CN102397481B - Medicinal preparation for wind dispelling and heat dissipating and preparation method thereof - Google Patents
Medicinal preparation for wind dispelling and heat dissipating and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a medicinal preparation for wind dispelling and heat dissipating and a preparation method thereof. The medicinal preparation comprises the following twelve traditional Chinese medicines: honeysuckle flower, Japanese honeysuckle stem, mint, Herba Schizonepetae, rehmannia, Weeping Forsythia, Platycodon grandiflorus, Fructus Arctii, cape jasmine, licorice, Fermented Soybean and Lophatherum gracile. According to the invention, honeysuckle flower is individually extracted, so the medicine recovery rate is improved, the cost is saved, and the medicinal effect is increased; medicinal materials of cape jasmine, rehmannia and Japanese honeysuckle stem are extracted with processes of ethanol heating reflux and macroporous resin adsorption, so a large amount of impurities of tannins, proteins and the like in the three medicines are effectively removed, the loss rate of an effective component alkaloid in the three medicines is reduced, and the purification and the refinement are more fully carried out; and five medicines of Fructus Arctii, Fermented Soybean, Lophatherum gracile, Platycodon grandiflorus and licorice are decocted with water to extract and are decolored by active carbon, so impurities in the five medicines are effectively removed. The medicinal preparation for wind dispelling and heat dissipating, which is prepared with the preparation method disclosed in the invention, has the advantages of refinement, high biological availability, substantial medicinal effect, and suitableness of the industrialization production.
Description
Technical field
The present invention relates to pharmaceutical composition of a kind of wind-dispelling heat-dissipating and preparation method thereof, belong to the field of Chinese medicines.
Background technology
Lonicerae and Forsythiae Powder is " Wenbing Tiaobian, Detailed Analysis of Epidemic Warm Diseases " first party, cures mainly the exterior syndrome due to pathogenic wind-warm, the pathogenic factor such as warm invasion and attack pulmonarys.Wind-dispelling heat-dissipating capsules is the Chinese medicine capsules through being processed on the basis of conventional Chinese medicine prescription Lonicerae and Forsythiae Powder, now takes in the 12 of " the Sanitation Ministry medicine standard " Traditional Chinese medicine historical preparation.By Flos Lonicerae, Caulis Lonicerae, Herba Menthae, Herba Schizonepetae, Radix Rehmanniae, Fructus Forsythiae, Radix Platycodonis, Fructus Arctii, Fructus Gardeniae, Radix Glycyrrhizae, Semen Sojae Preparatum, Herba Lophatheri totally ten two the flavor Chinese medicines form, effect with heat-clearing and toxic substances removing, wind-dispelling heat-dissipating, the treatment of be used for anemopyretic cold, fever and headache, cough xerostomia, having sore throat.
Flos Lonicerae, Fructus Forsythiae relieving the exterior syndrome with drugs of pungent in flavor and cool in nature in the prescription of wind-dispelling heat-dissipating, heat-clearing and toxic substances removing is monarch drug.It is ministerial drug that Herba Menthae, Fructus Arctii, Herba Schizonepetae, Semen Sojae Preparatum help Flos Lonicerae, Fructus Forsythiae inducing diaphoresis to expel pathogens.Full side is take inducing diaphoresis to expel pathogens as main, and heat-clearing and toxic substances removing is auxiliary, can be rated as the side of relieving the exterior syndrome with drugs of pungent in flavor and cool in nature classics.Allly experience the caused diseases of pathogen such as pathogenic wind-warm is damp and hot, winter-warm syndrome, show as that micro evil wind is cold, heating, spontaneous perspiration, headache, thirsty or thirsty and cough, floating and rapid pulse, tongue fur be white, belongs to the anemopyretic person, all available we's treatments, respond well.
Flos Lonicerae is caprifoliaceae plant Radix Ophiopogonis and the dry flower that belongs to various plants together, is traditional Chinese medical science common medicine, and function is heat-clearing and toxic substances removing, cool dispersing wind and cold.Along with deepening continuously of chemical composition and modern pharmacology effect research, Flos Lonicerae and congener Content of Chlorogenic Acid class (comprising chlorogenic acid and isochlorogenic acid) thereof, flavonoid, triterpene saponin, iridoids, volatilization wet goods compound are proved to be its effective ingredient, have multiple pharmacological effect.
Fructus Forsythiae has another name called yerbadetajo seed (" property of medicine opinion "), sticks up son (" Newly Revised Canon of Materia Medica ") greatly, is the dry fruit of Oleaceae plants Fructus Forsythiae.Bitter in the mouth is slightly cold, and returns lung, the heart, small intestine meridian, has the effect of heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, and chemical composition mainly contains phenethyl alcohol glycosides, lignan and glycoside thereof, pentacyclic triterpene, volatile oil.Staphylococcus aureus, Hemolytic streptococcus, Diplococcus pneumoniae, bacillus pyocyaneus, Bacillus typhi etc. had antibacterial action; Some funguses, virus all there is inhibitory action in various degree; And, singultus hemorrhage to acute nephritis, pulmonary tuberculosis, macula retinae district, constipation etc. all tool have certain effect; The effects such as Fructus Forsythiae also has that the town tells in addition, analgesic, antiinflammatory and liver protecting.Its Volatile Oil from Seed also has antibiotic, antiviral activity.
Chlorogenic acid is a kind of phenylpropanoids that plant forms through shikimic acid pathway in the aerobic respiration process, belong to phenolic acid compound, having the effects such as antibiotic, antiviral, leukocyte increasing, hepatic cholagogic, antitumor, blood pressure lowering, blood fat reducing, is one of main effective ingredient of Flos Lonicerae, Caulis Lonicerae leaf.
Fructus Gardeniae is the dry mature fruit of Maguireothamnus speciosus Fructus Gardeniae.Be clinical conventional Chinese medicine, main product in the Hunan, Jiangxi provinces, also there is a small amount of distribution in Sichuan, Hubei, Zhejiang, Fujian, Guangdong, Guangxi, Guizhou Province etc.Its nature and flavor are bitter, and are cold.GUIXIN, lung, tri-jiao channel.Has the pathogenic fire purging relieving restlessness, clearing away heat and promoting diuresis, the effect of removing pathogenic heat from blood and toxic substance from the body.Pharmacology report jasminoidin is the main active of Fructus Gardeniae, has the effects such as antiinflammatory, analgesic, function of gallbladder promoting, and Fructus Gardeniae is rich in the pigment composition.
The main component of Radix Rehmanniae is glycoside, saccharide and aminoacid, and take glycoside as main, in glycoside again take iridoid glycoside as main.Isolated 32 kinds of iridoid glycoside compounds from Radix Rehmanniae a few days ago, wherein the highest with catalpol content.
Existing method for making is: above 12 flavors, get Radix Platycodonis 15g, Radix Glycyrrhizae 15g mixing porphyrize powder is standby.Herba Menthae, Herba Schizonepetae, Fructus Forsythiae are first carried the another device of volatile oil and are preserved, and medicinal residues and all the other medical material water extractions 2 times are got the thick paste that filtrate is concentrated into relative density 1.30 (80 ℃), let cool, receive cream with powder, drying is pulverized, and adds the volatile oil such as Herba Menthae, encapsulated, make 500, and get final product.
