CN104435231A - Method for preparing medicine preparation named Fangfengtongsheng - Google Patents

Method for preparing medicine preparation named Fangfengtongsheng Download PDF

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Publication number
CN104435231A
CN104435231A CN201410615232.8A CN201410615232A CN104435231A CN 104435231 A CN104435231 A CN 104435231A CN 201410615232 A CN201410615232 A CN 201410615232A CN 104435231 A CN104435231 A CN 104435231A
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Prior art keywords
radix
parts
add
holy
decoct
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Inventor
曲宏伟
迟江波
王继鹏
姜仁禹
车晓青
于文潇
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YANTAI TIANZHENG PHARMACEUTICAL CO Ltd
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YANTAI TIANZHENG 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)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/238Saposhnikovia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/04Sulfur, selenium or tellurium; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/12Magnesium silicate
    • 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
    • A61K36/17Gnetophyta, e.g. Ephedraceae (Mormon-tea family)
    • 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
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    • 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
    • A61K36/236Ligusticum (licorice-root)
    • 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)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/284Atractylodes
    • 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)
    • A61K36/34Campanulaceae (Bellflower family)
    • 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)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
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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
    • A61K36/534Mentha (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
    • A61K36/538Schizonepeta
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/539Scutellaria (skullcap)
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/63Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
    • A61K36/634Forsythia
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/65Paeoniaceae (Peony family), e.g. Chinese peony
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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)
    • A61K36/70Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/708Rheum (rhubarb)
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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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)
    • A61K36/74Rubiaceae (Madder family)
    • A61K36/744Gardenia
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

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Abstract

The invention discloses a method for preparing a medicine preparation named Fangfengtongsheng and belongs to the field of pharmacy. According to the preparation process, volatile oil active ingredients contained in a medicine can be coated before being prepared, so that the problem that volatile oil volatilizes and lose effect cannot be easily caused in the process of storing the preparation, and the quality stabilization and clinical curative effect of medicines can be guaranteed.

Description

A kind of Radix Saposhnikoviae leads to the preparation method of holy pharmaceutical preparation
Technical field
The present invention relates to pharmaceutical field, be specifically related to the preparation method that a kind of Radix Saposhnikoviae leads to holy pharmaceutical preparation.
Background technology
Radix Saposhnikoviae is led to sage and comes from " Xuanming Lun Fang, Clear Synopsis on Recipes ", is one of representative side that Jin Dynasty well-known doctor Liu Wansu is famous, has internal cleaning By inducing sweat, effect of heat-clearing and toxic substances removing.For exogenous cold interior-heat, excess in both the exterior and interior, aversion to cold high fever, headache dry pharynx, oliguria with reddish urine, constipation, scrofula is from the beginning of, rubella eczema.Because FANGFENG TOGSHENG SAN therapeutic effect is remarkable, over the party came out for more than 800 years, by later age, doctor widely applies.Qing Dynasty doctor Wang Tai woods is commented on this side and says: " antiperspirant does not hinder table, under do not hinder in, name is said logical holy, and what its use was sayed in pole imitates ear." among the peoplely also there is the proverb of " ill do not have disease, Radix Saposhnikoviae is logical holy ".
The listing kind of current State Food and Drug Administration approval has fangfeng tongsheng pill and Radix Saposhnikoviae to lead to holy granule two kinds of dosage forms; record respectively in existing version " Chinese Pharmacopoeia " (one) (719-720 page) and supplement version (29-31 page); wherein Radix Saposhnikoviae leads to holy granule is the herbal species that Yantai Tianzheng Pharmaceutical Co., Ltd. is producing, and declares Kind protection system for CM.Because the volatile oil in former granule directly sprays in semi-finished granules without inclusion before finished product packing, preparation easily causes the loss of volatile oil in process depositing, affect quality and the clinical efficacy of medicine, and dose is larger.For overcoming above-mentioned disadvantage, improving volatile oil stability in the formulation, reducing clinical taking dose, make to take and carry convenient, and meet the demand of market to capsule further, therefore holy granule is led to the Radix Saposhnikoviae that my enterprise produces carried out new technical study.
