CN105012400A - Soft traditional Chinese medicine composition capsules for treating cold and preparation method thereof - Google Patents
Soft traditional Chinese medicine composition capsules for treating cold and preparation method thereof Download PDFInfo
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Abstract
The invention relates to soft traditional Chinese medicine composition capsules for treating cold. The soft traditional Chinese medicine composition capsules for treating cold are characterized in that the ingredients contained in capsule liquid include 30%-50% of traditional Chinese medicine extracts, 40%-70% of dispersing agent, 0%-6% of suspending agent and 0%-4% of wetting agent. The traditional Chinese medicine extracts include a dry extract and volatile oil which are prepared by, by weight, 50-200 parts of forsythia suspensa, 50-200 parts of notopterygium roots, 20-150 parts of mint, 50-200 parts of common andrographis herb, 20-150 parts of Chinese trichosanthes roots and 40-200 parts of dayflower. The soft capsules are produced after a countercurrent extraction process is adopted for extraction, extraction efficiency is high, energy is saved, the produced soft capsules are good in sealing performance, and objectionable odor of the medicines is masked. The soft traditional Chinese medicine composition capsules are good in medicine stability, do not absorb moisture and meanwhile have the advantages of being high in disintegration speed and bioavailability and the like. The virus cold treating effect of the soft capsules is remarkably superior to that of antiviral particles and is further superior to that of a traditional water-soluble preparation.
Description
Technical field
The present invention relates to field of traditional Chinese medicine pharmacy, be specifically related to a kind of Chinese medicine composition composition soft capsule for the treatment of flu and preparation method thereof.
Background technology
Flu is a kind of common exogenous diseases.According to statistics, adult is annual to be occurred 1-3 time, and 2-7 respiratory tract disease occurs child every year, and wherein number is caused by virus mostly.Flu not only affects the mankind and normally works and life health risk, also correspondingly consumes a large amount of expense.The harm that flu causes anemia of pregnant woman, old man and child is also very large, and its caused complications, as pneumonia and secondary infection etc., has certain mortality rate.Flu is divided into wind and cold and anemopyretic cold by motherland's medical science, due to the difference of type of catching a cold, variant in medication.When suffering from anemofrigid cold, need treat with the pungent temperature medicine of dispersing wind-cold, and during anemopyretic cold, need with the pungent medicine of a cold nature treatment of dispersing wind heat.
Application number be 200510095620.9 name be called that the prescription of " a kind of compound preparation and preparation technology thereof being used for the treatment of flu " is the compound preparation developed on basis, old docter of TCM clinical experience side, always for decoction form uses in long-term clinical application, the extraction process of this patent is based on water extraction, and its yield of extract is higher; In side in lignanoid's glycoside, the Rhizoma Et Radix Notopterygii such as effective ingredient Phillyrin in Forsythia suspensa with active ingredient poorly water-solubles such as the andrographolide in Notopterol, nodakenin, the isoimperatorin coumarin kind compound that is representative, Herba Andrographis, and there is obvious thermal instability in the active ingredient such as andrographolide, very easily lose in traditional heating leaching process, therefore extraction process by water active constituent content is low; Because volatile ingredient is in the solid preparation of routine and relative instability in oral liquid (granule, tablet, capsule, powder, pill, syrup, oral liquid etc.), volatile loss, and mouthfeel is not good.And traditional extraction process often exists problems such as extracting cycle is long, heating-up temperature is high, heat-sensitive ingredients destructible, have a strong impact on quality and the clinical efficacy of follow-up preparation.
Along with the progress of technology and the development of society, the extraction process of traditional Chinese medicine preparation also exists the shortcomings such as energy and material consumption is large, impurity is many, efficiency is low, because effective ingredient is to thermally labile when soak by water or alcohol heating reflux, cause functional component low, content is unstable; The dosage forms such as traditional granule, oral liquid, also exist that dose is large, loss of volatile oil is serious, mouthfeel is not good, bioavailability is low, have a strong impact on application and the sale of this product, constrain the demand of people's medication, be difficult to the requirement adapting to modernization, international Chinese medicine preparation.
Summary of the invention
In order to make up the deficiencies such as high, the consuming time length of existing energy consumption in production process, effective component extraction rate be low, the invention provides a kind of countercurrent extraction technique for the treatment of the Chinese medicine composition of flu that a kind of technique is simple, effective ingredient is high.
In order to make up, the Chinese medicine compound preparation such as granule, oral liquid dose is large, mouthfeel is not good, bioavailability is low waits deficiency, it is simple that another goal of the invention of the present invention there is provided a kind of technique, dose is little, effective ingredient and bioavailability high, improve soft capsule and preparation technology thereof that the utilization rate of volatile oil and a kind of of stability treat the Chinese medicine composition of flu.
The present invention realizes by the following technical solutions:
Treat a Chinese medicine composition composition soft capsule for flu, comprise capsule liquid, softgel shell, it is characterized in that the percentage by weight of each component in capsule liquid is: Chinese medicine extract 30 ~ 50%, dispersant 40 ~ 70%, suspending agent 0 ~ 6%, wetting agent 0 ~ 4%;
Described Chinese medicine extract comprises the dry cream and volatile oil that are obtained through extracting preparation by the raw material of Chinese medicine of following weight portion: Fructus Forsythiae 50 ~ 200 portions of Rhizoma Et Radix Notopterygiis 50 ~ 200 portions of Herba Menthaes 20 ~ 150 parts
Herba Andrographis 50 ~ 200 parts of Radix Trichosanthis 20 ~ 150 parts of Herba Commelinaes 40 ~ 200 parts.
