CN105012400B - A kind of Chinese traditional medicine composition composition soft capsule and preparation method thereof for treating flu - Google Patents

Abstract

The present invention relates to a kind of Chinese traditional medicine composition composition soft capsules for treating flu, it is characterised in that the ratio of each component is in cyst fluid: Chinese medical extract 30~50%, dispersing agent 40~70%, suspending agent 0~6%, wetting agent 0~4%；The Chinese medical extract includes the extracted dry cream being prepared of Chinese medicine material and volatile oil by following parts by weight: 50~200 parts of Fructus Forsythiae, 50~200 parts of Rhizoma Et Radix Notopterygii, 20~150 parts of peppermint, 50~200 parts of Herba Andrographitis, 20~150 parts of radices trichosanthis, 40~200 parts of dayflower.Soft capsule, extraction efficiency height, energy saving is made in the present invention after extracting using adverse current extraction process, manufactured soft capsule good airproof performance masks the bad smell of drug；Medicine stability is good, is not easy the moisture absorption；Have many advantages, such as that disintegration rate is fast simultaneously, bioavilability is high.The soft capsule is significantly better than antiviral granule to the therapeutic effect of virus flu, is also advantageous over traditional water and obtains through refining agent.

Description

A kind of Chinese traditional medicine composition composition soft capsule and preparation method thereof for treating flu

Technical field

The present invention relates to field of traditional Chinese medicine pharmacy, and in particular to a kind of Chinese traditional medicine composition composition soft capsule for treating flu and its preparation Method.

Background technique

Flu is a kind of common exogenous diseases.According to statistics, adult annual generation 1-3 times, children occur to exhale for 2-7 times every year Road illness is inhaled, wherein number is caused by virus mostly.Flu not only influences mankind's normal work and life harm health, also accordingly Consume a large amount of expenses.Flu endangered caused by pregnant woman, old man and children it is also very big, caused complications such as pneumonia with it is secondary Sexuality dye etc., there is certain death rate.Flu is divided into chill and anemopyretic cold by motherland's medicine, due to catch a cold type difference, It is variant in terms of medication.When suffering from anemofrigid cold, need to be treated with the pungent-warm medicine of expelling cold, eliminating, and when anemopyretic cold, hair need to be used The pungent medicine of a cold nature of dissipating wind-heat is treated.

Application No. is a kind of 200510095620.9 entitled " compound preparations and its preparation work for treating flu The prescription of skill " is the compound preparation developed on the basis of old docter of TCM clinical experience side, is always decoction in long-term clinical application Form uses, and based on the extraction process of the patent is mentioned with water, yield of extract is relatively high；Effective component Phillyrin in Forsythia suspensa in side In equal lignanoids' glycoside, Rhizoma Et Radix Notopterygii using Notopterol, nodakenin, Isomperatorin as the coumarin kind compound of representative, wear The effective components poorly water-soluble such as andrographolide in heart lotus, and there are apparent thermally labiles for the effective components such as andrographolide Property, it is easily lost in traditional heating extraction process, therefore extraction process by water active constituent content is low；Since volatile component is in routine Solid pharmaceutical preparation and oral liquid (granule, tablet, capsule, powder, pill, syrup, oral solution etc.) in relatively not Stablize, volatile loss, and mouthfeel is bad.And traditional extraction process often exists that extracting cycle is long, heating temperature is high, temperature-sensitive at The problems such as dividing destructible, seriously affect the quality and clinical efficacy of subsequent preparation.

With advances in technology with the development of society, that there is energy and material consumptions is big for the extraction process of traditional Chinese materia medica preparation, The disadvantages of impurity is more, low efficiency lead to functional component since effective component is to thermally labile when water decocts or ethyl alcohol is heated to reflux Low, content is unstable；The dosage forms such as traditional granule, oral solution, that there is doses is big, loss of volatile oil is serious, and mouthfeel is not Good, bioavilability is low, seriously affects the application and sale of the product, constrains the demand of people's medication, is difficult to adapt to modern Change, the requirement of international Chinese materia medica preparation.

Summary of the invention

In order to make up the deficiencies such as existing energy consumption in production process is high, time-consuming, effective component extraction rate is low, the present invention provides A kind of a kind of adverse current extraction process of the high Chinese medicine composition for treating flu of simple process, effective component.

The traditional Chinese medicine compound preparations dose such as granule, oral solution is big, mouthfeel is bad in order to make up, bioavilability it is low it is equal not Foot, another object of the present invention is to provide a kind of simple processes, and dose is small, and effective component and bioavilability are high, Improve the soft capsule and its preparation process of the utilization rate of volatile oil and a kind of Chinese medicine composition for treating flu of stability.

What the present invention adopts the following technical solutions to realize:

A kind of Chinese traditional medicine composition composition soft capsule for treating flu, including cyst fluid, softgel shell, it is characterised in that each component in cyst fluid Weight percent are as follows: Chinese medical extract 30~50%, dispersing agent 40~70%, suspending agent 0~6%, wetting agent 0~4%；

The Chinese medical extract includes the extracted dry cream and volatilization being prepared of Chinese medicine material by following parts by weight Oil: 50~200 portions of Fructus Forsythiae, 20~150 parts of peppermint of 50~200 portions of Rhizoma Et Radix Notopterygii

50~200 portions of Herba Andrographitis, 40~200 parts of dayflower of 20~150 portions of radices trichosanthis.

Preferably, in cyst fluid each component weight percent are as follows: Chinese medical extract 40~45%, dispersing agent 50~55%, Suspending agent 3~5%, wetting agent 1~3%.

