CN102258719B - Preparation method of traditional Chinese medicinal oral liquid preparation for treating children's cold - Google Patents

Preparation method of traditional Chinese medicinal oral liquid preparation for treating children's cold Download PDF

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CN102258719B
CN102258719B CN 201110189584 CN201110189584A CN102258719B CN 102258719 B CN102258719 B CN 102258719B CN 201110189584 CN201110189584 CN 201110189584 CN 201110189584 A CN201110189584 A CN 201110189584A CN 102258719 B CN102258719 B CN 102258719B
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volatile oil
oral liquid
fructus
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CN102258719A (en
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肖军平
康兴东
吴永忠
李旭
余显英
张荷英
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JIANGXI POZIN PHARMACEUTICAL Co Ltd
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Abstract

A preparation method of a traditional Chinese medicinal oral liquid preparation for treating children's cold belongs to the technical field of traditional Chinese medicine preparation, and comprises the following steps of: distilling mint and Spica Schizonepetae to obtain a volatile oil; distilling apricot kernel to obtain an almond juice; decocting great burdock achene, Baikal skullcap root, balloonflower root, radix peucedani, Angelica dahurica, cape jasmine, haw, medicated leaven, malt, Rhizoma Phragmitis, honeysuckle flower and weeping forsythia by adding water to obtain a water decoction, followed by filtering and condensation to obtain a water extract concentrated solution, and carrying out pretreatment to obtain a pretreatment solution; purifying the pretreatment solution by a membrane to obtain a traditional Chinese medicinal supernatant; carrying out clathration on the volatile oil by the use of a beta-cyclodextrin derivative to obtain a volatile oil clathrate aqueous solution; adding the volatile oil clathrate aqueous solution and pharmaceutic adjuvants into the traditional Chinese medicinal supernatant, boiling to dissolve, adding the almond juice, and naturally cooling to obtain the traditional Chinese medicinal compound oral liquid preparation. With the volatile oil packed by the beta-cyclodextrin derivative, the taste of the traditional Chinese medicinal oral liquid is improved, the quality of the product is stabilized, and the clarity of the product stored for a long time is observably raised.

Description

A kind of preparation method for the treatment of the extract oral liquid preparation of infantile common cold
Technical field
The invention belongs to the Chinese medicine preparing technical field, be specifically related to a kind of preparation method of extract oral liquid preparation.
Background technology
Flu is the acute upper respiratory tract infection that is caused by cold virus, is clinical modal disease in children's's period, and children's is ill easily holds expectorant under the arm afterwards, it is stagnant to hold under the arm, shows as: Fa Gaore, inappetence, sleep disorder, frequent cough etc. more.The Chinese medicine that is usually used at present treating infantile common cold is wean to pacify common cold in children, Herba Menthae, Fructus Arctii relieving the exterior syndrome with drugs of pungent in flavor and cool in nature in its formula, dispelling wind and heat pathogens, relieving sore throat and diminishing swelling; Herba Schizonepetae, Radix Angelicae Dahuricae relieving the exterior syndrome with drugs of pungent in flavor and warm in nature dispel the wind; Radix Scutellariae, Fructus Gardeniae heat clearing and damp drying; Flos Lonicerae, Fructus Forsythiae heat-clearing and toxic substances removing; The Rhizoma Phragmitis clearing away heat and promoting production of body fluid; Semen Armeniacae Amarum, Radix Platycodonis, Radix Peucedani lung qi dispersing eliminating phlegm and stopping cough; Fructus Crataegi, Massa Medicata Fermentata, Fructus Hordei Germinatus relieving dyspepsia.
Due to pediatric patient oral disposition liquid, mixture, the compliance of the oral liquids such as syrup is better, and in above-mentioned side, Herba Menthae, Herba Schizonepetae acrid in the mouth can fall apart and induce sweat, and its effective ingredient is mainly volatile oil.These volatile oil are water insoluble, volatile, and mouthfeel is bad, application number is that the patent employing beta-cyclodextrin inclusion compound volatile oil of CN200410081639.3 hides the volatile oil component in flavor and stable wean to pacify common cold in children, yet because the derivant water solublity of beta-schardinger dextrin-is relatively poor, the formed Benexate Hydrochloride water solublity of its enclose volatile oil is poorer, affects the stability of liquid preparation.In addition, because Chinese medicine ingredients is complicated, Chinese medicine extraction liquid is a kind of suspension of complicated component normally, comprising complicated ingredients such as solid particle, hydrophilic colloid, starch, protein, tannin, pigment, natural gum, inorganic salts, the precipitation of separating out from these materials make the clarity of Chinese medicine extraction liquid and stability all relatively poor, and then affect the quality of product extract oral liquid preparation.Traditional remove impurity clarification process is decoction and alcohol sedimentation technique, but the precipitation of this method is incomplete, still has a large amount of precipitations after long-term the placement and produces, and affects product quality.
