CN100431594C - Compound preparation for treating summer wet type cold and its preparing method - Google Patents
Compound preparation for treating summer wet type cold and its preparing method Download PDFInfo
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Abstract
The compound medicine preparation for treating cold is compounded with the effective components extracted from five kinds of Chinese medicinal materials, including honeysuckle, elsholtzia, eupatorium, cardamomum and areca peel. The preparation process includes steaming elsholtzia, eupatorium and cardamomum to obtain volatile oil, coating the volatile oil with beta-cyclodextrin, decocting the residual medicine liquid and dregs together with honeysuckle and areca peel to obtain extractum, drying the extractum, and mixing with the volatile oil to obtain the compound medicine preparation. The compound medicine preparation is used for treating summer wet type cold, and possesses the functions of eliminating summer heat, relieving pain, resisting bacteria, resisting virus and strengthening immunity.
Description
(1) technical field:
The present invention relates to a kind of is the medicine that raw material is made by Chinese herbal medicine, and particularly a kind of compound preparation for the treatment of summer-wet type common cold the invention still further relates to the preparation method of this medicine.
(2) background technology:
Flu is modal disease, does not still have especially effectively Therapeutic Method, and the Therapeutic Method of bibliographical information is a lot of, and the medicine of treatment flu comprises that Chinese medicine and Western medicine reach more than hundreds of on the market.
Modern medicine thinks that flu is that virus causes more than 90%, has the different types of viral collunarium of human that the people is caught a cold, and finds that the flu that different virus causes is the difference of length incubation period, and the symptom performance is the same substantially, illustrates that flu has identical pathomechanism.Recent viewpoint is thought, the inflammatory reaction that various paathogenic factors cause is the reason that causes the flu General Symptoms, the generation and release, the parasympathetic nervous reflection etc., particularly allergy that comprise interferon, Kallidin I, prostaglandin, histamine, interleukin play an important role in the flu pathomechanism.Therefore, antiinflammatory antiallergic and the antiviral therapeutic alliance at the beginning of symptom occurs is considered to most promising Therapeutic Method.No matter whether the situation of ubiquity abuse of antibiotics merge bacterial infection in the treatment of flu, unites the use antibacterials mostly, the medication of so-called big encirclement formula, antibiotic becomes the maximum medicine of the actual use of China's clinical treatment flu, and not only waste, and side effect and drug resistance increase.
Pharmaceutical research proves that many Chinese herbal medicine such as Herba Ephedrae, Flos Lonicerae, Herba Moslae, Herba Eupatorii, Ramulus Cinnamomi, Radix Isatidis, Rhizoma Osmundae, Radix Scutellariae, Folium Isatidis etc. have anti-cold virus effect, report is arranged, and Radix Ginseng extract, YUPINGFENG SAN etc. can improve body immunity and anti-curing cold.Flos Lonicerae has dispelling wind and heat pathogens, the function of clearing away summer-heat.Various pathogens all there is certain inhibitory action, comprise staphylococcus aureus, Hemolytic streptococcus, escherichia coli, dysentery bacterium, vibrio cholera, Bacillus typhi, Salmonella paratyphi, also effective to streptococcus pneumoniae, meningococcus, bacillus pyocyaneus, tubercule bacillus, the water logging agent is stronger than decoct effect.Flos Lonicerae is to morbific Streptococcus mutans, unwrapping wire Bacillus adhaerens and cause that product melanin bacillus, gingiva bacteroid and companion's unwrapping wire haemophilus of periodontal disease have also shown stronger antibacterial activity.The Flos Lonicerae water decoction also has the obvious suppression effect in the extracellular to Coxsackie virus and Echovirus.Herba Moslae has the function of clearing away heat and eliminating dampness expelling summer-heat, is the expelling superficial pathogens and clearing away summer-heat phase moon in summer key medicine.Influenza virus there is certain deactivation; Staphylococcus aureus, group B streptococcus, Bacillus typhi, diphtheria corynebacterium, meningococcus there is stronger antibacterial action.Also has refrigeration function.Can excited sweat gland and play refrigeration function.Herba Eupatorii has removing dampness by means of aromatics, drive away summer heat and in function, volatile oil has direct repression and phlegm-dispelling functions for influenza virus.It is to contain Radix Scutellariae serum to DNA, protein synthesis and Ca in the pyrogen process in the generation of rabbit mononuclear cell that Radix Scutellariae has tangible antipyretic effect, its mechanism of action to typhoid fever, paratyphoid fever, the microbial fever in rabbits Huang of second etc.
2+Interior stream has the obvious suppression effect, thereby gives birth to the synthetic of pyrogen in stoping.
A large amount of clinical reports, use Chinese medicine name side and good effect is arranged as treatments such as Lonicerae and Forsythiae Powder, Ephedrae Decoction, guizhi decoction, shensu drink, CHAIHU GUIZHI TANG, Mahuang Fuzi Xixin Tang, HUOXIANG ZHENGQI WAN flu, research and develop out thus multiple Chinese patent medicine and in this medicine composite preparation become the coldrex that people like, as tablet for treating common cold, cold drug sheet, WEI C YINQIAO PIAN, QINGKAILING KOUFUYE and injection, antivirus oral liquid, double coptis root injection, Andrographolide injection etc.Though generally believe, treatment for viral diseases such as flu wishes to be Chinese medicine, after particularly finding the side effect of phenylpropanolamine, multiple flu Western medicine is stopped using by explicit order, people are dread to the flu Western medicine, sight is more turned to Chinese medicine, but still do not have a kind of coldrex to demonstrate the outstanding curative effect of summer-wet type common cold.
(3) summary of the invention:
Task of the present invention is according to above traditional Chinese medical science principle, provides a kind of and can suitability for industrialized production treat the effective cold medicine of summer-wet type common cold.
Another task of the present invention is fully to contain various active ingredients in order to ensure this medicine, and a kind of preparation method of this medicine is provided.