Preferably, the dispersing agent is polyethylene glycols or vegetable oil；The suspending agent is beeswax, aluminum monostearate, second The mixture of one or more of base cellulose, propylene glycol；Wetting agent is soybean lecithin, Tween-80, Tween-60, department One or more of disk -80 or Arlacel-60.

Preferably, the vegetable oil is the one of peanut oil, soybean oil, sesame oil, rapeseed oil or other edible vegetable oils Kind or in which several mixtures；The suspending agent is beeswax；Wetting agent is soybean lecithin or Tween-80.

The present invention also provides the preparation methods of the Chinese traditional medicine composition composition soft capsule of the treatment flu, it is characterised in that step It is rapid as follows:

Medicinal material is respectively crushed into most coarse powder respectively, it is spare；

Radices trichosanthis, dayflower medicinal material are set in countercurrent extraction tank, extracted with water adverse current, filtration, leaching radices trichosanthis and duck plantar Careless Aqueous extracts；Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint are used into extraction by steam distillation volatile oil, filtering, leaching proposes decocting liquid after oil, receives Collect volatile oil and the dregs of a decoction are spare；The dregs of a decoction and Herba Andrographitis medicinal material after Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint to be extracted to volatile oil set countercurrent extraction tank It is interior, it is extracted with 70%~85% ethyl alcohol adverse current, above-mentioned radices trichosanthis and dayflower is added in filtering, filtrate recycling ethanol to no alcohol taste Aqueous extracts and decocting liquid after oil is proposed, is concentrated under reduced pressure into the thick paste that relative density is 1.25~1.30 (50 DEG C of heat are surveyed), 60 DEG C or less It is dried under reduced pressure, is ground into fine powder, dispersing agent, suspending agent, wetting agent and above-mentioned volatile oil is added, it is equal that colloid mill is ground to mixing It is even, obtain cyst fluid, using compacting or dropping preparation method be packed into softgel shell, be prepared into soft capsule to get；

Alternatively, radices trichosanthis, dayflower medicinal material are set in countercurrent extraction tank, extracted with water adverse current, filtration, leaching radices trichosanthis and Dayflower Aqueous extracts；Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint are extracted into volatile oil using supercritical carbon dioxide extraction method, collect volatile oil；It will The dregs of a decoction and Herba Andrographitis medicinal material after Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint extraction volatile oil are set in countercurrent extraction tank, inverse with 70%~85% ethyl alcohol Stream extracts, and above-mentioned radices trichosanthis and dayflower Aqueous extracts is added in filtration, filtrate recycling ethanol to no alcohol taste, is concentrated under reduced pressure into opposite Density is the thick paste of 1.25~1.30 (50 DEG C of heat are surveyed), is dried under reduced pressure, is ground into fine powder, dispersing agent, suspending agent, wetting agent is added And above-mentioned volatile oil, colloid mill are ground to uniformly mixed, obtain cyst fluid, are packed into softgel shell using compacting or dropping preparation method, are prepared into soft Capsule to get.

Further, when the extraction by steam distillation volatile oil, amount of water is 6-8 times, and distillation time is that 4-8 is small When；Supercritical carbon dioxide extracting parameter are as follows: 30~60 DEG C of extraction kettle temperature, 15~35MPa of pressure；Separating still temperature 15~30 DEG C, 4~8MPa of pressure；Extraction time 1.5~4 hours, 15~30Kg/h of carbon dioxide gas flow.

Further, the condition that the adverse current is extracted are as follows: add the 8-12 times of water measured or 70%~85% ethanol solution, Adverse current Extracting temperature is 40~60 DEG C, speed of agitator 2r/min, and adverse current is extracted 0.5-1.5 hours.

Flu is the common cold disease because of caused by human feeling's exopathogen.Western modern medicine lacks treatment flu to the factor at present With the effective therapeutic agent taken into account of suiting the medicine to the illness.Flu is occurred according to theory of traditional Chinese medical science, the heightened awareness of development, dialectical with differentiation of disease phase In conjunction on the basis of, the vital task that treatment cold medicine is Chinese medicine study is developed.

Prescription of the present invention is made of Fructus Forsythiae, Herba Andrographitis, Rhizoma Et Radix Notopterygii, dayflower, peppermint, radices trichosanthis.Fructus Forsythiae bitter is micro- in side Cold, clearing heat and detoxicating heresy dissipates the heat of the part of the body cavity above the diaphragm housing the heart and lungs；Herba Andrographitis taste bitter and cold, clearing heat-fire detumescence, the shared tool of two medicines is clearing heat and detoxicating, thoroughly The function that hotlist reaches, eliminates emphatically pathogenesis, for our monarch drug in a prescription.Peppermint it is clear light it is cool dissipate, help main ingredient clearing heat and detoxicating, solution wind-heat it Heresy mitigates and attacks caused headache and abscess of throat in wind-heat；Dayflower nature and flavor are sweet, bitter, cold, clearing heat and detoxicating, detumescence of bringing down a fever, and thin Lotus, with Fructus Forsythiae, Herba Andrographitis, peppermint compatibility, still has with that can reinforce the effect of its dispelling wind and heat from the body and mitigates abscess of throat effect；Radices trichosanthis Tool promotes the production of body fluid to quench thirst, eliminating heat from the lung, fall fire moisturize effect, are longer than clearing heat and promoting fluid especially, hurts saliva for heat evil, mouth parched and tongue scorched can both increase Strong heat-clearing, and impaired body fluid can be supplemented.Three medicines cooperate main ingredient, and the power of clearing heat and detoxicating, dispelling wind and heat from the body heresy is made to increase, altogether For the ministerial drug of we.Rhizoma Et Radix Notopterygii acrid flavour, hardship, warm-natured, a surname's hair lung qi, radiate table out, wind-expelling pain-stopping effect, same with cold-pungent and diaphoretic drugs With, can enhance the effect of diaphoretic medicine inducing sweat and dispelling exogenous evils, and peppermint compatibility is then conducive to heat dissipation analgesic relieving sore-throat, and in we it is pungent it is cool in be equipped with The product of a little pungent-warm be not only conducive to heresy thoroughly, but also have not carried on the back pungent cool purport, were the adjuvant of we.To anemopyretic cold it occurs for full policy The interpretation of the cause, onset and process of an illness integrates clearing heat and detoxicating, a surname hair lung qi, relieving sore-throat and promotes the production of body fluid drug, and Six-element matches, and saturating heresy lets out lung, heat detoxicating solution, all diseases from It is 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.Mainly contain benzene Ethyl alcohol glycoside is such as: forsythin, forsythol compound, volatile oil 1~2.5% etc., and document report Forsythia volatile oil has significant And stable antibiosis and antiviral functions, wherein forsythin is its most important quality control index, and forsythin is lignanoid's glycoside Compound is insoluble in water, is soluble in the organic solvents such as ethyl alcohol, methanol.

