CN102552462B - Effervescent preparation as well as preparation method and application thereof - Google Patents
Effervescent preparation as well as preparation method and application thereof Download PDFInfo
- Publication number
- CN102552462B CN102552462B CN2012100104196A CN201210010419A CN102552462B CN 102552462 B CN102552462 B CN 102552462B CN 2012100104196 A CN2012100104196 A CN 2012100104196A CN 201210010419 A CN201210010419 A CN 201210010419A CN 102552462 B CN102552462 B CN 102552462B
- Authority
- CN
- China
- Prior art keywords
- parts
- effervescent
- preparation
- acid
- hoveniae
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Landscapes
- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses an effervescent preparation as well as a preparation method and an application of the effervescent preparation. The effervescent preparation provided by the invention is prepared by compounding medicinal materials including Hovenia dulcis Thunb, the root of kudzu vine, lotus leaf, mung bean, Chinese mosla herb, pawpaw, Microcos paniculata, liquorice and the like, and has the functions of removing summer heat and dampness, harmonizing the spleen and stomach and alleviating a hangover; and the effects are better than those of currently common traditional Chinese medicines or compounds. The effervescent preparation provided by the invention is a new product of solid Chinese herb tea and the volume of the product is small so that the product is conveniently carried and transported; after being contacted with cool water, even ice water, the effervescent preparation is rapidly dissolved into an ice Chinese herb tea beverage with a good mouth feel, and the use is convenient, so that the effervescent preparation accords with the habits of modern people who like drinking cold or ice Chinese herb tea; the effervescent preparation does not contain sugar and is low in calories, so as to meet requirements of diabetes mellitus patients; a lot of gas can be generated in the drinking process and the beverage has a mouth feel of a carbonated beverage, thereby meeting the mouth feel requirements of young groups (particularly children).
Description
Technical field
The present invention relates to a kind of effervescent formulation and its production and use.
Background technology
Herbal tea is a kind of functional drinks of tool south of the Five Ridges local characteristic, it often selects clearing away summer-heat for use, dry disappear stagnant, give birth to that Feng quenches the thirst, the SHENGCAO medicine of effects such as refreshment or beauty care stews and makes soup, being used as tea for people drinks, with the gas of the heat-damp in summer in the elimination human body in summer, or treat the illness such as throat pain that the winter drying causes.Along with State Council approved in 2006 and announced that herbal tea is first batch of national non-material cultural heritage, guangdong herbal tea becomes the beverage of the country word of " be popular in the whole nation, go to the world ", becomes the best drink variety of each hypermarket sales volume of the whole nation.Continuous development along with herbal tea, behind compound compatibility, but herbal tea except heat-clearing and toxic substances removing (fire of dispelling), the living Feng that dries, make eye bright, the eliminating carbuncle eliminating stagnation, also can control conjunctival congestion headache, dizziness and tinnitus, furuncle swelling toxin and hypertension, can work as refreshment drink fully summer and drink, it has become one of health tea indispensable in the daily life.
As number of patent application: CN201010577890.4, a kind of plant health-care cold tea is disclosed in this application, be prepared from by Flos Lonicerae, Flos Chrysanthemi, Flos Plumeriae Acutifoliae, Herba mesonae chinensis, Radix Platycodonis, Fructus Momordicae, Radix Puerariae, Rhizoma Imperatae, Radix Glycyrrhizae, Rhizoma Polygonati, Folium camelliae assamicae, Fructus Mori, CitrusaurantiumL.Var.amara Engl., Cymbidium ensifolium (L.) Sw., have the heat clearing away health-care effecies such as fire, nourishing YIN and moistening the lung, spleen benefiting and stimulating the appetite of dispelling.Number of patent application: CN201010268291.4 discloses a kind of herbal tea in this application, contain the extractum of each medical material such as Rhizoma Phragmitis, Radix Ophiopogonis, Flos Lonicerae, Herba Menthae and Fructus Mume, and the sunstroke prevention health preserving is the quench the thirst health beverage of living Feng heat-clearing and toxic substances removing of a kind of sunstroke prevention.
Though herbal tea has certain health care, it is not the universal health-care medicine.Most herbal tea prescription is formed by the local medical material in the south of the Five Ridges in the market, these medical material research weak foundations, material base and pharmacological effect are all indeterminate, and the inclined to one side bitter cold of the most property of medicine of herbal tea medical material, some persons of having a delicate constitution (as infant, puerpera, prolonged illness patient) take this class herbal tea for a long time, easy damaged human body and taste cause a series of untoward reaction.Some herbal tea prescription flavour of a drug is too many, and it is very bitter to decoct the back mouthfeel, needs to add to come flavoring than polysaccharide.The problem of above-mentioned these existence, all having hindered herbal tea becomes the masses in all parts of the country health tea suitable for four seasons.
Simultaneously, present herbal tea commodity are on the market mainly used with decoction (comprising flexible package, canned antipyretic beverage), granule forms such as (solid herbal tea).Wherein liquid herbal tea volume is big, store and carry inconvenience, and character is stable not as solid preparation.The granule herbal tea mostly is the sugared granule that has that simple processing makes, and sugariness is big, and melting is not good, often need more hot water just can dissolve, like the custom of obeying the tea that cools with the modern and be not inconsistent, people take aftersensation and are taking medicine, rather than drink the health beverage that a kind of mouthfeel is better, can often take.
The effervescent dosage form is a kind of good novel solid dosage form of developing in recent years, has that " good reputation of Peroral solid dosage form liquid obtains more and more widely application at China's food, health product, medicine field.The difference of it and common solid preparation is to contain gas-producing disintegrant, meets water (hot, cold, frozen water all can) and produces great amount of carbon dioxide rapidly, and contained composition is dissolved fast, is conducive to improve bioavailability.Through after the seasoning, color, smell and taste are all good, and a large amount of carbon dioxides stimulates taste bud, can produce the local flavor of soda pop, accepted by numerous crowds easilier.Effervescent formulation has overcome the shortcoming of traditional liquid dosage form and solid dosage forms, all is the very rising dosage forms of a class at food, health product, medicine field.
The effervescent dosage form is compared with other dosage forms has lot of advantages, but the commercially available prod is very not many, particularly lacks especially at Chinese medicine association area product, does not find at present the open source literature reports such as patent, paper that herbal tea prepared the effervescence type Related product.This is because effervescent formulation is compared all stricter and difficult in each side such as supplementary material selection, production technology, working conditions with conventional formulation.Production contains Chinese medicine and puies forward the main difficult point of thing effervescent formulation the following aspects is arranged: 1, Chinese medicine extract often has stronger hygroscopicity, and in molding and storage process, easily the moisture absorption causes the inefficacy of effervescent formulation; 2, Chinese medicine extract viscosity is stronger, need to add diluent, otherwise easily sticking or the granule that makes are harder; 3, strict to adjuvant, require soluble in waterly, moisture absorption is little, to Acidity of Aikalinity stable in properties etc.; 4, to whole production environmental requirement strictness, should avoid water in the production, and envionmental humidity should be controlled preferably below 30% as far as possible; 5, acid source and carbon dioxide source should separate as far as possible; 6, to select the strong packaging material of moisture resistance.
Summary of the invention
The object of the present invention is to provide a kind of effervescent formulation with herbal tea effect, and its preparation method and purposes.
The invention provides a kind of effervescent formulation, it is the preparation that the supplementary material by following weight proportion is prepared from:
Raw material:
Semen Hoveniae (Fructus Hoveniae) 189-351 part, Radix Puerariae 189-351 part, Folium Nelumbinis 84-156 part, Semen phaseoli radiati 189-351 part, Herba Moslae 84-156 part, Fructus Chaenomelis 126-234 part, Folium Microcoris paniculatae 105-195 part, Radix Glycyrrhizae 105-195 part;
Adjuvant:
Filler 70-130 part, effervescent 114-213 part, stabilizing agent 21-39 part, binding agent 3.5-6.5 part, correctives 1.05-1.95 part.
Further, it is the preparation that the supplementary material by following weight proportion is prepared from:
Raw material:
270 parts of Semen Hoveniae (Fructus Hoveniae)s, 270 parts of Radix Puerariaes, 120 parts on Folium Nelumbinis, 270 parts in Semen phaseoli radiati, 120 parts of Herba Moslaes, 180 parts of Fructus Chaenomeliss, 150 parts of Folium Microcoris paniculataes, 150 parts in Radix Glycyrrhizae;
Adjuvant:
100 parts of filleies, 163.5 parts of effervescents, 30 parts of stabilizing agents, 5 parts of binding agents, 1.5 parts of correctivess.
Wherein, described filler is starch, dextrin, Icing Sugar, lactose, mannitol, calcium sulfate or microcrystalline Cellulose;
Described effervescent is acid source and carbon dioxide source, and wherein, acid source is organic acid, and carbon dioxide source is carbonate or bicarbonate;
Described stabilizing agent is PEG, gelatin, Resina persicae, tragacanth or Rhizoma Bletillae gel;
Described binding agent is PVP, HPMC or PEG;
Described correctives is sweeting agent.