In above method for making, the monarch drug Flos Lonicerae is adopted the method for water extraction together with other medical materials, and the extraction of effective ingredient easily is subjected to the interference of other medical materials, causes extraction ratio low; Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae three flavor medical materials adopt the method extracts active ingredients of water-soluble extraction insufficient, and the medical material utilization rate is low; In addition, in existing method for making, after Herba Menthae, Herba Schizonepetae, Fructus Forsythiae extracted volatile oil, medicinal residues and other medical materials only adopted water extraction, very easily introduce impurity.
Summary of the invention
This research staff overcomes existing wind-dispelling heat-dissipating pharmaceutical composition preparation technology's deficiency through long-term research, and a kind of new wind-dispelling heat-dissipating pharmaceutical preparation and preparation method thereof is provided, and the method extraction ratio is high, good stability, instant effect, be easy to long-time preservation.
This preparation comprises capsule, tablet, granule, oral liquid, drop pill, soft capsule etc.The present invention adopts separately the monarch drug Flos Lonicerae and extracts, and the medicinal material extract rate improves, and saves cost, increases drug effect; After Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae medical material use alcohol heating reflux, extract passes through macroporous adsorptive resins again, further separate drug effective ingredient, effectively remove the impurity such as tannins a large amount of in medicine, protein, also can reduce simultaneously the alkaloidal loss rate of effective ingredient in medicine, purification refine is more abundant, extracts more concise; After Fructus Arctii, Semen Sojae Preparatum, Herba Lophatheri, Radix Platycodonis, Radix Glycyrrhizae five tastes medical material water are decocted extraction, adopt decolorizing with activated carbon, reconcentration filters, and effectively removes medical material kind impurity.The wind-dispelling heat-dissipating pharmaceutical preparation of adopting extracting method of the present invention to be prepared from, extraction process is stable, and step is simple, is fit to industrialized great production, and active constituent content is higher, and bioavailability is higher, and is evident in efficacy.
Wind-dispelling heat-dissipating pharmaceutical composition provided by the invention calculates according to composition by weight, is prepared from by following raw material medicaments and adjuvant:
Flos Lonicerae 50-80 part, Fructus Forsythiae 100-160 part, Caulis Lonicerae 50-80 part, Radix Platycodonis 60-96 part, Herba Menthae 60-96 part, Fructus Arctii 60-96 part, Radix Rehmanniae 60-96 part, Herba Lophatheri 40-64 part, Herba Schizonepetae 40-64 part, Fructus Gardeniae 40-64 part, Semen Sojae Preparatum 50-80 part, Radix Glycyrrhizae 50-80 part.
Specifically, calculate according to composition by weight, be prepared from by following raw material medicaments and adjuvant:
68.5 parts of Flos Loniceraes, 137.0 parts of Fructus Forsythiaes, 68.5 parts of Caulis Loniceraes, 82.2 parts of Radix Platycodoniss, 82.2 parts of Herba Menthaes, 82.2 parts of Fructus Arctiis, 82.2 parts of Radix Rehmanniae, 54.8 parts of Herba Lophatheris, 54.8 parts of Herba Schizonepetae, 54.8 parts of Fructus Gardeniaes, 68.5 parts of Semen Sojae Preparatums, 68.5 parts, Radix Glycyrrhizae.
The preparation technology of wind-dispelling heat-dissipating pharmaceutical composition of the present invention is:
(1) Flos Lonicerae section decocts with water, and is concentrated, adds the ethanol precipitation, and decompression recycling ethanol obtains Flos Lonicerae extract;
(2) Herba Menthae, Herba Schizonepetae, Fructus Forsythiae extract volatile oil, and another device stores, and medicinal residues are standby;
(3) Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae alcohol heating reflux merge, and reclaim ethanol, are condensed into thick paste, and concentrated solution is dissolved in water, and upper macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, and be concentrated, filters, and the gained extracting solution is standby;
(4) after Fructus Arctii, Semen Sojae Preparatum, Herba Lophatheri, Radix Platycodonis, Radix Glycyrrhizae five tastes medical material reach the medicinal residues water extraction of (2), adopt decolorizing with activated carbon, reconcentration filters, and gets extractum;
(5) extractum of the extracting solution of the Flos Lonicerae extract of combining step (1), (3) and (4), drying is pulverized, and adds the extraction volatile oil in step (2), mixing.Then add suitable adjuvant, be prepared into the preparation formulation that needs with conventional method.
Specifically, the preparation technology of wind-dispelling heat-dissipating pharmaceutical composition of the present invention is:
(1) Flos Lonicerae section adds the decocting in water 2～4 times of 5～10 times of amounts, each 2～4 hours extraction times, collecting decoction, concentrated, adding 60～75% ethanol, to make pure content be 50～60%, standing 24～60 hours, makes precipitation, merge, reclaim ethanol, decompression recycling ethanol obtains Flos Lonicerae extract;
(2) Herba Menthae, Herba Schizonepetae, Fructus Forsythiae extract volatile oil, and another device stores;
(3) Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae is with 50～75% alcohol heating reflux 3～4 times, the ethanol consumption that reaches later number of times for the 2nd time is 5～15 times of medical material weight, filter, merging filtrate, filtrate is concentrated into that relative density is 1.10～1.30 under 50～70 ℃ of conditions, add ethanol and make that to contain alcohol amount be 50～80%, standing 24～60 hours, make precipitation, merge, reclaim ethanol, be condensed into thick paste, it is 1-5: 5-1 that concentrated solution adds water to every milliliter of ratio with the every gram of medical material amount of volume, upper macroporous adsorbent resin, with 20～80% ethanol elutions, collect eluent, reclaim ethanol, concentrated, filter, standby, merge, reclaim ethanol, be condensed into thick paste, concentrated solution is dissolved in water, and upper macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, and is concentrated, filters, and the gained extracting solution is standby,
(4) medicinal residues of Fructus Arctii, Semen Sojae Preparatum, Herba Lophatheri, Radix Platycodonis, Radix Glycyrrhizae five tastes medical material and (2) add the water of 10～20 times of amounts, extract 3～4 times under 50～60 ℃ of conditions, each 2～4 hours, merge extractive liquid,, add 0.2～0.4% decolorizing with activated carbon 10～15 hours, and filtered merging filtrate, be concentrated into relative density and be 1.10～1.25 extractum, standby;
(5) extractum of the extracting solution of the Flos Lonicerae extract of combining step (1), (3) and (4), drying is pulverized, and adds the extraction volatile oil in step (2), mixing.Then add suitable adjuvant, be prepared into the preparation formulation that needs with conventional method.