Summary of the invention
The objective of the invention is provides a kind of effective ingredient good water solubility for top described defective, the preparation method of the extract oral liquid preparation of the treatment infantile common cold that extracting solution clarity and stability are high.
The objective of the invention is to be achieved by the following technical programs.
A kind of preparation method for the treatment of the extract oral liquid preparation of infantile common cold, formula comprises Chinese medicine Herba Menthae, Herba Schizonepetae, Semen Armeniacae Amarum, Fructus Arctii, Radix Scutellariae, Radix Platycodonis, Radix Peucedani, the Radix Angelicae Dahuricae, Fructus Gardeniae, Fructus Crataegi, Massa Medicata Fermentata, Fructus Hordei Germinatus, Rhizoma Phragmitis, Flos Lonicerae, Fructus Forsythiae, it is characterized in that, comprise the following steps:
(1) Herba Menthae, Herba Schizonepetae steam distillation, obtain volatile oil;
(2) the bitter almond water steam distillation, obtain aqua armeniacae;
(3) add water after Fructus Arctii, Radix Scutellariae, Radix Platycodonis, Radix Peucedani, the Radix Angelicae Dahuricae, Fructus Gardeniae, Fructus Crataegi, Massa Medicata Fermentata, Fructus Hordei Germinatus, Rhizoma Phragmitis, Flos Lonicerae, Fructus Forsythiae mix and fry in shallow oil altogether, it is 1.05~1.20 that the rear merging of gained decocting liquid filtration is concentrated into relative density, gets water extracting liquid;
(4) carry out pretreatment after step (3) gained water extraction liquid is concentrated, get pretreatment fluid;
(5) with step (4) gained pretreatment fluid through the film purification, get the Chinese medicine clear liquor;
(6) with step (1) gained volatile oil beta-cyclodextrin derivative enclose, get the volatile oil clathrate compound aqueous solution;
(7) add step (6) gained volatile oil clathrate compound aqueous solution and pharmaceutic adjuvant in step (5) gained Chinese medicine clear liquor, add step (2) gained aqua armeniacae mix homogeneously after boiling dissolving, namely get the traditional Chinese medicine compound oral liquid body preparation after cooling.
The parts by weight of described formulation of drug are: 10~150 parts of Herba Menthaes, 10~150 parts of Herba Schizonepetaes, 10~150 parts of Semen Armeniacae Amarums, 10~150 parts of Fructus Arctiis, 10~150 parts of Radix Scutellariaes, 10~150 parts of Radix Platycodoniss, 10~150 parts of Radix Peucedanis, 10~150 parts of the Radixs Angelicae Dahuricae, 10~150 parts of Fructus Gardeniaes, 10~150 parts of Fructus Crataegis, 10~150 parts of Massa Medicata Fermentatas, 10~150 parts, Fructus Hordei Germinatus, 10~150 parts of Rhizoma Phragmitiss, 10~150 parts of Flos Loniceraes, 10~150 parts of Fructus Forsythiaes.
In described step (1), Herba Menthae, Herba Schizonepetae add the water distillation of 3~6 times of amount volumes, and the volatile oil volume of collecting is Herba Menthae and Herba Schizonepetae quality of medicinal material 1/1000~1/100 times.
In described step (2), Semen Armeniacae Amarum adds the water distillation of 3~6 times of amount volumes, and the aqua armeniacae volume of collecting is 1~3 times of Semen Armeniacae Amarum quality of medicinal material.
Decocting number of times in described step (3) is 1~3 time, and the decocting that at every turn adds 2~8 times of amount volumes boils, and each decocting time is 1~3 hour.
Pretreatment in described step (4) comprises one or more in the method precipitated with the gelatin, improvement the method precipitated with the gelatin, polycaprolactam method, the chitosan sedimentation method, the chitin sedimentation method, ZTC1+1 clarifier fining process, juice clarification method, heat treatment refrigeration, supercentrifugal process.