" Chinese Pharmacopoeia " first describes fangfeng tongsheng pill [prescription] Radix Saposhnikoviae 50g, Herba Schizonepetae 25g, Herba Menthae 50g, Herba Ephedrae 50g, Radix Et Rhizoma Rhei 50g, Natrii Sulfas 50g, Fructus Gardeniae 25g, Talcum 300g, Radix Platycodonis 100g, Gypsum Fibrosum 100g, Rhizoma Chuanxiong 50g, Radix Angelicae Sinensis 50g, Radix Paeoniae Alba 50g, Radix Scutellariae 100g, Fructus Forsythiae 50g, Radix Glycyrrhizae 200g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 25g.[process of preparing Chinese medicine] upper 17 tastes, except Natrii Sulfas, Talcum, ten ground spices such as all the other Radix Saposhnikoviaes are broken into fine powder, sieve, mixing.Natrii Sulfas is dissolved in water, and filters; Pulvis Talci is broken into impalpable powder.Get above-mentioned powder, with the general ball of Natrii Sulfas filtrate, dry, use Pulvis Talci coating, polishing, dry, to obtain final product.[function cures mainly] internal cleaning By inducing sweat, heat-clearing and toxic substances removing.For exogenous cold interior-heat, excess in both the exterior and interior, aversion to cold high fever, headache dry pharynx, oliguria with reddish urine, constipation, scrofula is from the beginning of, rubella eczema.[usage and dosage] is oral, a 6g, 2 times on the one.
Summary of the invention
The present invention aims to provide the preparation method that a kind of Radix Saposhnikoviae leads to holy pharmaceutical preparation, by improving traditional handicraft, reaches the object improved product quality stability.
In order to achieve the above object, the present invention is by the following technical solutions:
Radix Saposhnikoviae leads to a preparation method for holy pharmaceutical preparation, and the raw medicinal material weight proportion that described Radix Saposhnikoviae leads to holy pharmaceutical preparation is: Radix Saposhnikoviae 75.5 parts, Herba Schizonepetae 37.8 parts, Herba Menthae 75.5 parts, 75.5 parts, Herba Ephedrae, Radix Et Rhizoma Rhei 75.5 parts, 75.5 parts, Natrii Sulfas, Fructus Gardeniae 37.8 parts, 453 parts, Talcum, Radix Platycodonis 151 parts, 151 parts, Gypsum Fibrosum, Rhizoma Chuanxiong 75.5 parts, Radix Angelicae Sinensis 75.5 parts, the Radix Paeoniae Alba 75.5 parts, Radix Scutellariae 151 parts, Fructus Forsythiae 75.5 parts, 302 parts, Radix Glycyrrhizae, Rhizoma Atractylodis Macrocephalae (parched) 37.8 parts; It is characterized in that, prepare according to following steps:
1. take the Radix Saposhnikoviae of described weight portion, Herba Schizonepetae, Herba Menthae, Herba Ephedrae, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Forsythiae, the Rhizoma Atractylodis Macrocephalae, add 6 ~ 10 times amount water distillation and extraction volatile oil 4 ~ 8 hours, fractionate aqueous solutions and volatile oil; By gained volatile oil beta cyclodextrin inclusion, evenly spread in the hydroxypropyl emthylcellulose aqueous solution of 0.5% ~ 5%, obtain intermediate product A, for subsequent use;
2. by step 1. gained medicinal residues add 4 ~ 8 times of water gagings again, decoct 1 ~ 2 hour, filter, gained filtrate and step 1. separating obtained aqueous solution merge, and obtain intermediate product B, for subsequent use;
3. the Radix Et Rhizoma Rhei of described weight portion, Fructus Gardeniae, Radix Platycodonis, the Radix Paeoniae Alba, Radix Glycyrrhizae is taken, add 6 ~ 10 times of water gagings, decoct 1 ~ 3 hour, filter, medicinal residues add 4 ~ 8 times of water gagings again, decoct 1 ~ 3 hour, filter, merging filtrate and intermediate product B, when being evaporated to 60 DEG C, relative density is 1.04 ~ 1.08 g/mL, under abundant stirring condition, slowly adds 2 times amount 95% ethanol and makes it produce precipitation, stir, 0 ~ 4 DEG C leaves standstill 48 hours, filters, gained filtrate recycling ethanol, and relative density is the thick paste A of 1.20 ~ 1.25 g/mL when being evaporated to 60 DEG C, for subsequent use;
4. take the Natrii Sulfas of described weight portion, add 100 weight parts waters and dissolve to obtain Natrii Sulfas aqueous solution, for subsequent use; Take the Gypsum Fibrosum of described weight portion, Talcum, add 6 ~ 10 times of water gagings, Radix Scutellariae is added after boiling, decoct 1 ~ 3 hour again, filter, gained medicinal residues add 5 ~ 7 times of water gagings again, decoct 1 ~ 3 hour, filter, merge twice filtrate, when being evaporated to 60 DEG C, relative density is the thick paste B of 1.20 ~ 1.25 g/mL, with step 3. gained thick paste A merge, then add described Natrii Sulfas aqueous solution and 30 weight portion dextrin, stir evenly, when adding water move to 60 DEG C, relative density is 1.18 ~ 1.20 g/mL, obtains intermediate product C, for subsequent use;
5. get ball core 100 weight portion, put in micropill machine, spray into intermediate product A and intermediate product C successively, make micropill, coating, 10 ~ 30 mesh sieves select the micropill of 0.55 ~ 2.0mm, then make finished dosage form, obtain described Radix Saposhnikoviae and lead to holy pharmaceutical preparation.