The traditional Chinese medical science thinks that flu is because of due to the diseases caused by exogenous pathogenic factor six evils.Summer-heat is one of six evils, is the main gas in summer, is burning hotization.Summer-heat being a kind of YANG pathogen, its property sweltering heat, the summer-heat Chang Zhi that hurts sb.'s feelings goes into edema caused by disorder of QI, causes the human body excess of YANG-heat, and the mind is disturbed, and perspiration leaks, and the body fluid loss is then seen restlessness and thirst, the oliguria yellow skin.Therefore be used for experiencing summer the summer-heat damp cold due to the wet heresy of summer-heat folder, control to deliver and drive away summer heat clearing away heat and eliminating dampness.The present invention is according to above traditional Chinese medical science principle, a kind of medicine of effective treatment summer-wet type common cold is provided, form compound recipe with Chinese medicines such as Flos Lonicerae, Herba Moslae, Herba Eupatorii, Fructus Amomi Rotundus, Pericarpium Arecae, and through abundant effective component extracting, make the preparation that is fit to clinical practice, have to deliver and drive away summer heat, the clearing away heat and eliminating dampness effect.Be used for summer-heat damp cold.Disease is seen heating, and antiperspirant is few, micro evil wind, and dizzy and headache, vague aching of limbs or pain, restlessness and thirst, turbid nasal discharge, cough with ropy sputum, the oliguria yellow skin, red tongue with thin and yellow fur is greasy, soft and rapid pulse.Being monarch drug with the Flos Lonicerae in the side, is ministerial drug with Herba Moslae, Herba Eupatorii etc., and Fructus Amomi Rotundus, Pericarpium Arecae etc. is adjuvant drug altogether.
Make a general survey of we and not only have the expelling summer-heat of delivering, and the clearing heat and expelling damp effect, obviously be better than existing tcm product and only have one of them effect, have novelty, be specially adapted to summer-heat damp cold, and simple, the with strong points advantage of tool flavour of a drug, market prospect is extensive.Can also on the basis of above flavour of a drug, suitably increase other medical material in the side, to strengthen the curative effect of this compound recipe.
Compound preparation component of the present invention and consumption thereof are summed up through inventor's long-felt and are drawn, it is to be made by following medicinal materials: Flos Lonicerae, Herba Moslae, Herba Eupatorii, Fructus Amomi Rotundus, Pericarpium Arecae, each medical material consumption all has curative effect preferably in following weight ratio scope: the weight ratio 7～15: 2～5: 2～5: 2～4: 4～9 of Flos Lonicerae, Herba Moslae, Herba Eupatorii, Fructus Amomi Rotundus, Pericarpium Arecae.
Medical material Flos Lonicerae: Herba Moslae: Herba Eupatorii: Fructus Amomi Rotundus: the preferred weight ratio of Pericarpium Arecae is 10: 3: 3: 3: 6.
The medical material of compound preparation of the present invention also includes Radix Scutellariae, Herba Artemisiae Annuae, Folium Perillae, the weight ratio 7～15: 2～5: 2～5: 3～6: 2～5: 2～5: 2～4: 4～9 of medical material Flos Lonicerae, Herba Moslae, Herba Eupatorii, Radix Scutellariae, Herba Artemisiae Annuae, Folium Perillae, Fructus Amomi Rotundus, Pericarpium Arecae.
The preferred weight ratio of medical material Flos Lonicerae, Herba Moslae, Herba Eupatorii, Radix Scutellariae, Herba Artemisiae Annuae, Folium Perillae, Fructus Amomi Rotundus, Pericarpium Arecae is 10: 3: 3: 4: 2: 2: 3: 6.
The preparation method of compound preparation of the present invention is as follows:
A) preparation of medical material Herba Moslae, Herba Eupatorii, Fructus Amomi Rotundus volatile oil: take by weighing each medical material Herba Moslae, Herba Eupatorii, Fructus Amomi Rotundus by weight proportion, add 6-10 times of water logging bubble 15-90 minute, with vapor distillation 0.5-6 hour, extract volatile oil, the volatile oil beta-cyclodextrin inclusion compound, to reduce the oxidation in the storage process, rotten and devolatilization, standby after the clathrate drying, be white or off-white powder;
B) preparation of medical material clear paste: last medicinal liquid medicinal residues behind the said extracted volatile oil and the medical material Flos Lonicerae that takes by weighing by weight proportion, Pericarpium Arecae are merged, add water 4-8 and doubly soaked 15-90 minute, add water to medical material amount 8-12 doubly, decocted 30-60 minute; Repeat above-mentioned decoction 1-3 time, collecting decoction filters, and filtrate decompression concentrates, and is concentrated into relative density and under 60 ℃ condition is 1.15～1.20 clear paste, and dry back is standby;
C) with above-mentioned spissated clear paste and volatile oil beta cyclodextrin inclusion complex mixing, obtain extract, i.e. the active component of compound preparation of the present invention;
D) active component of above-mentioned compound preparation, excipient direct through conventional operation or that adding is pharmaceutically accepted is made acceptable forms clinically, comprises tablet, capsule, granule, syrup, oral liquid, chewable tablet, oral cavity disintegration tablet, drop pill, soft capsule, injection.
Preparation method of the present invention, extract water absorption rate, amount of water and distillation time and the betacyclodextrin clathrate process of volatile oil part medical material by examination, and investigate water and put forward water absorption rate, the soak time of medical material, add water multiple, extraction time and extraction time, further realize in the following manner: after Herba Moslae, Herba Eupatorii, Fructus Amomi Rotundus soak 0.5 hour with 6 times of water gagings, vapor distillation 2 hours, the volatile oil that obtains adds 8 times of amount betacyclodextrin enclose, left standstill cold preservation 24 hours, filter, oven dry, get volatile oil betacyclodextrin clathrate, be white or off-white powder.Herba Moslae behind the vapor distillation, Herba Eupatorii, Fructus Amomi Rotundus residue and Flos Lonicerae, Pericarpium Arecae add 12 times of water gagings, use water extraction together, extract each 45 minutes 2 times.Extracting solution adopts the concentrating under reduced pressure method, is concentrated into relative density and is 1.15～1.20 clear paste under 60 ℃ condition, with volatile oil betacyclodextrin clathrate mixing.