Further, described acid source is citric acid, tartaric acid, fumaric acid, malic acid or succinic acid; Carbon dioxide source is potassium carbonate, potassium bicarbonate, sodium carbonate or sodium bicarbonate; Described sweeting agent is sucrose, aspartame or steviosin.
Further, it is the preparation that the supplementary material by following weight proportion is prepared from:
Raw material:
270 parts of Semen Hoveniae (Fructus Hoveniae)s, 270 parts of Radix Puerariaes, 120 parts on Folium Nelumbinis, 270 parts in Semen phaseoli radiati, 120 parts of Herba Moslaes, 180 parts of Fructus Chaenomeliss, 150 parts of Folium Microcoris paniculataes, 150 parts in Radix Glycyrrhizae;
Adjuvant:
100 parts of lactose, 92 parts of citric acids, 71.5 parts of sodium bicarbonate, 30 parts of PEG-6000,1.5 parts of aspartames, 5 parts of PVP-K30.
Wherein, described preparation is effervescent granule or effervescent tablet.
The present invention also provides the preparation method of above-mentioned effervescent formulation, and it comprises the steps:
(1) take by weighing supplementary material by the prescription proportioning:
Raw material:
Semen Hoveniae (Fructus Hoveniae) 189-351 part, Radix Puerariae 189-351 part, Folium Nelumbinis 84-156 part, Semen phaseoli radiati 189-351 part, Herba Moslae 84-156 part, Fructus Chaenomelis 126-234 part, Folium Microcoris paniculatae 105-195 part, Radix Glycyrrhizae 105-195 part;
Adjuvant:
Filler 70-130 part, effervescent 114-213 part, stabilizing agent 21-39 part, binding agent 3.5-6.5 part, correctives 1.05-1.95 part; Acid source is that 64-119 part, carbon dioxide source are 50-94 part in the effervescent;
(2) with the crude drug extracting in water, the centrifugal back of water extract concentrates, and drying gets dry extract;
(3) earlier with behind the stabilizing agent parcel carbon dioxide source, with dry extract, filler, correctives, acid source mix homogeneously, add anhydrous binder solution again, preparation granule or tablet namely get effervescent granule or tablet.
Further, it comprises the steps:
(1) take by weighing supplementary material by the prescription proportioning,
Raw material:
270 parts of Semen Hoveniae (Fructus Hoveniae)s, 270 parts of Radix Puerariaes, 120 parts on Folium Nelumbinis, 270 parts in Semen phaseoli radiati, 120 parts of Herba Moslaes, 180 parts of Fructus Chaenomeliss, 150 parts of Folium Microcoris paniculataes, 150 parts in Radix Glycyrrhizae;
Adjuvant:
100 parts of lactose, 92 parts of citric acids, 71.5 parts of sodium bicarbonate, 30 parts of PEG-6000,1.5 parts of aspartames, 5 parts of PVP-K30;
(2) getting crude drug earlier adds water 8-12 and doubly measures, decoct 2-4 time, each 0.5-1.5 hour, merge decocting liquid, be concentrated into 80 ℃ and survey relative density 1.02～1.05, the cooling back is centrifugal, get supernatant and continue to be concentrated into 80 ℃ of survey relative densities 1.10～1.15, spray drying, drying condition is: inlet temperature is 170～180 ℃, 90～100 ℃ of leaving air temps namely get dry extract; Wherein, the preferred 15000 commentaries on classics/min of centrifugal speed, centrifugal 15 minutes.
(3) get 30 parts of PEG-6000 heating and melting earlier after, add 71.5 parts of sodium bicarbonate, behind the mixing, cooling, after the pulverizing, again with dry extract, 100 parts of lactose, 1.5 parts of aspartames, 92 parts of citric acid mix homogeneously after, add the PVP K-30 ethanol solution of 3%w/v again, the preparation granule namely gets effervescent granule; Or, get granule, tabletting namely gets effervescent tablet.
Further, get crude drug in the step (2) earlier and add 8 times of amounts of water, decoct each 1 hour 2 times.
The present invention also provide last effervescent formulation at the preparation expelling summer-heat, relieve the effect of alcohol, treat or/and prevent purposes in food, health product or the medicine of summer-heat damp cold.
Wherein, described effervescent formulation be sober up, food, health product or the pharmaceutical composition of pre-preventing drunkenness.
Semen Hoveniae (Fructus Hoveniae) described in the present invention is selected dry mature fruit and meat fruit stem or the seed of Rhamnaceae plant Semen Hoveniae (Fructus Hoveniae) for use; Radix Puerariae is selected the dry root of legume pueraria lobata Pueraria lobata (Willd.) Ohwi or Radix Puerariae rattan Pueraria thomsonii Benth. for use; Folium Nelumbinis is selected the fresh leaf of nymphaeaceae plant lotus Nelumbonucifera Gaertn. for use; Semen phaseoli radiati is selected the dry seed of leguminous plant Semen phaseoli radiati Phaseolus radiatus L. for use; Herba Moslae is selected the dry aerial parts of labiate Mosla chinensis Maxim. Mosla chinensis Maxim. and Mosla chinensis Maxim.cv.Jiangxiangru Mosla chinensis Maxim.cv.jiangxiangru. for use; Fructus Chaenomelis is selected the dry almost ripe fruit of Rosaceae chaenomeles lagenaria Chaenomeles speciosa (Sweet) Nakai for use; Folium Microcoris paniculatae is selected the dried leaves of Tiliaceae plant rag tree Microcos paniculata L. for use; Radix Glycyrrhizae is selected glycyrrhizic legume Glycyrrhiza uralensis Fisch. for use, Glycyrrhiza inflata Bat. G.inflata Bat., or the root and rhizome of Glycyrrhiza glabra L. G.glabra L..
According to " Chinese pharmacopoeia and document record:
The flat sweet in the mouth acid of Semen Hoveniae (Fructus Hoveniae) has heat clearing away, ends excessive thirst, and the effect of invigorating the spleen and replenishing QI, moistening five ZANG-organs, Shujin network is usually used in controlling diseases such as drunk, dysphoria with smothery sensation, thirsty, vomiting, difficulty in urination and defecation.Its fruit contains volume glucose, calcium malate, studies show that fruit has significant diuresis to rabbit, and without any side effects.
Radix Puerariae sweet in the mouth, suffering, cold.Return spleen, stomach warp.Have expelling pathogenic factors from muscles for reducing heat, rash is given birth to Feng and is quenched the thirst, the effect of yang invigorating antidiarrheal, and modern study shows that it also has sober up effect preferably.Radix Puerariae mainly contains Flavonoid substances such as daiazi, daidzein, puerarin etc., also has big legumin-4,7-diglucoside, puerarin-7-xyloside, Radix Puerariae alcohol, Radix Puerariae rattan element and isoflavone aglycone and starch.Pharmacological action: Radix Puerariae decoct, pure preserved material, total flavones, daiazi, puerarin all can resist the acute myocardial ischemia that pituitrin causes.Radix Puerariae total flavones energy dilating coronary blood vessel and cerebrovascular, coronary blood flow increasing and cerebral blood flow reduce myocardial oxygen consumption, increase the oxygen supply.Radix Puerariae is blood vessel dilating directly, Peripheral resistance is descended, and obvious hypotensive effect is arranged.Puerarin energy microcirculation improvement improves local little blood flow, suppresses platelet aggregation.Radix Puerariae has beta-receptor retardation widely.The mice intestine in vitro there is obvious spasmolysis, can be to the intestinal tube spasm due to the anti-acetylcholine.Radix Puerariae also has the trivial solution heat effect, and slight hypoglycemic activity is arranged.
The Folium Nelumbinis bitter in the mouth is hot little puckery, cool in nature, and GUIXIN, liver, spleen channel have the damp eliminating of relieving summer heat, the spleen invigorating yang invigorating, and the effect of dissipating blood stasis hemostasis is usually used in the pathogenic summer-heat in QINGXIA season, can rise again and send out a spleen sun, and the treatment diarrhea due to summer heat and dampness is also had good effect.Pharmacological research shows that Folium Nelumbinis has effect for reducing blood fat.Nuciferine is the alkaloid that extracts in the Folium Nelumbinis, the expansible blood vessel of nuciferine, and clearing away summer-heat has the effect of blood pressure lowering, simultaneously the good medicine of still losing weight.Document announcement is arranged, and the alkaloid in the Folium Nelumbinis has effect for reducing blood fat, and is usually used in the treatment of obesity clinically.The Folium Nelumbinis weight-losing principle is namely taken the back and is formed one deck fat isolating membrane at the human body intestinal wall, effectively stops the absorption of fat, the bounce-back of fundamentally loss of weight, and more effective control.
The Semen phaseoli radiati sweet in the mouth, cold in nature, GUIXIN, stomach warp have the effect of clearing away heat and removing summer, diuretic, detoxifcation.Semen phaseoli radiati contains protein, fat, carbohydrate, vitamin B1, B2, carotene, nicotinic acid(NA, folic acid, compositions such as mineral calcium, phosphorus, ferrum, modern study show that it has blood fat reducing, cholesterol reducing, antiallergic, antibiotic, antitumor, appetite strengthening, protects the liver pharmacological actions such as protecting kidney.