By step 5. gained micropill load in No. 1 transparent hard capsule by every 0.42g, obtain Radix Saposhnikoviae and lead to holy capsule.
Step 1. in, still-process adds 8 times of water gagings, distillating extracting oil 6 hours, fractionate aqueous solutions and volatile oil; By gained volatile oil beta cyclodextrin inclusion, evenly spread in the hydroxypropyl emthylcellulose aqueous solution of 1.5%, obtain intermediate product A.
Step 2. in, by step 1. gained medicinal residues add 6 times of water gagings, decoct 1 hour.
Step 3. in, take the Radix Et Rhizoma Rhei of described weight portion, Fructus Gardeniae, Radix Platycodonis, the Radix Paeoniae Alba, Radix Glycyrrhizae, add 8 times of water gagings, decoct 2 hours, filter, gained medicinal residues add 6 times of water gagings again, decoct 2 hours, filtration, merging filtrate and intermediate product B.
Step 4. in, take the Gypsum Fibrosum of described weight portion, Talcum, add 8 times of water gagings, decoct 2 hours, filter, gained medicinal residues add 6 times of water gagings, decoct 2 hours, filtration.
Beneficial effect of the present invention:
Advanced coating before the volatile oil preparation of active ingredient that medicine contains by preparation technology of the present invention, such gained preparation is just not easy to produce volatile oils and the problem that lost efficacy depositing in process, and then has ensured steady quality and the clinical efficacy of medicine.
Detailed description of the invention
In order to understand better and implement the present invention, further illustrate the present invention below in conjunction with specific embodiment.
Specific embodiment 1
Radix Saposhnikoviae leads to a preparation method for holy pharmaceutical preparation, and the raw medicinal material weight proportion that described Radix Saposhnikoviae leads to holy pharmaceutical preparation is: Radix Saposhnikoviae 75.5 parts, Herba Schizonepetae 37.8 parts, Herba Menthae 75.5 parts, 75.5 parts, Herba Ephedrae, Radix Et Rhizoma Rhei 75.5 parts, 75.5 parts, Natrii Sulfas, Fructus Gardeniae 37.8 parts, 453 parts, Talcum, Radix Platycodonis 151 parts, 151 parts, Gypsum Fibrosum, Rhizoma Chuanxiong 75.5 parts, Radix Angelicae Sinensis 75.5 parts, the Radix Paeoniae Alba 75.5 parts, Radix Scutellariae 151 parts, Fructus Forsythiae 75.5 parts, 302 parts, Radix Glycyrrhizae, Rhizoma Atractylodis Macrocephalae (parched) 37.8 parts; Prepare according to following steps:
1. take the Radix Saposhnikoviae of described weight portion, Herba Schizonepetae, Herba Menthae, Herba Ephedrae, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Forsythiae, the Rhizoma Atractylodis Macrocephalae, add 8 times amount water distillation and extraction volatile oil 6 hours, fractionate aqueous solutions and volatile oil; By gained volatile oil beta cyclodextrin inclusion, evenly spread in the hydroxypropyl emthylcellulose aqueous solution of 1.5%, obtain intermediate product A, for subsequent use;
2. by step 1. gained medicinal residues add 6 times of water gagings again, decoct 1 hour, filter, gained filtrate and step 1. separating obtained aqueous solution merge, and obtain intermediate product B, for subsequent use;
3. the Radix Et Rhizoma Rhei of described weight portion, Fructus Gardeniae, Radix Platycodonis, the Radix Paeoniae Alba, Radix Glycyrrhizae is taken, add 6 ~ 10 times of water gagings, decoct 1 ~ 3 hour, filter, medicinal residues add 4 ~ 8 times of water gagings again, decoct 1 ~ 3 hour, filter, merging filtrate and intermediate product B, when being evaporated to 60 DEG C, relative density is 1.04 ~ 1.08 g/mL, under abundant stirring condition, slowly adds 2 times amount 95% ethanol and makes it produce precipitation, stir, 0 ~ 4 DEG C leaves standstill 48 hours, filters, gained filtrate recycling ethanol, and relative density is the thick paste A of 1.20 ~ 1.25 g/mL when being evaporated to 60 DEG C, for subsequent use;
4. take the Natrii Sulfas of described weight portion, add 100 weight parts waters and dissolve to obtain Natrii Sulfas aqueous solution, for subsequent use; Take the Gypsum Fibrosum of described weight portion, Talcum, add 8 times of water gagings, after boiling, add Radix Scutellariae, decoct 2 hours again, filter, gained medicinal residues add 6 times of water gagings again, decoct 2 hours, filter, merge twice filtrate, when being evaporated to 60 DEG C, relative density is the thick paste B of 1.20 ~ 1.25 g/mL, with step 3. gained thick paste A merge, then add described Natrii Sulfas aqueous solution and 30 weight portion dextrin, stir evenly, when adding water move to 60 DEG C, relative density is 1.18 ~ 1.20 g/mL, obtains intermediate product C, for subsequent use;
5. get ball core 100 weight portion, put in micropill machine, spray into intermediate product A and intermediate product C successively, make micropill, coating, 20 mesh sieves select the micropill of 0.55 ~ 2.0mm, then make finished dosage form, obtain described Radix Saposhnikoviae and lead to holy pharmaceutical preparation.
