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CN107898942A - A kind of GANMAO QINGRE JIAONANG and preparation method thereof - Google Patents

A kind of GANMAO QINGRE JIAONANG and preparation method thereof Download PDF

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Publication number
CN107898942A
CN107898942A CN201711193292.5A CN201711193292A CN107898942A CN 107898942 A CN107898942 A CN 107898942A CN 201711193292 A CN201711193292 A CN 201711193292A CN 107898942 A CN107898942 A CN 107898942A
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parts
jiaonang
weight
chitosan
ganmao qingre
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CN107898942B (en
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曾胜
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Guangdong Yili Luoding Pharmaceutical Co Ltd
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Guangdong Yili Luoding Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/538Schizonepeta
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232Angelica
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/233Bupleurum
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    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/34Campanulaceae (Bellflower family)
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    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/534Mentha (mint)
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/535Perilla (beefsteak plant)
    • AHUMAN NECESSITIES
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/66Papaveraceae (Poppy family), e.g. bloodroot
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    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/736Prunus, e.g. plum, cherry, peach, apricot or almond
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
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    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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Abstract

The invention belongs to technical field of traditional Chinese medicines, and in particular to a kind of GANMAO QINGRE JIAONANG and preparation method thereof.The invention discloses a kind of GANMAO QINGRE JIAONANG, the GANMAO QINGRE JIAONANG includes following components and its parts by weight:5 15 parts of 40 60 parts of ching-chieh, 10 20 parts of peppermint, 20 30 parts windproof, 10 20 parts of perilla leaf, 20 30 parts of pueraria lobata, 10 20 parts of campanulaceae, 10 20 parts of the root of Dahurain angelica, 40 60 parts of corydlis bungeana, 30 50 parts of reed root, 20 30 parts of radix bupleuri, 15 25 parts of semen armeniacae amarae, 13 parts of modification of chitosan, 15 parts of beta cyclodextrin, 0.5 1.5 parts of starch, 13 parts of hydroxypropyl cellulose, 85 95 parts of water and ethanol solution.GANMAO QINGRE JIAONANG produced by the present invention has the advantages of hygroscopicity is low, and stability is good, and bioavilability is high, easy disintegrating, and clinical efficacy is good, and medicine powder mobility is high in preparation process, the uniform quality of capsule.

Description

A kind of GANMAO QINGRE JIAONANG and preparation method thereof
Technical field
The invention belongs to technical field of traditional Chinese medicines, and in particular to a kind of GANMAO QINGRE JIAONANG and preparation method thereof.
Background technology
Flu is a kind of common disease, and cardinal symptom is headache, fever, cough, nasal obstruction, abscess of throat etc., to work and life Work affects, or even can also trigger complication, causes life danger.The common formulation of existing cold medicine is particle Agent, capsule, tablet etc., the technique of existing capsule generally use identification, processing, the drying of following methods, first medicinal material, so Routine smashes afterwards, extraction, then is pelletized by granulating process, and arrangement, be made capsule after always mixing.But existing granulating process is usual For indefinite form, particle dissipates, is broken, and shape is poor, poor fluidity, and the easy moisture absorption, is unfavorable for preserving, dispenses, while manufactured capsule is given birth to Thing availability is low, weak curative effect, works slow etc..
Chinese patent application CN101049485A discloses a kind of mulberry leaf-ginger common cold soft capsule and preparation method thereof, the mulberry ginger Soft capsule for treating common cold is made of mulberry leaf, chrysanthemum, purple perilla, Fructus Forsythiae, semen armeniacae amarae, rhizoma zingiberis and suitable pharmaceutic adjuvant, has relieve heat heat-clearing, dispels The effect of cold cough-relieving.The capsule is stable, disintegration is fast, bioavilability is high, rapid-action, but in the preparation method powder flowing Property it is poor, cause loading amount to have differences, and be easy to absorb moisture, influence drug quality.
Chinese patent CN1254266C discloses a kind of oral cold capsule, using by peppermint, mountain naphthalene, three taste medicine of chamomile Soak, extract volatile oil, the aqueous solution filtration after distillation is spare, collects volatile oil, with beta-cyclodextrin inclusion, refrigerated At night, filter, dry, finely ground, sieving for standby;The dregs of a decoction add water decoction, filtering, and filtrate merges spare with the aqueous solution after distillation; Jujube, radix glycyrrhizae, nymphaea tetragona, rag wood fruit, another name for Sichuan Province Cai Zi, rheum officinale, pappy shell seven flavor medicine material are added water to cook again, collecting decoction, mistake Filter, filtrate merge with reserve liquid, are concentrated under reduced pressure, and add ethanol, stand, filtration, filtrate decompression concentration, concentrate spray drying Method prepares extract powder, after addition inclusion compound is mixed, adds the auxiliary material of microcrystalline cellulose starch, granulation, low temperature drying, whole grain, adds Enter superfine silica gel powder to be mixed, it is filling, to obtain the final product.The capsule is evident in efficacy, but the capsule hygroscopicity, mobility are to be improved.