Preferably, in capsule liquid, the percentage by weight of each component is: Chinese medicine extract 40 ~ 45%, dispersant 50 ~ 55%, suspending agent 3 ~ 5%, wetting agent 1 ~ 3%.
Preferably, described dispersant is polyethylene glycols or vegetable oil; Described suspending agent is the mixture of one or more in Cera Flava, aluminum monostearate, ethyl cellulose, propylene glycol; Wetting agent is one or more in soybean lecithin, tween 80, Tween-60, Arlacel-80 or Arlacel-60.
Preferably, described vegetable oil is a kind of or wherein several mixture of Oleum Arachidis hypogaeae semen, soybean oil, Oleum sesami, Oleum Brassicae campestris or other consumption vegetable oil; Described suspending agent is Cera Flava; Wetting agent is soybean lecithin or tween 80.
Present invention also offers the preparation method of the Chinese medicine composition composition soft capsule of described treatment flu, it is characterized in that step is as follows:
Respectively medical material is ground into respectively most coarse powder, for subsequent use;
Radix Trichosanthis, Herba Commelinae medical material are put in countercurrent extraction tank, uses water countercurrent extraction, filter, leaching Radix Trichosanthis and Herba Commelinae Aqueous extracts, Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae are adopted extraction by steam distillation volatile oil, filters, decocting liquid after oil is carried in leaching, collect volatile oil and medicinal residues for subsequent use, by Fructus Forsythiae, Rhizoma Et Radix Notopterygii, medicinal residues after Herba Menthae extracts volatile oil and Herba Andrographis medical material are put in countercurrent extraction tank, with 70% ~ 85% ethanol countercurrent extraction, filter, filtrate recycling ethanol is extremely without alcohol taste, decocting liquid after adding above-mentioned Radix Trichosanthis and Herba Commelinae Aqueous extracts and carrying oil, be evaporated to the thick paste that relative density is 1.25 ~ 1.30 (50 DEG C of heat are surveyed), less than 60 DEG C drying under reduced pressure, be ground into fine powder, add dispersant, suspending agent, wetting agent and above-mentioned volatile oil, colloid mill is ground to mix homogeneously, obtain capsule liquid, compacting or dropping preparation method is adopted to be packed into softgel shell, be prepared into soft capsule, obtain,
Or, Radix Trichosanthis, Herba Commelinae medical material are put in countercurrent extraction tank, use water countercurrent extraction, filter, leaching Radix Trichosanthis and Herba Commelinae Aqueous extracts; Adopt supercritical carbon dioxide extraction method to extract volatile oil Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae, collect volatile oil; Medicinal residues after Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae are extracted volatile oil and Herba Andrographis medical material are put in countercurrent extraction tank, with 70% ~ 85% ethanol countercurrent extraction, filter, filtrate recycling ethanol is extremely without alcohol taste, add above-mentioned Radix Trichosanthis and Herba Commelinae Aqueous extracts, be evaporated to the thick paste that relative density is 1.25 ~ 1.30 (50 DEG C of heat are surveyed), drying under reduced pressure, be ground into fine powder, add dispersant, suspending agent, wetting agent and above-mentioned volatile oil, colloid mill is ground to mix homogeneously, obtain capsule liquid, adopt compacting or dropping preparation method to be packed into softgel shell, be prepared into soft capsule, obtain final product.
Further, during described extraction by steam distillation volatile oil, amount of water is 6-8 times, and distillation time is 4-8 hour; Supercritical carbon dioxide extraction parameter is: extraction kettle temperature 30 ~ 60 DEG C, pressure 15 ~ 35MPa; Separating still temperature 15 ~ 30 DEG C, pressure 4 ~ 8MPa; Extraction time 1.5 ~ 4 hours, flow of carbon dioxide gas amount 15 ~ 30Kg/h.
Further, the condition of described countercurrent extraction is: the water or 70% ~ 85% alcoholic solution that add 8-12 times amount, countercurrent extraction temperature is 40 ~ 60 DEG C, speed of agitator 2r/min, countercurrent extraction 0.5-1.5 hour.
Flu is the common cold disease caused because of human feeling's exopathogen.Current western modern medicine lacks treatment flu to the factor and the effective medicine taken into account to the ill.The heightened awareness occurring flu according to theory of Chinese medical science, develop, combines on basis dialectical with differential diagnosis of diseases, and development treatment cold medicine is the vital task of Chinese medicine study.