Rhizoma Et Radix Notopterygii is umbelliferae Rhizoma Et Radix Notopterygii Notopterygium incisum Ting ex H.T.Chang or notopterygium forbesii The dry rhizome and root of Notoperygium forbesii Boiss..It is bright that modern age pharmaceutical research shows that Rhizoma Et Radix Notopterygii medicinal material has Aobvious analgesia, it is anti-inflammatory, improve blood circulation and enhance the effect of body immune function, main active be volatile oil and with Notopterol, nodakenin, the liposoluble constituent coumarin kind compound that Isomperatorin is representative.Volatile oil contains about 2.3%, Its volatile oil can be such that pyrogenicity rat temperature is substantially reduced, and have significant refrigeration function.

Peppermint is the dry aerial parts of Lamiaceae plant peppermint Mentha haplocalyx Briq..It is main to contain volatilization Oily 0.8-1% or so, ingredient is mainly the ingredients such as menthones and menthol in oil, and volatile oil has and makes telangiectasis, is increased Add heat dissipation, sweating and heat resolving effect；Peppermint is in addition to containing volatile component, also containing the involatile constituents such as flavonoids, triterpenes, tool Have anti-inflammatory, antibacterial, anti-oxidant and other effects.And the solubility of its flavonoids, triterpenes in water is small.

Herba Andrographitis is the dry ground of acanthaceous plant Herba Andrographitis Andrographis paniculata (Burm.F.) Nees Upper part.Mainly containing Diterpenes constituents such as andrographolide, Dehydro and drographolide etc., flavonoids such as qroxylin A, the Chinese The compounds such as baicalein, Ginkgolide Component have antibacterial anti-inflammatory, antiviral, anti-inflammatory effect.The principle active component two of Herba Andrographitis Solubility is very low in water for terpene lactones ingredient, and there are apparent thermal instabilitys for the effective components such as andrographolide, are passing It is easily lost during system heating and refluxing extraction.Contain multiple active hydrogens and unsaturated lactone ring in andrographolide structure, by The reactions such as degradation, oxidation, isomerization or rearrangement easily occur in thermal process, the retention rate of andrographolide is caused to decline.

Radices trichosanthis is cucurbitaceous plant snakegourd Trichosanthes kirilowii Maxim. or trichosanthes rosthornii Harms The dry root of Trichosanthes rosthornii Harms.The main classes containing saponin(e, protein-based, polysaccharide, amino acid etc. Equal compounds have the pharmacological actions such as antitumor, anti-inflammatory, antiviral.Trichosanthin has antivirus action, but meets high temperature meeting Denaturation.

Dayflower is Commelianaceae Commelina, there is the effect of inducing diuresis for removing edema, clearing heat and detoxicating, modern studies have found that duck Plantar grass is containing a variety of natural products such as flavonoids, alkaloids, polysaccharide, organic acids.Existing literature shows that dayflower water extract exists Inside and outside all has the effect of obvious resisiting influenza virus.

It is indicated above, it takes directly water after extracting volatile oil to mention, cannot effectively extract the effective component in medicinal material, and long Time, which decocts, extracts, and can destroy the effective components such as andrographolide, trichosanthin；Novelty of the invention uses hydrous ethanol Having in low temperature adverse current extraction Fructus Forsythiae, Herba Andrographitis, Rhizoma Et Radix Notopterygii, peppermint medicinal material and water low temperature adverse current extraction radices trichosanthis, dayflower medicinal material Imitate ingredient, not only can maximum effective component extracting, but also can be reduced the destruction of effective component, so as to improve effectively Component content.

It extracts and prepares in the embodiment of the present invention 2 and comparative examples (200510095620.9 patent tradition extraction process by water) Dry extract active constituent content comparison result, be shown in Table 1.

1 active constituent content of table compares

Remarks: table Chinese medicine is with a collection of medicinal material, and active constituent content is converted by following prescription: Fructus Forsythiae 200g, Qiang 100g, peppermint 100g, Herba Andrographitis 200g, radices trichosanthis 150g, dayflower 150g living.

As known from Table 1, adverse current extraction process of the present invention compared with traditional water decocting process, wear by andrographolide and dehydration Heart lotus lactone total amount recovery rate improves 4 times or more, and forsythin recovery rate improves 20% or more, and Notopterol and Isomperatorin mention Rate is taken to improve 30% or more, meanwhile, reduce the water-solubility impurities such as starch, reduce dried cream yield, reduces a day dose； Significant effect, solvent-oil ratio are decreased obviously, and extraction time also greatly shortens, and production efficiency increases substantially.