In particular, the preparation technology of wind-dispelling heat-dissipating pharmaceutical composition of the present invention is:
(1) Flos Lonicerae section adds the decocting in water 3 times of 8 times of amounts, each 3 hours extraction times, and collecting decoction, concentrated, adding 75% ethanol, to make pure content be 50%, standing 48 hours, make precipitation, merge, reclaim ethanol, decompression recycling ethanol obtains Flos Lonicerae extract;
(2) Herba Menthae, Herba Schizonepetae, Fructus Forsythiae extract volatile oil, and another device stores;
(3) Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae are with 50% alcohol heating reflux 3 times, the ethanol consumption that reaches later number of times for the 2nd time is 10 times of medical material weight, filter, merging filtrate, filtrate is concentrated into that relative density is 1.10～1.30 under 60 ℃ of conditions, add ethanol and make that to contain alcohol amount be 60%, standing 48 hours, make precipitation, merge, reclaim ethanol, be condensed into thick paste, it is 1-3: 3-1 that concentrated solution adds water to every milliliter of ratio with the every gram of medical material amount of volume, upper macroporous adsorbent resin, use 30% ethanol elution, collect eluent, reclaim ethanol, concentrated, filter, standby; Merge, reclaim ethanol, be condensed into thick paste, concentrated solution is dissolved in water, and upper macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, and is concentrated, filters, and the gained extracting solution is standby;
(4) medicinal residues of Fructus Arctii, Semen Sojae Preparatum, Herba Lophatheri, Radix Platycodonis, Radix Glycyrrhizae five tastes medical material and (2) add the water of 15 times of amounts, extract 3 times under 55 ℃ of conditions, each 3 hours, merge extractive liquid,, add 0.3% decolorizing with activated carbon 10 hours, and filtered merging filtrate, be concentrated into relative density and be 1.10～1.25 extractum, standby;
(5) extractum of the extracting solution of the Flos Lonicerae extract of combining step (1), (3) and (4), drying is pulverized, and adds the extraction volatile oil in step (2), mixing.Then add suitable adjuvant, be prepared into the preparation formulation that needs with conventional method.
The present invention adopts the conventional corresponding preparations method of knowing altogether, adds conventional adjuvant, as disintegrating agent, lubricant, binding agent etc., makes various oral formulations, comprises capsule, granule, sheet, drop pill, oral liquid, soft capsule etc.Be preferably capsule.
With the wind-dispelling heat-dissipating pharmaceutical preparation that the inventive method makes, through the discovery that studies for a long period of time, clinical effectiveness is definite, and safety is good, and the medical material effective component extraction rate is high, good stability, be easy to long-time preservation.
In order to make those of ordinary skills better understand the present invention, the applicant has carried out series of experiment research, to prove effect of the present invention:
One, pharmacodynamic study
Experimental example 1 wind-dispelling heat-dissipating medicine of the present invention heat-clearing and toxic substances removing, wind-dispelling heat-dissipating clinical observation test
1.1 material:
1.1.1 medicine:
Preparation of the present invention: be prepared into capsule (pressing embodiment 1 preparation), specification: every dress 0.25g according to preparation method of the present invention.
Contrast medicine 1: make capsule, specification according to the preparation technology under national drug standards WS3-B-2443-97 method for making item: every 0.25g.
Contrast medicine 2: aspirin phenacetin caffeine (Beijing Double-Crane Pharmaceutical Co., Ltd's production), specification: every 0.5g.
1.1.2 subjects: Kunming mouse 18～20g, male and female half and half, the Wistar rat according to different experiments, has 80～100g, male and female half and half.Be purchased from the Guiyang Medical College Experimental Animal Center.
1.2 test method and result
1.2.1 test method
A, to the inhibitory action of mice auricle swelling
40 Kunming kind white mice are divided into experimental group, 1 group of contrast, contrast 2 groups, blank group, 10 every group at random.Preparation of the present invention, contrast medicine 1, contrast medicine 2 are diluted with distilled water into the suspension of 1.0g/ml, give respectively mouse stomach by body weight, experimental group is to preparation of the present invention, dosage is 1200mg/kg, contrast 1 group of administration contrast medicine 1, dosage is 1200mg/kg, contrasts 2 groups to contrast medicine 2, dosage is 1200mg/kg, and the blank group makes blank for 0.9% sodium chloride solution of the capacity of grade.1 time on the 1st, totally 5 days.After last administration 1h, the two sides is coated with 2% Oleum Tiglii proinflammatory agent 0.1ml before and after its left ear, and auris dextra compares.After 4h, the disconnected neck of mice is put to death, cut two ears along the auricle baseline, lay round auricle at same position respectively with the punching of 9mm diameter, weigh with analytical balance, calculate white mice ear swelling degree, ear swelling rate and inhibitory rate of intumesce.The results are shown in Table 1.
The inhibitory action of table 1 pair mice auricle swelling
Above data show, the experimental group medicine can alleviate white mice ear swelling due to Oleum Tiglii, reduce the ear swelling rate, check through t, experimental group and matched group 1 are relatively, experimental group suppresses the mice ear rate higher than matched group (P＜0.01), contrasts 1 group and 2 groups of effects of contrast suitable (P＞0.05).
Explanation can obviously suppress mice auricle swelling according to the wind-dispelling heat-dissipating preparation that the inventive method makes.
B, the Bacillus typhi endotoxin is caused the impact of rat fever reaction
Rat feeding in laboratory (22 ± 1) ℃ adaptation 5 days, is surveyed the anus temperature every day 2 times, continuous 3 days.Begin to test front fasting 12h, freely drink water.survey the anus temperature morning next day 2 times, interval 1h, average and be normal body temperature, choose 2 temperature difference and be no more than 0.3 ℃ of mean body temperature at the rat back subcutaneous injection 20% dry yeast suspension 10ml/kg of 36.6-38.3 ℃, after pyrogenicity 6h, get 40 of the rat of fervescence more than 0.8 ℃ and be divided at random 4 groups, give respectively preparation of the present invention as experimental group, dosage is 1200mg/kg, contrast 1 group of administration contrast medicine 1, dosage is 1200mg/kg, contrast 2 groups to contrast medicine 2, dosage is 1200mg/kg, and blank group (isometric(al) distilled water), medicinal liquid is gastric infusion after 37.5 ℃ of water temperatures.Respectively at after administration 1,2,4,6 and 8h survey the anus temperature 1 time, take normal body temperature as radix, calculate each time point body temperature changing value (△ ℃), the results are shown in Table 2.
Table 2 respectively organize rat different time body temperature change relatively (
N=10, △ ℃)
Result shows, the experimental group medicine can obviously suppress the exothermic reaction (P＜0.05) of rat, and after 4h, experimental group, matched group 1 reach mutually 2 groups of contrasts and compare with the blank group and all demonstrate stronger refrigeration function (P＜0.01 or P＜0.05).
The wind-dispelling heat-dissipating preparation that explanation makes according to the inventive method can obviously reduce the rat temperature that is caused by the Bacillus typhi endotoxin and raise.
Experimental example 2 safety testings
1 acute toxicity test: get healthy mice and carry out separately getting 40 white mice after trial test and carry out formal test, before test with animal fasting 16 hours, not water restriction, dosage is that 1000g (crude drug)/kg observed 7 days, normal diet, drinking-water, observation index is the animal dead number.As a result, this concentration single administration (mice) was observed 7 days, none dead mouse.
2 successive administration toxicity tests: get 80 of healthy mices, be divided at random 4 groups, investigational agent small dose group administration every day 1 time; Middle dosage group administration every day 3 times; Heavy dose of (adult's dosage 100 times) group administration every day 6 times; The blank group is to the N.S of equivalent; According to acute oral toxicity test, investigational agent is little, in, heavy dose of group dosage is 3mg/g, successive administration 14 days, normal diet drinking-water, Continuous Observation, matched group with.Observation index is the weight of animals growth pattern, active situation, diet situation, feces situation and death condition.As a result, each organizes mice all without poisoning situation, and movable, diet drinking-water, feces situation are all normal, none death, and the body weight situation is carried out statistical procedures with the blank group, and the p value is all greater than 0.05, there was no significant difference.Result of the test sees Table 3.