Film in described step (5) is one or more in micro-filtration membrane, ultrafilter membrane, NF membrane.
Described micro-filtration membrane aperture is 0.1 to 10 micron, and the ultrafilter membrane aperture is 5 to 50 nanometers, and the NF membrane aperture is 0.5 to 5 nanometer.
Beta-cyclodextrin derivative in described step (6) comprises DM-β-CD, TM-β-CD, 2-hydroxyethyl-β-cyclodextrin, 2-HP-BETA-CD, 3-HP-β-CD; The quality of described beta-cyclodextrin derivative is 5~20 times of volatile oil volume.
The dosage form of the traditional Chinese medicine compound oral liquid body preparation in described step (7) comprises oral liquid, mixture and syrup.
The invention has the beneficial effects as follows: the present invention is by beta-cyclodextrin derivative enclose volatile oil, and the beta-cyclodextrin derivative water solublity is better, has not only improved mouthfeel but also has stablized the quality of product; First carry out pretreatment before membrane separation technique purification Chinese medicine extraction liquid, increased the service life of diffusion barrier, when having preserved effective ingredient, medicinal liquid clarity has improved 80%~95%, and the product physical and chemical stability is good, and the clarity of long-term storage significantly improves.
The specific embodiment
Embodiment 1.
Get Herba Menthae 8kg, Herba Schizonepetae 6.7kg adds the distillation of 60L water, collects and obtains 120ml volatile oil; Semen Armeniacae Amarum 8kg adds the distillation of 30L water, collects to get the 12.5L aqua armeniacae; Get Fructus Arctii 8kg, Radix Scutellariae 8kg, Radix Platycodonis 6.7kg, Radix Peucedani 8kg, Radix Angelicae Dahuricae 2.7kg, Fructus Gardeniae 4kg, Fructus Crataegi 2.7kg, Massa Medicata Fermentata 2.7kg, Fructus Hordei Germinatus 2.7kg, Rhizoma Phragmitis 12kg, Flos Lonicerae 12kg, Fructus Forsythiae 8kg mixing, decoct twice, add water 400L at every turn, decocted 2 hours at every turn.Decocting liquid with 200 order filter-cloth filterings after, merging filtrate, filtrate is concentrated into relative density 1.10 left and right, gets water extracting liquid.
The 120ml volatile oil of gained is with 2-HP-BETA-CD 840g enclose (carrying out enclose with volatile oil: 2-HP-BETA-CD=1:7).Clathrate process is: 2-HP-BETA-CD 840g adds the 8.4L water dissolution; After 120ml volatile oil adds the 600ml dissolve with ethanol, add under 30 ℃ in the 2-HP-BETA-CD aqueous solution, the limit edged stirs, and stirs after adding 45 minutes again, obtains the 2-HP-BETA-CD clathrate aqueous solution of volatile oil.
Water extracting liquid is added 4% gelatin solution 3L, and the limit edged stirs, and stirs after adding 10 minutes again; Add ethanol to make to contain the alcohol amount to reach 75%, standing 12 hours of cold preservation is filtered again, and filtrate is 0.08MPa in vacuum, reclaims ethanol and concentrated when temperature is 50 ℃, obtains pretreatment fluid.The pretreatment fluid via hole diameter is interior pressure-pipe type ceramic micro filter film cross flow filter under 0.10MPa of 0.2 micron, collects permeate and is the Chinese medicine clear liquor.
The Chinese medicine clear liquor adds the aqua armeniacae mix homogeneously that makes after adding the pharmaceutic adjuvants such as the 2-HP-BETA-CD clathrate aqueous solution that makes, 20kg sucrose, 0.2kg steviosin, 0.5kg sodium benzoate to boil dissolving again, cools, and is prepared into the 100L mixture.
Embodiment 2.