The content of the invention
In order to solve the problems in the existing technology, it is an object of the invention to provide a kind of GANMAO QINGRE JIAONANG and its Preparation method.GANMAO QINGRE JIAONANG provided by the invention is low with hygroscopicity, and stability is good, and bioavilability is high, easy disintegrating Advantage, and medicine powder mobility is high in preparation process, the uniform quality of capsule.
The present invention provides a kind of GANMAO QINGRE JIAONANG, the capsule is made of pellet, coatings and capsule shells;
The pellet includes following components and its weight fraction:
40-60 parts of ching-chieh, 10-20 parts of peppermint, 20-30 parts windproof, 10-20 parts of perilla leaf, 20-30 parts of pueraria lobata, campanulaceae 10-20 parts, it is 10-20 parts of the root of Dahurain angelica, 40-60 parts of corydlis bungeana, 30-50 parts of reed root, 20-30 parts of radix bupleuri, 15-25 parts of semen armeniacae amarae, modified 1-3 parts of chitosan, 1-5 parts of beta-cyclodextrin, 0.5-1.5 parts of starch, 1-3 parts of hydroxypropyl cellulose, 85-95 parts of water and 95% ethanol 5-15 parts;
The coatings are made of following components and its parts by weight:
50-60 parts of 10-15 parts of hydroxypropyl methylcellulose, 1-3 parts of three triacetin vinegar, 1-5 parts of magnesium stearate and 95% ethanol.
Further, pellet is made of following components and its parts by weight in the GANMAO QINGRE JIAONANG:
50 parts of ching-chieh, 15 parts of peppermint, 25 parts windproof, 15 parts of perilla leaf, 25 parts of pueraria lobata, 15 parts of campanulaceae, 15 parts of the root of Dahurain angelica, hardship 50 parts of Chinese violet, 40 parts of reed root, 25 parts of radix bupleuri, 20 parts of semen armeniacae amarae, 2 parts of modification of chitosan, 3 parts of beta-cyclodextrin, 1 part of starch, hydroxypropyl 10 parts of 2 parts of base cellulose, 90 parts of water and ethanol solution;
The coatings are made of following components and its parts by weight:
50-60 parts of 12.5 parts of hydroxypropyl methylcellulose, 2 parts of three triacetin vinegar, 3 parts of magnesium stearate and ethanol solution.
Further, the modification of chitosan is chitosan-g- lactose.
Further, the preparation method of the chitosan-g- lactose is:
(1) by chitosan and lactose by weight 1:3 are uniformly mixed, and obtain mixture;
(2) by acetic acid aqueous solution that methanol and volume fraction are 0.3% by volume 1:3 mixing, obtain solvent;
(3) solvent obtained by step (2) is added into mixture obtained by step (1), stirring adds sodium cyanoborohydride, room Temperature reaction 24h, the solution after reaction is diluted with deionized water, then is dialysed with triple distillation water, is freezed, to obtain the final product.
Further, the ethanol solution is the ethanol solution that volume fraction is 85-95%.