2, the determination of preparation process thereof:

It carried since decoction exists, take inconvenience, the disadvantages of quality is difficult to control, be restricted clinical application. Stable and controllable for quality to prepare, safely, effectively, storage, carries, dosage form easy to use transport clinical use, is contained according to this product Have the characteristics of volatile component, be prepared into bioavilability is high, content is accurate, can avoid volatile component volatilization loss, Bad odor, soft capsule convenient to take, appearance is good are covered, to improve the stability of preparation and the compliance of patient.It is soft Capsule has the advantages that good airproof performance, can prevent Oxidative demage of the loss of volatile component with extraneous oxygen to content, The medicine preparation high suitable for volatile component content.And middle Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint all contain a large amount of volatilization in the present invention Oil, in order to guarantee the stability of volatile component in drug, we have selected soft capsule dosage form to improve former dosage form.

Auxiliary material as soft capsule suspension medium is mixed with drug must have good mobility to guarantee extensive life It produces, while mixed liquor must also have good physical stability.Whether the decentralized medium selected in soft capsule suitable, soft capsule The proportion of composition and each auxiliary material component directly influences the stability of soft capsule.Therefore, the medicine for being suitble to the Chinese medicine composition is found It is key technology of the invention with auxiliary material and ratio of adjuvant.

1) selection of dispersing agent: the selection of drug dispersing agent is the key that develop one of soft capsule, it should ensure that content Accuracy and preparation stability, so that it is guaranteed that the safety and effectiveness of drug.Common dispersants have edible vegetable oil at present With polyethylene glycol-400 (PEG-400), inventor screens both above dosage by testing.

Three parts of Chinese medical extracts (containing medicinal powder and volatile oil) are taken, enough soybean oils, peanut oil and poly- second are separately added into Glycol -400 grinds 30 minutes through colloid mill after being sufficiently mixed, sets in 2000 revs/min of centrifuge and be centrifuged 20 minutes, observes The precipitation status of two mixed liquors, the results are shown in Table 2.

The different dispersing agents of table 2 settle situation test result

Vegetable oil and polyethylene glycols are with good stability, and super quality and competitive price can be used as the dispersing agent of invention formulation. It is verified by experiments, the present invention uses other polyethylene glycols solvents or sesame oil, rapeseed oil and other edible vegetable oil, Essentially identical effect can be obtained.

2) selection of preparation cyst fluid prescription: the dosage of dispersing agent, suspending agent and lubricant directly influence soft capsule at Product rate and loading amount.Dispersive agent ratio is too low, and stability is good, but poor fluidity, is not easy pelleting, and yield rate is low；Dispersive agent ratio Excessive, thixotroping is worth low, good fluidity, but loading amount is big and is easy to leak.Therefore dispersing agent, suspending agent and the profit of different proportion are screened Lubrication prescription, so that it is determined that best cyst fluid prescription ratio.

Example 3 prepares Chinese medical extract (containing medicinal powder and volatile oil), is separately added into different amounts of decentralized medium, helps Suspension, lubricant grind 30 minutes through colloid mill after being sufficiently mixed, observe its state, the results are shown in Table 3.

The Selection experiment result of 3 soft capsule different auxiliary material ratio of table

The above result shows that controlling prescription ratio in Chinese medical extract 30~50%, dispersing agent 40~70%, suspending agent 0~6%, in 0~4% range of wetting agent, the soft capsule system that property is stable, is suitable for industrialization generation can preferably be obtained Agent.In order to guarantee that the quality of final products is stablized, a certain amount of preservative can also be added in cyst fluid, as parabens, list are hard Resin acid glycerolipid etc., according to circumstances different, additional amount is also different, generally 0.3% or so in liquid volume, as long as reaching antibacterial effect Fruit.

The long-time stability experimental data of capsule (embodiment 2) of the present invention, is shown in Table 4.

The long-term stable experiment result of the soft capsule preparation of 4 embodiment of the present invention 2 of table

The result shows that: through 24 months long-term stable experiments, every quality index, without significant difference, showed compared with 0 month Product quality is highly stable.

Compared with the existing technology, the present invention has the advantage that

(1) by using adverse current extraction process, it is ensured that medicinal material and solvent maintain biggish effective component concentration difference, increase Extraction motive force is added, Accelerative mass transfer diffusion process accelerates extraction rate, 50% or more solvent usage of saving, while solvent Reverse flow is played the role of being sufficiently stirred during the extraction process, improves extraction efficiency；Extracting temperature is reduced by original boiling It is 40 DEG C -60 DEG C, low temperature, which extracts, guarantees that thermal instability ingredient does not decompose, while the excessive cracking of starch in material being avoided to be gelatinized Effective component dissolution is influenced, impurity is few in medicinal material extract medicinal extract, and extraction cost is greatly lowered, and improves in final solvent effectively The concentration of ingredient has forsythin, Notopterol and Isomperatorin total amount, Dehydro and drographolide and andrographolide total amount etc. Imitating the raising of constituents extraction rate, (present invention compared with traditional extraction process by water, extract by andrographolide and Dehydro and drographolide total amount Rate improves 4 times or more, and forsythin recovery rate improves 20% or more, Notopterol and Isomperatorin recovery rate improve 30% with On), energy saving about 80% efficiently avoids the shortcomings that original technique produces product.