Get Herba Menthae 8kg, Herba Schizonepetae 6.7kg adds the distillation of 60L water, collects and obtains 120ml volatile oil; Semen Armeniacae Amarum 8kg adds the distillation of 30L water, collects to get the 12.5L aqua armeniacae; Get Fructus Arctii 8kg, Radix Scutellariae 8kg, Radix Platycodonis 6.7kg, Radix Peucedani 8kg, Radix Angelicae Dahuricae 2.7kg, Fructus Gardeniae 4kg, Fructus Crataegi 2.7kg, Massa Medicata Fermentata 2.7kg, Fructus Hordei Germinatus 2.7kg, Rhizoma Phragmitis 12kg, Flos Lonicerae 12kg, Fructus Forsythiae 8kg mixing, decoct twice, add water 400L at every turn, decocted 2 hours at every turn.Decocting liquid with 200 order filter-cloth filterings after, merging filtrate, filtrate is concentrated into relative density 1.10 left and right, gets water extracting liquid.
The 120ml volatile oil of gained is with 2-HP-BETA-CD 720g enclose (carrying out enclose with volatile oil: 2-HP-BETA-CD=1:6).Clathrate process is: 2-HP-BETA-CD 720g adds the 7.2L water dissolution; After 120ml volatile oil adds the 600ml dissolve with ethanol, add under 30 ℃ in the 2-HP-BETA-CD aqueous solution, the limit edged stirs, and stirs after adding 45 minutes again, obtains the 2-HP-BETA-CD clathrate aqueous solution of volatile oil.
Water extracting liquid is added 1% chitosan 0.5L, the limit edged stirs; Stirred again after adding 15 minutes, standing 12 hours, to filter, filtrate is pretreatment fluid.The pretreatment fluid via hole diameter is intrinsic pressure doughnut formula polyvinylidene fluoride microporous filtering film cross flow filter under 0.20MPa of 0.15um, collects permeate and is the Chinese medicine clear liquor.
The Chinese medicine clear liquor adds the aqua armeniacae mix homogeneously that makes after adding the pharmaceutic adjuvants such as the 2-HP-BETA-CD clathrate aqueous solution that makes, 20kg sucrose, 0.2kg steviosin, 0.5kg sodium benzoate to boil dissolving again, cools, and is prepared into the 100L oral liquid.
Embodiment 3.
Get Herba Menthae 9kg, Herba Schizonepetae 5kg adds the distillation of 60L water, collects and obtains 100ml volatile oil; Semen Armeniacae Amarum 6kg adds the distillation of 30L water, collects to get the 10L aqua armeniacae; Get Fructus Arctii 8kg, Radix Scutellariae 8kg, Radix Platycodonis 6kg, Radix Peucedani 8kg, Radix Angelicae Dahuricae 3kg, Fructus Gardeniae 4kg, Fructus Crataegi 3kg, Massa Medicata Fermentata 3kg, Fructus Hordei Germinatus 3kg, Rhizoma Phragmitis 15kg, Flos Lonicerae 10kg, Fructus Forsythiae 8kg mixing, decoct twice, add water 400L at every turn, decocted 2 hours at every turn.Decocting liquid with 200 order filter-cloth filterings after, merging filtrate, filtrate is concentrated into relative density 1.10 left and right, gets water extracting liquid.
The 100ml volatile oil of gained is with 2-HP-BETA-CD 800g enclose (carrying out enclose with volatile oil: 2-HP-BETA-CD=1:8).Clathrate process is: 2-HP-BETA-CD 800g adds the 8L water dissolution; After 100ml volatile oil adds the 400ml dissolve with ethanol, add under 30 ℃ in the 2-HP-BETA-CD aqueous solution, the limit edged stirs, and stirs after adding 45 minutes again, obtains the 2-HP-BETA-CD clathrate aqueous solution of volatile oil.
Water extracting liquid is added 1% ZTC1+1 III type B component 2000ml, be heated to approximately 70 ℃, stirred once every 15 minutes; After one hour, add 1% ZTC1+1 III type A component 1000ml, stirred once every 15 minutes, 200 order filter-cloth filterings after a hour, filtrate is pretreatment fluid.The pretreatment fluid via hole diameter is intrinsic pressure doughnut formula polysulfones micro-filtration membrane cross flow filter under 0.20MPa of 0.1um, collects permeate and is the Chinese medicine clear liquor.
The Chinese medicine clear liquor adds the aqua armeniacae mix homogeneously that makes after adding the pharmaceutic adjuvants such as 2-HP-BETA-CD clathrate aqueous solution, 20kg sucrose, 0.2kg steviosin, 0.5kg sodium benzoate to boil dissolving again, cools, and is prepared into the 100L oral liquid.
Embodiment 4.