Table 3 successive administration toxicity test result
Test Summary: test shows that preparation of the present invention is nontoxic.
Two, technical study
Experimental example 3 extracting method are selected
A. extracting honeysuckle 68.5g, totally 4 parts, adopt respectively method 1 (Flos Lonicerae decocts with water separately the ethanol precipitation again) and method 2 (Flos Lonicerae is water extraction together with Fructus Arctii 82.2g, Semen Sojae Preparatum 68.5g, Herba Lophatheri 54.8g, Radix Platycodonis 82.2g, Radix Glycyrrhizae 68.5g), every kind of method is done 2 groups of parallel tests, adopt high performance liquid chromatograph that the content of two kinds of method gained extracting solution Content of Chlorogenic Acids is measured, investigate the extraction ratio of two kinds of method Content of Chlorogenic Acids, the results are shown in following table 4.
Table 4 determination of chlorogenic acid result
| Peak area | Content (%) | |
| Method 1 | 291205 | 2.5 |
| Method 1 | 279557 | 2.4 |
| Method 2 | 221316 | 1.9 |
| Method 2 | 232964 | 2.0 |
Above data show, the chlorogenic acid content that the method that adopts Flos Lonicerae to carry separately obtains is higher.
B. get Fructus Gardeniae 54.8g, Radix Rehmanniae 82.2g, Caulis Lonicerae 68.5g is pulverized and mixed, after adopting respectively water extraction, ethanol extraction, alcohol extraction, upper three kinds of methods of macroporous resin are extracted, the clarity of the jasminoidin in the Fructus Gardeniae, the catalpol in Radix Rehmanniae, the chlorogenic acid content in Caulis Lonicerae and extracting solution, filtration complexity are as index, investigate the extraction ratio of three kinds of methods, the results are shown in following table 5.
Table 5 extracting method is selected
Experimental result shows, three kinds of method extracting solution are all more transparent, adopts the method for crossing macroporous resin after water extract-alcohol precipitation, alcohol extraction to filter and is easier to, and the effective ingredient that wherein obtains with the method for crossing macroporous resin after alcohol extraction is the highest, extracts more complete.Therefore cross the extracting method of macroporous resin after preferred alcohol extraction.
Experimental example 4 stability experiments
With the wind-dispelling heat-dissipating capsules content that makes in embodiment 1, preserve under normal circumstances, respectively at 1 day, 3 days, 10 days, sampling in 30 days, with its character, the identification check of Caulis Lonicerae, Fructus Gardeniae, the content of Fructus Arctii the results are shown in Table 6 for investigating index.
Table 6 character and identification check result
The method of Fructus Arctii assay is: with the capsule 's content mixing, precision takes 1g, puts in the 100ml conical flask, and precision adds methanol 50ml, close plug, weighed weight, supersound process 20 minutes lets cool, supply the weight of less loss with methanol, filter, get subsequent filtrate and filter with 0.45 μ m microporous filter membrane, make need testing solution.It is appropriate that precision takes the Arctiin reference substance, makes the solution of 0.25mg/ml with dissolve with methanol and dilution, makes reference substance solution.Carry out the assay test of contained effective ingredient Arctiin in Fructus Arctii with reference to " the HPLC method is measured the assay of Arctiin " under the 48th page " Fructus Arctii " and the 607th page " tablet of antelope horn for common cold " item of Chinese Pharmacopoeia version in 2005.Test sample and reference substance solution assay the results are shown in Table 7
Table 7 Fructus Arctii assay result
The experimental data of table 6 and table 7 shows, the wind-dispelling heat-dissipating capsules good stability that adopts the method for making in embodiment 1 to make is easy to long-time preservation.
Below, enumerate embodiment the present invention is further described, but the present invention is not limited to following embodiment.
The specific embodiment:
Embodiment 1: the preparation of capsule
Flos Lonicerae 68.5g, Fructus Forsythiae 137.0g, Caulis Lonicerae 68.5g, Radix Platycodonis 82.2g, Herba Menthae 82.2g, Fructus Arctii 82.2g, Radix Rehmanniae 82.2g, Herba Lophatheri 54.8g, Herba Schizonepetae 54.8g, Fructus Gardeniae 54.8g, Semen Sojae Preparatum 68.5g, Radix Glycyrrhizae 68.5g
Preparation technology is:
(1) Flos Lonicerae section adds the decocting in water 3 times of 8 times of amounts, each 3 hours extraction times, and collecting decoction, concentrated, adding 75% ethanol, to make pure content be 50%, standing 48 hours, make precipitation, merge, reclaim ethanol, decompression recycling ethanol obtains Flos Lonicerae extract;
(2) Herba Menthae, Herba Schizonepetae, Fructus Forsythiae extract volatile oil, and another device stores;
(3) Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae are with 50% alcohol heating reflux 3 times, the ethanol consumption that reaches later number of times for the 2nd time is 10 times of medical material weight, filter, merging filtrate, filtrate is concentrated into that relative density is 1.10～1.30 under 60 ℃ of conditions, add ethanol and make that to contain alcohol amount be 60%, standing 48 hours, make precipitation, merge, reclaim ethanol, be condensed into thick paste, it is 1-3: 3-1 that concentrated solution adds water to every milliliter of ratio with the every gram of medical material amount of volume, upper macroporous adsorbent resin, use 30% ethanol elution, collect eluent, reclaim ethanol, concentrated, filter, standby; Merge, reclaim ethanol, be condensed into thick paste, concentrated solution is dissolved in water, and upper macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, and is concentrated, filters, and the gained extracting solution is standby;
(4) medicinal residues of Fructus Arctii, Semen Sojae Preparatum, Herba Lophatheri, Radix Platycodonis, Radix Glycyrrhizae five tastes medical material and (2) add the water of 15 times of amounts, extract 3 times under 55 ℃ of conditions, each 3 hours, merge extractive liquid,, add 0.3% decolorizing with activated carbon 10 hours, and filtered merging filtrate, be concentrated into relative density and be 1.10～1.25 extractum, standby;
(5) extractum of the extracting solution of the Flos Lonicerae extract of combining step (1), (3) and (4), drying is pulverized, add the extraction volatile oil in step (2), mixing is pulverized, cross 100 mesh sieves, mixing is after 100 mesh sieves, make soft material with 80% ethanol, cross 14 mesh sieves, granulate, dry in about 60 ℃, granulate, encapsulated.Namely get 1000 of capsules.
Usage and dosage: 3 times on the one, each 4.