(2) present invention refines prescription Chinese medicinal materials according to effective component property after modern extraction process effective component extracting At soft capsule, there is embedding and cover effect, the volatilization loss of oil component can be prevented, prevents the oxidation of drug or by light point Solution.Soft capsule dosage form disintegration rate is fast simultaneously, is uniformly dispersed, directly absorbs after disintegration in enteron aisle；Bioavilability is high；Drug is steady It is qualitative good, it is not easy the moisture absorption；Good airproof performance masks the bad smell of drug；It is convenient to take, it is easy to carry the advantages that.Quality is steady Fixed: through 24 months long-term stable experiments, every quality index, without significant difference, showed that product quality is very steady compared with 0 month It is fixed.

(3) show that soft capsule of the invention is significantly better than the therapeutic effect of virus flu by clinical observation result Antiviral granule is also advantageous over traditional extraction process by water preparation；Treating both manifestation and root cause of disease of the present invention, to virus flu fever, pharyngalgia, nasal obstruction The curative effect of the symptoms such as runny nose, headache, general malaise, thirsty and dry pharynx is especially pronounced.Clinical effectiveness shows that soft capsule of the invention is controlled Treating virus flu has good therapeutic effect, is worth clinical expansion.

Specific embodiment

With embodiment, further description of the technical solution of the present invention below, it will help to technical side of the invention , there are further understanding in the advantages of case, effect, and the scope of protection of the present invention is not limited for embodiment, protection scope of the present invention by Claim determines.

Embodiment 1:

1, prescription:

2, preparation method:

1) it extracts: medicinal material being respectively crushed into most coarse powder respectively, it is spare.

Radices trichosanthis, dayflower medicinal material are set in countercurrent extraction tank, add the water adverse current of 10 times of amounts to extract, Extracting temperature 50 DEG C, speed of agitator 2r/min, adverse current is extracted 1.5 hours, filtration, leaching radices trichosanthis and dayflower Aqueous extracts.

Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint are extracted into volatile oil using supercritical carbon dioxide extraction method, it is (another to collect volatile oil 25ml Deposit), the dregs of a decoction it is spare；The condition of supercritical extract is: pressure 20MPa, 40 DEG C of temperature, 4 hours time.

By after Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint supercritical extract volatile oil the dregs of a decoction and Herba Andrographitis medicinal material set in countercurrent extraction tank, add 70% ethyl alcohol of 10 times of amounts, adverse current Extracting temperature are 50 DEG C, speed of agitator 2r/min, and adverse current is extracted 1.0 hours, is filtered, and are merged Above-mentioned radices trichosanthis and dayflower Aqueous extracts is added to no alcohol taste in filtrate recycling ethanol, be concentrated under reduced pressure into relative density be 1.25~ The thick paste of 1.30 (50 DEG C of heat are surveyed), 50 DEG C are dried under reduced pressure, and are ground into fine powder and obtain 260g, spare.

2) it prepares:

Suspending agent beeswax 25g, dispersing agent soybean oil 312g are heated and melted, mixes, is down to room temperature；Medicinal powder and wetting is added Agent soybean lecithin 12.4g and above-mentioned volatile oil, colloid mill are ground to uniformly mixed, obtain cyst fluid, are filled out using compacting or dropping preparation method Be filled with softgel shell, be prepared into soft capsule 1000 to get.

Embodiment 2:

1, prescription:

2, preparation method:

1) it extracts: medicinal material being respectively crushed into most coarse powder respectively, it is spare；

Radices trichosanthis, dayflower medicinal material are set in countercurrent extraction tank, the water of 10 times of amounts is added, adverse current Extracting temperature is 50 DEG C, is stirred Revolving speed 2r/min is mixed, adverse current is extracted 1.5 hours, filtration, leaching radices trichosanthis and dayflower Aqueous extracts.

Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint are used into extraction by steam distillation volatile oil, amount of water is 6 times of amounts, distillation time 6 Hour, filtering, leaching decocting liquid；Collection volatile oil 16ml (separately depositing), the dregs of a decoction are spare.

The dregs of a decoction and Herba Andrographitis medicinal material after Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint to be extracted to volatile oil are set in countercurrent extraction tank, and 10 times of amounts are added 70% ethyl alcohol, adverse current Extracting temperature be 50 DEG C, speed of agitator 2r/min, adverse current extract 1.0 hours, filtration, merging filtrate return Ethyl alcohol is received to no alcohol taste, above-mentioned radices trichosanthis and dayflower Aqueous extracts are added and propose decocting liquid after oil, are concentrated under reduced pressure into relative density For the thick paste of 1.25~1.30 (50 DEG C of heat are surveyed), 60 DEG C or less are dried under reduced pressure, and are ground into fine powder 287g, spare.

2) it prepares:

Suspending agent beeswax 24g, dispersing agent soybean oil 265g are heated and melted, mixes, is down to room temperature；Medicinal powder and wetting is added Agent soybean lecithin 12g and above-mentioned volatile oil, colloid mill are ground to uniformly mixed, obtain cyst fluid, are filled using compacting or dropping preparation method Enter softgel shell, be prepared into soft capsule 1000 to get.

Embodiment 3:

1, prescription:

2, preparation method:

1) it extracts: medicinal material being respectively crushed into most coarse powder respectively, it is spare；

Radices trichosanthis, dayflower medicinal material are set in countercurrent extraction tank, the water of 12 times of amounts is added, adverse current Extracting temperature is 40 DEG C, is stirred Revolving speed 2r/min is mixed, adverse current is extracted 0.5 hour, filtration, leaching radices trichosanthis and dayflower Aqueous extracts.

Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint are used into extraction by steam distillation volatile oil, amount of water is 8 times of amounts, distillation time 8 Hour, filtering, leaching decocting liquid；Collection volatile oil 20.5ml (separately depositing), the dregs of a decoction are spare.