Meanwhile present invention provides a kind of preparation method of GANMAO QINGRE JIAONANG, comprise the following steps:
S1 takes ching-chieh, peppermint and perilla leaf, crushes, obtains medicinal material A;The water of its 6-8 times of weight, water into above-mentioned medicinal material A Steam distillation method extracts volatile oil, and extraction time 5-6h, collects volatile oil, solution is filtered, obtains liquor B and filter residue;
Volatile oil beta-cyclodextrin inclusion compound obtained by step S1 is included temperature 60 C, includes time 1-2h, refrigerated, taken out by S2 Filter, dry, ground 100 mesh sieve, obtains inclusion powder;
S3 crushes windproof, pueraria lobata, campanulaceae, the root of Dahurain angelica, corydlis bungeana, reed root, radix bupleuri and semen armeniacae amarae, and is filtered with step S1 gained Slag is uniformly mixed, and obtains medicinal material C;The water that its 7-9 times of weight is successively added into above-mentioned medicinal material C decocts twice, and each 1-2h, merges Decoct, filtering, obtains filtrate D;Above-mentioned filtrate D is merged with liquor B obtained by step S1, concentrates, is spray-dried, crush, cross 80 mesh Sieve, obtains extract powder;
S4 is by extract powder obtained by step S3 with nano silicon dioxide by weight 99:1 mixing, is mixed with rotating speed 26r/min 5min, then with pelletizing machine modification 10 times is smashed, obtain modified extract powder;
Starch, water and ethanol solution are uniformly mixed by S5, obtain binder;By inclusion powder, step S3 institutes obtained by step S2 Extract powder, modification of chitosan and hydroxypropyl cellulose must be modified to be uniformly mixed, obtain mixed-powder, with above-mentioned binder softwood, Using 45r/min, sieve sky is extruded into 1.0mm, round as a ball using 12000r/min, is placed on drying in fluid bed, is crossed 40 mesh, obtain Pellet;
S6 mixes hydroxypropyl methylcellulose, three triacetin vinegar, magnesium stearate and ethanol solution, obtains coating solution;By step Pellet obtained by S5 is placed in air-flow coating device, with above-mentioned coating solution bag barrier gown, art for coating condition:Blower frequency 26Hz, whiff pressure 0.2MPa, hydrojet flow velocity 1mL/min, 32 DEG C of stream temperature, coating weight gain 4-6%, obtains pill;Will be above-mentioned Pill loads capsule shells, sterilizes, to obtain the final product.
Further, fluidized-bed process condition is in the step S5:Air quantity 70-90m3/ h, 40-50 DEG C of temperature, time 40-60min。
The present invention is by chitin modified, being prepared into chitosan-g- lactose, not only reducing the hygroscopicity of pellet, also Add the mobility of powder so that obtained pellet uniform quality, solves the problems, such as quality difference in capsule filling;Separately Outside, the present invention is embedded the volatile oil of ching-chieh, peppermint and perilla leaf by beta-cyclodextrin, can effectively reduce volatilization The volatilization of oil and its contact with the external world, reduce the hygroscopicity of capsule, improve the stability and curative effect of medicine;Meanwhile this Invention is effectively reduced intergranular frictional force, is improved and collapsed by hydroxypropyl cellulose and modification of chitosan collective effect Solve speed, dissolution rate and medicine stability.
The present invention is coated pellet by the way that medicine is made pellet, effectively reduces the hygroscopicity of pellet, together When can make it that medicine duration in blood is long, Small side effects, improve bioavilability and the stability of medicine.
Compared with prior art, GANMAO QINGRE JIAONANG hygroscopicity produced by the present invention is low, and stability is good, bioavilability The advantages of height, easy disintegrating, clinical efficacy is good, and medicine powder mobility is high in preparation process, the uniform quality of capsule.
Embodiment
Explanation is further explained to the present invention below by specific embodiment, these embodiments are only used for the mesh of illustration , do not limit protection scope of the present invention.
A kind of 1 GANMAO QINGRE JIAONANG of embodiment
The GANMAO QINGRE JIAONANG is made of pellet, coatings and capsule shells, wherein
The pellet is made of following components and its parts by weight:
40 parts of ching-chieh, 10 parts of peppermint, 20 parts windproof, 10 parts of perilla leaf, 20 parts of pueraria lobata, 10 parts of campanulaceae, 10 parts of the root of Dahurain angelica, hardship 40 parts of Chinese violet, 30 parts of reed root, 20 parts of radix bupleuri, 15 parts of semen armeniacae amarae, 1 part of chitosan-g- lactose, 1 part of beta-cyclodextrin, 0.5 part of starch, 1 part of hydroxypropyl cellulose, 85 parts of water and volume fraction are 85% 5 parts of ethanol solution;
The coatings are made of following components and its parts by weight:
The ethanol that 10 parts of hydroxypropyl methylcellulose, 1 part of three triacetin vinegar, 1 part of magnesium stearate and volume fraction are 85% is molten 50 parts of liquid.
The preparation method of the chitosan-g- lactose is:
(1) by chitosan and lactose by weight 1:3 are uniformly mixed, and obtain mixture;
(2) by acetic acid aqueous solution that methanol and volume fraction are 0.3% by volume 1:3 mixing, obtain solvent;
(3) solvent obtained by step (2) is added into mixture obtained by step (1), stirring adds sodium cyanoborohydride, room Temperature reaction 24h, the solution after reaction is diluted with deionized water, then is dialysed with triple distillation water, is freezed, to obtain the final product.