Prescription of the present invention is made up of Fructus Forsythiae, Herba Andrographis, Rhizoma Et Radix Notopterygii, Herba Commelinae, Herba Menthae, Radix Trichosanthis.Fructus Forsythiae bitter in the mouth cold nature in side, heat-clearing and toxic substances removing expelling pathogenic factors from the exterior, the heat of the loose part of the body cavity above the diaphragm housing the heart and lungs; Herba Andrographis nature and flavor bitter cold, clearing away heat-fire is subsided a swelling, and two medicines share tool heat-clearing and toxic substances removing, and the merit of diathermanous expression, eliminates pathogenesis emphatically, are our monarch drug.Herba Menthae is clear light cool loose, helps principal agent heat-clearing and toxic substances removing, separates the heresy of wind heat, alleviate in wind heat and attack caused headache and laryngopharynx swelling and pain; Herba Commelinae nature and flavor are sweet, bitter, cold, heat-clearing and toxic substances removing, detumescence of bringing down a fever, and with Herba Menthae with strengthening its dispelling wind and heat pathogens effect, with Fructus Forsythiae, Herba Andrographis, Herba Menthae compatibility, still have and alleviate laryngopharynx swelling and pain effect; Radix Trichosanthis tool promoting the production of body fluid to quench thirst, eliminating heat from the lung, pathogenic fire reducing moisturize effect, are especially longer than clearing away heat and promoting production of body fluid, and for pathogenic heat impairment of body fluid, dry mouth and tougue, both can strengthen the merit of heat clearing away, can supplement impaired body fluid again.Three medicines coordinate principal agent, and the power of the heresy of heat-clearing and toxic substances removing, dispelling wind and heat pathogens is increased, and are the ministerial drug of we altogether.Rhizoma Et Radix Notopterygii acrid in the mouth, hardship, warm in nature, its a surname sends out lung qi, dispel the heat table, wind-expelling pain-stopping effect, use same with pungent and cold medicine for relieving the exterior syndrome, can strengthen the effect of diaphoretic medicine relieving the exterior syndrome by diaphoresis, with Herba Menthae compatibility, then be beneficial to heat radiation pain relieving sore-throat relieving, and in we pungent cool in be equipped with a little pungent using warming therapy product, be both beneficial to expelling pathogenic factors from the exterior, not carrying on the back again pungent cool purport, is the adjuvant of we.Full policy is to the pathogenesis of anemopyretic cold generation, and integrate heat-clearing and toxic substances removing, a surname sends out lung qi, sore-throat relieving promotes the production of body fluid medicine, Six-element matches, and expelling pathogenic factors from the exterior lets out lung, hot detoxicating solution, and all diseases are from flat.
1, the determination of extraction process reasonability and process route:
Fructus Forsythiae is the dry fruit of Oleaceae plants Fructus Forsythiae Forsythia suspense (Thunb.) Vahl.Main containing phenethyl alcohol glycosides as the compound such as phillyrin, forsythol, volatile oil 1 ~ 2.5% etc., bibliographical information Forsythia volatile oil has remarkable and stable antibiosis and antiviral functions, wherein phillyrin is its topmost quality control index, phillyrin is lignan glycosides compounds, be insoluble in water, be soluble in the organic solvent such as ethanol, methanol.
Rhizoma Et Radix Notopterygii is dry rhizome and the root of samphire Rhizoma Et Radix Notopterygii Notopterygium incisum Ting ex H.T.Chang or Radix et Rhizoma Notopterygii Notoperygium forbesii Boiss..Modern age, pharmaceutical research showed, Rhizoma Et Radix Notopterygii medical material has obvious analgesia, antiinflammatory, improves blood circulation and strengthen the effect of body immune function, and its main active is volatile oil and the liposoluble constituent coumarin kind compound that is representative with Notopterol, nodakenin, isoimperatorin.Volatile oil is containing about 2.3%, and its volatile oil can make pyrogenicity rat temperature obviously reduce, and has significant refrigeration function.
Herba Menthae is the dry aerial parts of labiate Herba Menthae Mentha haplocalyx Briq..Main containing volatile oil about 0.8-1%, in oil, composition is mainly the composition such as menthone and Mentholum, and its volatile oil makes telangiectasis, increases heat radiation, sweating and heat resolving effect; Herba Menthae except containing except volatile ingredient, also containing the involatile constituent such as flavonoid, triterpenes, has the effects such as antiinflammatory, antibacterial, antioxidation.And its flavonoid, the triterpenes dissolubility in water is little.
Herba Andrographis is the dry aerial parts of acanthaceous plant Herba Andrographis Andrographis paniculata (Burm.F.) Nees.The main Diterpenes constituents that contains is if andrographolide, dehydrorographolide etc., flavonoid are as the compound such as oroxylin A, wogonin, and its Ginkgolide Component has anti-inflammation, antiviral, antiinflammatory action.Principle active component Diterpenes constituents dissolubility in water of Herba Andrographis is very low, and the active ingredient such as andrographolide exist obvious thermal instability, very easily lose in traditional heating reflux, extract, process.Containing multiple active hydrogen and unsaturated lactone ring in andrographolide structure, easily degrade in thermal histories, be oxidized, the reaction such as isomerization or rearrangement, cause the retention rate of andrographolide to decline.
Radix Trichosanthis is the dry root of cucurbitaceous plant Fructus Trichosanthis Trichosanthes kirilowii Maxim. or trichosanthes rosthornii Harms Trichosanthes rosthornii Harms.Main containing the compounds such as class such as saponin, protein-based, polysaccharide, aminoacid, there is the pharmacological actions such as antitumor, antiinflammatory, antiviral.Trichosanthin has antivirus action, but meets high temperature meeting degeneration.
Herba Commelinae is Commelianaceae Commelina, has effect of inducing diuresis to remove edema, heat-clearing and toxic substances removing, and modern study finds that Herba Commelinae is containing multiple natural products such as flavonoid, alkaloids, polysaccharide, organic acid.Existing document shows, Herba Commelinae water extract all has the effect of obvious resisiting influenza virus in vivo and in vitro.
More than show, direct water extraction after taking to extract volatile oil, effectively can not extract the effective ingredient in medical material, and decoct extraction for a long time, can destroy the active ingredient such as andrographolide, trichosanthin; Effective ingredient in the employing aquiferous ethanol low temperature countercurrent extraction Fructus Forsythiae of novelty of the present invention, Herba Andrographis, Rhizoma Et Radix Notopterygii, Herba Menthae medical material and water low temperature countercurrent extraction Radix Trichosanthis, Herba Commelinae medical material, not only can effective component extracting to greatest extent, and the destruction of effective ingredient can also be reduced, thus active constituent content can be improved.
Embodiments of the invention 2 and comparative examples (200510095620.9 patent tradition extraction process by water) the middle active constituent content comparative result extracting the dry extract prepared, in table 1.