Embodiment 2: the preparation of tablet
Flos Lonicerae 80g, Fructus Forsythiae 160g, Caulis Lonicerae 80g, Radix Platycodonis 96g, Herba Menthae 96g, Fructus Arctii 96g, Radix Rehmanniae 96g, Herba Lophatheri 64g, Herba Schizonepetae 64g, Fructus Gardeniae 64g, Semen Sojae Preparatum 80g, Radix Glycyrrhizae 80g
Preparation technology is:
(1) Flos Lonicerae section adds the decocting in water 4 times of 10 times of amounts, each 4 hours extraction times, and collecting decoction, concentrated, adding 75% ethanol, to make pure content be 60%, standing 60 hours, make precipitation, merge, reclaim ethanol, decompression recycling ethanol obtains Flos Lonicerae extract;
(2) Herba Menthae, Herba Schizonepetae, Fructus Forsythiae extract volatile oil, and another device stores;
(3) Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae are with 75% alcohol heating reflux 3 times, the ethanol consumption that reaches later number of times for the 2nd time is 15 times of medical material weight, filter, merging filtrate, filtrate is concentrated into that relative density is 1.15～1.30 under 70 ℃ of conditions, add ethanol and make that to contain alcohol amount be 80%, standing 60 hours, make precipitation, merge, reclaim ethanol, be condensed into thick paste, it is 1-5: 5-1 that concentrated solution adds water to every milliliter of ratio with the every gram of medical material amount of volume, upper macroporous adsorbent resin, use 80% ethanol elution, collect eluent, reclaim ethanol, concentrated, filter, standby; Merge, reclaim ethanol, be condensed into thick paste, concentrated solution is dissolved in water, and upper macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, and is concentrated, filters, and the gained extracting solution is standby;
(4) medicinal residues of Fructus Arctii, Semen Sojae Preparatum, Herba Lophatheri, Radix Platycodonis, Radix Glycyrrhizae five tastes medical material and (2) add the water of 20 times of amounts, extract 3 times under 60 ℃ of conditions, each 4 hours, merge extractive liquid,, add 0.4% decolorizing with activated carbon 10 hours, and filtered merging filtrate, be concentrated into relative density and be 1.10～1.25 extractum, standby;
(5) extractum of the extracting solution of the Flos Lonicerae extract of combining step (1), (3) and (4), drying is pulverized, add the extraction volatile oil in step (2), fully mixing, granulate, with 16 mesh sieve granulate, adding 1% magnesium stearate is lubricant, add microcrystalline Cellulose, the abundant mixing of amylum pregelatinisatum is pressed into 1000, film coating, and get final product.
Usage and dosage: 3 times on the one, each 4.
Embodiment 3: the preparation of granule
Flos Lonicerae 50g, Fructus Forsythiae 100g, Caulis Lonicerae 50g, Radix Platycodonis 60g, Herba Menthae 60g, Fructus Arctii 60g, Radix Rehmanniae 60g, Herba Lophatheri 40g, Herba Schizonepetae 40g, Fructus Gardeniae 40g, Semen Sojae Preparatum 50g, Radix Glycyrrhizae 50g
Preparation method is:
(1) Flos Lonicerae section adds the decocting in water 4 times of 5 times of amounts, each 2 hours extraction times, and collecting decoction, concentrated, adding 60% ethanol, to make pure content be 50%, standing 24 hours, make precipitation, merge, reclaim ethanol, decompression recycling ethanol obtains Flos Lonicerae extract;
(2) Herba Menthae, Herba Schizonepetae, Fructus Forsythiae extract volatile oil, and another device stores;
(3) Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae are with 50% alcohol heating reflux 4 times, the ethanol consumption that reaches later number of times for the 2nd time is 15 times of medical material weight, filter, merging filtrate, filtrate is concentrated into that relative density is 1.10～1.25 under 50 ℃ of conditions, add ethanol and make that to contain alcohol amount be 50%, standing 24 hours, make precipitation, merge, reclaim ethanol, be condensed into thick paste, it is 1-3: 3-1 that concentrated solution adds water to every milliliter of ratio with the every gram of medical material amount of volume, upper macroporous adsorbent resin, use 20% ethanol elution, collect eluent, reclaim ethanol, concentrated, filter, standby; Merge, reclaim ethanol, be condensed into thick paste, concentrated solution is dissolved in water, and upper macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, and is concentrated, filters, and the gained extracting solution is standby;
(4) medicinal residues of Fructus Arctii, Semen Sojae Preparatum, Herba Lophatheri, Radix Platycodonis, Radix Glycyrrhizae five tastes medical material and (2) add the water of 10 times of amounts, extract 3 times under 50 ℃ of conditions, each 4 hours, merge extractive liquid,, add 0.2% decolorizing with activated carbon 10 hours, and filtered merging filtrate, be concentrated into relative density and be 1.10～1.25 extractum, standby;
(5) extractum of the extracting solution of the Flos Lonicerae extract of combining step (1), (3) and (4), drying is pulverized, and adds the extraction volatile oil in step (2), mixing; Adding dextrin to total amount is 1000g again, pulverizes, and mixing is granulated, drying, granulate, packing.
Usage and dosage: 3 times on the one, each 1 bag.
The preparation of embodiment 4 drop pills
Flos Lonicerae 60g, Fructus Forsythiae 120g, Caulis Lonicerae 60g, Radix Platycodonis 72g, Herba Menthae 72g, Fructus Arctii 72g, Radix Rehmanniae 72g, Herba Lophatheri 48g, Herba Schizonepetae 48g, Fructus Gardeniae 48g, Semen Sojae Preparatum 60g, Radix Glycyrrhizae 60g
Preparation method is:
(1) Flos Lonicerae section adds the decocting in water 3 times of 7 times of amounts, each 3 hours extraction times, and collecting decoction, concentrated, adding 65% ethanol, to make pure content be 55%, standing 48 hours, make precipitation, merge, reclaim ethanol, decompression recycling ethanol obtains Flos Lonicerae extract;
(2) Herba Menthae, Herba Schizonepetae, Fructus Forsythiae extract volatile oil, and another device stores;
(3) Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae are with 60% alcohol heating reflux 3 times, the ethanol consumption that reaches later number of times for the 2nd time is 15 times of medical material weight, filter, merging filtrate, filtrate is concentrated into that relative density is 1.10～1.30 under 60 ℃ of conditions, add ethanol and make that to contain alcohol amount be 70%, standing 60 hours, make precipitation, merge, reclaim ethanol, be condensed into thick paste, it is 1-4: 4-1 that concentrated solution adds water to every milliliter of ratio with the every gram of medical material amount of volume, upper macroporous adsorbent resin, use 40% ethanol elution, collect eluent, reclaim ethanol, concentrated, filter, standby; Merge, reclaim ethanol, be condensed into thick paste, concentrated solution is dissolved in water, and upper macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, and is concentrated, filters, and the gained extracting solution is standby;
(4) medicinal residues of Fructus Arctii, Semen Sojae Preparatum, Herba Lophatheri, Radix Platycodonis, Radix Glycyrrhizae five tastes medical material and (2) add the water of 104 times of amounts, extract 3 times under 55 ℃ of conditions, each 2 hours, merge extractive liquid,, add 0.3% decolorizing with activated carbon 10 hours, and filtered merging filtrate, be concentrated into relative density and be 1.10～1.25 extractum, standby;
(5) extractum of the extracting solution of the Flos Lonicerae extract of combining step (1), (3) and (4), drying is pulverized, add the extraction volatile oil in step (2), mixing adds in the Polyethylene Glycol M6000 of molten condition, stir, it is uniformly dispersed, be incubated standby; As in the attemperator pill dripping machine and keep substrate in stirring, start is instiled, and makes the coolant of drop pill molding of liquid paraffin or silicone oil with the melting substrate of mix homogeneously.The drop pill of making is taken out from coolant, carry out Rapid Cleaning with a small amount of dehydrated alcohol and be placed on forced air drying under 30～40 ℃ of conditions in the dish of stand, choose ball, glazing, packing.Namely get 1000 of drop pills.