Preparation method:
S1 takes ching-chieh, peppermint and perilla leaf, crushes, obtains medicinal material A;The water of its 7 times of weight into above-mentioned medicinal material A, water steam Steam distillation method extracts volatile oil, and extraction time 5.5h, collects volatile oil, solution is filtered, obtains liquor B and filter residue;
Volatile oil beta-cyclodextrin inclusion compound obtained by step S1 is included temperature 60 C, includes time 1.5h, refrigerated, taken out by S2 Filter, dry, ground 100 mesh sieve, obtains inclusion powder;
S3 crushes windproof, pueraria lobata, campanulaceae, the root of Dahurain angelica, corydlis bungeana, reed root, radix bupleuri and semen armeniacae amarae, and is filtered with step S1 gained Slag is uniformly mixed, and obtains medicinal material C;The water that its 8 times of weight are successively added into above-mentioned medicinal material C decocts twice, and each 1.5h, merges and decoct Boil, filter, obtain filtrate D;Above-mentioned filtrate D is merged with liquor B obtained by step S1, concentrates, is spray-dried, crush, cross 80 mesh sieves, Obtain extract powder;
S4 is by extract powder obtained by step S3 with nano silicon dioxide by weight 99:1 mixing, is mixed with rotating speed 26r/min 5min, then with pelletizing machine modification 10 times is smashed, obtain modified extract powder;
The ethanol solution that starch, water and volume fraction are 85% is uniformly mixed by S5, obtains binder;It will be wrapped obtained by step S2 Modified extract powder, chitosan-g- lactose and hydroxypropyl cellulose are uniformly mixed obtained by conjunction powder, step S3, obtain mixed-powder, are used Above-mentioned binder softwood, using 45r/min, sieve sky is extruded into 1.0mm, round as a ball using 12000r/min, is placed on fluidisation Dry in bed, wherein fluidized-bed process condition is:Air quantity 70m3/ h, 40 DEG C, time 40min of temperature, crosses 40 mesh, obtains pellet;
S6 mixes the ethanol solution that hydroxypropyl methylcellulose, three triacetin vinegar, magnesium stearate and volume fraction are 85%, Obtain coating solution;Pellet obtained by step S5 is placed in air-flow coating device, with above-mentioned coating solution bag barrier gown, art for coating bar Part:Blower frequency 26Hz, whiff pressure 0.2MPa, hydrojet flow velocity 1mL/min, 32 DEG C of stream temperature, coating weight gain 5%, obtains Pill;Above-mentioned pill is loaded into capsule shells, is sterilized, to obtain the final product.A kind of 2 GANMAO QINGRE JIAONANG of embodiment
The GANMAO QINGRE JIAONANG is made of pellet, coatings and capsule shells, wherein
The pellet is made of following components and its parts by weight:
50 parts of ching-chieh, 15 parts of peppermint, 25 parts windproof, 15 parts of perilla leaf, 25 parts of pueraria lobata, 15 parts of campanulaceae, 15 parts of the root of Dahurain angelica, hardship 50 parts of Chinese violet, 40 parts of reed root, 25 parts of radix bupleuri, 20 parts of semen armeniacae amarae, 2 parts of chitosan-g- lactose, 3 parts of beta-cyclodextrin, 1 part of starch, hydroxyl 2 parts of propyl cellulose, 90 parts of water and volume fraction are 90% 10 parts of ethanol solution;
The coatings are made of following components and its parts by weight:
12.5 parts of hydroxypropyl methylcellulose, 2 parts of three triacetin vinegar, 3 parts of magnesium stearate and volume fraction are 90% ethanol 55 parts of solution.
The preparation method of the chitosan-g- lactose is similar to Example 1.
Preparation method:
Except fluidized-bed process condition is in step S5:Air quantity 80m3/ h, temperature 45 C, outside time 50min, remaining step It is similar to Example 1.
A kind of 3 GANMAO QINGRE JIAONANG of embodiment
The GANMAO QINGRE JIAONANG is made of pellet, coatings and capsule shells, wherein
The pellet is made of following components and its parts by weight:
60 parts of ching-chieh, 20 parts of peppermint, 30 parts windproof, 20 parts of perilla leaf, 30 parts of pueraria lobata, 20 parts of campanulaceae, 20 parts of the root of Dahurain angelica, hardship 60 parts of Chinese violet, 50 parts of reed root, 30 parts of radix bupleuri, 25 parts of semen armeniacae amarae, 3 parts of chitosan-g- lactose, 5 parts of beta-cyclodextrin, 1.5 parts of starch, 3 parts of hydroxypropyl cellulose, 95 parts of water and volume fraction are 95% 15 parts of ethanol solution;
The coatings are made of following components and its parts by weight:
60 parts of 15 parts of hydroxypropyl methylcellulose, 3 parts of three triacetin vinegar, 5 parts of magnesium stearate and ethanol solution.