Table 1 active constituent content compares
Remarks: table Chinese crude drug is with a collection of medical material, and active constituent content is converted by following prescription: Fructus Forsythiae 200g, Rhizoma Et Radix Notopterygii 100g, Herba Menthae 100g, Herba Andrographis 200g, Radix Trichosanthis 150g, Herba Commelinae 150g.
As known from Table 1, countercurrent extraction technique of the present invention is compared with traditional soak by water technique, andrographolide and dehydrorographolide total amount extraction ratio improve more than 4 times, phillyrin extraction ratio improves more than 20%, Notopterol and isoimperatorin extraction ratio improve more than 30%, meanwhile, decrease the water-solubility impurities such as starch, reduce dried cream yield, decrease a day dose; Be very effective, solvent-oil ratio obviously declines, and extraction time also shortens greatly, and production efficiency increases substantially.
2, the determination of preparation process thereof:
Carry because decoction exists, take inconvenience, the shortcomings such as quality is wayward, make clinical application be restricted.For preparation quality is stablized controlled, Clinical practice safely, effectively, preserve, transport, carry, dosage form easy to use, the feature of volatile ingredient is contained according to this product, be prepared into that bioavailability is high, content accurately, volatile ingredient volatilization loss can be avoided, cover and badly smell taste, taking convenience, soft capsule that outward appearance is good, to improve the stability of preparation and the compliance of patient.Soft capsule has the advantage of good airproof performance, the loss of volatile ingredient and extraneous oxygen can be prevented the Oxidative demage of content, be applicable to the medicine preparation that volatile component content is high.And middle Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae all contain a large amount of volatile oil in the present invention, in order to ensure the stability of volatile ingredient in medicine, we have selected soft capsule dosage form to improve former dosage form.
Must have good mobility to ensure large-scale production as the adjuvant of soft capsule suspension medium and medicament mixed, mixed liquor also must possess good physical stability simultaneously.The stability that whether disperse medium selected in soft capsule is suitable, soft capsule composition and the proportioning of each adjuvant component directly have influence on soft capsule.Therefore, the pharmaceutic adjuvant of this Chinese medicine composition applicable and ratio of adjuvant is found to be key technologies of the present invention.
1) selection of dispersant: the selection of medicine dispersant is one of key of development soft capsule, and it should be able to ensure the accuracy of content and the stability of preparation, thus guarantees the safety and effectiveness of medicine.Current common dispersants has consumption vegetable oil and PEG-4000 (PEG-400), and inventor screens the two consumption above by experiment.
Get three parts of Chinese medicine extract (containing medicated powder and volatile oil), add enough soybean oils, Oleum Arachidis hypogaeae semen and PEG-4000 respectively, 30 minutes are ground through colloid mill after abundant mixing, to put in the centrifuge of 2000 revs/min centrifugal 20 minutes, observe the precipitation status of two mixed liquors, the results are shown in Table 2.
Table 2 different dispersant sedimentation situation result of the test
Vegetable oil and polyethylene glycols have good stability, and super quality and competitive price, can be used as the dispersant of invention formulation.Confirm through experiment, the present invention adopts other Polyethylene Glycol kind solvents or Oleum sesami, Oleum Brassicae campestris and other edible vegetable oil, all can obtain substantially identical effect.
2) selection of preparation capsule liquid prescription: the consumption of dispersant, suspending agent and lubricant directly has influence on yield rate and the loading amount of soft capsule.Dispersive agent ratio is too low, good stability, but poor fluidity, not easily pelleting, yield rate is low; Dispersive agent ratio is excessive, and thixotroping value is low, good fluidity, but loading amount is large and be easy to seepage.Therefore screen the dispersant of different proportion, suspending agent and lubricant, thus determine best capsule liquid prescription ratio.
Example 3 prepares Chinese medicine extract (containing medicated powder and volatile oil), adds not commensurability disperse medium, suspending agent, lubricant respectively, fully grinds 30 minutes through colloid mill after mixing, observes its state, the results are shown in Table 3.
The Selection experiment result of table 3 soft capsule different auxiliary material ratio
Above result shows, the soft capsule preparation of the industrialization generation that prescription ratio controlled in Chinese medicine extract 30 ~ 50%, dispersant 40 ~ 70%, suspending agent 0 ~ 6%, wetting agent 0 ~ 4% scope, can obtain stable in properties preferably, is suitable for.In order to ensure the steady quality of final products, also can add a certain amount of antiseptic in capsule liquid, as parabens, glyceryl monostearate etc., according to circumstances different, addition is also different, generally in about 0.3% of amount of liquid medicine, as long as reach fungistatic effect.
The long-time stability experimental data of capsule of the present invention (embodiment 2), in table 4.
The long-term stable experiment result of the soft capsule preparation of table 4 embodiment of the present invention 2
Result showed: through 24 months long-term stable experiments, and every quality index without significant difference, showed that product quality was highly stable compared with 0 month.
Relative to prior art, tool of the present invention has the following advantages:
(1) by adopting countercurrent extraction technique, guarantee that medical material and solvent all maintain larger effective ingredient concentration difference, add extraction motive force, Accelerative mass transfer diffusion process accelerates extraction rate, save solvent load more than 50%, well-beaten effect is played in the reverse flow of solvent simultaneously in leaching process, improves extraction efficiency, Extracting temperature is reduced to 40 DEG C-60 DEG C by original boiling, extract at low temperature ensures that thermal instability composition does not decompose, avoid the undue cracking gelatinizing of starch in material to affect effective ingredient stripping simultaneously, in medicinal material extract extractum, impurity is few, significantly reduce extraction cost, improve the concentration of effective ingredient in final solvent, make phillyrin, Notopterol and isoimperatorin total amount, the effective component extraction rates such as dehydrorographolide and andrographolide total amount improve that (the present invention is compared with traditional extraction process by water, andrographolide and dehydrorographolide total amount extraction ratio improve more than 4 times, phillyrin extraction ratio improves more than 20%, Notopterol and isoimperatorin extraction ratio improve more than 30%), energy efficient about 80%, efficiently avoid the shortcoming of original explained hereafter product.