The Herba Moslae acrid in the mouth, tepor.Return lung, spleen, stomach warp.Has relieving the exterior syndrome by diaphoresis, removing dampness for regulating stomach, the effect of inducing diuresis to remove edema.Many taste of holding concurrently for anemofrigid cold wet and are stranded, and disease is seen aversion to cold, heating, and the heavy sensation of the body of having a headache, lossless, the full poor appetite of gastral cavity, greasy fur, or nausea and vomiting, diarrhoea person, the merit of separating wind and cold, internalization turbid damp outside can receiving.This card is more common in the cold people of greedy cool drink on hot summer days, so preceding person " Herba Moslae is the medicine that Xia Yue induces sweat ".The Herba Moslae chemical constituent mainly contains volatile oil, mainly contains compositions such as carvacrol, thymol in the oil; Other contains sterol, flavonoid glycoside etc.Pharmacological action: volatile oil has the sweating and heat resolving effect, and glandular secretion and gastrointestinal peristalsis can stimulate digestion.Volatile oil has stronger inhibitory action to staphylococcus aureus, Bacillus typhi, meningococcus etc.The water decoction of elsholtzia splendens has antivirus action.In addition, the Herba Moslae tincture can the stimulation of renal blood vessel and make glomerule hyperemia, and filterability increases and diuresis arranged.
The Fructus Chaenomelis sour in the mouth, temperature.Return liver, spleen channel.Has relaxing muscles and tendons and activating QI and blood in the collateral, the effect of stomach function regulating removing dampness, the living Feng that helps digestion.Can be used for dyspepsia, the Feng wound is thirsty etc.The Fructus Chaenomelis chemical constituent contains oleanolic acid, malic acid, citric acid, tartaric acid and saponin etc.Pharmacological action: the Fructus Chaenomelis suspension has hepatoprotective effect; Fresh Sucus Chaenomelis and Fructus Chaenomelis decoct have tangible bacteriostasis to intestinal and staphylococcus; Its extract has inhibitory action to mice ehrlich carcinoma and peritoneal macrophage phagocytic function.
Lightly seasoned, the little acid of Folium Microcoris paniculatae, property is flat, have heat clearing away disappear stagnant, the dampness removing jaundice eliminating, clears phlegm is mainly used in flu, heatstroke, inappetence, dyspepsia, the abdominal pain of damp and hot dyspepsia, lack of appetite is had loose bowels, jaundice due to damp-heat etc.This product contains alkaloid, organic acid, saccharide, phenols and tannin.Since ancient times, Folium Microcoris paniculatae is just in the extensive use among the people in area, China south of the Five Ridges, and Folium Microcoris paniculatae commonly used among the people simmers tea and makes the beverage in summer, quenches one's thirst the appetizing effect.
The Radix Glycyrrhizae sweet in the mouth is flat.GUIXIN, lung, spleen, stomach warp have invigorating the spleen and replenishing QI, expelling phlegm for arresting cough, relieving spasm to stop pain, heat-clearing and toxic substances removing, the effect of coordinating the actions of various ingredients in a prescription.This product all can be brought into play the effect of the mediation property of medicine in many prescriptions, its sweet taste is strong, the flavour of rectifiable side's Chinese medicine.Radix Glycyrrhizae chemical constituent side will contain compositions such as triterpenes (potassium of triterpene saponin glycyrrhizic acid, calcium salt are glycyrrhizin, are the sweet ingredients of Radix Glycyrrhizae), flavonoid, alkaloid, polysaccharide.Its pharmacological action: Radix Glycyrrhizae has anti-arrhythmia effect; Antiulcer is arranged, and gastrointestinal smooth muscular spasm and analgesic activity are alleviated in gastric acid inhibitory secretion, and with the effective ingredient peoniflorin of Radix Paeoniae synergism are arranged; Can promote pancreatic secretion; Tangible antitussive effect is arranged, and phlegm-dispelling functions is also more remarkable, also has certain antiasthmatic effect; Antibiotic, antiviral, antiinflammatory, anti-allergic effects are arranged; Can protect throat and the tunica mucosa tracheae of inflammation; Some poisonous substance there is the Detoxication of similar glucuronic acid; The effect of similar adrenocortical hormone sample is arranged; Effect such as also have diuresis, blood fat reducing, protect the liver.
In the effervescent formulation of the present invention, be monarch with Semen Hoveniae (Fructus Hoveniae), its sweet in the mouth is flat, and alcoholic intoxication quenches the thirst and relieves restlessness and prevents vomiting.Radix Puerariae is ministerial drug, and sweet in the mouth is cool in nature, and light clear the liter loose, and kindly rises the gas of sending out the clear sun of taste and quenches the thirst, and antidiarrheal dysentery is with the enhancing Semen Hoveniae (Fructus Hoveniae) merit of relieving restlessness of quenching the thirst of relieving the effect of alcohol.Assistant is with Herba Moslae, Semen phaseoli radiati, Folium Nelumbinis removing summer-heat heat-damp in summer, Fructus Chaenomelis, Folium Microcoris paniculatae dyspepsia and intestinal stasis relieving, again with Radix Glycyrrhizae for making coordinating the actions of various ingredients in a prescription.The removing summer-heat heat-damp in summer is played, the spleen and stomach regulating, the effect of relieving the effect of alcohol altogether by full side.It is excessive to be particularly suitable for wine meat, and cold and summer-heat is mingled with, and disease is seen the flu headache, drunk xerostomia, and the crowd of diarrhoea abdominal distention also is fit to because operating pressure is big very much, and eating and drinking without temperance, air-conditioning cold drink excessively cause the crowd of diseases such as abdominal distention, diarrhoea, inappetence.Side's taste of Chinese medicine is the medicine-food two-purpose medical material that Ministry of Public Health is promulgated, the property of medicine is gentle, and uses with a long historyly, and material base and pharmacological effect are clearer and more definite, and the safety of prescription gained herbal tea and effectiveness are guaranteed thus, and all types of crowds all can take for a long time.Simultaneously, effervescent formulation provided by the invention is solid herbal tea new product, compares with existing herbal tea series products, has the following advantages:
1, small product size is little, and is easy to carry and transport, especially is fit to business people and crowd during the journey.
2, product just contacts with cold water even frozen water and can dissolve into the good antipyretic beverage of mouthfeel rapidly, and is easy to use, meets the modern and likes the custom of obeying cold or ice-cold tea.
3, product does not contain sugar, and is low in calories, satisfies the needs of diabetic population.
4, product is taken in the process and can be produced a large amount of gases, has the mouthfeel of soda pop, satisfies young colony (particularly child's) mouthfeel demand.
The specific embodiment
The preparation of embodiment 1 effervescent formulation of the present invention
Prescription:
Method for making:
Get the herbal tea medical material of recipe quantity, add 8 times of water gagings, decoct 2 times, each 1 hour, 300 eye mesh screens filter, filtrate decompression concentrate (80 ℃, 0.08～0.1Mpa) to relative density be 1.02～1.05 (80 ℃ of surveys), cooling back high speed centrifugation (15000 changes/min) 15 minutes, get supernatant and continue (80 ℃ of concentrating under reduced pressure, 0.08～0.1Mpa) extremely to relative density 1.10～1.15 (80 ℃), spray drying (inlet temperature is 170～180 ℃, 90～100 ℃ of leaving air temps), collect dried cream powder, check moisture content, make the content water management below 3%, standby.
Get other adjuvant, all after the drying, pulverized 100 mesh sieves, standby.Get wherein PEG-6000, after the heating and melting, add sodium bicarbonate, mixing, cooling is ground into fine powder, presses the abundant mix homogeneously of equivalent incremental method with above-mentioned herbal tea dried cream powder, lactose, aspartame.PVP K-30 is added dehydrated alcohol be mixed with 3% solution, add in the above-mentioned mixed powder, mixing is made granule, and drying is made 100 bags, and every bag of 5g namely gets effervescent granule.(mixing, granulation, packaging process all should be 15～25 ℃ of temperature, relative humidity is less than operating under 30% the environment)
The preparation of embodiment 2 effervescent formulations of the present invention
Prescription:
Method for making:
With embodiment 1.
The preparation of embodiment 3 effervescent formulations of the present invention
Prescription:
Method for making:
With embodiment 1.
The preparation of embodiment 4 effervescent formulations of the present invention
Prescription:
Method for making:
With embodiment 1.
The preparation of embodiment 5 effervescent formulations of the present invention
Prescription:
Method for making:
Get the herbal tea medical material of recipe quantity, add 8 times of water gagings, decoct 2 times, each 1 hour, 300 eye mesh screens filter, filtrate decompression concentrate (80 ℃, 0.08～0.1Mpa) to relative density be 1.02～1.05 (80 ℃ of surveys), cooling back high speed centrifugation (15000 changes/min) 15 minutes, get supernatant and continue (80 ℃ of concentrating under reduced pressure, 0.08～0.1Mpa) extremely to relative density 1.10～1.15 (80 ℃), spray drying (inlet temperature is 170～180 ℃, 90～100 ℃ of leaving air temps), collect dried cream powder, check moisture content, make the content water management below 3%, standby.