Increase other medical material in the compound recipe of the present invention,, extract volatile oil or carry out water with Flos Lonicerae, Pericarpium Arecae and carry with Herba Moslae, Herba Eupatorii, Fructus Amomi Rotundus then according to the characteristic and the available research achievements of medical material.Compound preparation of the present invention also contains Radix Scutellariae, Herba Artemisiae Annuae, Folium Perillae, and its preparation method is:
A) preparation of medical material Herba Moslae, Herba Eupatorii, Folium Perillae, Fructus Amomi Rotundus volatile oil: take by weighing each medical material Herba Moslae, Herba Eupatorii, Folium Perillae, Fructus Amomi Rotundus by weight proportion, add 6-10 times of water logging bubble 15-90 minute, with vapor distillation 0.5-6 hour, extract volatile oil, the volatile oil beta-cyclodextrin inclusion compound, to reduce the oxidation in the storage process, rotten and devolatilization, standby after the clathrate drying, be white or off-white powder;
B) preparation of medical material clear paste: last medicinal liquid medicinal residues behind the said extracted volatile oil and the medical material Flos Lonicerae that takes by weighing by weight proportion, Pericarpium Arecae, Radix Scutellariae, Herba Artemisiae Annuae are merged, adding water 4-8 doubly soaked 15-90 minute, add water 8-12 times, decocted 30-60 minute to the medical material amount; Repeat above-mentioned decoction 1-3 time, collecting decoction filters, and filtrate decompression concentrates, and is concentrated into relative density and under 60 ℃ condition is 1.15～1.20 clear paste, and dry back is standby;
C) with above-mentioned spissated clear paste and volatile oil beta cyclodextrin inclusion complex mixing, obtain extract, i.e. the active component of compound preparation of the present invention;
D) active component of above-mentioned compound preparation, excipient direct through conventional operation or that adding is pharmaceutically accepted is made the dosage form of accepting clinically, comprises tablet, capsule, granule, syrup, oral liquid, chewable tablet, oral cavity disintegration tablet, drop pill, soft capsule, injection.
Can differentiate in the following manner by the preparation that the present invention obtains:
(1) get the present invention's product (raw medicinal material or extract) 1g, porphyrize adds dilute hydrochloric acid 1ml and ethyl acetate 20ml, and supersound process 30 minutes filters, and filtrate evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution.Other gets the chlorogenic acid reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2005) test, draw above-mentioned solution 1 μ l and reference substance solution 0.5 μ l, put respectively on same polyamide film, upper solution with toluene-ethyl acetate-formic acid-glacial acetic acid-water (1: 15: 1: 1: 2) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.Show that the present invention's product contain chlorogenic acid.
2) get the present invention's product (raw medicinal material or extract) 2.5g, porphyrize is put in the 250ml round-bottomed flask, add water 100ml, mixing connects volatile oil extractor, add water to scale from the determinator upper end, and till overflow goes in the flask, add normal hexane 3ml again, connect reflux condensing tube, be heated to and boil, and keep little and boiled 2 hours, put coldly, divide and get the normal hexane layer as need testing solution.Other gets the eucalyptol reference substance, adds normal hexane and makes the solution that every 1ml contains 10mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2005) test, draw above-mentioned need testing solution 2 μ l and reference substance solution 1 μ l, put respectively on same silica gel g thin-layer plate, with benzene-ethyl acetate (19: 1) is developing solvent, launches, and takes out, dry, spray is heated to clear spot with 5% vanillin sulfuric acid solution at 105 ℃, inspects immediately.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.Show that the present invention's product contain eucalyptol.
Press practice of pharmacy, the extract that the present invention can be obtained can be made into the various clinical pharmaceutical dosage form, medicine as the treatment summer-wet type common cold comprises tablet, capsule, granule, syrup, oral liquid, chewable tablet, oral cavity disintegration tablet, drop pill, soft capsule, injection.
Excipient in the compound preparation of the present invention is meant conventional excipient, as starch, PVP, carboxymethyl starch sodium, mannitol, aspartame, magnesium stearate, sodium benzoate, citric acid, PEG4000 etc.
The compound preparation that the present invention makes is taken three every day.Use HPLC and detect contained chlorogenic acid, content is no less than 30mg in the preparation of at every turn taking, and chlorogenic acid is no less than 90mg in the every day dose.The chromatographic condition that detects is: be filler with the octadecylsilane chemically bonded silica; With acetonitrile-0.4% phosphoric acid solution (13: 87) is mobile phase; The detection wavelength is 327nm.Number of theoretical plate calculates by the chlorogenic acid peak should be not less than 1000.
Compound preparation of the present invention is a natural product, has no side effect, and has to deliver to drive away summer heat, the clearing away heat and eliminating dampness effect is used for the treatment of the heating that summer-heat damp cold causes, antiperspirant is few, micro evil wind, dizzy and headache, vague aching of limbs or pain, restlessness and thirst, turbid nasal discharge, cough with ropy sputum, oliguria yellow skin, red tongue with thin and yellow fur is greasy, symptoms such as soft and rapid pulse.We's collection has the expelling summer-heat of delivering, and two kinds of effects of clearing heat and expelling damp are specially adapted to summer-heat damp cold, and carry out reasonable formula according to theory of Chinese medical science and on the basis of modern pharmacology research, give full play to the comprehensive function of each medical material, obviously be better than the single effect of existing product, have novelty.