Get Herba Menthae 9kg, Herba Schizonepetae 5kg adds the distillation of 60L water, collects and obtains 100ml volatile oil; Semen Armeniacae Amarum 6kg adds the distillation of 30L water, collects to get the 10L aqua armeniacae; Get Fructus Arctii 8kg, Radix Scutellariae 8kg, Radix Platycodonis 6kg, Radix Peucedani 8kg, Radix Angelicae Dahuricae 3kg, Fructus Gardeniae 4kg, Fructus Crataegi 3kg, Massa Medicata Fermentata 3kg, Fructus Hordei Germinatus 3kg, Rhizoma Phragmitis 15kg, Flos Lonicerae 10kg, Fructus Forsythiae 8kg mixing, decoct twice, add water 400L at every turn, decocted 2 hours at every turn.Decocting liquid with 200 order filter-cloth filterings after, merging filtrate, filtrate is concentrated into relative density 1.10 left and right, gets water extracting liquid.
The 100ml volatile oil of gained is with DM-β-CD 800g enclose (carrying out enclose with volatile oil: DM-β-CD=1:8).Clathrate process is: DM-β-CD 800g adds the 8L water dissolution; After 100ml volatile oil adds the 400ml dissolve with ethanol, add under 30 ℃ in the DM-β-CD aqueous solution, the limit edged stirs, and stirs after adding 45 minutes again, obtains the DM-β-CD clathrate aqueous solution of volatile oil.
Water extracting liquid through the high speed centrifugation of 5000r/min 15 minutes, is got supernatant and is pretreatment fluid.Pretreatment fluid is doughnut polysulphones hyperfiltration membrane cross flow filter under 0.10MPa of 6000 through molecular cut off, collects permeate and is the Chinese medicine clear liquor.
The Chinese medicine clear liquor adds the aqua armeniacae mix homogeneously that makes after adding the pharmaceutic adjuvants such as DM-β-CD clathrate aqueous solution, 20kg sucrose, 0.2kg steviosin, 0.5kg sodium benzoate to boil dissolving again, cools, and is prepared into the 100L mixture.
Embodiment 5.
Get Herba Menthae 5kg, Herba Schizonepetae 9kg adds the distillation of 60L water, collects and obtains 110ml volatile oil; Semen Armeniacae Amarum 7kg adds the distillation of 35L water, collects to get the 12L aqua armeniacae; Get Fructus Arctii 7kg, Radix Scutellariae 7kg, Radix Platycodonis 5kg, Radix Peucedani 7kg, Radix Angelicae Dahuricae 2kg, Fructus Gardeniae 4kg, Fructus Crataegi 2kg, Massa Medicata Fermentata 3kg, Fructus Hordei Germinatus 3kg, Rhizoma Phragmitis 10kg, Flos Lonicerae 8kg, Fructus Forsythiae 6kg mixing, decoct twice, add water 400L at every turn, decocted 2 hours at every turn.Decocting liquid with 200 order filter-cloth filterings after, merging filtrate, filtrate is concentrated into relative density 1.10 left and right, gets water extracting liquid.
The 110ml volatile oil of gained is with 2-HP-BETA-CD 990g enclose (carrying out enclose with volatile oil: 2-HP-BETA-CD=1:9).Clathrate process is: 2-HP-BETA-CD 990g adds the 9.9L water dissolution; After 110ml volatile oil adds the 440ml dissolve with ethanol, add under 30 ℃ in the 2-HP-BETA-CD aqueous solution, the limit edged stirs, and stirs after adding 45 minutes again, obtains the 2-HP-BETA-CD clathrate aqueous solution of volatile oil.
Water extracting liquid is added 1% chitosan 0.5L, the limit edged stirs; Stirred again after adding 15 minutes, and standing 12 hours, filtered; Filtrate through the high speed centrifugation of 5000r/min 15 minutes, is got supernatant liquid and is pretreatment fluid again.The pretreatment fluid via hole diameter is interior pressure-pipe type ceramic micro filter film cross flow filter under 0.10MPa of 0.2um, and permeate is doughnut polysulphones hyperfiltration membrane cross flow filter under 0.10MPa of 6000 again through molecular cut off, collects permeate and is the Chinese medicine clear liquor.
The Chinese medicine clear liquor adds the aqua armeniacae mix homogeneously that makes after adding the pharmaceutic adjuvants such as 2-HP-BETA-CD clathrate aqueous solution, 45kg sucrose, 0.2kg steviosin, 0.5kg sodium benzoate to boil dissolving again, cools, and is prepared into the 100L syrup.