Get other adjuvant, all after the drying, pulverized 100 mesh sieves, standby.Get wherein PEG-6000 150g, after the heating and melting, add sodium bicarbonate, mixing, cooling is ground into fine powder, presses the abundant mix homogeneously of equivalent incremental method with above-mentioned herbal tea dried cream powder, lactose, aspartame.PVP K-30 is added dehydrated alcohol be mixed with 3% solution, add in the above-mentioned mixed powder, mixing is made granule, drying, granulate adds remaining 50gPEG-6000 fine powder, fully mixing again, with the specification tabletting of every 2.5g, make 1000, packing namely gets effervescent tablet.(mixing, granulation, tabletting, packaging process all should be 15～25 ℃ of temperature, relative humidity is less than operating under 30% the environment)
The Study on Preparation of dry extract in embodiment 6 effervescent formulations of the present invention
1. pre-treatment in the prescription
Semen Hoveniae (Fructus Hoveniae): remove impurity.
Radix Puerariae: remove impurity, clean, run through, cut sheet, dry.
Folium Nelumbinis: water spray, moisten shredding, drying slightly.
Semen phaseoli radiati: remove impurity.
Herba Moslae: remove undesirable root and impurity, cutting.
Fructus Chaenomelis: clean, run through or steam the back shave, dry.
Folium Microcoris paniculatae: remove impurity.
Radix Glycyrrhizae: remove impurity, clean, run through, cut sheet, drying.
2. extraction process technology Study on Conditions
2.1 pick up test
Vegetable drug all has the ability of absorption solvent in various degree, and the big young pathbreaker who absorbs the solvent amount influences the effect of extraction.Therefore, in test the pick up of medical materials such as Semen Hoveniae (Fructus Hoveniae) is investigated.
Take by weighing Semen Hoveniae (Fructus Hoveniae) 27g, Radix Puerariae 27g, Folium Nelumbinis 12g, Semen phaseoli radiati 27g, Herba Moslae 12g, Fructus Chaenomelis 18g, Folium Microcoris paniculatae 15g, Radix Glycyrrhizae 15g, each two parts, weight is W0, add 10 times of water gagings respectively, after being dipped to medical material and caring, filter, medical material is weighed, and is W1, by formula calculates water absorption rate.The results are shown in following table 1.
Table 1 medical material pick up is investigated the result
By above result of the test as can be known, the medical material water absorption is about 200%, so should add into 2 times of water gagings when extracting for the first time.
2.2 extraction conditions screening
Carry in the factor influencing water, amount of water, extraction time, extraction time are more important factor, determine level separately according to documents and materials, adopt L
9(3
)4 orthogonal table are tested.
Determining of evaluation index: Radix Puerariae is our monarch drug, and puerarin is its main effective ingredient, measures its content in technical study, and the index sake of clarity is estimated definitely, can lay good basis for preparation quality standard research.In the extraction process by water research, select puerarin content as one of evaluation index, weight is 0.8.Alternative is selected and is received the cream rate as another evaluation index, and the weight height is 0.2.
Experimental technique: get Semen Hoveniae (Fructus Hoveniae) 27g, Radix Puerariae 27g, Folium Nelumbinis 12g, Semen phaseoli radiati 27g, Herba Moslae 12g, Fructus Chaenomelis 18g, Folium Microcoris paniculatae 15g, Radix Glycyrrhizae 15g, carry, filter, be concentrated into 250ml by orthogonal table condition water, standby.
1. receive cream rate assay method:
Get each 25ml of orthogonal test gained medicinal liquid (being equivalent to crude drug 15.3g) respectively, place the evaporating dish (weight is M) that is dried to constant weight, water bath method, in 105 ℃ of dryings 3 hours, put in the exsiccator cooling 0.5 hour, weigh rapidly (weight is N), calculate the aqueous extract yield, the results are shown in Table 3.
2. puerarin content is measured:
Chromatographic condition and system suitability test are immobile phase with octadecylsilane chemically bonded silica; Methanol-water (25: 75) is mobile phase; The detection wavelength is 250nm; Number of theoretical plate calculates by puerarin peak, should be not less than 4000.
It is an amount of that the puerarin reference substance is got in the preparation of reference substance solution, and accurate the title decides, and makes the solution that every 1ml contains 60 μ g with 30% alcoholic solution, namely.
Orthogonal test gained medicinal liquid 1ml is got in the preparation of need testing solution, puts in the 50ml measuring bottle, adds 30% alcoholic solution 40ml, supersound process 10 minutes, and cooling adds 30% ethanol and is settled to scale, shakes up, and filters, and gets subsequent filtrate, namely.
Algoscopy is accurate reference substance solution and each 10 μ l of need testing solution of drawing respectively, injects chromatograph of liquid, measures peak area, calculates, namely.
Water is put forward part orthogonal test factor level table and result of the test and is seen Table 2 and table 3:
Table 2 water is carried the factor level table
Table 3 water is put forward orthogonal experiments
Annotate: comprehensive grading=(receiving cream rate/37.11) * 20+ (puerarin content/3.712) * 80
Table 4 water is proposed the orthogonal test variance analysis
*F
0.05(2，2)＝19**F
0.001(2，2)＝99
Extreme difference value (R) shows in the orthogonal experiments, and the factor that influences extraction process is in proper order: extraction time 〉=extraction time 〉=amount of water.
By the K value as can be known: extraction time is with 3 suboptimums; Amount of water is with 10 times of the bests; Extraction time was with 1 hour the best.Integrate with A
3B
3C
2, namely add 10 times of amounts of water, decoct 3 times, each 1 hour is best extraction process by water condition.
Can be got by K value and variance analysis: amount of water is to extraction efficiency there are no significant influence, and gap is less between 8 times, 10 times of the amount of water, and for saving follow-up concentration time, can adjust amount of water is 8 times.Extraction time, times influence are bigger, and all and significant difference is arranged, but from result of the test as can be known, gap is minimum between the extraction time 2 times, 3 times, and can adjust extraction time is 2 times.
In sum, from saving production cost, extraction process by water can be selected time good condition, namely adds 8 times of amounts of water and decocts each 1 hour 2 times.Carry out water for this reason and put forward the contrast test of optimum condition and time good condition.
Table 5 water is put forward the contrast test of optimum condition and time good condition
Result of the test shows that optimum condition is suitable with time good condition test result, takes all factors into consideration, and when guaranteeing extraction effect, is energy savings, man-hour, can select time good condition.
Analysis-by-synthesis: filtering out this product extraction process by water condition by above-mentioned result of the test is: add 8 times of amounts of water, decoct each 1 hour 2 times.
2.3 water is carried confirmatory experiment
Get Semen Hoveniae (Fructus Hoveniae) 27g, Radix Puerariae 27g, Folium Nelumbinis 12g, Semen phaseoli radiati 27g, Herba Moslae 12g, Fructus Chaenomelis 18g, Folium Microcoris paniculatae 15g, Radix Glycyrrhizae 15g, put forward condition with the water that filters out and carry out confirmatory experiment, result of the test sees Table 6:
Table 6 water is put forward the confirmatory experiment result
Experimental result shows that determined extraction process by water is reasonable, stable.
3. separation, purification condition research
In the water extract except visible foreign body, also contain water soluble polymer impurity such as a large amount of saccharides, tannin, protein, these impurity also can cause dried cream yield too high except influencing stability of drug, influence moulding process, need take certain method that extracting solution is separated and purification.
According to the character of this prescription Chinese medicine effective ingredient and the adaptability of follow-up big production, in separation purifying technique research, compared high speed centrifugation, precipitate with ethanol and added the effect of purifying process such as clarifier.Test method is as follows:
High speed centrifugation: after the water intaking decocting liquid filters with 300 order filter clothes, be condensed into the medicinal liquid of relative density 1.02～1.05 (80 ℃ of surveys), cross centrifugal 15 minutes of high speed centrifuge (15000 rev/mins), get supernatant.
Alcohol deposition method: decocting liquid 300 filter clothes are concentrated into relative density 1.10～1.15 (80 ℃ of surveys) after filtering, and adding ethanol is 70% to containing the alcohol amount, leaves standstill 12 hours, gets supernatant.
ZTC1+1 clarifier impurity removal method: the preparation of (1) ZTC1+1.The A component: it is an amount of to get the A component, adds low amounts of water furnishing pasty state, adds the water of requirement then, and swelling 24 hours stirs, and filters, and gets 1% viscose.The B component: it is an amount of to get the B component, becomes pasty state with a small amount of 1% acetate dissolution earlier, adds 1% acetic acid of aequum, swelling 24 hours, and filtration namely gets 1% viscose.(2) impurity-removing method: the thing aqueous extract of getting it filled, be condensed into the medicinal liquid of 0.2g crude drug/ml, get 100ml, add the 2mlA component, stir evenly, continuing adds B component 2ml, stir evenly, 80 ℃ of water bath heat preservations 20 minutes, centrifugal, get supernatant.
Determining of evaluation index: (1) receives the cream rate: separate purpose is to remove water soluble polymer impurity such as saccharide in the extracting solution, tannin, protein as far as possible, reduces and receives the cream rate, to reach the minimizing dose, is easy to the purpose of molding.So it is suitable to drop to receive cream rate index.(2) puerarin content: the main effective ingredient of monarch drug Radix Puerariae in the puerarin side of being also is the evaluation index of extraction process by water, the situation of change of puerarin in the extracting solution before and after the examination precipitate with ethanol, the reasonability of energy effective evaluation alcohol precipitation process.The puerarin content loss should be advisable as far as possible less.Come the best purifying process of overall merit by above-mentioned two indexs.