(2) prescription Chinese crude drug is refined into soft capsule according to effective ingredient character by the present invention after modern extraction process effective component extracting, have embedding with cover effect, the volatilization loss of oil component can be prevented, prevent medicine oxidation or by photolysis.Soft capsule dosage form disintegration rate is fast simultaneously, is uniformly dispersed, directly absorbs after disintegrate at intestinal; Bioavailability is high; Medicine stability is good, not easily the moisture absorption; Good airproof performance, masks the bad smell of medicine; Taking convenience, the advantage such as be easy to carry.Steady quality: through 24 months long-term stable experiments, every quality index without significant difference, showed that product quality was highly stable compared with 0 month.
(3) shown by clinical observation result, the therapeutic effect of soft capsule of the present invention to viral influenza is significantly better than antiviral granule, is also better than traditional extraction process by water preparation; Treating both the principal and secondary aspects of a disease of the present invention, particularly remarkable to the curative effect of the symptoms such as viral influenza heating, pharyngalgia, nasal obstruction watery nasal discharge, headache, general malaise, thirsty and dry pharynx.Clinical effectiveness shows that soft capsule of the present invention treatment viral influenza has good therapeutic effect, and clinic is promoted.
Detailed description of the invention
By embodiment, technical scheme of the present invention is further described below; the advantage contributed to technical scheme of the present invention, effect are had and further understands; embodiment does not limit protection scope of the present invention, and protection scope of the present invention is decided by claim.
Embodiment 1:
1, prescription:
2, method for making:
1) extract: respectively medical material is ground into respectively most coarse powder, for subsequent use.
Put in countercurrent extraction tank by Radix Trichosanthis, Herba Commelinae medical material, add the water countercurrent extraction of 10 times amount, Extracting temperature is 50 DEG C, speed of agitator 2r/min, countercurrent extraction 1.5 hours, filters, leaching Radix Trichosanthis and Herba Commelinae Aqueous extracts.
Adopt supercritical carbon dioxide extraction method to extract volatile oil Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae, collect volatile oil 25ml (separately depositing), medicinal residues are for subsequent use; The condition of supercritical extraction is: pressure 20MPa, temperature 40 DEG C, 4 hours time.
Medicinal residues after Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae supercritical extraction volatile oil and Herba Andrographis medical material are put in countercurrent extraction tank, add 70% ethanol of 10 times amount, countercurrent extraction temperature is 50 DEG C, speed of agitator 2r/min, countercurrent extraction 1.0 hours, filter, merging filtrate reclaims ethanol to without alcohol taste, adds above-mentioned Radix Trichosanthis and Herba Commelinae Aqueous extracts, be evaporated to the thick paste that relative density is 1.25 ~ 1.30 (50 DEG C of heat are surveyed), 50 DEG C of drying under reduced pressure, are ground into fine powder and obtain 260g, for subsequent use.
2) prepare:
By suspending agent Cera Flava 25g, dispersant soybean oil 312g heat fused, mixing, is down to room temperature; Add medicated powder and wetting agent soybean lecithin 12.4g and above-mentioned volatile oil, colloid mill is ground to mix homogeneously, obtains capsule liquid, adopts compacting or dropping preparation method to be packed into softgel shell, is prepared into soft capsule 1000, obtains final product.
Embodiment 2:
1, prescription:
2, method for making:
1) extract: respectively medical material is ground into respectively most coarse powder, for subsequent use;
Put in countercurrent extraction tank by Radix Trichosanthis, Herba Commelinae medical material, add the water of 10 times amount, countercurrent extraction temperature is 50 DEG C, speed of agitator 2r/min, countercurrent extraction 1.5 hours, filters, leaching Radix Trichosanthis and Herba Commelinae Aqueous extracts.
Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae are adopted extraction by steam distillation volatile oil, and amount of water is 6 times amount, and distillation time is 6 hours, filters, leaching decocting liquid; Collect volatile oil 16ml (separately depositing), medicinal residues are for subsequent use.
Medicinal residues after Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae are extracted volatile oil and Herba Andrographis medical material are put in countercurrent extraction tank, add 70% ethanol of 10 times amount, countercurrent extraction temperature is 50 DEG C, speed of agitator 2r/min, countercurrent extraction 1.0 hours, filter, merging filtrate reclaims ethanol extremely without alcohol taste, decocting liquid after adding above-mentioned Radix Trichosanthis and Herba Commelinae Aqueous extracts and carrying oil, be evaporated to the thick paste that relative density is 1.25 ~ 1.30 (50 DEG C of heat are surveyed), less than 60 DEG C drying under reduced pressure, are ground into fine powder 287g, for subsequent use.
2) prepare:
By suspending agent Cera Flava 24g, dispersant soybean oil 265g heat fused, mixing, is down to room temperature; Add medicated powder and wetting agent soybean lecithin 12g and above-mentioned volatile oil, colloid mill is ground to mix homogeneously, obtains capsule liquid, adopts compacting or dropping preparation method to be packed into softgel shell, is prepared into soft capsule 1000, obtains final product.