Embodiment 6.
Get Herba Menthae 8kg, Herba Schizonepetae 6.7kg adds the distillation of 60L water, collects and obtains 120ml volatile oil; Semen Armeniacae Amarum 8kg adds the distillation of 30L water, collects to get the 12.5L aqua armeniacae; Get Fructus Arctii 8kg, Radix Scutellariae 8kg, Radix Platycodonis 6.7kg, Radix Peucedani 8kg, Radix Angelicae Dahuricae 2.7kg, Fructus Gardeniae 4kg, Fructus Crataegi 2.7kg, Massa Medicata Fermentata 2.7kg, Fructus Hordei Germinatus 2.7kg, Rhizoma Phragmitis 12kg, Flos Lonicerae 12kg, Fructus Forsythiae 8kg mixing, decoct twice, add water 400L at every turn, decocted 2 hours at every turn.Decocting liquid with 200 order filter-cloth filterings after, merging filtrate, filtrate is concentrated into relative density 1.10 left and right, gets water extracting liquid.
The 120ml volatile oil of gained is with 2-HP-BETA-CD 840g enclose (carrying out enclose with volatile oil: 2-HP-BETA-CD=1:7).Clathrate process is: 2-HP-BETA-CD 840g adds the 8.4L water dissolution; After 120ml volatile oil adds the 600ml dissolve with ethanol, add under 30 ℃ in the 2-HP-BETA-CD aqueous solution, the limit edged stirs, and stirs after adding 45 minutes again, obtains the 2-HP-BETA-CD clathrate aqueous solution of volatile oil.
Be 5.20 with water extracting liquid pH, transfer pH to 4.00 with hydrochloric acid; Standing 24 hours of cold preservation is filtered, and filtrate pH is 4.20, transfers pH to 5.20 with sodium hydroxide; Add 1% chitosan 0.2L, the limit edged stirs; Stirred again after adding 15 minutes, and standing 12 hours, filtered; Filtrate through the high speed centrifugation of 5000r/min 15 minutes, is got supernatant liquid and is pretreatment fluid again.The pretreatment fluid via hole diameter is interior pressure-pipe type ceramic micro filter film cross flow filter under 0.10MPa of 0.2um, and permeate is doughnut polysulphones hyperfiltration membrane cross flow filter under 0.08MPa of 6000 again through molecular cut off, collects permeate and is the Chinese medicine clear liquor.
The Chinese medicine clear liquor adds the aqua armeniacae mix homogeneously that makes after adding the pharmaceutic adjuvants such as the 2-HP-BETA-CD clathrate aqueous solution that makes, 20kg sucrose, 0.2kg steviosin, 0.5kg sodium benzoate to boil dissolving again, cools, and is prepared into the 100L oral liquid.
The more former technique mouthfeel of the mouthfeel of this oral liquid is much better, and numb feeling in the tongue obviously alleviates and taste does not rush; Product is placed and can be detected volatile oil more than 24 months simultaneously.The clarity of the mixture that the more former technique of clarity (decoction and alcohol sedimentation technique remove impurity clarification) of the oral liquid that the more former technique of clarity (decoction and alcohol sedimentation technique remove impurity clarification) is produced is produced has improved 80%~90% left and right, the effective ingredient content of baicalin is about 1mg/ml, and placing for a long time clarity stability significantly improves, place not precipitation appearance in 12 months, placing only has a small amount of precipitation to produce after 24 months.