The ethanol solution is the ethanol water that volume fraction is 95%.
The preparation method of the chitosan-g- lactose is similar to Example 1.
Preparation method:
Except fluidized-bed process condition is in step S5:Air quantity 90m3/ h, temperature 50 C, outside time 60min, remaining step It is similar to Example 1.
A kind of 1 GANMAO QINGRE JIAONANG of comparative example
The GANMAO QINGRE JIAONANG is made of pellet, coatings and capsule shells, wherein
The pellet is made of following components and its parts by weight:
50 parts of ching-chieh, 15 parts of peppermint, 25 parts windproof, 15 parts of perilla leaf, 25 parts of pueraria lobata, 15 parts of campanulaceae, 15 parts of the root of Dahurain angelica, hardship 50 parts of Chinese violet, 40 parts of reed root, 25 parts of radix bupleuri, 20 parts of semen armeniacae amarae, 2 parts of chitosan, 3 parts of beta-cyclodextrin, 1 part of starch, hydroxypropyl are fine Tie up 10 parts of the ethanol solution that 2 parts of element, 90 parts of water and volume fraction are 90%;
The coatings are made of following components and its parts by weight:
12.5 parts of hydroxypropyl methylcellulose, 2 parts of three triacetin vinegar, 3 parts of magnesium stearate and volume fraction are 90% ethanol 55 parts of solution.
Preparation method is similar to Example 2.
Difference lies in be substituted for chitosan by chitosan-g- lactose with embodiment 2.
A kind of 2 GANMAO QINGRE JIAONANG of comparative example
The GANMAO QINGRE JIAONANG is made of pellet and capsule shells, wherein
The pellet is made of following components and its parts by weight:
50 parts of ching-chieh, 15 parts of peppermint, 25 parts windproof, 15 parts of perilla leaf, 25 parts of pueraria lobata, 15 parts of campanulaceae, 15 parts of the root of Dahurain angelica, hardship 50 parts of Chinese violet, 40 parts of reed root, 25 parts of radix bupleuri, 20 parts of semen armeniacae amarae, 2 parts of chitosan-g- lactose, 3 parts of beta-cyclodextrin, 1 part of starch, hydroxyl 2 parts of propyl cellulose, 90 parts of water and volume fraction are 90% 10 parts of ethanol solution.
Preparation method is similar to Example 2.
Difference lies in the GANMAO QINGRE JIAONANG is free of coatings with embodiment 2.
A kind of 3 GANMAO QINGRE JIAONANG of comparative example
The GANMAO QINGRE JIAONANG is made of pellet, coatings and capsule shells, wherein
The pellet is made of following components and its parts by weight:
50 parts of ching-chieh, 15 parts of peppermint, 25 parts windproof, 15 parts of perilla leaf, 25 parts of pueraria lobata, 15 parts of campanulaceae, 15 parts of the root of Dahurain angelica, hardship 50 parts of Chinese violet, 40 parts of reed root, 25 parts of radix bupleuri, 20 parts of semen armeniacae amarae, 2 parts of chitosan-g- lactose, 3 parts of beta-cyclodextrin, 1 part of starch, hydroxyl 2 parts of propyl cellulose, 90 parts of water and volume fraction are 90% 10 parts of ethanol solution;
The coatings are made of following components and its parts by weight:
12.5 parts of hydroxypropyl methylcellulose, 2 parts of three triacetin vinegar, 3 parts of magnesium stearate and volume fraction are 90% ethanol 55 parts of solution.