Compound preparation with preparation method preparation of the present invention can fully extract the fat-soluble and water miscible effective ingredient in the Chinese crude drug, uses beta-cyclodextrin inclusion compound volatile oil, has improved the utilization rate and the stability of volatile oil.Preparation technology of the present invention shows that through the research of beta-cyclodextrin inclusion compound technology the ratio in volatile oil and beta-schardinger dextrin-is the inclusion rate height of 1: 4～1: 16 the interior enclose of scope, and taste is preferable.Can also on the basis of five tastes principal agent, suitably increase other medical material in the prescription, to strengthen the curative effect of this compound recipe.
Use prescription of the present invention, in clinical, the treatment summer-wet type common cold is obtained effect preferably by the medicinal application after the prepared of the present invention.Include case 30 examples in by the diagnosis standard, male's 11 examples wherein, women's 19 examples, the age 18～67 (average 38.13 ± 15.27), fall ill to consultation time be 12 hours～10 days (average 3.73 ± 2.44), body temperature 37.2-39 ℃, whole dialectical genus syndrome of summer-heat-dampness.After taking 3 days, symptom obviously alleviates, even alleviates fully.Its main symptom (heating, feeling of fullness in the head, watery nasal discharge) all disappears, and fever time is 12 hours～3 days, and the feeling of fullness in the head extinction time is 1～3 day, and watery nasal discharge, limb acid, symptom such as feel sick obviously alleviate.
The doing well,improving situation sees Table 1 before and after the treatment.
Table 1: doing well,improving situation before and after the treatment
The back comprehensive therapeutic effect of taking medicine is evaluated, and cure rate is 40%, and obvious effective rate is 40%, and effective percentage is 20%, and total effective rate reaches 100%.Wherein the relation of syndrome integration and comprehensive therapeutic effect sees Table 2.
The relation of table 2 syndrome integration and comprehensive therapeutic effect
All case is all taken medicine on request, and untoward reaction does not take place.Model case:
Liu * * the 67 12 first visit times of numbering of women: on August 7th, 2005
Main suit: low grade fever, feeling of fullness in the head 2 days.
History of present illness: nearly 2 days low grade fever of patient, feeling of fullness in the head is as wrapping up in, and companion's cardiopalmus is uncomfortable in chest, cough watery nasal discharge, limb aching pain.Poor appetite, big dry stool, red tongue, tongue is greasy in vain, soft and rapid pulse.
Check: T:37.5 ℃, P:90 time/minute, R:18 time/minute.BP:120mmHg, pharyngeal congestion, tonsil is little, auscultation of lung: feminine gender
Lab testing: routine blood test: WBC:4.7 * 10
9/ L, N:70%.
Rabat: feminine gender.
Total mark before the treatment: 18 minutes.
Treat check after 3 days: body temperature is normal, and all cards all disappear.
Treatment back total mark: 0 minute.
Efficacy determination: recovery from illness.
The extract that obtains by preparation method of the present invention, it has following pharmacological action by animal and external antibacterium, antiviral evidence, has obtained beyond thought effect:
1. refrigeration function causes that to yeast rat and Typhoid Vaccine cause that the fervescence of rabbit all has the obvious suppression effect, points out this medicine that tangible refrigeration function is arranged.
2. antivirus action in vitro tests: select the common virus relevant for use, show, to influenza virus A 3 type (A by test with respiratory tract infection
3), Parainfluenza type 1 virus (HVJ), respiratory syncytial virus (RSV), (HSV-1 HSV-2) all demonstrates certain inhibitory action to herpes simplex virus types 1 and 2, and is wherein stronger to influenza virus A 3 type inhibitory action.In vivo test shows that the pneumonia that the influenza virus infecting mouse is caused all has the obvious suppression effect, and lung ponderal index value obviously reduces, weight increase, and pathological examination results shows, obviously suppresses mice interstitial lung inflammatory cell infiltration, improves the lung tissue pathological changes; Death due to the influenza virus infecting mouse there is significant protective effect, can obviously prolongs the mice time-to-live.
3. the bacteriostasis in vitro tests shows that the 56 kinds of bacterial strains of 6 kinds of antibacterials to being tried all have inhibitory action in various degree; In vivo test is the result show, staphylococcus aureus is caused dead mouse certain inhibition trend.
4. immunoregulation effect can obviously improve the reticuloendothelial system phagocytic function of virus infected mice, improves T lymphocyte rate of dyeing and the secreted antibody amount of antibody forming cell.
5. antiinflammatory action can significantly suppress the mouse peritoneal capillary permeability that acetic acid causes and increases; Obviously alleviate Oleum Tiglii induced mice ear swelling.
6. analgesic activity pain that chemical stimulation is brought out has obvious inhibitory action.
(4) specific embodiments:
Below, with reference to subsidiary embodiment the present invention being described in more detail, these embodiment are limitation of the present invention anything but.
Embodiment 1
Prescription: extracting honeysuckle: Herba Moslae: Herba Eupatorii: Fructus Amomi Rotundus: the weight ratio of Pericarpium Arecae 7: 2: 2: 2: 4 medical material;
Preparation method: (1) is got above-mentioned medical material Herba Moslae, Herba Eupatorii, Fructus Amomi Rotundus and is added 6～10 times of water loggings bubbles 15～90 minutes, with vapor distillation 0.5～6 hour, extract volatile oil, the volatile oil beta-cyclodextrin inclusion compound, the consumption weight ratio of volatile oil and beta-schardinger dextrin-is: 1: 4～1: 16, standby after the clathrate drying that obtains, be white or off-white powder;
(2) the last medicinal liquid medicinal residues of step (1) and medical material Flos Lonicerae, Pericarpium Arecae were soaked 15～90 minutes, boiled 30～60 minutes with 8～10 times of decoctings, decoct 1～3 time, each 30～60 minutes, collecting decoction, filter, concentrating under reduced pressure is concentrated into relative density and is 1.15～1.20 clear paste under 60 ℃ of conditions;
(3) volatile oil beta cyclodextrin inclusion complex that makes after the clear paste that step (2) is made and step (1) drying mixes, and obtains extract.