The dregs of a decoction and Herba Andrographitis medicinal material after Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint to be extracted to volatile oil are set in countercurrent extraction tank, and 8 times of amounts are added 80% ethyl alcohol, adverse current Extracting temperature be 60 DEG C, speed of agitator 2r/min, adverse current extract 0.5 hour, filtration, merging filtrate return Ethyl alcohol is received to no alcohol taste, above-mentioned radices trichosanthis and dayflower Aqueous extracts are added and propose decocting liquid after oil, are concentrated under reduced pressure into relative density For the thick paste of 1.25~1.30 (50 DEG C of heat are surveyed), 60 DEG C or less are dried under reduced pressure, and are ground into fine powder 284g, spare.

2) it prepares:

Suspending agent beeswax 20g, dispersing agent soybean oil 280g are heated and melted, mixes, is down to room temperature；Medicinal powder and above-mentioned is added Volatile oil, colloid mill are ground to uniformly mixed, obtain cyst fluid, are packed into softgel shell using compacting or dropping preparation method, are prepared into soft capsule 1000 to get.

Embodiment 4:

1, prescription:

2, preparation method:

1) it extracts: medicinal material being respectively crushed into most coarse powder respectively, it is spare；

Radices trichosanthis, dayflower medicinal material are set in countercurrent extraction tank, the water of 8 times of amounts is added, adverse current Extracting temperature is 60 DEG C, stirring Revolving speed 2r/min, adverse current are extracted 1.0 hours, filtration, leaching radices trichosanthis and dayflower Aqueous extracts.

Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint are used into extraction by steam distillation volatile oil, amount of water is 8 times of amounts, distillation time 8 Hour, filtering, leaching decocting liquid；Collection volatile oil 18ml (separately depositing), the dregs of a decoction are spare.

The dregs of a decoction and Herba Andrographitis medicinal material after Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint to be extracted to volatile oil are set in countercurrent extraction tank, and 10 times of amounts are added 85% ethyl alcohol, adverse current Extracting temperature be 40 DEG C, speed of agitator 2r/min, adverse current extract 1.5 hours, filtration, merging filtrate return Ethyl alcohol is received to no alcohol taste, above-mentioned radices trichosanthis and dayflower Aqueous extracts are added and propose decocting liquid after oil, are concentrated under reduced pressure into relative density For the thick paste of 1.25~1.30 (50 DEG C of heat are surveyed), 60 DEG C or less are dried under reduced pressure, and are ground into fine powder 265g, spare.

2) it prepares:

Wetting agent soybean lecithin 15g, dispersing agent soybean oil 320g are heated and mixed, room temperature is down to；Be added medicinal powder and on State volatile oil, colloid mill is ground to uniformly mixed, obtains cyst fluid, is packed into softgel shell using compacting or dropping preparation method, is prepared into soft capsule 1000 to get.

Embodiment 5:

1, prescription:

2, preparation method:

1) it extracts: medicinal material being respectively crushed into most coarse powder respectively, it is spare；

Radices trichosanthis, dayflower medicinal material are set in countercurrent extraction tank, the water of 10 times of amounts is added, adverse current Extracting temperature is 55 DEG C, is stirred Revolving speed 2r/min is mixed, adverse current is extracted 1.0 hours, filtration, leaching radices trichosanthis and dayflower Aqueous extracts.

Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint are used into extraction by steam distillation volatile oil, amount of water is 8 times of amounts, distillation time 6 Hour, filtering, leaching decocting liquid；Collection volatile oil 19ml (separately depositing), the dregs of a decoction are spare.

The dregs of a decoction and Herba Andrographitis medicinal material after Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint to be extracted to volatile oil are set in countercurrent extraction tank, and 12 times of amounts are added 80% ethyl alcohol, adverse current Extracting temperature be 50 DEG C, speed of agitator 2r/min, adverse current extract 1.0 hours, filtration, merging filtrate return Ethyl alcohol is received to no alcohol taste, above-mentioned radices trichosanthis and dayflower Aqueous extracts are added and propose decocting liquid after oil, are concentrated under reduced pressure into relative density For the thick paste of 1.25~1.30 (50 DEG C of heat are surveyed), 60 DEG C or less are dried under reduced pressure, and are ground into fine powder 255g, spare.

2) it prepares:

Suspending agent beeswax 10g, dispersing agent soybean oil 300g are heated and melted, mixes, is down to room temperature；Medicinal powder and above-mentioned is added Volatile oil, colloid mill are ground to uniformly mixed, obtain cyst fluid, are packed into softgel shell using compacting or dropping preparation method, are prepared into soft capsule 1000 to get.

Comparative examples:

1, prescription:

2, preparation method:

1) extract: Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint add the water heating of 6 times of amounts to be kept for slightly boiled 6 hours, and steam distillation extracts volatilization Oil, volatile oil (separately depositing), the dregs of a decoction and aqueous solution are spare；Three tastes such as Herba Andrographitis, radices trichosanthis, three taste of dayflower and above-mentioned Fructus Forsythiae extract The dregs of a decoction after volatile oil are placed in multi-function extractor, add 12,10 times of amount water, and decoction is secondary, 2 hours every time, merge secondary water Extract is stood, the aqueous solution after filtration, with the three taste medicinal material extract volatile oil such as Fructus Forsythiae, and being concentrated under reduced pressure into relative density is 1.25 The clear cream of~1.30 (50 DEG C) is spare.