Embodiment 3:
1, prescription:
2, method for making:
1) extract: respectively medical material is ground into respectively most coarse powder, for subsequent use;
Put in countercurrent extraction tank by Radix Trichosanthis, Herba Commelinae medical material, add the water of 12 times amount, countercurrent extraction temperature is 40 DEG C, speed of agitator 2r/min, countercurrent extraction 0.5 hour, filters, leaching Radix Trichosanthis and Herba Commelinae Aqueous extracts.
Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae are adopted extraction by steam distillation volatile oil, and amount of water is 8 times amount, and distillation time is 8 hours, filters, leaching decocting liquid; Collect volatile oil 20.5ml (separately depositing), medicinal residues are for subsequent use.
Medicinal residues after Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae are extracted volatile oil and Herba Andrographis medical material are put in countercurrent extraction tank, add 80% ethanol of 8 times amount, countercurrent extraction temperature is 60 DEG C, speed of agitator 2r/min, countercurrent extraction 0.5 hour, filter, merging filtrate reclaims ethanol extremely without alcohol taste, decocting liquid after adding above-mentioned Radix Trichosanthis and Herba Commelinae Aqueous extracts and carrying oil, be evaporated to the thick paste that relative density is 1.25 ~ 1.30 (50 DEG C of heat are surveyed), less than 60 DEG C drying under reduced pressure, are ground into fine powder 284g, for subsequent use.
2) prepare:
By suspending agent Cera Flava 20g, dispersant soybean oil 280g heat fused, mixing, is down to room temperature; Add medicated powder and above-mentioned volatile oil, colloid mill is ground to mix homogeneously, obtains capsule liquid, adopts compacting or dropping preparation method to be packed into softgel shell, is prepared into soft capsule 1000, obtains final product.
Embodiment 4:
1, prescription:
2, method for making:
1) extract: respectively medical material is ground into respectively most coarse powder, for subsequent use;
Put in countercurrent extraction tank by Radix Trichosanthis, Herba Commelinae medical material, add the water of 8 times amount, countercurrent extraction temperature is 60 DEG C, speed of agitator 2r/min, countercurrent extraction 1.0 hours, filters, leaching Radix Trichosanthis and Herba Commelinae Aqueous extracts.
Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae are adopted extraction by steam distillation volatile oil, and amount of water is 8 times amount, and distillation time is 8 hours, filters, leaching decocting liquid; Collect volatile oil 18ml (separately depositing), medicinal residues are for subsequent use.
Medicinal residues after Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae are extracted volatile oil and Herba Andrographis medical material are put in countercurrent extraction tank, add 85% ethanol of 10 times amount, countercurrent extraction temperature is 40 DEG C, speed of agitator 2r/min, countercurrent extraction 1.5 hours, filter, merging filtrate reclaims ethanol extremely without alcohol taste, decocting liquid after adding above-mentioned Radix Trichosanthis and Herba Commelinae Aqueous extracts and carrying oil, be evaporated to the thick paste that relative density is 1.25 ~ 1.30 (50 DEG C of heat are surveyed), less than 60 DEG C drying under reduced pressure, are ground into fine powder 265g, for subsequent use.
2) prepare:
Wetting agent soybean lecithin 15g, dispersant soybean oil 320g are heated mixing, is down to room temperature; Add medicated powder and above-mentioned volatile oil, colloid mill is ground to mix homogeneously, obtains capsule liquid, adopts compacting or dropping preparation method to be packed into softgel shell, is prepared into soft capsule 1000, obtains final product.
Embodiment 5:
1, prescription:
2, method for making:
1) extract: respectively medical material is ground into respectively most coarse powder, for subsequent use;
Put in countercurrent extraction tank by Radix Trichosanthis, Herba Commelinae medical material, add the water of 10 times amount, countercurrent extraction temperature is 55 DEG C, speed of agitator 2r/min, countercurrent extraction 1.0 hours, filters, leaching Radix Trichosanthis and Herba Commelinae Aqueous extracts.
Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae are adopted extraction by steam distillation volatile oil, and amount of water is 8 times amount, and distillation time is 6 hours, filters, leaching decocting liquid; Collect volatile oil 19ml (separately depositing), medicinal residues are for subsequent use.
Medicinal residues after Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae are extracted volatile oil and Herba Andrographis medical material are put in countercurrent extraction tank, add 80% ethanol of 12 times amount, countercurrent extraction temperature is 50 DEG C, speed of agitator 2r/min, countercurrent extraction 1.0 hours, filter, merging filtrate reclaims ethanol extremely without alcohol taste, decocting liquid after adding above-mentioned Radix Trichosanthis and Herba Commelinae Aqueous extracts and carrying oil, be evaporated to the thick paste that relative density is 1.25 ~ 1.30 (50 DEG C of heat are surveyed), less than 60 DEG C drying under reduced pressure, are ground into fine powder 255g, for subsequent use.
2) prepare:
By suspending agent Cera Flava 10g, dispersant soybean oil 300g heat fused, mixing, is down to room temperature; Add medicated powder and above-mentioned volatile oil, colloid mill is ground to mix homogeneously, obtains capsule liquid, adopts compacting or dropping preparation method to be packed into softgel shell, is prepared into soft capsule 1000, obtains final product.
Comparative examples:
1, prescription:
2, method for making:
1) extract: the water heating that Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae add 6 times amount keeps micro-boiling 6 hours, and vapor distillation extracts volatile oil, and volatile oil (separately depositing), medicinal residues and aqueous solution are for subsequent use; Medicinal residues after three tastes such as Herba Andrographis, Radix Trichosanthis, Herba Commelinae three taste and above-mentioned Fructus Forsythiae extract volatile oil are placed in multi-function extractor, add 12,10 times of water gagings, decoct secondary, each 2 hours, merge intermediate water extract, leave standstill, filter, with the aqueous solution after the three taste medicinal material extract volatile oil such as Fructus Forsythiae, being evaporated to relative density is that the clear paste of 1.25 ~ 1.30 (50 DEG C) is for subsequent use.