Embodiment 2
Prescription: extracting honeysuckle: Herba Moslae: Herba Eupatorii: Fructus Amomi Rotundus: the weight ratio of Pericarpium Arecae 15: 5: 5: 4: 9 medical material;
Preparation method is with embodiment 1.
Embodiment 3
Prescription: extracting honeysuckle: Herba Moslae: Herba Eupatorii: Fructus Amomi Rotundus: the weight ratio of Pericarpium Arecae 10: 3: 3: 3: 6 medical material;
Preparation method is with embodiment 1.
Embodiment 4
Prescription: extracting honeysuckle: Herba Moslae: Herba Eupatorii: Radix Scutellariae: Herba Artemisiae Annuae: Folium Perillae: Fructus Amomi Rotundus: the weight ratio of Pericarpium Arecae 10: 3: 3: 4: 2: 2: 3: 6 medical material;
Preparation method: (1) is got above-mentioned medical material Herba Moslae, Herba Eupatorii, Folium Perillae, Fructus Amomi Rotundus and is added 6～10 times of water loggings bubbles 15～90 minutes, with vapor distillation 0.5～6 hour, extract volatile oil, the volatile oil beta-cyclodextrin inclusion compound, the consumption weight ratio of volatile oil and beta-schardinger dextrin-is: 1: 4～1: 16, standby after the clathrate drying that obtains, be white or off-white powder;
(2) the last medicinal liquid medicinal residues of step (1) and medical material Flos Lonicerae, Pericarpium Arecae, Radix Scutellariae, Herba Artemisiae Annuae were soaked 15～90 minutes, boiled 30～60 minutes with 8～10 times of decoctings, decoct 1～3 time, each 30～60 minutes, collecting decoction, filter, concentrating under reduced pressure is concentrated into relative density and is 1.15～1.20 clear paste under 60 ℃ of conditions;
(3) volatile oil beta cyclodextrin inclusion complex that makes after the clear paste that step (2) is made and step (1) drying mixes, and obtains extract.
Embodiment 5
Prescription: extracting honeysuckle: Herba Moslae: Herba Eupatorii: Radix Scutellariae: Herba Artemisiae Annuae: Folium Perillae: Fructus Amomi Rotundus: the weight ratio of Pericarpium Arecae 7: 2: 2: 3: 2: 2: 2: 4 medical material;
Preparation method is with embodiment 4.
Embodiment 6
Prescription: extracting honeysuckle: Herba Moslae: Herba Eupatorii: Radix Scutellariae: Herba Artemisiae Annuae: Folium Perillae: Fructus Amomi Rotundus: the weight ratio of Pericarpium Arecae 15: 5: 5: 6: 5: 5: 4: 9 medical material;
Preparation method is with embodiment 4.
Embodiment 7 extracts of the present invention are prepared into granule
Granule prescription: extract 610 grams, mannitol 368 grams, aspartame 22 grams, system 1000g granule
Granule technology: extract 610 grams of the present invention mix with mannitol and aspartame, granulate, and promptly obtain brown granular; Gas perfume (or spice), it is sweet to distinguish the flavor of.
Usage and consumption: use warm boiled water, each 3～5 grams, 3 times on the one.
Embodiment 8 extracts of the present invention are prepared into tablet
Tablet formulation: extract 610 grams, mannitol 90 grams, magnesium stearate 1 gram is made 1000
Tablet technology: extract 610 grams of the present invention are granulated with mannitol, add the magnesium stearate mixing, tabletting, bag film-coat; Show sepia, gas perfume (or spice) after removing film-coat.
Usage and consumption: oral, each 3～5,3 times on the one.
Embodiment 9 extracts of the present invention are prepared into oral solutions
The oral solutions prescription: clear paste 180 grams, volatile oil clathrate compound 60 grams, aspartame 1 gram, sodium benzoate 2.5g makes 1000 milliliters.
Oral solutions technology: the present invention extracts clear paste 180 grams, adds clarifier, staticly settles, and filters, and filtrate adds aspartame, adds volatile oil clathrate compound 60 grams of the present invention, sodium benzoate, transfers pH4.0～6.0, adds water to ormal weight, stir evenly, and fill, promptly.Be rufous liquid, gas perfume (or spice), the flavor sweet.
Usage and consumption: each 7～12 milliliters, 3 times on the one.
Embodiment 10 extracts of the present invention are prepared into syrup:
The syrup prescription: clear paste 180 grams, volatile oil clathrate compound 60 grams, simple syrup 450 grams, sodium benzoate 2.5 grams, citric acid is an amount of
Syrup technology: the present invention extracts clear paste 180 grams, adds simple syrup and boils, and puts cold rnning and goes into volatile oil clathrate compound 60 grams, sodium benzoate, citric acid, adds water to ormal weight, transfers pH4.0～6.0,, stir evenly, fill, promptly.Be rufous liquid, gas perfume (or spice), the flavor sweet.
Usage and consumption: each 7～12 milliliters, 3 times on the one.
Embodiment 11 extracts of the present invention are prepared into capsule:
Tablet formulation: extract 610 grams, make 1000
Tablet technology: extract 610 gram capsule charges of the present invention; Content shows sepia, gas perfume (or spice).
Usage and consumption: oral, each 3～5,3 times on the one.
Embodiment 12 extracts of the present invention are prepared into soft capsule:
Soft capsule prescription: extract 610 grams, glycerol: gelatin: water=0.5: 1: 1 is rubber
Soft capsule technology: with extract 610g mixing of the present invention, with glycerol: gelatin: water=0.5: 1: 1 is rubber, makes soft capsule.Content is the sepia paste; Gas perfume (or spice), mildly bitter flavor.
Usage and consumption: oral, each 3～5,3 times on the one.