Usage and dosage: 3 times on the one, each 4.
The preparation of embodiment 5 oral liquids
Flos Lonicerae 70g, Fructus Forsythiae 139g, Caulis Lonicerae 70g, Radix Platycodonis 84g, Herba Menthae 84g, Fructus Arctii 84g, Radix Rehmanniae 84g, Herba Lophatheri 56g, Herba Schizonepetae 56g, Fructus Gardeniae 56g, Semen Sojae Preparatum 70g, Radix Glycyrrhizae 70g
Preparation method is:
(1) Flos Lonicerae section adds the decocting in water 2 times of 6 times of amounts, each 3 hours extraction times, and collecting decoction, concentrated, adding 60% ethanol, to make pure content be 50%, standing 48 hours, make precipitation, merge, reclaim ethanol, decompression recycling ethanol obtains Flos Lonicerae extract;
(2) Herba Menthae, Herba Schizonepetae, Fructus Forsythiae extract volatile oil, and another device stores;
(3) Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae are with 60% alcohol heating reflux 3 times, the ethanol consumption that reaches later number of times for the 2nd time is 12 times of medical material weight, filter, merging filtrate, filtrate is concentrated into that relative density is 1.10～1.30 under 60 ℃ of conditions, add ethanol and make that to contain alcohol amount be 70%, standing 60 hours, make precipitation, merge, reclaim ethanol, be condensed into thick paste, it is 1-4: 4-1 that concentrated solution adds water to every milliliter of ratio with the every gram of medical material amount of volume, upper macroporous adsorbent resin, use 40% ethanol elution, collect eluent, reclaim ethanol, concentrated, filter, standby; Merge, reclaim ethanol, be condensed into thick paste, concentrated solution is dissolved in water, and upper macroporous adsorbent resin use ethanol elution, and eluent reclaims ethanol, and is concentrated, filtration, extracting solution standby;
(4) medicinal residues of Fructus Arctii, Semen Sojae Preparatum, Herba Lophatheri, Radix Platycodonis, Radix Glycyrrhizae five tastes medical material and (2) add the water of 12 times of amounts, extract 3 times under 50 ℃ of conditions, each 2 hours, merge extractive liquid,, add 0.3% decolorizing with activated carbon 10 hours, and filtered merging filtrate, be concentrated into relative density and be 1.10～1.25 extractum, standby;
(5) extractum of the extracting solution of the Flos Lonicerae extract of combining step (1), (3) and (4), drying is pulverized, and adds the extraction volatile oil in step (2), mixing.Add 5000ml water, decoct 80 minutes with slow fire, filter, get filtrate preservation, filtrate is about 400ml.Spice adds 4000ml water again, decocts 60 minutes with slow fire, filters out filtrate preservation, and filtrate is 300ml.Spice adds 4000ml water again, decocts 60 minutes with slow fire, filters out filtrate preservation, and filtrate is 300ml.With the filtrate mix homogeneously of three gained, oral liquid is made in packing.
Usage and dosage: 3 times on the one, each 10ml.
The preparation of embodiment 6 soft capsules
Flos Lonicerae 75g, Fructus Forsythiae 150g, Caulis Lonicerae 75g, Radix Platycodonis 90g, Herba Menthae 90g, Fructus Arctii 90g, Radix Rehmanniae 90g, Herba Lophatheri 60g, Herba Schizonepetae 60g, Fructus Gardeniae 60g, Semen Sojae Preparatum 75g, Radix Glycyrrhizae 75g
Preparation method is:
(1) Flos Lonicerae section adds the decocting in water 2 times of 9 times of amounts, each 3 hours extraction times, and collecting decoction, concentrated, adding 65% ethanol, to make pure content be 55%, standing 60 hours, make precipitation, merge, reclaim ethanol, decompression recycling ethanol obtains Flos Lonicerae extract;
(2) Herba Menthae, Herba Schizonepetae, Fructus Forsythiae extract volatile oil, and another device stores;
(3) Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae are with 75% alcohol heating reflux 3 times, the ethanol consumption that reaches later number of times for the 2nd time is 12 times of medical material weight, filter, merging filtrate, filtrate is concentrated into that relative density is 1.10～1.30 under 70 ℃ of conditions, add ethanol and make that to contain alcohol amount be 70%, standing 60 hours, make precipitation, merge, reclaim ethanol, be condensed into thick paste, it is 1-5: 5-1 that concentrated solution adds water to every milliliter of ratio with the every gram of medical material amount of volume, upper macroporous adsorbent resin, use 50% ethanol elution, collect eluent, reclaim ethanol, concentrated, filter, standby; Merge, reclaim ethanol, be condensed into thick paste, concentrated solution is dissolved in water, and upper macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, and is concentrated, filters, and the gained extracting solution is standby;
(4) medicinal residues of Fructus Arctii, Semen Sojae Preparatum, Herba Lophatheri, Radix Platycodonis, Radix Glycyrrhizae five tastes medical material and (2) add the water of 10 times of amounts, extract 3 times under 50 ℃ of conditions, each 2 hours, merge extractive liquid,, add 0.2% decolorizing with activated carbon 15 hours, and filtered merging filtrate, be concentrated into relative density and be 1.10～1.25 extractum, standby;
(5) extractum of the extracting solution of the Flos Lonicerae extract of combining step (1), (3) and (4), drying is pulverized, add the extraction volatile oil in step (2), fully mixing, granulate, granulate adds Cera Flava appropriate, mixes, mixture rolls wafer with automatic rotation and makes 1000, drying is taken out, and uses washing with alcohol, dry 48 hours, and get final product.
Usage and dosage: 3 times on the one, each 4.
Claims (8)
1. the pharmaceutical composition of a wind-dispelling heat-dissipating, calculate according to composition by weight, by following raw material medicaments: Flos Lonicerae 50-80 part, Fructus Forsythiae 100-160 part, Caulis Lonicerae 50-80 part, Radix Platycodonis 60-96 part, Herba Menthae 60-96 part, Fructus Arctii 60-96 part, Radix Rehmanniae 60-96 part, Herba Lophatheri 40-64 part, Herba Schizonepetae 40-64 part, Fructus Gardeniae 40-64 part, Semen Sojae Preparatum 50-80 part, Radix Glycyrrhizae 50-80 part and adjuvant are prepared from; It is characterized in that: preparation method is:
(1) Flos Lonicerae section adds the decocting in water 2～4 times of 5～10 times of amounts, each 2～4 hours extraction times, collecting decoction, concentrated, adding 60～75% ethanol, to make pure content be 50～60%, standing 24～60 hours, makes precipitation, merge, reclaim ethanol, decompression recycling ethanol obtains Flos Lonicerae extract;
(2) Herba Menthae, Herba Schizonepetae, Fructus Forsythiae extract volatile oil, and another device stores;
(3) Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae is with 50～75% alcohol heating reflux 3～4 times, the ethanol consumption that reaches later number of times for the 2nd time is 5～15 times of medical material weight, filter, merging filtrate, filtrate is concentrated into that relative density is 1.10～1.30 under 50～70 ℃ of conditions, add ethanol and make that to contain alcohol amount be 50～80%, standing 24～60 hours, make precipitation, merge, reclaim ethanol, be condensed into thick paste, it is 1-5: 5-1 that concentrated solution adds water to every milliliter of ratio with the every gram of medical material amount of volume, upper macroporous adsorbent resin, with 20～80% ethanol elutions, collect eluent, reclaim ethanol, concentrated, filter, standby, merge, reclaim ethanol, be condensed into thick paste, concentrated solution is dissolved in water, and upper macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, and is concentrated, filters, and the gained extracting solution is standby,
(4) medicinal residues of Fructus Arctii, Semen Sojae Preparatum, Herba Lophatheri, Radix Platycodonis, Radix Glycyrrhizae five tastes medical material and (2) add the water of 10～20 times of amounts, extract 3～4 times under 50～60 ℃ of conditions, each 2～4 hours, merge extractive liquid,, add 0.2～0.4% decolorizing with activated carbon 10～15 hours, and filtered merging filtrate, be concentrated into relative density and be 1.10～1.25 extractum, standby;
(5) extractum of the extracting solution of the Flos Lonicerae extract of combining step (1), (3) and (4), drying is pulverized, and adds the extraction volatile oil in step (2), mixing; Then add suitable adjuvant, be prepared into the preparation formulation that needs with conventional method.