Claims (6)

1. preparation method for the treatment of the extract oral liquid preparation of infantile common cold, formula is made by the Chinese medicine of following parts by weight: 10~150 parts of Herba Menthaes, 10~150 parts of Herba Schizonepetaes, 10~150 parts of Semen Armeniacae Amarums, 10~150 parts of Fructus Arctiis, 10~150 parts of Radix Scutellariaes, 10~150 parts of Radix Platycodoniss, 10~150 parts of Radix Peucedanis, 10~150 parts of the Radixs Angelicae Dahuricae, 10~150 parts of Fructus Gardeniaes, 10~150 parts of Fructus Crataegis, 10~150 parts of Massa Medicata Fermentatas, 10~150 parts, Fructus Hordei Germinatus, 10~150 parts of Rhizoma Phragmitiss, 10~150 parts of Flos Loniceraes, 10~150 parts of Fructus Forsythiaes, it is characterized in that, comprise the following steps:
(1) Herba Menthae, Herba Schizonepetae steam distillation, obtain volatile oil;
(2) the bitter almond water steam distillation, obtain aqua armeniacae;
(3) add water after Fructus Arctii, Radix Scutellariae, Radix Platycodonis, Radix Peucedani, the Radix Angelicae Dahuricae, Fructus Gardeniae, Fructus Crataegi, Massa Medicata Fermentata, Fructus Hordei Germinatus, Rhizoma Phragmitis, Flos Lonicerae, Fructus Forsythiae mix and fry in shallow oil altogether, it is 1.05~1.20 that the rear merging of gained decocting liquid filtration is concentrated into relative density, gets water extracting liquid;
(4) carry out pretreatment after step (3) gained water extraction liquid is concentrated, get pretreatment fluid;
(5) with step (4) gained pretreatment fluid through the film purification, get the Chinese medicine clear liquor;
(6) with step (1) gained volatile oil beta-cyclodextrin derivative enclose, get the volatile oil clathrate compound aqueous solution;
(7) add step (6) gained volatile oil clathrate compound aqueous solution and pharmaceutic adjuvant in step (5) gained Chinese medicine clear liquor, add step (2) gained aqua armeniacae mix homogeneously after boiling dissolving, namely get the traditional Chinese medicine compound oral liquid body preparation after cooling;
Pretreatment in described step (4) is one or more in the method precipitated with the gelatin, the chitosan sedimentation method, ZTC1+1 clarifier fining process, supercentrifugal process;
Film in described step (5) is one or both in micro-filtration membrane, ultrafilter membrane, and the micro-filtration membrane aperture is 0.1 to 0.2 micron, and the molecular cut off of ultrafilter membrane is 6000;
Beta-cyclodextrin derivative in described step (6) is DM-β-CD, 2-HP-BETA-CD.
2. a kind of preparation method for the treatment of the extract oral liquid preparation of infantile common cold according to claim 1, it is characterized in that: in described step (1), Herba Menthae, Herba Schizonepetae add the water distillation that is equivalent to Herba Menthae, 3~6 times of amount volumes of Herba Schizonepetae medical material, and the volatile oil volume of collecting is Herba Menthae, Herba Schizonepetae quality of medicinal material 1/1000~1/100 times.
3. a kind of preparation method for the treatment of the extract oral liquid preparation of infantile common cold according to claim 1, it is characterized in that: in described step (2), Semen Armeniacae Amarum adds the water distillation of 3~6 times of amount volumes, and the aqua armeniacae volume of collecting is 1~3 times of Semen Armeniacae Amarum quality of medicinal material.
4. a kind of preparation method for the treatment of the extract oral liquid preparation of infantile common cold according to claim 1, it is characterized in that: decocting number of times in described step (3) is 1~3 time, add at every turn be equivalent to the decoctings of 2~8 times of the quality of medicinal materials that extracts amount volumes boil, each decocting time is 1~3 hour.
5. a kind of preparation method for the treatment of the extract oral liquid preparation of infantile common cold according to claim 1, it is characterized in that: the quality of the described beta-cyclodextrin derivative of step (6) is 5~20 times of volatile oil volume.
6. a kind of preparation method for the treatment of the extract oral liquid preparation of infantile common cold according to claim 1, it is characterized in that: the dosage form of the traditional Chinese medicine compound oral liquid body preparation in described step (7) comprises oral liquid, mixture and syrup.
CN 201110189584 2011-07-07 2011-07-07 Preparation method of traditional Chinese medicinal oral liquid preparation for treating children's cold Expired - Fee Related CN102258719B (en)

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CN102771613A (en) * 2012-08-22 2012-11-14 李娴 Herb tea for children
CN105456834A (en) * 2016-01-14 2016-04-06 江西京通美联药业有限公司 Preparation method of medicine preparation for treating common cold in children
CN106237180A (en) * 2016-08-31 2016-12-21 江西普正制药有限公司 A kind of preparation technology of the pharmaceutical preparation for improving infantile common cold curative effect
CN114191569A (en) * 2021-12-19 2022-03-18 扬州大学 Preparation method of nano-drug based on hydroxypropyl-beta-cyclodextrin

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