Result of the test sees Table 7:
Table 7 separation purifying technique result of study
* annotate: rate of change refers to data comparison before the data and purification behind the purification.
Experimental result shows that in three kinds of purification process, the loss of supercentrifugal process puerarin is minimum, and alcohol deposition method is received the cream rate and descended maximum.Take all factors into consideration, best with the high speed centrifugation effect.The ZTC1+1 clarifier should not be selected for use owing to can cause a large amount of losses of effective ingredient.
4. the research of concentration technology
Advantages such as this product concentration technology intend to adopt the concentrating under reduced pressure method, and it concentrates with normal pressure and compares, and it is low to have a thickening temperature, and speed is fast are widely used in concentrating of Chinese medicine extraction liquid in herbal pharmaceutical enterprise.Concrete concentration technology parameter is as follows:
Water extract concentrating under reduced pressure (80 ℃, 0.08～0.1Mpa) to relative density be 1.02～1.05 (80 ℃ of surveys), cooling back high speed centrifugation (15000 changes/min) 15 minutes, gets supernatant and continue concentrating under reduced pressure (80 ℃, 0.08～0.1Mpa) to suitable degree.
5. drying process research
In preparation process research, should extremely amass applicating new process, new technique, also must be in conjunction with the working condition in pharmaceutical factory, drying means commonly used mainly contains in medicine enterprise produces at present: normal pressure oven drying method, hypobaric drying method, spray drying method, fluid-bed drying, micro-wave drying method etc.This several method respectively has pluses and minuses, is suitable for the drying of heterogeneity material respectively.
Under study for action, the effect that has compared drying meanss such as normal pressure oven drying method, hypobaric drying method, spray drying method and micro-wave drying method respectively.Experimental technique is as follows:
Constant pressure and dry: with decocting liquid purification and be concentrated into relative density 1.30～1.35 (80 ℃) and put constant pressure and dry in 80 ℃ of convection oven.
Drying under reduced pressure: with decocting liquid purification and be concentrated into relative density 1.30～1.35 (80 ℃) and put in the vacuum drying apparatus, in 80 ℃, dry under the condition of-0.08～0.1Mpa.
Micro-wave drying method: with decocting liquid purification and be concentrated into relative density 1.30～1.35 (80 ℃) and put in the vacuum drying apparatus, in 60 ℃ ,-0.06～0.08Mpa is dry under the condition of 2450 ± 50MHz.
Spray drying method: with decocting liquid purification and be concentrated into relative density 1.10～1.15 (80 ℃), spray drying (inlet temperature is 170～180 ℃, 90～100 ℃ of leaving air temps).
Collect dry extract or extract powder that above-mentioned drying obtains, relatively the indexs such as character, puerarin content and drying time of different dry drying method products obtained therefrom.The results are shown in Table 8.
Table 8 drying process result of study table
The result shows that decompression, spraying, microwave drying are compared constant pressure and dry, and the used time shortens greatly, and the puerarin loss is less, and institute's quality that gets dry extract is more excellent, is drying means preferably.Wherein the shortest with the spray drying required time again, puerarin content is the highest, gained be dried cream powder again, saved follow-up pulverising step, be suitable as the drying means of this product most.So the drying process of this product intends selecting for use the spray drying method drying, concrete technological parameter is as follows: after the remove impurity of water extract purification, be evaporated to relative density 1.10～1.15 (80 ℃), spray drying (inlet temperature is 170～180 ℃, 90～100 ℃ of leaving air temps).
6. the method for making of herbal tea dried cream powder
Get the herbal tea medical material of recipe quantity, add 8 times of water gagings, decoct 2 times, each 1 hour, 300 eye mesh screens filter, filtrate decompression concentrate (80 ℃, 0.08～0.1Mpa) to relative density be 1.02～1.05 (80 ℃ of surveys), cooling back high speed centrifugation (15000 changes/min) 15 minutes, get supernatant and continue (80 ℃ of concentrating under reduced pressure, 0.08～0.1Mpa) extremely to relative density 1.10～1.15 (80 ℃), spray drying (inlet temperature is 170～180 ℃, 90～100 ℃ of leaving air temps), collect dried cream powder, detect moisture content, make the content water management below 3%, namely.
The research of embodiment 7 effervescent granule prescription screenings
The Chinese medicine effervescent is in preparation and storage process, because the Chinese medical concrete powder has stronger hygroscopicity, the effervescent reaction can take place for make moist back acid source and carbon dioxide source, causes finished product to lose the effervescent effect.Wherein ideal method is to adopt PEG-6000 parcel carbon dioxide source, isolating acid source and carbon dioxide source effectively, thereby guarantees stability of formulation.Also should select the more weak adjuvant of hygroscopicity in preparation as far as possible, adopt anhydrous granulation, the methods such as humidity that reduce production environment improve the production of effervescent and the stability in the use.
According to above principle, designed the preparation technology of effervescent granule: get PEG-6000, after the heating and melting, add carbon dioxide source, mixing, cooling is ground into fine powder, with herbal tea dried cream powder, diluent, acid source, correctives, by the abundant mix homogeneously of equivalent incremental method, it is an amount of to get anhydrous wetting agent or binder solution, makes granule, drying, packing gets final product.
By above-mentioned technology, the prescription of effervescent granule has been carried out screening study, specific as follows.
1. the selection of diluent
For reducing the moisture absorption of Chinese medical concrete powder, be convenient to granulate, need to add a certain amount of diluent.Diluent commonly used has starch, dextrin, Icing Sugar, lactose, mannitol, calcium sulfate etc.Because calcium sulfate is water insoluble, the Icing Sugar hygroscopicity is big and easily transform in acid-base environment, so this prescription is not selected for use.Be evaluation index with granulation situation, melting, kind and the consumption of diluent are studied, the results are shown in Table 9.
Table 9 difference is released the selection result of agent
| Kind | The granulation situation | Melting |
| Soluble starch | Soft material is more sticking, and it is harder to make granule, | Slightly muddy |
| Dextrin | Be easy to granulate, even particle size, neither too hard, nor too soft | Slightly muddy |
| Lactose | Be easy to granulate, even particle size, neither too hard, nor too soft | Settled solution |
| Mannitol | Be easy to granulate, even particle size, neither too hard, nor too soft | Settled solution |
From experimental result as can be known, lactose and mannitol are effervescent granule diluent preferably, and wherein mannitol has certain sweet taste, can also play the effect of flavoring.In this technology, select lactose as diluent.
2. the selection of gas-producing disintegrant
Acid source in the effervescent excipient has citric acid, tartaric acid, fumaric acid, adipic acid, malic acid etc.; Carbon dioxide source has sodium bicarbonate, potassium carbonate, potassium bicarbonate, calcium carbonate etc.Wherein the most frequently used acid source is citric acid (citricacid), claims citric acid again, its wide material sources, and mouthfeel is better, is strong organic acid, and soluble in water, but moisture absorption is stronger.The most frequently used carbon dioxide source is sodium bicarbonate.This prescription is studied kind and the proportioning of gas-producing disintegrant, make granule after, with the effervescent time, pH value, solution appearance, mouthfeel are leading indicator, the results are shown in Table 10.
The selection result of the different gas-producing disintegrants of table 10
Experimental result shows that the granule of above-mentioned prescription is met water and produced bubble immediately, and effervescence is obvious, but different soda acid proportionings are not clearly to the effervescent time effects.And pH value reduces with the increase of sour consumption, and mouthfeel is meta-acid gradually.Generate sodium citrate after citric acid and sodium bicarbonate react, meta-alkalescence so strengthen the consumption of acid, with reference to mouthfeel and pH value, is selected for use about 1.3: 1 to well.
3. the selection of correctives
The herbal tea solution of this prescription preparation, its mildly bitter flavor has Hui Tian, does not have bad abnormal smells from the patient, does not need to add the taste requirement that correctives can satisfy most people.But the requirement (as the crowd of child and happiness food sweet taste) for the suitable more extensive crowd of property can add an amount of sweeting agent as required in prescription.Aspartame (claiming aspartame, sweetener, protein sugar, aspartame, radix asparagi sweet extract, day benzene sugar again) is the most frequently used sweeting agent that arrives in present food, the medicine, and sugariness is 200 times of sucrose, and sweet taste is pure.It is all in the sugar to human body security study product the most completely, safe, human body is had no adverse reaction.It is sweeting agent that this product is selected aspartame for use, adds aspartame according to output 0.1%, 0.3%, 0.5%, 1.0% ratio, and the solution mouthfeel is observed in the dissolving back, the results are shown in Table 11.
The selection result of table 11 aspartame consumption
The result shows, aspartame consumption 0.3%～0.5% can reach and better increases sweet flavored action.