2. the pharmaceutical composition of wind-dispelling heat-dissipating according to claim 1 is characterized in that: calculate according to composition by weight, be prepared from by following raw material medicaments and adjuvant:
68.5 parts of Flos Loniceraes, 137.0 parts of Fructus Forsythiaes, 68.5 parts of Caulis Loniceraes, 82.2 parts of Radix Platycodoniss, 82.2 parts of Herba Menthaes, 82.2 parts of Fructus Arctiis, 82.2 parts of Radix Rehmanniae, 54.8 parts of Herba Lophatheris, 54.8 parts of Herba Schizonepetae, 54.8 parts of Fructus Gardeniaes, 68.5 parts of Semen Sojae Preparatums, 68.5 parts, Radix Glycyrrhizae.
3. the pharmaceutical composition of wind-dispelling heat-dissipating according to claim 1 and 2, it is characterized in that: the preparation that described compositions is made is capsule, tablet, granule, oral liquid, drop pill or soft capsule.
4. the pharmaceutical composition of wind-dispelling heat-dissipating according to claim 1, it is characterized in that: preparation method is:
(1) Flos Lonicerae section adds the decocting in water 3 times of 8 times of amounts, each 3 hours extraction times, and collecting decoction, concentrated, adding 75% ethanol, to make pure content be 50%, standing 48 hours, make precipitation, merge, reclaim ethanol, decompression recycling ethanol obtains Flos Lonicerae extract;
(2) Herba Menthae, Herba Schizonepetae, Fructus Forsythiae extract volatile oil, and another device stores;
(3) Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae are with 50% alcohol heating reflux 3 times, the ethanol consumption that reaches later number of times for the 2nd time is 10 times of medical material weight, filter, merging filtrate, filtrate is concentrated into that relative density is 1.10～1.30 under 60 ℃ of conditions, add ethanol and make that to contain alcohol amount be 60%, standing 48 hours, make precipitation, merge, reclaim ethanol, be condensed into thick paste, it is 1-3: 3-1 that concentrated solution adds water to every milliliter of ratio with the every gram of medical material amount of volume, upper macroporous adsorbent resin, use 30% ethanol elution, collect eluent, reclaim ethanol, concentrated, filter, standby; Merge, reclaim ethanol, be condensed into thick paste, concentrated solution is dissolved in water, and upper macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, and is concentrated, filters, and the gained extracting solution is standby;
(4) medicinal residues of Fructus Arctii, Semen Sojae Preparatum, Herba Lophatheri, Radix Platycodonis, Radix Glycyrrhizae five tastes medical material and (2) add the water of 15 times of amounts, extract 3 times under 55 ℃ of conditions, each 3 hours, merge extractive liquid,, add 0.3% decolorizing with activated carbon 10 hours, and filtered merging filtrate, be concentrated into relative density and be 1.10～1.25 extractum, standby;
(5) extractum of the extracting solution of the Flos Lonicerae extract of combining step (1), (3) and (4), drying is pulverized, and adds the extraction volatile oil in step (2), mixing; Then add suitable adjuvant, be prepared into the preparation formulation that needs with conventional method.
5. the preparation method of the pharmaceutical composition of wind-dispelling heat-dissipating according to claim 1, it is characterized in that: the preparation method of capsule is:
(1) Flos Lonicerae section adds the decocting in water 3 times of 8 times of amounts, each 3 hours extraction times, and collecting decoction, concentrated, adding 75% ethanol, to make pure content be 50%, standing 48 hours, make precipitation, merge, reclaim ethanol, decompression recycling ethanol obtains Flos Lonicerae extract;
(2) Herba Menthae, Herba Schizonepetae, Fructus Forsythiae extract volatile oil, and another device stores;
(3) Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae are with 50% alcohol heating reflux 3 times, the ethanol consumption that reaches later number of times for the 2nd time is 10 times of medical material weight, filter, merging filtrate, filtrate is concentrated into that relative density is 1.10～1.30 under 60 ℃ of conditions, add ethanol and make that to contain alcohol amount be 60%, standing 48 hours, make precipitation, merge, reclaim ethanol, be condensed into thick paste, it is 1-3: 3-1 that concentrated solution adds water to every milliliter of ratio with the every gram of medical material amount of volume, upper macroporous adsorbent resin, use 30% ethanol elution, collect eluent, reclaim ethanol, concentrated, filter, standby; Merge, reclaim ethanol, be condensed into thick paste, concentrated solution is dissolved in water, and upper macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, and is concentrated, filters, and the gained extracting solution is standby;
(4) medicinal residues of Fructus Arctii, Semen Sojae Preparatum, Herba Lophatheri, Radix Platycodonis, Radix Glycyrrhizae five tastes medical material and (2) add the water of 15 times of amounts, extract 3 times under 55 ℃ of conditions, each 3 hours, merge extractive liquid,, add 0.3% decolorizing with activated carbon 10 hours, and filtered merging filtrate, be concentrated into relative density and be 1.10～1.25 extractum, standby;
(5) extractum of the extracting solution of the Flos Lonicerae extract of combining step (1), (3) and (4), drying is pulverized, add the extraction volatile oil in step (2), mixing is pulverized, cross 100 mesh sieves, mixing is after 100 mesh sieves, make soft material with 80% ethanol, cross 14 mesh sieves, granulate, dry in about 60 ℃, granulate, encapsulated, namely get capsule.