2) inclusion of volatile oil: according to volatile oil: the ratio of beta-cyclodextrin (1:10g/g) weighs a certain amount of β-ring paste β-CD the water that regulation times amount is added is ground well, pours into colloid mill, machine by essence, slowly continuous to be added dropwise and appropriate anhydrous second The volatile oil of alcohol dissolution, mills certain time, is dried in vacuo in 40 DEG C, it is spare to obtain inclusion compound.

3) mixing granulation: clear cream, volatile oil beta cyclodextrin inclusion complex and appropriate dextrin, 0.5% Steviosin are mixed 1000g particle is made in softwood, granulation, dry (≤60 DEG C).

4) dry particle whole grain: is crossed into 10 mesh and 50 meshes.

5) pack: by gained particle In Aluminium Foil Packing, be distributed into 10g/ bags to get.

Verify example: soft capsule of the invention treats virus flu clinical observation

In order to observe soft capsule of the invention to the clinical efficacy of anemopyretic cold, we select antiviral granule (Sugarless type) Granule with reference examples carries out treatment observation to 128 anemopyretic cold patients, brief summary is as follows as comparison medicine.

1 clinical data

1.1 observation objects

This group 128 are viral influenza patient, and doctor trained in Western medicine diagnosis meets the infection of the upper respiratory tract.Randomly select wherein 53 be Soft capsule treatment group of the present invention, chooses that wherein 49 are reference examples particle control group 1,26 is that antiviral granule (Sugarless type) is right According to group 2.Male 28 in treatment group, it is women 25, average age 42.8 years old, 60 years old maximum, it is 21 years old minimum；It is male in control group 1 Property 26, it is women 23, average age 43.5 years old, maximum 62 years old, 20 years old minimum；2 male of control group 14, puts down by women 12 It is equal 41.2 years old age, 60 years old maximum, it is 22 years old minimum.

1.2 diagnostic criteria

Flu main symptom: fever, foul wind, pharyngalgia, cough；Secondary card: nasal obstruction, runny nose, sneeze, alliteration and pain, general fatigue are not Suitable, sweat lets out red unsmooth, thirsty and dry pharynx, tongue side point, thin white fur of tongue, micro- yellow, superficial and rapid pulse.Doctor trained in Western medicine diagnosis meets the infection of the upper respiratory tract. It is required that main symptom at least conforms to 1, accompanying symptoms meets 2.

1.3 administrated method

Treatment group: soft capsule prepared by the embodiment of the present invention 2,5 tablets each time, 3 times a day.Control group 1: reference examples of the present invention The granule of preparation, 1 bag every time (10 grams), 3 times a day.Control group 2: (Sugarless type is had antiviral granule by the wide pharmacy in Sichuan The production of limit company), 1 bag every time (3 grams), 3 times a day.The course for the treatment of is 3 days.

1.4 efficacy evaluation

Referring to " guideline of clinical investigations of new Chinese medicine treatment flu ", score computation syndrome is classified by main symptom, secondary card Therapeutic index evaluates curative effect.Recovery from illness: temperature recovery is normal within treatment 3 days, and the symptom of flu all disappears, and therapeutic index > 95%.Effective: temperature recovery is normal within treatment 3 days, and most of symptom of flu disappears, therapeutic index > 75%.It is effective: to control Body temperature reduces earlier above within treating 3 days, the cardinal symptom partial disappearance of flu, therapeutic index > 30%.Invalid: treatment 3 days with inner body Temperature is not dropped or is increased, and the cardinal symptom of flu is without improvement, therapeutic index < 30%.

2 results

2.1 curative effects compare

5 curative effect of table compares

It is examined through Ridit, granule prepared by the reference examples 1 of soft capsule prepared by the present invention and traditional extraction process by water preparation It is significant in efficacy, it is better than antiviral granule；And soft capsule prepared by the present invention is better than the reference examples system of traditional extraction process by water preparation Standby granule.

2.2 cardinal symptoms, sign curative effect

6 cardinal symptom of table, sign curative effect compare

Show that capsule of the invention imitates the treatment of fever, pharyngalgia, nasal congestion, headache, general malaise, thirsty and dry pharynx Fruit is better than the granule of control group 1, and the two is substantially better than the antiviral granule of control group 2.3 discuss

It is antiviral that this item clinical observation result shows that pungent clear cold granules are significantly better than the therapeutic effect of virus flu Particle, treating both manifestation and root cause of disease, the treatment to symptoms such as virus flu fever, pharyngalgia, nasal congestion, headache, general malaise, thirsty and dry pharynxs It imitates especially pronounced.Show that soft capsule treatment virus flu of the invention has good therapeutic effect, the particle extracted better than traditional water Agent is significantly better than antiviral granule.

Claims (8)

1. a kind of preparation method for the Chinese traditional medicine composition composition soft capsule for treating flu, it is characterised in that:

The soft capsule includes cyst fluid, softgel shell, the weight percent of each component in cyst fluid are as follows: Chinese medical extract 30~50%, Dispersing agent 40~70%, suspending agent 3~6%, wetting agent 1~4%；

The Chinese medical extract is the extracted dry cream being prepared of the Chinese medicine material of following parts by weight and volatile oil: Fructus Forsythiae 50 ~200 portions of 50~200 portions of Rhizoma Et Radix Notopterygii, 20~150 parts of peppermints

50~200 portions of Herba Andrographitis, 40~200 parts of dayflower of 20~150 portions of radices trichosanthis；

The dispersing agent is polyethylene glycols or vegetable oil；

The suspending agent is the mixture of one or more of beeswax, aluminum monostearate, ethyl cellulose, propylene glycol；

The wetting agent is one or more of soybean lecithin, Tween-80, Tween-60, Arlacel-80 or Arlacel-60；

Steps are as follows for the preparation method:

Medicinal material is respectively crushed into most coarse powder respectively, it is spare；

Radices trichosanthis, dayflower medicinal material are set in countercurrent extraction tank, extracted with water adverse current, filtration, leaching radices trichosanthis and dayflower water Extract；Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint are used into extraction by steam distillation volatile oil, filtering, leaching proposes decocting liquid after oil, and collection is waved Hair oil and the dregs of a decoction are spare；The dregs of a decoction and Herba Andrographitis medicinal material after Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint to be extracted to volatile oil are set in countercurrent extraction tank, It is extracted with 70%~85% ethyl alcohol adverse current, filtering, filtrate recycling ethanol to no alcohol taste, is added above-mentioned radices trichosanthis and dayflower water mentions Liquid and decocting liquid after oil is proposed, is concentrated under reduced pressure into 50 DEG C of heat and surveys the thick pastes that relative densities are 1.25~1.30,60 DEG C or less decompressions are done It is dry, it is ground into fine powder, is added dispersing agent, suspending agent, wetting agent and above-mentioned volatile oil, colloid mill is ground to uniformly mixed, obtains capsule Liquid, using compacting or dropping preparation method be packed into softgel shell, be prepared into soft capsule to get.

2. a kind of preparation method for the Chinese traditional medicine composition composition soft capsule for treating flu, it is characterised in that:

The Chinese medicine composition includes cyst fluid, softgel shell, the weight percent of each component in cyst fluid are as follows: and Chinese medical extract 30~ 50%, dispersing agent 40~70%, suspending agent 3~6%, wetting agent 1~4%；

The Chinese medical extract is the extracted dry cream being prepared of the Chinese medicine material of following parts by weight and volatile oil: Fructus Forsythiae 50 ~200 portions of 50~200 portions of Rhizoma Et Radix Notopterygii, 20~150 parts of peppermints

50~200 portions of Herba Andrographitis, 40~200 parts of dayflower of 20~150 portions of radices trichosanthis；

The dispersing agent is polyethylene glycols or vegetable oil；

The suspending agent is the mixture of one or more of beeswax, aluminum monostearate, ethyl cellulose, propylene glycol；

The wetting agent is one or more of soybean lecithin, Tween-80, Tween-60, Arlacel-80 or Arlacel-60；

Steps are as follows for the preparation method:

Medicinal material is respectively crushed into most coarse powder respectively, it is spare；

Radices trichosanthis, dayflower medicinal material are set in countercurrent extraction tank, extracted with water adverse current, filtration, leaching radices trichosanthis and dayflower water Extract；Fructus Forsythiae, Rhizoma Et Radix Notopterygii, peppermint are extracted into volatile oil using supercritical carbon dioxide extraction method, collect volatile oil；By Fructus Forsythiae, Qiang The dregs of a decoction and Herba Andrographitis medicinal material living, after peppermint extraction volatile oil are set in countercurrent extraction tank, are extracted with 70%~85% ethyl alcohol adverse current, Above-mentioned radices trichosanthis and dayflower Aqueous extracts is added in filtration, filtrate recycling ethanol to no alcohol taste, is concentrated under reduced pressure into 50 DEG C of heat and surveys relatively The thick paste that density is 1.25~1.30, is dried under reduced pressure, and is ground into fine powder, and dispersing agent, suspending agent, wetting agent and above-mentioned volatilization is added Oil, colloid mill are ground to uniformly mixed, obtain cyst fluid, are packed into softgel shell using compacting or dropping preparation method, be prepared into soft capsule to get.

3. the preparation method of the Chinese traditional medicine composition composition soft capsule for the treatment of flu according to claim 1 or 2, which is characterized in that The weight percent of each component in soft capsule cyst fluid are as follows: Chinese medical extract 40~45%, dispersing agent 50~55%, suspending agent 3~ 5%, wetting agent 1~3%.

4. the preparation method of the Chinese traditional medicine composition composition soft capsule for the treatment of flu according to claim 1 or 2, it is characterised in that: The vegetable oil is peanut oil, soybean oil, sesame oil, one kind of rapeseed oil or other edible vegetable oils or in which several mixed Close object；The suspending agent is beeswax；Wetting agent is soybean lecithin or Tween-80.

5. the preparation method of the Chinese traditional medicine composition composition soft capsule for the treatment of flu according to claim 1, it is characterised in that: water steams When steam distillation method extracts volatile oil, amount of water is 6~8 times, and distillation time is 4~8 hours.

6. the preparation method of the Chinese traditional medicine composition composition soft capsule for the treatment of flu according to claim 1, it is characterised in that: adverse current The condition of extraction are as follows: add the water or 70%~85% ethanol solution of 8~12 times of amounts, adverse current Extracting temperature is 40~60 DEG C, stirring Revolving speed 2r/min, adverse current are extracted 0.5~1.5 hour.

7. the preparation method of the Chinese traditional medicine composition composition soft capsule for the treatment of flu according to claim 2, it is characterised in that: super to face The extracting parameter of boundary's carbon dioxide extraction method are as follows: 30~60 DEG C of extraction kettle temperature, 15~35MPa of pressure；Separating still temperature 15~ 30 DEG C, 4~8MPa of pressure；Extraction time 1.5~4 hours, 15~30Kg/h of carbon dioxide gas flow.

8. the preparation method of the Chinese traditional medicine composition composition soft capsule for the treatment of flu according to claim 2, it is characterised in that: adverse current The condition of extraction are as follows: add the water or 70%~85% ethanol solution of 8~12 times of amounts, adverse current Extracting temperature is 40~60 DEG C, stirring Revolving speed 2r/min, adverse current are extracted 0.5~1.5 hour.