Preparation method:
S1 takes ching-chieh, peppermint and perilla leaf, crushes, obtains medicinal material A;The water of its 7 times of weight into above-mentioned medicinal material A, water steam Steam distillation method extracts volatile oil, and extraction time 5.5h, collects volatile oil, solution is filtered, obtains liquor B and filter residue;
Volatile oil beta-cyclodextrin inclusion compound obtained by step S1 is included temperature 60 C, includes time 1.5h, refrigerated, taken out by S2 Filter, dry, ground 100 mesh sieve, obtains inclusion powder;
S3 crushes windproof, pueraria lobata, campanulaceae, the root of Dahurain angelica, corydlis bungeana, reed root, radix bupleuri and semen armeniacae amarae, and is filtered with step S1 gained Slag is uniformly mixed, and obtains medicinal material C;The water that its 8 times of weight are added into above-mentioned medicinal material C decocts twice, and each 1.5h, merges and decoct, Filtering, obtains filtrate D;Above-mentioned liquor B is merged with filtrate D, is concentrated, is spray-dried, is crushed, 80 mesh sieves is crossed, obtains extract powder;
The ethanol solution that starch, water and volume fraction are 90% is uniformly mixed by S4, obtains binder;It will be wrapped obtained by step S2 Close powder, step S3 gained extract powder, chitosan-g- lactose and hydroxypropyl cellulose to be uniformly mixed, obtain mixed-powder, use is above-mentioned Binder softwood, using 45r/min, sieve sky is extruded into 1.0mm, and, 45 DEG C dryings round as a ball using 12000r/min, cross 40 Mesh, obtains pellet;
S5 mixes the ethanol solution that hydroxypropyl methylcellulose, three triacetin vinegar, magnesium stearate and volume fraction are 90%, Obtain coating solution;Pellet obtained by step S4 is placed in air-flow coating device, with above-mentioned coating solution bag barrier gown, art for coating bar Part:Blower frequency 26Hz, whiff pressure 0.2MPa, hydrojet flow velocity 1mL/min, 32 DEG C of stream temperature, coating weight gain 5%, obtains Pill;Above-mentioned pill is loaded into capsule shells, is sterilized, to obtain the final product.
Difference lies in be not modified extract powder in preparation method, and pellet uses conventional drying with embodiment 2.Experiment Example one, mobility and content uniformity experiment
1. fluidity test:
The mixed-powder in mixed-powder, 3 step S4 of comparative example in 1 step S5 of Example 1-3 and comparative example, uses Fixed cone method measure angle of repose.Angle of repose is the method for examining powder fluidity quality, and angle of repose is smaller, and frictional force is smaller, Mobility is better, and the angle of repose of general powder can meet the needs for producing mobility when being less than 40 °.
2. content uniformity is tested
According to《Chinese Pharmacopoeia》In 2015 editions the 3rd 10 capsules of general rule content uniformity detection method to embodiment 1-3 and GANMAO QINGRE JIAONANG made from comparative example 1,3 carries out content uniformity detection.
3. result of the test:Mobility and content uniformity measurement result are shown in Table 1.
1 mobility of table and content uniformity measurement result
Group Embodiment 1 Embodiment 2 Embodiment 3 Comparative example 1 Comparative example 3
Angle of repose 25.7° 25.2° 26.3° 31.2° 34.5°
Content uniformity limit ± 5.2% ± 5.0% ± 5.5% ± 6.5% ± 7.5%
As shown in Table 1, GANMAO QINGRE JIAONANG content uniformity of the present invention meets regulation, and in its preparation mixed-powder flowing Property is preferable.Compared with comparative example 1,3, the present invention improves the mobility of mixed-powder by being modified to chitosan and extract powder, And then the quality of capsule is improved, reduce content uniformity, and the best results embodiment of embodiment 2.
Test example two, wettability test
(1) sodium chloride supersaturated solution is placed in glass desicator, room temperature is placed, and its interior humidity balance is formed not With the environment of relative humidity, the relative humidity of drier is 75% at this time;
(2) by pill drying made from embodiment 1-3 and comparative example 1-2 to constant weight, take and dry to the pill of constant weight 1.0g is placed in the flat measuring cup of constant weight, precise weighing, opens weigh the cap, is put into the drier that above-mentioned relative humidity is 75% In, weighed after 48h, calculate hydroscopicity, calculation formula is:
Weight × 100% before hydroscopicity %=(weight before weight-moisture absorption after moisture absorption)/moisture absorption,
Hygroscopicity the results are shown in Table 2.
2 hygroscopicity result of table
Group Embodiment 1 Embodiment 2 Embodiment 3 Comparative example 1 Comparative example 2
Hydroscopicity/% 15.12 14.56 15.78 20.21 22.32
As shown in Table 2, the pill hygroscopicity that prepared by the present invention is low, and hydroscopicity is 14.56-15.78%.With comparative example 1 Compare, the hydroscopicity of pill reduces 28% made from the embodiment of the present invention 2, illustrates the addition of chitosan-g- lactose of the present invention Effectively reduce the wettability power of pill;Compared with comparative example 2, the hydroscopicity of pill made from the embodiment of the present invention 2 reduces 35%, illustrate that the present invention can also alleviate its wettability power using packaging technique to pill coating.
Test example three, stability test
1. test material:GANMAO QINGRE JIAONANG made from embodiment 1-3 and comparative example 1-3.