4. the selection of moistening or binding agent
The moistening that effervescent formulation is the most frequently used or binding agent have the syrup of water, alcohol-water, polyvinylpyrrolidone (PVP) aqueous solution or alcoholic solution, sugar and polyhydric alcohol.Chinese medical concrete adds the viscosity that can bring out self behind the suitable wetting agent, and the effervescent formulation process should be avoided the existence of moisture content again as far as possible, and this technology intends selecting the ethanol solution of dehydrated alcohol or polyvinylpyrrolidone (PVP-K30) as moistening or binding agent.Be evaluation index with granulation difficulty or ease and particle appearance, the selection result of moistening or binding agent sees Table 12.
The selection result of table 12 moistening or binding agent
According to experimental result, this product selects for use 3% polyvinylpyrrolidone (PVP-K30) ethanol solution as binding agent.
5. the preparation process prescription is preferred
By above-mentioned experiment, the adjuvant of effervescent granule is carried out initial option, but the consumption of all kinds of adjuvants also can have influence on effect and the stability of preparation, because of a bit for citric acid: the consumption of sodium bicarbonate total amount, PVP-K30, PEG-6000 is investigated.Each factor designs three levels respectively, selects L for use
9(3)
4Orthogonal table is tested, and sees Table 13.
According to rules of preparations, effervescent granule is except the general requirement that should reach granule, melting must meet following provisions: get 1 bag of test sample, put in the beaker that fills 200ml water, water temperature is 15 ℃～25 ℃, should produce gas rapidly and be the effervescent shape, endoparticle should be dispersed or dissolved in the water fully in 5 minutes.Find in experiment, the herbal tea effervescent granule is put into water, just have bubble to produce immediately, effervescence is obvious.Therefore be that index is analyzed the quadrature result with the effervescent time, the result is following to see Table 14～15.
The preferred factor level table of table 13 prescription
* percentage calculation is as follows: 100 bags of this product, design every packed 5g, namely total amount is 500g, percentage rate is the percentage rate of prescription total amount in the water-glass, the herbal tea dry extract is about 200g, remove other adjuvant after, add lactose and regulate weight to 500g.
The preferred orthogonal experiments of table 14 prescription
The variance analysis of table 15 prescription orthogonal test
*F
0.05(2，2)＝19**F
0.001(2，2)＝99
Extreme difference value (R) shows in the orthogonal experiments, and the factor that influences the effervescent effect is in proper order: PEG-6000 〉=effervescent consumption 〉=PVP-K30.By the K value as can be known: the best during effervescent consumption 50%; PVP-K30 consumption 0.5% the best; PEG-6000 consumption 6% the best.Can be got by K value and variance analysis: the PVP-K30 consumption does not have the significance influence to the effervescent effect, but the soft material viscosity that 0.5% consumption makes is not enough, and the granule fine powder is more, so its consumption is defined as 1%.Effervescent consumption, PEG-6000 consumption are bigger to the effervescent influential effect, and all and significant difference is arranged, but from result of the test as can be known, gap is minimum between the effervescent consumption 50% and 33%, from the saving cost consideration, determines that the effervescent consumption is 33%.
Below by concrete test example beneficial effect of the present invention is described.
The sober-up function of test example 1 effervescent formulation of the present invention
According to bibliographical information, the Semen Hoveniae (Fructus Hoveniae) among the present invention and Radix Puerariae have clearer and more definite sober-up function.Pre-preventing drunkenness and sober up effect for after relatively Semen Hoveniae (Fructus Hoveniae) and Radix Puerariae and our other medicines compatibility use have designed following test and have compared.
1. pre-preventing drunkenness test
(1) experimental animal: get 90 of Kunming kind white mice, body weight 18～22g, male, be divided into 6 groups of A, B, C, D, E, F etc. at random, 15 every group.Fasting is 6 hours before the experiment.
(2) different formulations herb tea concentrated solution preparation: the A group is of the present invention group (proportioning is participated in embodiment 1), it is the Semen Hoveniae (Fructus Hoveniae) group that B organizes, and the C group is the Radix Puerariae group, and the D group is that Semen Hoveniae (Fructus Hoveniae) and Radix Puerariae are pressed 1: 1 compatibility group, E group other medical material compatibility group for removing Semen Hoveniae (Fructus Hoveniae) and Radix Puerariae, the F group is blank group.Each group prepares concentrated solution by equal following methods.
Get the medical material of different formulations, add 2 times of water gagings and soaked 30 minutes, add 6～8 times of water gagings again, decoct 2 times, each 30～60 minutes, collecting decoction filtered, and remove impurity is evaporated to the concentrated solution that every 1ml contains the 1g crude drug, and is standby.
(3) test method: A～E group is calculated administration, the every 100g body weight of white mice 1.7ml medicine concentrated solution gastric infusion by 50 times of amounts of adult's dosage 17g/50kg.The F group is then with equivalent distilled water gastric infusion.Behind the 30min, each group gives 52 ° of distilled spirits by 2.5ml/100g and irritates stomach.Observe the drunk situation of white mice after 1 hour.With mice creep shakiness, be slow in action or the tired contracting of health, the hair loose be drunk index.
(4) data statistics: adopt χ
2Check.The results are shown in Table 16.
Table 16 different formulations is to the pre-preventing drunkenness result of white mice
| Group | Dosage | Number of animals (only) | Drunk number (only) | Drunk rate (%) |
| Of the present invention group of A | 17g/kg | 20 | 2 | 10 △△ |
| B Semen Hoveniae (Fructus Hoveniae) group | 17g/kg | 20 | 8 | 40 *△△ |
| C Radix Puerariae group | 17g/kg | 20 | 9 | 45* △△ |
| D Semen Hoveniae (Fructus Hoveniae)+Radix Puerariae group | 17g/kg | 20 | 6 | 25 △△ |
| Other medical material group of E | 17g/kg | 20 | 16 | 80 ** |
| The blank group of F | --- | 20 | 18 | 90 ** |
Annotate: * and of the present invention group of comparison; △ compares with blank group.*P＜0.05，**P＜0.01
2. the test of sobering up
(1) experimental animal grouping and the preparation of different formulations herb tea concentrated solution are with " 1. pre-preventing drunkenness test ".
(2) test method: get each test group white mice, give 52 ° of distilled spirits by 2.5ml/100g and irritate stomach, observe drunk after, A～E group is calculated administrations, the every 100g body weight of white mice 1.7ml medicine concentrated solution gastric infusion by 50 times of amounts of adult's dosage 17g/50kg.The F group is then with equivalent distilled water gastric infusion.Observe white mice and recover the normal time.
(3) data statistics: adopt the T check.The results are shown in Table 17.
Table 17 different formulations is to the result that sobers up of white mice
| Group | Dosage | Drunk number (only) | (min) sobers up the time |
| Of the present invention group of A | 17g/kg | 18 | 72.6±31.3 △△ |
| B Semen Hoveniae (Fructus Hoveniae) group | 17g/kg | 17 | 91.2±29.6 *△△ |
| C Radix Puerariae group | 17g/kg | 18 | 93.5±40.7 *△△ |
| D Semen Hoveniae (Fructus Hoveniae)+Radix Puerariae group | 17g/kg | 19 | 89.6±38.4 *△△ |
| Other medical material group of E | 17g/kg | 16 | 142.8±55.2 ** |
| The blank group of F | --- | 19 | 167.4±43.3 ** |
Annotate: * and of the present invention group of comparison; △ compares with blank group.*P＜0.05，**P＜0.01
Result of the test shows that herbal tea compound recipe of the present invention has pre-preventing drunkenness and the effect of relieving the effect of alcohol preferably, and is better than the effect of Semen Hoveniae (Fructus Hoveniae) and Radix Puerariae coupling.
Test example 2 effervescent formulations of the present invention are to the effect of summer-heat damp cold
The cause of disease of summer-heat damp cold has been human feeling heat-damp in summer seasonal pathogen in summer because liking enjoying the cool and drinking coldly, makes the heat-damp in summer in the body be held back by wind and cold again, and catharsis is obstructed, thereby falls ill.Modern Warming, people are dark to the dependence day of air-conditioning, cold drink, and this disease has become commonly encountered diseases in summer.Its sick position is flesh table and middle burnt taste, so it is bad-looking then to generate heat outside the symptom performance, and heaviness sensation over the head and body; In then breast gastral cavity painful abdominal mass is vexed, incoordination between the spleen and stomach, the digestive system function obstacle, rapid pulse, though mouthful do and drink few, though tongue fur is greasy and few yellow.If heat-damp in summer is violated lung, lung qi is unclear, also has cough with ropy sputum, the symptom of turbid nasal discharge.
We have removing summer-heat heat-damp in summers such as Folium Nelumbinis, Semen phaseoli radiati, Herba Moslae, and Semen Hoveniae (Fructus Hoveniae) diuresis, Radix Puerariae solution hypergene Feng quench the thirst, Fructus Chaenomelis, Folium Microcoris paniculatae the spleen and stomach regulating, dyspepsia and intestinal stasis relieving, Radix Glycyrrhizae relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.Full side share, and summer-heat damp cold is had preventive and therapeutic action preferably.For proving its effect, carried out following comparative test.