6. the preparation method of the pharmaceutical composition of wind-dispelling heat-dissipating according to claim 1, it is characterized in that: the preparation method of tablet is:
(1) Flos Lonicerae section adds the decocting in water 4 times of 10 times of amounts, each 4 hours extraction times, and collecting decoction, concentrated, adding 75% ethanol, to make pure content be 60%, standing 60 hours, make precipitation, merge, reclaim ethanol, decompression recycling ethanol obtains Flos Lonicerae extract;
(2) Herba Menthae, Herba Schizonepetae, Fructus Forsythiae extract volatile oil, and another device stores;
(3) Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae are with 75% alcohol heating reflux 3 times, the ethanol consumption that reaches later number of times for the 2nd time is 15 times of medical material weight, filter, merging filtrate, filtrate is concentrated into that relative density is 1.15～1.30 under 70 ℃ of conditions, add ethanol and make that to contain alcohol amount be 80%, standing 60 hours, make precipitation, merge, reclaim ethanol, be condensed into thick paste, it is 1-5: 5-1 that concentrated solution adds water to every milliliter of ratio with the every gram of medical material amount of volume, upper macroporous adsorbent resin, use 80% ethanol elution, collect eluent, reclaim ethanol, concentrated, filter, standby; Merge, reclaim ethanol, be condensed into thick paste, concentrated solution is dissolved in water, and upper macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, and is concentrated, filters, and the gained extracting solution is standby;
(4) medicinal residues of Fructus Arctii, Semen Sojae Preparatum, Herba Lophatheri, Radix Platycodonis, Radix Glycyrrhizae five tastes medical material and (2) add the water of 20 times of amounts, extract 3 times under 60 ℃ of conditions, each 4 hours, merge extractive liquid,, add 0.4% decolorizing with activated carbon 10 hours, and filtered merging filtrate, be concentrated into relative density and be 1.10～1.25 extractum, standby;
(5) extractum of the extracting solution of the Flos Lonicerae extract of combining step (1), (3) and (4), drying is pulverized, add the extraction volatile oil in step (2), fully mixing, granulate, with 16 mesh sieve granulate, adding 1% magnesium stearate is lubricant, add microcrystalline Cellulose, the abundant mixing of amylum pregelatinisatum, tabletting, film coating, and get final product.
7. the preparation method of the pharmaceutical composition of wind-dispelling heat-dissipating according to claim 1, it is characterized in that: the preparation method of granule is:
(1) Flos Lonicerae section adds the decocting in water 4 times of 5 times of amounts, each 2 hours extraction times, and collecting decoction, concentrated, adding 60% ethanol, to make pure content be 50%, standing 24 hours, make precipitation, merge, reclaim ethanol, decompression recycling ethanol obtains Flos Lonicerae extract;
(2) Herba Menthae, Herba Schizonepetae, Fructus Forsythiae extract volatile oil, and another device stores;
(3) Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae are with 50% alcohol heating reflux 4 times, the ethanol consumption that reaches later number of times for the 2nd time is 15 times of medical material weight, filter, merging filtrate, filtrate is concentrated into that relative density is 1.10～1.25 under 50 ℃ of conditions, add ethanol and make that to contain alcohol amount be 50%, standing 24 hours, make precipitation, merge, reclaim ethanol, be condensed into thick paste, it is 1-3: 3-1 that concentrated solution adds water to every milliliter of ratio with the every gram of medical material amount of volume, upper macroporous adsorbent resin, use 20% ethanol elution, collect eluent, reclaim ethanol, concentrated, filter, standby; Merge, reclaim ethanol, be condensed into thick paste, concentrated solution is dissolved in water, and upper macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, and is concentrated, filters, and the gained extracting solution is standby;
(4) medicinal residues of Fructus Arctii, Semen Sojae Preparatum, Herba Lophatheri, Radix Platycodonis, Radix Glycyrrhizae five tastes medical material and (2) add the water of 10 times of amounts, extract 3 times under 50 ℃ of conditions, each 4 hours, merge extractive liquid,, add 0.2% decolorizing with activated carbon 10 hours, and filtered merging filtrate, be concentrated into relative density and be 1.10～1.25 extractum, standby;
(5) extractum of the extracting solution of the Flos Lonicerae extract of combining step (1), (3) and (4), drying is pulverized, and adds the extraction volatile oil in step (2), mixing; Add dextrin to total amount to be calculated as 1000g with weight g again, pulverize, mixing is granulated, drying, granulate, packing.
8. the preparation method of the pharmaceutical composition of wind-dispelling heat-dissipating according to claim 1, it is characterized in that: the preparation method of soft capsule is:
(1) Flos Lonicerae section adds the decocting in water 2 times of 9 times of amounts, each 3 hours extraction times, and collecting decoction, concentrated, adding 65% ethanol, to make pure content be 55%, standing 60 hours, make precipitation, merge, reclaim ethanol, decompression recycling ethanol obtains Flos Lonicerae extract;
(2) Herba Menthae, Herba Schizonepetae, Fructus Forsythiae extract volatile oil, and another device stores;
(3) Fructus Gardeniae, Radix Rehmanniae, Caulis Lonicerae are with 75% alcohol heating reflux 3 times, the ethanol consumption that reaches later number of times for the 2nd time is 12 times of medical material weight, filter, merging filtrate, filtrate is concentrated into that relative density is 1.10～1.30 under 70 ℃ of conditions, add ethanol and make that to contain alcohol amount be 70%, standing 60 hours, make precipitation, merge, reclaim ethanol, be condensed into thick paste, it is 1-5: 5-1 that concentrated solution adds water to every milliliter of ratio with the every gram of medical material amount of volume, upper macroporous adsorbent resin, use 50% ethanol elution, collect eluent, reclaim ethanol, concentrated, filter, standby; Merge, reclaim ethanol, be condensed into thick paste, concentrated solution is dissolved in water, and upper macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, and is concentrated, filters, and the gained extracting solution is standby;
(4) medicinal residues of Fructus Arctii, Semen Sojae Preparatum, Herba Lophatheri, Radix Platycodonis, Radix Glycyrrhizae five tastes medical material and (2) add the water of 10 times of amounts, extract 3 times under 50 ℃ of conditions, each 2 hours, merge extractive liquid,, add 0.2% decolorizing with activated carbon 15 hours, and filtered merging filtrate, be concentrated into relative density and be 1.10～1.25 extractum, standby;
(5) extractum of the extracting solution of the Flos Lonicerae extract of combining step (1), (3) and (4), drying is pulverized, add the extraction volatile oil in step (2), fully mixing, granulate, granulate adds Cera Flava appropriate, mixes, mixture rolls wafer with automatic rotation and makes soft capsule, drying is taken out, and uses washing with alcohol, dry 48 hours, and get final product.
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| CN103933486A (en) * | 2014-05-09 | 2014-07-23 | 夏先枝 | Medicinal composition for treating ectopic pregnancy and preparation method thereof |
| CN105012391B (en) * | 2015-08-13 | 2020-05-22 | 贵州中医药大学 | Medicine for treating viral influenza and preparation method thereof |
| CN113350299B (en) * | 2021-06-28 | 2022-09-06 | 陕西映诺嘉生物科技有限公司 | Slow-release medicine suitable for pets and preparation method thereof |
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| CN1449805A (en) * | 2003-01-10 | 2003-10-22 | 贵州民族制药厂 | Traditional Chinese medicine for dispelling wind and removing heat and preparation process thereof |
| CN1709366A (en) * | 2005-06-24 | 2005-12-21 | 王衡新 | Chinese medicine formulation for dispelling wind, diaphoresis and expelling toxin by cooling, and its preparing method |
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| CN1449805A (en) * | 2003-01-10 | 2003-10-22 | 贵州民族制药厂 | Traditional Chinese medicine for dispelling wind and removing heat and preparation process thereof |
| CN1709366A (en) * | 2005-06-24 | 2005-12-21 | 王衡新 | Chinese medicine formulation for dispelling wind, diaphoresis and expelling toxin by cooling, and its preparing method |
| CN101632804A (en) * | 2008-07-25 | 2010-01-27 | 北京亚东生物制药有限公司 | Quality control method for wind-dispelling heat-dissipating capsules |
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