Embodiment 13 extracts of the present invention are prepared into chewable tablet
Chewable tablet prescription: extract 610 grams, lactose 140 grams, aspartame 10 grams, mannitol 40 grams
Chewable tablet technology: extract 610 grams, add lactose, aspartame, mannitol, granulate tabletting.Be brown tablet, gas perfume (or spice), it is sweet to distinguish the flavor of.
Usage and consumption: oral, each 3～5,3 times on the one.
Embodiment 14 extracts of the present invention are prepared into drop pill:
Pill prescription: extract 407 grams, PEG4000593 gram
Dropping pill technique: the PEG4000 heating for dissolving, the extract of adding, molten loosing splashes in the coolant fluid paraffin body.
Usage and consumption: oral, each 5～8 grams, 3 times on the one.
The extract drug effect result that embodiment 15 embodiment of the invention 1-4 obtain relatively
Yeast is caused the influence of heating rat temperature
Method is got 60 of healthy rats, be divided into 5 groups at random by body weight, test elder generation in morning on the same day surveys animal basis anus temperature, fresh yeast solution back subcutaneous injection pyrogenicity with 10%, 2ml/100g surveys the anus temperature after 3.5 hours, the anus temperature rise more than 0.8 ℃ the person be used for test, with anus temperature rise value adjustment grouping, 10 every group.Each group is irritated stomach respectively and is given relative medicine, and model control group is irritated the distilled water that stomach gives equal volume.Respectively surveyed the anus temperature once in 1,2,4,6 hour behind the medicine, totally 4 times, surveyed anus temperature and basic anus using warming therapy difference with different time, as the index of body temperature variation.Carry out statistical procedures with the t check.
The influence of table 3 pair yeast pyrogenicity rat temperature
The influence (n=10) of table 4 pair yeast pyrogenicity rat temperature
Annotate: compare with model control group
*P＜0.05
*P＜0.01
The result shows: each extract all has the effect that the inductive body temperature of significant reduction yeast increases, and wherein the extract that obtains of embodiment 4 is good than the drug effect of other extract.Show that the three flavor medical materials that increased have the collaborative effect that increases curative effect.
The pharmacodynamic study of the extract of embodiment 16 the present invention preparation
1, refrigeration function
1.1 vaccine is caused the influence of fever in rabbit body temperature
Method is got healthy rabbits, in testing the normal rectal temperature of before measurement 2 times.Selecting the anus temperature to differ 0.4 ℃ 38.5-39.2 ℃ and twice temperature is for experiment with interior animal.Test is established 5 groups altogether, is respectively model control group, positive control drug YUYE JIEDU KELI group, high, medium and low (3.6,1.8, three dosage groups of 0.9g crude drug/kg), 8 every group.Morning on the same day was surveyed animal basis anus temperature earlier in test, was injected by tame rabbit ear vein with the typhoid Vi polysaccharide vaccine of 0.5ml/kg, after 0.5 hour, surveyed anus temperature rise value, and each group of grouping back is irritated stomach respectively and given relative medicine, and model control group is irritated the distilled water of stomach with volume.Behind the medicine 0.5 and per hour respectively survey the anus temperature once, totally 4 times, surveyed anus temperature and basic anus using warming therapy difference with different time, be the body temperature changing value.
The influence of table 5 pair vaccine pyrogenicity rabbit body temperature
Annotate: number of animals is 8; Compare with model control group
*P＜0.05
*P＜0.01
Table 5 result shows as a result, and extract of the present invention institute amount of reagent causes that to Typhoid Vaccine the fervescence of rabbit has inhibition effect in various degree, and the prompting medicine has significantly refrigeration function.
2. antivirus action
Method is got the 13-15g mice, is divided into 7 groups at random by body weight, is respectively the normal control group, model control group, high, medium and low three the dosage groups of embodiment 4 extracts, positive control drug ribavirin granule and YUYE JIEDU KELI group, 10 every group.Except that the normal control group, mice is slightly anaesthetized with ether, with 15LD
50Influenza virus liquid (FM
1) the collunarium infection, every 0.05ml.Begin administration, every day 2 times, continuous 5 days the previous day from infecting.Fix after taking by weighing the mice body weight on the 6th day, blood-letting, dissection are won full lung and are weighed (10% formaldehyde fixed send the pathology chamber to check), calculate lung ponderal index value one by one, and obtain lung index suppression ratio.
The influence of table 6 pair mice influenza virus property pneumonia (X ± SD)
Compare with the infection matched group
*P＜0.05,
*P＜0.01
The influence of the susceptible toxicity pneumonia of table 7 convection current mouse lung inflammation (pathological observation)
Annotate: H 0.01=71, H 0.05=78.
Extract of the present invention as a result all has the obvious suppression effect to the pneumonia that the influenza virus infecting mouse causes, lung ponderal index value obviously reduces, weight increase, and pathological examination results shows, obviously suppresses mice interstitial lung inflammatory cell infiltration, improves the lung tissue pathological changes; Death due to the influenza virus infecting mouse there is significant protective effect, can obviously prolongs the mice time-to-live.
3. bacteriostasis
To the deadly protective effect of dying of bacterial infection mice
Method is got the 16-18g healthy mice, is divided into 5 groups at random by body weight, is respectively the antibacterial matched group, the high, medium and low dosage group of embodiment 4 extracts, positive control drug penicillin sodium group.Bacterial infection beginning in preceding 72 hours administration, every day 2 times, infect the same day, staphylococcus aureus has been increased 18 hours culture of bacterium, suitably dilute (with the minimum bacterial concentration that causes the 70-90% dead mouse bacterial concentration) with 5% dry yeast suspension, press 0.5ml/20g body weight lumbar injection, observe and add up animal dead number in 72 hours as infecting mouse, calculate survival rate, with X
2Carry out statistical procedures, relatively between administration group and the antibacterial matched group there was no significant difference is arranged.