1. summer-heat damp cold diagnostic criteria:
Sick time is in May～JIUYUE, and high temperature and rainy all has diseases caused by exogenous pathogenic factor symptom and gastrointestinal dysfunction symptom.Be embodied in: full vexed, indigestion and loss of appetite weak, the nausea and vomiting of heating, slight chill, headache, chest and diaphragm, dull pain in the epigastrium, borborygmus diarrhea, tastelessness and no thirst, white and greasy fur.All get rid of diseases such as influenza, bacterial enteritis, dysentery.
2. criterion of therapeutical effect:
Cure: clinical symptom disappearance, body temperature are normal, diet is normally followed up a case by regular visits to and do not recurred January.Take a turn for the better: clinical symptom disappearance or alleviate, or weather and diet change slightly and symptom namely occurs, but use with quadrat method effective.Invalid: symptom does not have improvement before and after the treatment.
3. different formulations herb tea concentrated solution preparation:
A group: of the present invention group, with Semen Hoveniae (Fructus Hoveniae) 9g, Radix Puerariae 9g, Folium Nelumbinis 4g, Semen phaseoli radiati 9g, Herba Moslae 4g, Fructus Chaenomelis 6g, Folium Microcoris paniculatae 5g, Radix Glycyrrhizae 5g, adding 2 times of water gagings soaked 30 minutes, add 6～8 times of water gagings again, decoct each 30～60 minutes 2 times, collecting decoction, filter, be condensed into about 1000ml, divide in 1 day and take for 2-3 time.
B group: Folium Nelumbinis, Semen phaseoli radiati, Herba Moslae group, with Folium Nelumbinis 20g, Semen phaseoli radiati 15g, Herba Moslae 15g, the same preparation and taking.
C group: other medicines group, Semen Hoveniae (Fructus Hoveniae) 10g, Radix Puerariae 15g, Fructus Chaenomelis 10g, Folium Microcoris paniculatae 10g, Radix Glycyrrhizae 5g, the same preparation and taking.
D group: Folium Nelumbinis, Semen phaseoli radiati group, with Folium Nelumbinis 25g, Semen phaseoli radiati 25g, the same preparation and taking.
E group: the Herba Moslae group, with Herba Moslae 50g, the same preparation and taking.
4. Therapeutic Method: take said medicine on request, took observe the curative effect continuously 3 days.
5. the result is relatively:
Because sample number is on the low side, data are added up, and adopt the method that directly compares.The results are shown in Table 18.
The result that sobers up of the white mice of table 18 different formulations
The result shows that herbal tea of the present invention has therapeutical effect preferably to summer-wet type common cold, and total effective rate reaches 100%, apparently higher than the effect of single medicine for relieving summer-heat or other prescription drug.
In sum, the present invention with medical material compatibilities such as Semen Hoveniae (Fructus Hoveniae), Radix Puerariae, Folium Nelumbinis, Semen phaseoli radiati, Herba Moslae, Fructus Chaenomelis, Folium Microcoris paniculatae, Radix Glycyrrhizaes after, have the removing summer-heat heat-damp in summer, the spleen and stomach regulating, the effect of relieving the effect of alcohol, and its effect obviously is better than Chinese medicine or compound recipe at present commonly used.Side's taste of Chinese medicine is the medicine-food two-purpose medical material that Ministry of Public Health is promulgated, the property of medicine is gentle, and uses with a long historyly, and material base and pharmacological effect are clearer and more definite, and the safety of prescription gained herbal tea and effectiveness are guaranteed thus, and all types of crowds all can take for a long time.
Simultaneously, effervescent formulation provided by the invention is solid herbal tea new product, and small product size is little, and is easy to carry and transport; Contact with cold water even frozen water and just can dissolve into the good antipyretic beverage of mouthfeel rapidly, easy to use, meet the custom that the modern likes the cold or ice-cold tea of clothes; Do not contain sugar, low in calories, satisfy the needs of diabetic population; Take in the process and can produce a large amount of gases, have the mouthfeel of soda pop, satisfy young colony (particularly child's) mouthfeel demand.
Claims (1)
1. effervescent formulation is characterized in that: it is the preparation that the supplementary material by following weight proportion is prepared from:
Raw material:
Semen Hoveniae (Fructus Hoveniae) 189-351 part, Radix Puerariae 189-351 part, Folium Nelumbinis 84-156 part, Semen phaseoli radiati 189-351 part, Herba Moslae 84-156 part, Fructus Chaenomelis 126-234 part, Folium Microcoris paniculatae 105-195 part, Radix Glycyrrhizae 105-195 part;
Adjuvant:
Filler 70-130 part, effervescent 114-213 part, stabilizing agent 21-39 part, binding agent 3.5-6.5 part, correctives 1.05-1.95 part.
2, effervescent formulation according to claim 1 is characterized in that: it is the preparation that the supplementary material by following weight proportion is prepared from:
Raw material:
270 parts of Semen Hoveniae (Fructus Hoveniae)s, 270 parts of Radix Puerariaes, 120 parts on Folium Nelumbinis, 270 parts in Semen phaseoli radiati, 120 parts of Herba Moslaes, 180 parts of Fructus Chaenomeliss, 150 parts of Folium Microcoris paniculataes, 150 parts in Radix Glycyrrhizae;
Adjuvant:
100 parts of filleies, 163.5 parts of effervescents, 30 parts of stabilizing agents, 5 parts of binding agents, 1.5 parts of correctivess.
3, effervescent formulation according to claim 1 and 2 is characterized in that: described filler is starch, dextrin, Icing Sugar, lactose, mannitol, calcium sulfate or microcrystalline Cellulose;
Described effervescent is acid source and carbon dioxide source, and wherein, acid source is organic acid, and carbon dioxide source is carbonate or bicarbonate;
Described stabilizing agent is PEG, gelatin, Resina persicae, tragacanth or Rhizoma Bletillae gel;
Described binding agent is PVP, HPMC or PEG;
Described correctives is sweeting agent.
4, effervescent formulation according to claim 3 is characterized in that: described acid source is citric acid, tartaric acid, fumaric acid, malic acid or succinic acid; Carbon dioxide source is potassium carbonate, potassium bicarbonate, sodium carbonate or sodium bicarbonate; Described sweeting agent is sucrose, aspartame or steviosin.
5, effervescent formulation according to claim 4 is characterized in that: it is the preparation that the supplementary material by following weight proportion is prepared from:
Raw material:
270 parts of Semen Hoveniae (Fructus Hoveniae)s, 270 parts of Radix Puerariaes, 120 parts on Folium Nelumbinis, 270 parts in Semen phaseoli radiati, 120 parts of Herba Moslaes, 180 parts of Fructus Chaenomeliss, 150 parts of Folium Microcoris paniculataes, 150 parts in Radix Glycyrrhizae;
Adjuvant:
100 parts of lactose, 92 parts of citric acids, 71.5 parts of sodium bicarbonate, 30 parts of PEG-6000,1.5 parts of aspartames, 5 parts of PVP-K30.
6, effervescent formulation according to claim 1 is characterized in that: described preparation is effervescent granule or effervescent tablet.
7, the preparation method of the described effervescent formulation of claim 6, it is characterized in that: it comprises the steps:
(1) take by weighing supplementary material by the prescription proportioning:
Raw material:
Semen Hoveniae (Fructus Hoveniae) 189-351 part, Radix Puerariae 189-351 part, Folium Nelumbinis 84-156 part, Semen phaseoli radiati 189-351 part, Herba Moslae 84-156 part, Fructus Chaenomelis 126-234 part, Folium Microcoris paniculatae 105-195 part, Radix Glycyrrhizae 105-195 part;
Adjuvant:
Filler 70-130 part, effervescent 114-213 part, stabilizing agent 21-39 part, binding agent 3.5-6.5 part, correctives 1.05-1.95 part; Acid source is that 64-119 part, carbon dioxide source are 50-94 part in the effervescent;
(2) with the crude drug extracting in water, the centrifugal back of water extract concentrates, and drying gets dry extract;
(3) earlier with behind the stabilizing agent parcel carbon dioxide source, with dry extract, filler, correctives, acid source mix homogeneously, add anhydrous binder solution again, preparation granule or tablet namely get effervescent granule or tablet.
8, preparation method according to claim 7, it is characterized in that: it comprises the steps:
(1) take by weighing supplementary material by the prescription proportioning,
Raw material:
270 parts of Semen Hoveniae (Fructus Hoveniae)s, 270 parts of Radix Puerariaes, 120 parts on Folium Nelumbinis, 270 parts in Semen phaseoli radiati, 120 parts of Herba Moslaes, 180 parts of Fructus Chaenomeliss, 150 parts of Folium Microcoris paniculataes, 150 parts in Radix Glycyrrhizae;
Adjuvant:
100 parts of lactose, 92 parts of citric acids, 71.5 parts of sodium bicarbonate, 30 parts of PEG-6000,1.5 parts of aspartames, 5 parts of PVP-K30;
(2) getting crude drug earlier adds water 8-12 and doubly measures, decoct 2-4 time, each 0.5-1.5 hour, merge decocting liquid, be concentrated into 80 ℃ and survey relative density 1.02～1.05, the cooling back is centrifugal, get supernatant and continue to be concentrated into 80 ℃ of survey relative densities 1.10～1.15, spray drying, drying condition is: inlet temperature is 170～180 ℃, 90～100 ℃ of leaving air temps namely get dry extract;
(3) get 30 parts of PEG-6000 heating and melting earlier after, add 71.5 parts of sodium bicarbonate, behind the mixing, cooling, after the pulverizing, again with dry extract, 100 parts of lactose, 1.5 parts of aspartames, 92 parts of citric acid mix homogeneously after, add the PVP K-30 ethanol solution of 3%w/v again, the preparation granule namely gets effervescent granule; Or, get granule, tabletting namely gets effervescent tablet.