2) enclose of volatile oil: according to volatile oil: the ratio of beta-schardinger dextrin-(1:10g/g) takes a certain amount of beta-schardinger dextrin-, the water that β-CD adds regulation times amount is ground well, pour in colloid mill, machine, slowly drip the volatile oil with appropriate anhydrous alcohol solution continuously, to mill certain hour, in 40 DEG C of vacuum dryings, obtain clathrate for subsequent use.
3) mixing granulation: clear paste, volatile oil beta cyclodextrin inclusion complex and dextrin is appropriate, 0.5% steviosin is mixed and made into soft material, granulates, and dry (≤60 DEG C), make 1000g granule.
4) granulate: the granule of drying is crossed 10 orders and 50 mesh sieves.
5) pack: by gained granule In Aluminium Foil Packing, be distributed into 10g/ bag, obtain final product.
Checking example: soft capsule treatment viral influenza of the present invention clinical observation
In order to observe the clinical efficacy of soft capsule of the present invention to anemopyretic cold, we select the granule medicine in contrast of antiviral granule (Sugarless type) and reference examples, and carry out Ureteral Calculus to 128 routine anemopyretic cold patients, brief summary is as follows.
1 clinical data
1.1 the object of observation
This is organized 128 examples and is viral influenza patient, and Western medicine diagnose meets upper respiratory tract infection.Random selecting wherein 53 examples for soft capsule treatment group of the present invention, choose wherein 49 examples for reference examples granule matched group 1,26 example be antiviral granule (Sugarless type) matched group 2.Male 28 example in treatment group, women 25 example, 42.8 years old mean age, maximum 60 years old, minimum 21 years old; Male 26 example in matched group 1, women 23 example, 43.5 years old mean age, maximum 62 years old, minimum 20 years old; Matched group 2 male 14 example, women 12 example, 41.2 years old mean age, maximum 60 years old, minimum 22 years old.
1.2 diagnostic criteria
Flu main symptom: heating, aversion to wind, pharyngalgia, cough; Secondary card: nasal obstruction, watery nasal discharge, sneeze, feeling of fullness in the head and pain, general fatigue are uncomfortable, antiperspirant lets out smooth, thirsty and dry pharynx, tongue tip side of red, thin white fur of tongue, micro-Huang, floating and rapid pulse.Western medicine diagnose meets upper respiratory tract infection.Require that main symptom at least meets 1, accompanied symptoms meets 2.
1.3 administrated method
Treatment group: soft capsule prepared by the embodiment of the present invention 2, each 5, every day 3 times.Matched group 1: granule prepared by reference examples of the present invention, each 1 bag (10 grams), every day 3 times.Matched group 2: antiviral granule (Sugarless type is produced by Sichuan Guangda Pharmaceutical Co., Ltd), each 1 bag (3 grams), every day 3 times.Be 3 days the course for the treatment of.
1.4 efficacy evaluation
With reference to " guideline of clinical investigations of new Chinese medicine treatment flu ", by main symptom, secondary card classification score computation therapeutic effect of syndrome index evaluation curative effect.Recovery from illness: normally, the symptom of flu all disappears, therapeutic index >95% to treat temperature recovery within 3 days.Effective: it is normal to treat within 3 days temperature recovery, most of transference cure of flu, therapeutic index >75%.Effective: to treat the comparatively front reduction of body temperature within 3 days, the cardinal symptom partial disappearance of flu, therapeutic index >30%.Invalid: to treat body temperature within 3 days and do not fall or raise, the cardinal symptom of flu without improvement, therapeutic index <30%.
2 results
2.1 comparitive study
Table 5 comparitive study
Through Ridit inspection, the granule of soft capsule prepared by the present invention and reference examples 1 prepared by traditional extraction process by water preparation is evident in efficacy, is better than antiviral granule; And soft capsule prepared by the present invention is better than granule prepared by reference examples prepared by traditional extraction process by water.
2.2 cardinal symptoms, sign curative effect
Table 6 cardinal symptom, sign comparitive study
Show that the therapeutic effect of capsule of the present invention to heating, pharyngalgia, nasal obstruction watery nasal discharge, headache, general malaise, thirsty and dry pharynx is better than the granule of matched group 1, both is obviously better than the antiviral granule of matched group 2.3 discuss
This clinical observation result shows, the therapeutic effect of pungent clear cold granules to viral influenza is significantly better than antiviral granule, treating both the principal and secondary aspects of a disease, particularly remarkable to the curative effect of the symptoms such as viral influenza heating, pharyngalgia, nasal obstruction watery nasal discharge, headache, general malaise, thirsty and dry pharynx.Show soft capsule of the present invention treatment viral influenza have good therapeutic effect, be better than traditional water extraction granule, be significantly better than antiviral granule.
Claims (8)
1. treat a Chinese medicine composition composition soft capsule for flu, comprise capsule liquid, softgel shell, it is characterized in that the percentage by weight of each component in capsule liquid is: Chinese medicine extract 30 ~ 50%, dispersant 40 ~ 70%, suspending agent 0 ~ 6%, wetting agent 0 ~ 4%;
Described Chinese medicine extract comprises the dry cream and volatile oil that are obtained through extracting preparation by the raw material of Chinese medicine of following weight portion: Fructus Forsythiae 50 ~ 200 portions of Rhizoma Et Radix Notopterygiis 50 ~ 200 portions of Herba Menthaes 20 ~ 150 parts
Herba Andrographis 50 ~ 200 parts of Radix Trichosanthis 20 ~ 150 parts of Herba Commelinaes 40 ~ 200 parts.