2. test method:
By this product under the conditions of commercially available back, 25 ± 2 DEG C of temperature is put, 36 are placed under conditions of relative humidity 60 ± 10% Month, respectively at 0 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, respectively sample once within 36 months, according to sense Antipyretic capsule quality standard is emitted, detects its character, discriminating, moisture, disintegration time limited, content uniformity, extract, content, microorganism The projects such as limit test.
3. result of the test:Stability test the results are shown in Table 3.
3 stability test result of table
As shown in Table 3, the GANMAO QINGRE JIAONANG that prepared by present invention stability in long-term storage is preferable.With comparative example 1-3 Compare, GANMAO QINGRE JIAONANG stability is preferable made from the embodiment of the present invention 2, illustrates that GANMAO QINGRE JIAONANG produced by the present invention is inhaled It is moist small, it is unlikely to deteriorate in long-term place, property is stablized.
Test example four, clinical effect trial
1. test material:GANMAO QINGRE JIAONANG prepared by embodiment 1-3 and comparative example 1.
2. subjects:
220 people of anemofrigid cold patient, age 18-60 Sui, symptom:Have a headache and fever, aversion to cold bodily pain, thin nasal discharge, cough pharynx Dry, nauseous apocleisis etc..
3. test method:
Patient after meal, take orally, one time 3,2 times a day, the course for the treatment of be 3 days.
Efficacy assessment standard:
Cure:Clinical symptoms disappear, and have a headache and fever, aversion to cold bodily pain, thin nasal discharge, cough dry throat, nauseous apocleisis disappear.
It is effective:Clinical symptoms disappear substantially, have a headache and fever, thin nasal discharge, cough dry throat it is normal, aversion to cold bodily pain, dislike Heart apocleisis is significantly improved.
Effectively:Clinical symptoms improve, and have a headache and fever, thin nasal discharge, cough dry throat symptom improve, and aversion to cold bodily pain, nausea are detested The symptoms such as food have a degree of improvement.
It is invalid:Clinical symptoms without improvement, have a headache and fever, aversion to cold bodily pain, thin nasal discharge, cough dry throat, nauseous anorexia Without improvement.
4. result of the test:Clinical efficacy the results are shown in Table 4.
4 clinical efficacy result of table
Group Number of cases/people Recovery from illness/people Effective/people Effectively/people Invalid/people Total effective rate/%
Embodiment 1 55 16 31 6 2 96.4
Embodiment 2 55 18 33 3 1 98.2
Embodiment 3 55 15 30 8 2 96.4
Comparative example 1 55 10 9 83.6
As shown in Table 4, GANMAO QINGRE JIAONANG clinical efficacy produced by the present invention is preferable, and bioavilability is high, can be effective Alleviate and have a headache and fever caused by anemofrigid cold, aversion to cold bodily pain, thin nasal discharge, the symptom such as cough dry throat, nauseous apocleisis.
In conclusion GANMAO QINGRE JIAONANG hygroscopicity produced by the present invention is low, stability is good, and bioavilability is high, easily collapses The advantages of solution, clinical efficacy is good, and medicine powder mobility is high in preparation process, the uniform quality of capsule.In addition, the present invention is implemented GANMAO QINGRE JIAONANG indices prepared by example 2 are superior to embodiment 1,3, are preferred embodiment.

Claims (7)

1. a kind of GANMAO QINGRE JIAONANG, it is characterised in that the capsule is made of pellet, coatings and capsule shells;The pellet Including following components and its parts by weight:
40-60 parts of ching-chieh, 10-20 parts of peppermint, 20-30 parts windproof, 10-20 parts of perilla leaf, 20-30 parts of pueraria lobata, campanulaceae 10-20 Part, 10-20 parts of the root of Dahurain angelica, 40-60 parts of corydlis bungeana, 30-50 parts of reed root, 20-30 parts of radix bupleuri, 15-25 parts of semen armeniacae amarae, modification of chitosan 1-3 parts, 1-5 parts of beta-cyclodextrin, 0.5-1.5 parts of starch, 1-3 parts of hydroxypropyl cellulose, 85-95 parts of water and ethanol solution 5-15 Part;
The coatings are made of following components and its parts by weight:
50-60 parts of 10-15 parts of hydroxypropyl methylcellulose, 1-3 parts of three triacetin vinegar, 1-5 parts of magnesium stearate and ethanol solution.
