foline 12 grams; Mixing is processed granule, and drying is processed 1000 grams, promptly gets.
On the basis of the above, the present invention has carried out pharmacological evaluation and clinical experiment respectively.
The experiment of one pollen hypersensitivity mouse blood IgE antibody
Get the 10-15 BALB female mice in week; Be divided into five groups; Every group 10; Wherein organize 1 and make its oral China fir pollen make case as inoculation, group 2-group 5 is the 5th day behind oral pollen, the tenth day preparation of feeding Chinese medicinal composition preparation embodiment 1-4 of the present invention respectively on the basis of oral isodose China fir pollen respectively, and dosage is each 500mg.
The last time after the medication two days later to getting whole blood under five groups of mouse anesthesia states, separation of serum carries out antibody titer then and measures, the assay method of IgE is the sandwich ELISA method.
The statistics testing result shows; The mice of group 1 detects the interior antibody amount of its blood and increases to 1571ng/ml; The mice of the 2-of family group 4 detects the interior antibody amount of its blood and increases to 882ng/ml, 920ng/ml, 950ng/ml, 1012ng/ml, compares with the mice of group 1, increases to receive obvious inhibition (statistics t-test P＜0.05); Explain that Chinese medicine composition of the present invention has significant effect to suppressing the pollen hypersensitivity reaction, can obviously suppress the allergy that pollen hypersensitivity causes.
Two clinical pollinosis patient treatment effects
Foundation general pollen hypersensitivity and allergic rhinitis diagnostic criteria at present: the clinical 20 (perennial onset of Allergic Rhinitis of selecting at random; Have sneeze (each continuous more than 3), snivel and three main clinical manifestation of nasal mucosa swelling; Morbidity number of days accumulative total surpasses 6 months in 1 year, and disease time accumulative total was above 0.5 hour in one day; The course of disease is at least one year), 20 of pollen hypersensitivity patients (seasonal morbidity, annual morbidity season basically identical, and be consistent with sensitization pollen pollinating period; At least two years in same morbidity in season; , there are typical clinical symptoms and sign stage of attack; Stage of attack nasal discharge (and/or conjunctiva scraping blade) EC is positive, or nasal mucosa scraping blade mastocyte (basophil) positive; The pollen allergen tuerculoderma is positive, and at least a is (++) or more than (++), or the allergen nasal provocation test is positive, the eye conjunctival butter is positive).
During anaphylaxis, give the preparation of pharmaceutical composition embodiment 1 of the present invention, the medication cycle is a week, and every day three times, each dosage is 15g; Matched group is chosen 20 pollen autopaths, 20 Allergic Rhinitis respectively according to above-mentioned standard; The conventional antihistamine drug zyrtec (chemical name: cetirizine dihydrochloride of difference feeding; Specification 10mg), use a week continuously, usage and dosage is according to its description regulation.
The medication effect assessment is: cure or be clearly better, be designated as A; The effect that take a favorable turn is designated as B; Effect slightly or to no effect is designated as C.
After one week, the result of experimental group and matched group contrasts as follows:
Find in the experiment that Chinese medicine composition of the present invention can take effect after taking half an hour, effect is remarkable.Can find out that from The above results Chinese medicine composition of the present invention all has notable therapeutic effect for pollen hypersensitivity patient and Allergic Rhinitis.
Claims (10)
1. Chinese medicine composition is characterized in that effective ingredient processed by following materials based on weight: 9～15 parts of Bulbus Liliies, 9～15 parts of Pheretimas, 9～15 parts of Periostracum Cicadaes, 9～15 parts of Zaocyss, 9～15 parts of Fructus Xanthii, 9～15 parts in Herba Spirodelae, 9～15 parts of Flos Magnoliaes, 9～15 parts of Semen Coicis, 3～9 parts of Semen Sinapis Albaes, 3～9 parts of Fructus Mumes, 3～9 parts in Radix Glycyrrhizae.
2. Chinese medicine composition according to claim 1, said Bulbus Lilii, Pheretima, Periostracum Cicadae, Zaocys, Fructus Xanthii, Herba Spirodelae, Flos Magnoliae, Semen Coicis, Semen Sinapis Albae, Fructus Mume, Radix Glycyrrhizae are respectively its water extract.
3. Chinese medicine preparation; Processed by described Chinese medicine composition of claim 1 and pharmaceutically acceptable carrier, said acceptable carrier is selected from one or more the mixture in diluent, lubricant, binding agent, disintegrating agent, sweeting agent, stabilizing agent, the antiseptic etc.
4. Chinese medicine preparation according to claim 2 is characterized in that said preparation is a granule.
5. the method for preparing of the described Chinese medicine preparation of claim 4 comprises the steps:
1) get Fructus Xanthii, Herba Spirodelae, Flos Magnoliae, the Semen Sinapis Albae of said parts by weight, soak reflux then, collect volatile oil, volatile oil adds microcrystalline Cellulose, mix homogeneously, volatile oil figuration powder; The medicinal liquid filtered while hot, filtrating merges, and must filtrate 1;
2) get said parts by weight Bulbus Lilii, Pheretima, Periostracum Cicadae, Zaocys, Semen Coicis, Fructus Mume,, Radix Glycyrrhizae, decocte with water, collecting decoction filters, and must filtrate 2;
3) merging filtrate 1 and filtrating 2 concentrate with the organic solvent filtration, reclaim organic solvent, are condensed into thick paste, and drying under reduced pressure is pulverized, and adds the volatile oil figuration powder and the adjuvant of step 1) then, and mixing is processed granule, drying, and granulate, packing promptly gets.
6. method for preparing according to claim 5 is characterized in that: said step 1) was soaked 0.5～1 hour, reflux 2～3 times, each 1～3 hour.
7. method for preparing according to claim 5 is characterized in that: said step 2) decocte with water twice, and 0.5～2 hour for the first time, 1～3 hour for the second time.
8. method for preparing according to claim 5 is characterized in that: the used organic solvent of said step 3) is an ethanol.
9. method for preparing according to claim 7 is characterized in that: the concentrated condition of said step 3) is 1.08～1.28 for being concentrated into relative density, adds ethanol and makes that to contain the alcohol amount be 50～70%.
10. the Chinese medicine composition of claim 1 is prevented and treated the purposes in the pollinosis medicine in preparation.
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Application publication date: 20120704 |