2. the Chinese medicine composition composition soft capsule for the treatment of flu according to claim 1, is characterized in that the percentage by weight of each component in capsule liquid is: Chinese medicine extract 40 ~ 45%, dispersant 50 ~ 55%, suspending agent 3 ~ 5%, wetting agent 1 ~ 3%.
3. the Chinese medicine composition composition soft capsule for the treatment of flu according to claim 1, is characterized in that: described dispersant is polyethylene glycols or vegetable oil; Described suspending agent is the mixture of one or more in Cera Flava, aluminum monostearate, ethyl cellulose, propylene glycol; Wetting agent is one or more in soybean lecithin, tween 80, Tween-60, Arlacel-80 or Arlacel-60.
4. the Chinese medicine composition composition soft capsule for the treatment of flu according to claim 3, is characterized in that: described vegetable oil is a kind of or wherein several mixture of Oleum Arachidis hypogaeae semen, soybean oil, Oleum sesami, Oleum Brassicae campestris or other consumption vegetable oil; Described suspending agent is Cera Flava; Wetting agent is soybean lecithin or tween 80.
5., according to the preparation method of the Chinese medicine composition composition soft capsule of the arbitrary described treatment flu of Claims 1 to 4, it is characterized in that step is as follows:
Respectively medical material is ground into respectively most coarse powder, for subsequent use;
Radix Trichosanthis, Herba Commelinae medical material are put in countercurrent extraction tank, uses water countercurrent extraction, filter, leaching Radix Trichosanthis and Herba Commelinae Aqueous extracts, Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae are adopted extraction by steam distillation volatile oil, filters, decocting liquid after oil is carried in leaching, collect volatile oil and medicinal residues for subsequent use, by Fructus Forsythiae, Rhizoma Et Radix Notopterygii, medicinal residues after Herba Menthae extracts volatile oil and Herba Andrographis medical material are put in countercurrent extraction tank, with 70% ~ 85% ethanol countercurrent extraction, filter, filtrate recycling ethanol is extremely without alcohol taste, decocting liquid after adding above-mentioned Radix Trichosanthis and Herba Commelinae Aqueous extracts and carrying oil, be evaporated to the thick paste that relative density is 1.25 ~ 1.30 (50 DEG C of heat are surveyed), less than 60 DEG C drying under reduced pressure, be ground into fine powder, add dispersant, suspending agent, wetting agent and above-mentioned volatile oil, colloid mill is ground to mix homogeneously, obtain capsule liquid, compacting or dropping preparation method is adopted to be packed into softgel shell, be prepared into soft capsule, obtain.
6., according to the preparation method of the Chinese medicine composition composition soft capsule of the arbitrary described treatment flu of Claims 1 to 4, it is characterized in that step is as follows:
Respectively medical material is ground into respectively most coarse powder, for subsequent use;
Radix Trichosanthis, Herba Commelinae medical material are put in countercurrent extraction tank, uses water countercurrent extraction, filter, leaching Radix Trichosanthis and Herba Commelinae Aqueous extracts; Adopt supercritical carbon dioxide extraction method to extract volatile oil Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae, collect volatile oil; Medicinal residues after Fructus Forsythiae, Rhizoma Et Radix Notopterygii, Herba Menthae are extracted volatile oil and Herba Andrographis medical material are put in countercurrent extraction tank, with 70% ~ 85% ethanol countercurrent extraction, filter, filtrate recycling ethanol is extremely without alcohol taste, add above-mentioned Radix Trichosanthis and Herba Commelinae Aqueous extracts, be evaporated to the thick paste that relative density is 1.25 ~ 1.30 (50 DEG C of heat are surveyed), drying under reduced pressure, be ground into fine powder, add dispersant, suspending agent, wetting agent and above-mentioned volatile oil, colloid mill is ground to mix homogeneously, obtain capsule liquid, adopt compacting or dropping preparation method to be packed into softgel shell, be prepared into soft capsule, obtain final product.
7. the preparation method of the Chinese medicine composition composition soft capsule of the treatment flu according to claim 5 or 6, it is characterized in that: during extraction by steam distillation volatile oil, amount of water is 6-8 times, and distillation time is 4-8 hour; Supercritical carbon dioxide extraction parameter is: extraction kettle temperature 30 ~ 60 DEG C, pressure 15 ~ 35MPa; Separating still temperature 15 ~ 30 DEG C, pressure 4 ~ 8MPa; Extraction time 1.5 ~ 4 hours, flow of carbon dioxide gas amount 15 ~ 30Kg/h.
8. the preparation method of the Chinese medicine composition composition soft capsule of the treatment flu according to claim 5 or 6, it is characterized in that: the condition of countercurrent extraction is: the water or 70% ~ 85% alcoholic solution that add 8-12 times amount, countercurrent extraction temperature is 40 ~ 60 DEG C, speed of agitator 2r/min, countercurrent extraction 0.5-1.5 hour.
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| CN107412522A (en) * | 2017-05-12 | 2017-12-01 | 江西九华药业有限公司 | A kind of Chinese traditional medicine composition composition soft capsule for treating pain in the back and preparation method thereof |
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| CN101293015A (en) * | 2008-06-24 | 2008-10-29 | 中国药科大学 | Chinese medicinal composition, preparation method and application thereof |
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| CN1813916A (en) * | 2005-11-25 | 2006-08-09 | 中国药科大学 | Compound chinese medicine formulation for treating common cold and its preparing process |
| CN101293015A (en) * | 2008-06-24 | 2008-10-29 | 中国药科大学 | Chinese medicinal composition, preparation method and application thereof |
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