9, any described effervescent formulation of claim 1-6 at the preparation expelling summer-heat, relieve the effect of alcohol, treat or/and prevent purposes in food, health product or the medicine of summer-heat damp cold.
10, purposes according to claim 9 is characterized in that: described effervescent formulation be sober up, food, health product or the pharmaceutical composition of pre-preventing drunkenness.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012100104196A CN102552462B (en) | 2012-01-12 | 2012-01-12 | Effervescent preparation as well as preparation method and application thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012100104196A CN102552462B (en) | 2012-01-12 | 2012-01-12 | Effervescent preparation as well as preparation method and application thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102552462A CN102552462A (en) | 2012-07-11 |
| CN102552462B true CN102552462B (en) | 2013-08-14 |
Family
ID=46399917
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2012100104196A Expired - Fee Related CN102552462B (en) | 2012-01-12 | 2012-01-12 | Effervescent preparation as well as preparation method and application thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102552462B (en) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104095222A (en) * | 2013-04-12 | 2014-10-15 | 谢金魁 | Effervescing agent for dispelling alcohol and protecting liver |
| CN103598384A (en) * | 2013-12-12 | 2014-02-26 | 安徽科技学院 | Compound tea drink formula |
| CN105432886A (en) * | 2015-12-08 | 2016-03-30 | 肇庆医学高等专科学校 | 24-flavor herbal tea effervescent tablet and preparation method thereof |
| CN105560317A (en) * | 2015-12-08 | 2016-05-11 | 肇庆医学高等专科学校 | Effervescent tablets containing frangipani tea, and preparation method of effervescent tablets |
| CN105497136A (en) * | 2015-12-08 | 2016-04-20 | 肇庆医学高等专科学校 | Five flower tea effervescent tablet and preparation method thereof |
| CN105519731A (en) * | 2015-12-08 | 2016-04-27 | 肇庆医学高等专科学校 | Dried tangerine peel tea effervescent tablet and preparation method thereof |
| CN107028976B8 (en) * | 2016-02-03 | 2022-01-14 | 中国人民解放军总医院 | Potassium supplementing potassium citrate effervescent tablet and its prepn |
| CN106106920A (en) * | 2016-06-23 | 2016-11-16 | 肇庆医学高等专科学校 | A kind of effervescent tablet for slimming herbal tea and preparation method thereof |
| CN105876036A (en) * | 2016-06-23 | 2016-08-24 | 肇庆医学高等专科学校 | Blood glucose reduction effervescent tablet herbal tea and preparation method thereof |
| CN106035876A (en) * | 2016-07-08 | 2016-10-26 | 肇庆医学高等专科学校 | Stomach-nourishing health-care effervescent tablets herbal tea and production method thereof |
| CN106173781A (en) * | 2016-07-08 | 2016-12-07 | 肇庆医学高等专科学校 | A kind of healthy effervescent tablet herbal tea of enhancing immunity and preparation method thereof |
| CN106265833A (en) * | 2016-08-01 | 2017-01-04 | 遵义医学院 | A kind of Flos Lonicerae effervescent tablet and preparation method thereof |
| CN106333365A (en) * | 2016-09-08 | 2017-01-18 | 吉林医药学院 | Hovenia acerba and ginseng effervescent tablet and preparation method |
| CA3045516A1 (en) | 2016-12-06 | 2018-06-14 | Amcor Rigid Plastics Usa, Llc | Co2 generator system for carbonated beverage containers |
| CN107361281B (en) * | 2017-07-13 | 2021-04-20 | 江苏中邦制药有限公司 | Momordica grosvenori effervescent tablet and preparation method thereof |
| CN108384692A (en) * | 2018-02-07 | 2018-08-10 | 北京百漾酒业科技股份有限公司 | A kind of rectification effervescent tablet |
| CN108606984A (en) * | 2018-05-02 | 2018-10-02 | 中山瑞德生物科技有限公司 | A kind of mystery fruit powder effervescent formulation and preparation method thereof and purposes |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997029642A1 (en) * | 1996-02-15 | 1997-08-21 | Eulogio Mas Criado | Effervescent tablet otbained from aromatic plant infusion extract |
| CN101502324A (en) * | 2009-03-06 | 2009-08-12 | 食品行业生产力促进中心 | Kava pepper extract effervescent tablet and technique for preparing the same |
| CN101574476A (en) * | 2009-05-26 | 2009-11-11 | 徐琳 | Medicinal material composition used for lowering lipid and protecting liver auxiliarily |
| CN102224962A (en) * | 2011-05-09 | 2011-10-26 | 常堡同 | Hangover alleviating beverage |
-
2012
- 2012-01-12 CN CN2012100104196A patent/CN102552462B/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997029642A1 (en) * | 1996-02-15 | 1997-08-21 | Eulogio Mas Criado | Effervescent tablet otbained from aromatic plant infusion extract |
| CN101502324A (en) * | 2009-03-06 | 2009-08-12 | 食品行业生产力促进中心 | Kava pepper extract effervescent tablet and technique for preparing the same |
| CN101574476A (en) * | 2009-05-26 | 2009-11-11 | 徐琳 | Medicinal material composition used for lowering lipid and protecting liver auxiliarily |
| CN102224962A (en) * | 2011-05-09 | 2011-10-26 | 常堡同 | Hangover alleviating beverage |
Also Published As
| Publication number | Publication date |
|---|---|
| CN102552462A (en) | 2012-07-11 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102552462B (en) | Effervescent preparation as well as preparation method and application thereof | |
| CN102578671B (en) | Alcoholism-relieving liver-protecting botanical nutritional beverage and making method thereof | |
| CN106343090A (en) | Fructus siraitiae, prebiotic and chrysanthemum flower tea instant beverage and preparation method thereof | |
| CN103961561B (en) | A kind of Herba Dendrobii is relieved summer heat Halth-care composition and preparation method thereof | |
| CN102048933A (en) | Chinese medicinal composition for treating infantile diarrhea and preparation method thereof | |
| CN103859547A (en) | Preparation method and application for solid beverage | |
| CN106509261A (en) | Sugar-free herbal tea plant composition, and method for preparing drink and granule from composition | |
| CN102198262A (en) | Chinese medicine preparation for treating infant rotavirus enteritis and preparation method thereof | |
| CN101502627A (en) | Chinese medicine health product preparation for preventing and treating alcoholic liver disease and preparation method thereof | |
| CN103168883A (en) | Pathogenic microorganism preventing antiviral tea beverage granules capable of boosting immunity and preparation method thereof | |
| CN102524781A (en) | Edible composition with alcoholism alleviation function and preparation method thereof | |
| CN102657791B (en) | Chinese medicinal composition containing pale butterflybush flower and preparation method thereof | |
| CN105901452A (en) | Tartary buckwheat beverage and preparation method thereof | |
| CN110897147A (en) | Dendrobium officinale alcohol-dispelling and liver-protecting composition and preparation method thereof | |
| CN103610803A (en) | Traditional Chinese medicine composition for protecting liver and dispelling effects of alcohol | |
| CN104041900A (en) | Alcohol-effect-dispelling and health-maintaining plant beverage and preparation method thereof | |
| CN102349950B (en) | Food, health product or pharmaceutical composition as well as preparation method and application thereof | |
| CN108813501A (en) | With the relieving cough and reducing sputum health honey paste relievingd asthma and adjust function of human body of clearing heat and moistening lung | |
| CN102511876B (en) | Hawthorn red jujube thick syrup and production process thereof | |
| CN104305193B (en) | Food having effect of promoting intestine propulsion and preparation method of food | |
| CN103355444A (en) | Health care tea paste for tonifying spleen and qi and preparation method | |
| CN103520287B (en) | Forsythia suspense leaves refreshing sugar | |
| CN105343593A (en) | Spica prunellae health oral liquid capable of decreasing blood pressure and blood lipid as well as preparation method of spica prunellae health oral liquid | |
| CN108684992A (en) | A kind of alcohol-decomposing beverage of plant formula and preparation method thereof of energy Quick sobering | |
| CN104585469B (en) | A kind of chewing gum to alcoholic liver injury with protective effect and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| TR01 | Transfer of patent right | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20170623 Address after: Panyu District Shawan Town, Guangzhou city of Guangdong Province, Qingfeng road 511400 No. 8 Patentee after: Guangzhou herb medical science and Technology Co Ltd Address before: 528436 Guangdong, Zhongshan Torch Development Zone, Zhongshan, Hong Kong Avenue, No. 60, No. Co-patentee before: Zhao Bin Patentee before: Zhongshan Torch Polytechnic College Co-patentee before: Wang Qiong |
|
| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20130814 Termination date: 20200112 |