The dead protective effect of table 8 pair bacterial infection mice
Compare with the antibacterial matched group
*P＜0.01
Result of the test shows as a result, and extract of the present invention can reduce the infection of staphylococcus aureus mortality of mice, presents certain antibacterial trend, but compares P＞0.05 (＜0.1) with the bacterial infection matched group, there was no significant difference.
4. immunoregulation effect
4.1 influence to the mouse cell immunity
Adopt T lymphocyte esterase staining to get the 13-15g mice and be divided into 6 groups at random by body weight, be respectively three dosage groups of normal control group, virus control group, embodiment 4 extracts (12.0,6.0,3.0g/kg), positive control drug YUYE JIEDU KELI group, 10 every group.Except that the normal control group, mice is slightly anaesthetized with ether, with 15LD
50Influenza virus liquid (FM
1) the collunarium infection, every 0.05ml.Begin administration, every day 2 times, continuous 5 days the previous day from infecting.Behind the 6th day last medicine 1 hour, the socket of the eye venous plexus was got blood to microscope slide, and esterase dyeing is measured lymphocytic esterase dyeing rate.
The influence of table 9 pair mouse cell immunity
Compare with the virus control group
*P＜0.05
*P＜0.01
Table 9 result shows as a result, and the normal matched group of infection group and viral infection group T lymphocyte rate of dyeing significantly reduces (p＜0.01), and extract of the present invention institute amount of reagent can improve T lymphocyte rate of dyeing in various degree.
4.2 influence to mouse humoral immune
The quantitative haemolysis algoscopy of employing Mianyang erythrocyte (SRBC) is got the 13-15g mice and is divided into 6 groups at random by body weight, be respectively three dosage groups of normal control group, virus control group, embodiment 4 extracts (12.0,6.0,3.0g/kg), positive control drug YUYE JIEDU KELI group, 10 every group.Except that the normal control group, mice is slightly anaesthetized with ether, with 15LD
50Influenza virus liquid (FM
1) the collunarium infection, every 0.05ml.Begin administration, every day 2 times, continuous 5 days the previous day from infecting.Administration the 2nd day is with 2 * 10
9SRBC tail vein injection sensitization.Eyeball blood-letting in the 6th day, put to death mice, take out spleen and take by weighing 30mg, the preparation splenocyte suspension, 3000 rev/mins, 10 minutes are centrifugal, sedimentation cell, add RPMI-1640 solution to 2.0ml, take out above-mentioned splenocyte liquid 0.5ml in another set of test tube, add 0.2%SRBC liquid 0.5ml and fresh GPC (1: 10) 0.5ml.Temperature was bathed 1 hour behind the mixing, and is centrifugal, gets supernatant and measure haemolysis OD value under the 413nm wavelength, and organize a t check.
The influence of table 10 pair mouse humoral immune
Compare with the virus control group
*P＜0.05
*P＜0.01
The result can find out that from table 10 viral infection matched group SRBC haemolysis value obviously reduces, and high after the administration, middle dosage group makes its obvious raising.Show that extract of the present invention can increase the secreted antibody amount of antibody forming cell, has tangible regulating action to mouse humoral immune.
5. antiinflammatory action
The method mice is by the body weight random packet, is respectively three dosage groups of model control group, embodiment 4 extracts (12.0,6.0,3.0g/kg), positive control drug YUYE JIEDU KELI group, 10 every group.Each group is gastric infusion respectively, and model control group gives the distilled water of equal volume.Behind the medicine 1 hour, be applied to two sides before and after the left ear with 2% Oleum Tiglii 0.05ml, auris dextra compares, and causes scorching back 4 hours mice is put to death, and cuts two ears along the auricle baseline, sweeps away auricle with the rustless steel punching pin of diameter 6mm respectively at same position, uses scales/electronic balance weighing.Weight difference with left and right sides auricle is the swelling value, with the t check, carries out group difference relatively.
The inhibitory action of table 11 pair mouse ear edema
Compare with model control group
*P＜0.05,
*P＜0.01
Three dosage groups of extract of the present invention as a result cause mice ear to Oleum Tiglii all in various degree inhibitory action.
6. analgesic activity
Get the 18-20g mice, by the body weight random packet, be respectively three dosage groups of model control group, embodiment 4 extracts (12.0,6.0,3.0g/kg), positive control drug YUYE JIEDU KELI group.Each group is gastric infusion respectively, and model control group gives the distilled water of equal volume.Behind the medicine 1 hour, inject 0.7% acetic acid by the 0.1ml/10g mouse peritoneal, observe after 5 minutes and typically turn round body number of times (stretching hind leg, abdominal part contraction and distortion health) in 15 minutes, will turn round the body number of times and carry out statistical procedures, and calculate the slip that the administration group is turned round the body number of times with the t check.
The analgesic activity (writhing method) of table 12 pair mice (X ± SD)
Annotate: compare with model control group
*P＜0.05
Table 12 result shows as a result, and three dosage groups of extract of the present invention all can obviously reduce mice and cause the incidence rate of turning round body because of acetic acid stimulates, and illustrate that the pain that chemical irritation is caused has the obvious suppression effect.
Claims (11)
1. compound preparation that is used for the treatment of summer-wet type common cold, it is characterized in that it is to be made by following medicinal materials: Flos Lonicerae, Herba Moslae, Herba Eupatorii, Fructus Amomi Rotundus, Pericarpium Arecae, the weight ratio 7～15: 2～5: 2～5: 2～4: 4～9 of medical material Flos Lonicerae, Herba Moslae, Herba Eupatorii, Fructus Amomi Rotundus, Pericarpium Arecae.
2. a kind of compound preparation that is used for the treatment of summer-wet type common cold according to claim 1, the weight ratio that it is characterized in that medical material Flos Lonicerae, Herba Moslae, Herba Eupatorii, Fructus Amomi Rotundus, Pericarpium Arecae is 10: 3: 3: 3: 6.