2. GANMAO QINGRE JIAONANG as claimed in claim 1, it is characterised in that the pellet is by following components and its parts by weight Composition:
50 parts of ching-chieh, 15 parts of peppermint, 25 parts windproof, 15 parts of perilla leaf, 25 parts of pueraria lobata, 15 parts of campanulaceae, 15 parts of the root of Dahurain angelica, corydlis bungeana 50 parts, 40 parts of reed root, 25 parts of radix bupleuri, 20 parts of semen armeniacae amarae, 2 parts of modification of chitosan, 3 parts of beta-cyclodextrin, 1 part of starch, hydroxypropyl it is fine 10 parts of 2 parts of dimension element, 90 parts of water and 95% ethanol;
The coatings are made of following components and its parts by weight:
55 parts of 12.5 parts of hydroxypropyl methylcellulose, 2 parts of three triacetin vinegar, 3 parts of magnesium stearate and ethanol solution.
3. GANMAO QINGRE JIAONANG as claimed in claim 1 or 2, it is characterised in that the modification of chitosan is chitosan-g- breasts Sugar.
4. GANMAO QINGRE JIAONANG as claimed in claim 3, it is characterised in that the preparation method of the chitosan-g- lactose is:
(1) by chitosan and lactose by weight 1:3 are uniformly mixed, and obtain mixture;
(2) by acetic acid aqueous solution that methanol and volume fraction are 0.3% by volume 1:3 mixing, obtain solvent;
(3) solvent obtained by step (2) is added into mixture obtained by step (1), stirring adds sodium cyanoborohydride, and room temperature is anti- Answer 24h, the solution after reaction is diluted with deionized water, then is dialysed with triple distillation water, is freezed, to obtain the final product.
5. GANMAO QINGRE JIAONANG as claimed in claim 1 or 2, it is characterised in that the ethanol solution is that volume fraction is 85- 95% ethanol solution.
6. the preparation method of the GANMAO QINGRE JIAONANG as described in claim 1-5 is any, it is characterised in that comprise the following steps:
S1 takes ching-chieh, peppermint and perilla leaf, crushes, obtains medicinal material A;The water of its 6-8 times of weight, water are added into above-mentioned medicinal material A Steam distillation method extracts volatile oil, and extraction time 5-6h, collects volatile oil, solution is filtered, obtains liquor B and filter residue;
Step S1 gained volatile oil beta-cyclodextrin inclusion compounds, inclusion temperature 60 C are included time 1-2h, refrigerated by S2, and suction filtration is dry Dry, ground 100 mesh sieve, obtains inclusion powder;
S3 crushes windproof, pueraria lobata, campanulaceae, the root of Dahurain angelica, corydlis bungeana, reed root, radix bupleuri and semen armeniacae amarae, and is mixed with step S1 gained filter residues Close uniformly, obtain medicinal material C;The water that its 7-9 times of weight is successively added into above-mentioned medicinal material C decocts twice, and each 1-2h, merges and decoct Boil, filter, obtain filtrate D;Above-mentioned filtrate D is merged with liquor B obtained by step S1, concentrates, is spray-dried, crush, cross 80 mesh sieves, Obtain extract powder;
S4 is by extract powder obtained by step S3 with nano silicon dioxide by weight 99:1 mixing, with rotating speed 26r/min mixing 5min, Again with pelletizing machine modification 10 times is smashed, modified extract powder is obtained;
Starch, water and ethanol solution are uniformly mixed by S5, obtain binder;Inclusion powder, step S3 gained obtained by step S2 are changed Property extract powder, modification of chitosan and hydroxypropyl cellulose be uniformly mixed, obtain mixed-powder, with above-mentioned binder softwood, use 45r/min, sieve sky is extruded into 1.0mm, round as a ball using 12000r/min, is placed on drying in fluid bed, is crossed 40 mesh, obtain micro- Ball;
S6 mixes hydroxypropyl methylcellulose, three triacetin vinegar, magnesium stearate and ethanol solution, obtains coating solution;By step S5 institutes Obtain pellet to be placed in air-flow coating device, with above-mentioned coating solution bag barrier gown, art for coating condition:Blower frequency 26Hz, spray Atmospheric pressure 0.2MPa, hydrojet flow velocity 1mL/min, 32 DEG C of stream temperature, coating weight gain 4-6%, obtains pill;Above-mentioned pill is loaded Capsule shells, sterilizing, to obtain the final product.
7. the preparation method of GANMAO QINGRE JIAONANG as claimed in claim 6, it is characterised in that fluid bed work in the step S5 Skill condition is:Air quantity 70-90m3/ h, 40-50 DEG C of temperature, time 40-60min.
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