3. the preparation method of compound preparation according to claim 1 and 2 is characterized in that comprising the following steps:
A) preparation of medical material Herba Moslae, Herba Eupatorii, Fructus Amomi Rotundus volatile oil: take by weighing each medical material Herba Moslae, Herba Eupatorii, Fructus Amomi Rotundus by weight proportion, add 6-10 times of water logging bubble 15-90 minute, use vapor distillation 0.5-6 hour, extract volatile oil, the volatile oil beta-cyclodextrin inclusion compound, dry back is standby;
B) preparation of medical material clear paste: last medicinal liquid medicinal residues behind the said extracted volatile oil and the medical material Flos Lonicerae that takes by weighing by weight proportion, Pericarpium Arecae are merged, add 4～8 times of amounts of water, soaked 15-90 minute, add water to medical material amount 8-12 doubly, decocted 30-60 minute; Repeat above-mentioned decoction 1-3 time, collecting decoction filters, and filtrate decompression concentrates, and is concentrated into relative density and under 60 ℃ condition is 1.15～1.20 clear paste, and dry back is standby;
C) with above-mentioned spissated clear paste and volatile oil beta cyclodextrin inclusion complex mixing, obtain extract, be the active component of compound preparation;
D) active component of above-mentioned compound preparation, excipient direct through conventional operation or that adding is pharmaceutically accepted is made acceptable forms clinically.
4. the preparation method of compound preparation according to claim 3, the consumption weight ratio that it is characterized in that volatile oil and beta-schardinger dextrin-is 1: 4～1: 16.
5. the preparation method of compound preparation according to claim 3 is characterized in that the clear paste that will extract adding adjuvant, adds volatile oil clathrate compound and the adjuvant that makes again, adds water, stirs evenly, and fill promptly makes syrup or oral liquid formulations.
6. compound preparation that is used for the treatment of summer-wet type common cold, it is characterized in that it is to be made by following medicinal materials: Flos Lonicerae, Herba Moslae, Herba Eupatorii, Fructus Amomi Rotundus, Pericarpium Arecae, Radix Scutellariae, Herba Artemisiae Annuae, Folium Perillae, the weight ratio 7～15: 2～5: 2～5: 3～6: 2～5: 2～5: 2～4: 4～9 of medical material Flos Lonicerae, Herba Moslae, Herba Eupatorii, Radix Scutellariae, Herba Artemisiae Annuae, Folium Perillae, Fructus Amomi Rotundus, Pericarpium Arecae.
7. a kind of compound preparation that is used for the treatment of summer-wet type common cold according to claim 6 is characterized in that the weight ratio of medical material Flos Lonicerae, Herba Moslae, Herba Eupatorii, Radix Scutellariae, Herba Artemisiae Annuae, Folium Perillae, Fructus Amomi Rotundus, Pericarpium Arecae was respectively 10: 3: 3: 4: 2: 2: 3: 6.
8. according to the preparation method of claim 6 or 7 described compound preparations, it is characterized in that comprising the following steps:
A) preparation of medical material Herba Moslae, Herba Eupatorii, Folium Perillae, Fructus Amomi Rotundus volatile oil: take by weighing each medical material Herba Moslae, Herba Eupatorii, Folium Perillae, Fructus Amomi Rotundus by weight proportion, add 6-10 times of water logging bubble 15-90 minute, with vapor distillation 0.5-6 hour, extract volatile oil, the volatile oil beta-cyclodextrin inclusion compound, dry back is standby;
B) preparation of medical material clear paste: last medicinal liquid medicinal residues behind the said extracted volatile oil and the medical material Flos Lonicerae that takes by weighing by weight proportion, Pericarpium Arecae, Radix Scutellariae, Herba Artemisiae Annuae are merged, add 4～8 times of amounts of water, soaked 15-90 minute, and added water to medical material amount 8-12 doubly, decocted 30-60 minute; Repeat above-mentioned decoction 1-3 time, collecting decoction filters, and filtrate decompression concentrates, and is concentrated into relative density and under 60 ℃ condition is 1.15～1.20 clear paste, and dry back is standby;
C) with above-mentioned spissated clear paste and volatile oil beta cyclodextrin inclusion complex mixing, obtain extract, be the active component of compound preparation;
D) active component of above-mentioned compound preparation, excipient direct through conventional operation or that adding is pharmaceutically accepted is made acceptable forms clinically.
9. the preparation method of compound preparation according to claim 8 is characterized in that the clear paste that will extract adding adjuvant, adds volatile oil clathrate compound and the adjuvant that makes again, adds water, stirs evenly, and fill promptly makes syrup or oral liquid formulations.
10. the preparation method of compound preparation according to claim 8, the consumption weight ratio that it is characterized in that volatile oil and beta-schardinger dextrin-is 1: 4～1: 16.
11., it is characterized in that being no less than 1.0g in the chlorogenic acid in every 100g extract according to claim 1 or 2 described a kind of compound preparations for the treatment of summer-wet type common cold.
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| CN101199784B (en) * | 2007-12-13 | 2011-03-23 | 凌志贤 | Chinese medicine agent for treating wean summer-heat wet stone furuncle |
| CN102671018B (en) * | 2012-05-02 | 2013-07-31 | 山东省立医院 | Medicament for treating hot cold |
| CN113521210B (en) * | 2020-04-17 | 2024-04-16 | 天士力医药集团股份有限公司 | Chinese medicinal composition containing herba Moslae |
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| CN1650930A (en) * | 2004-11-26 | 2005-08-10 | 广州康采恩医药有限公司 | Oral agent for relieving summer heal and its preparation method |
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Address after: 312500 Zhejiang city of Shaoxing province Xinchang County Mei Zhu Zhen Xing Mei Road No. 68 Patentee after: ZHEJIANG QIANJIN PHARMACEUTICAL Co.,Ltd. Address before: 310023 Xixi Road, Zhejiang, China, No. 950, No. Patentee before: Hangzhou Advance Pharmaceutical Co.,Ltd. |
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