By step 5. gained micropill load in No. 1 transparent hard capsule by every 0.42g, obtain Radix Saposhnikoviae and lead to holy capsule.
Specific embodiment 2
Radix Saposhnikoviae leads to a preparation method for holy pharmaceutical preparation, and the raw medicinal material weight proportion that described Radix Saposhnikoviae leads to holy pharmaceutical preparation is: Radix Saposhnikoviae 75.5 parts, Herba Schizonepetae 37.8 parts, Herba Menthae 75.5 parts, 75.5 parts, Herba Ephedrae, Radix Et Rhizoma Rhei 75.5 parts, 75.5 parts, Natrii Sulfas, Fructus Gardeniae 37.8 parts, 453 parts, Talcum, Radix Platycodonis 151 parts, 151 parts, Gypsum Fibrosum, Rhizoma Chuanxiong 75.5 parts, Radix Angelicae Sinensis 75.5 parts, the Radix Paeoniae Alba 75.5 parts, Radix Scutellariae 151 parts, Fructus Forsythiae 75.5 parts, 302 parts, Radix Glycyrrhizae, Rhizoma Atractylodis Macrocephalae (parched) 37.8 parts; Prepare according to following steps:
1. take the Radix Saposhnikoviae of described weight portion, Herba Schizonepetae, Herba Menthae, Herba Ephedrae, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Forsythiae, the Rhizoma Atractylodis Macrocephalae, add 6 times amount water distillation and extraction volatile oil 8 hours, fractionate aqueous solutions and volatile oil; By gained volatile oil beta cyclodextrin inclusion, evenly spread in the hydroxypropyl emthylcellulose aqueous solution of 0.5%, obtain intermediate product A, for subsequent use;
2. by step 1. gained medicinal residues add 8 times of water gagings again, decoct 1 hour, filter, gained filtrate and step 1. separating obtained aqueous solution merge, and obtain intermediate product B, for subsequent use;
3. the Radix Et Rhizoma Rhei of described weight portion, Fructus Gardeniae, Radix Platycodonis, the Radix Paeoniae Alba, Radix Glycyrrhizae is taken, add 6 times of water gagings, decoct 3 hours, filter, medicinal residues add 4 times of water gagings again, decoct 3 hours, filter, merging filtrate and intermediate product B, when being evaporated to 60 DEG C, relative density is 1.04 ~ 1.08 g/mL, under abundant stirring condition, slowly adds 2 times amount 95% ethanol and makes it produce precipitation, stir, 0 ~ 4 DEG C leaves standstill 48 hours, filters, gained filtrate recycling ethanol, and relative density is the thick paste A of 1.20 ~ 1.25 g/mL when being evaporated to 60 DEG C, for subsequent use;
4. take the Natrii Sulfas of described weight portion, add 100 weight parts waters and dissolve to obtain Natrii Sulfas aqueous solution, for subsequent use; Take the Gypsum Fibrosum of described weight portion, Talcum, add 6 times of water gagings, after boiling, add Radix Scutellariae, decoct 3 hours again, filter, gained medicinal residues add 5 times of water gagings again, decoct 3 hours, filter, merge twice filtrate, when being evaporated to 60 DEG C, relative density is the thick paste B of 1.20 ~ 1.25 g/mL, with step 3. gained thick paste A merge, then add described Natrii Sulfas aqueous solution and 30 weight portion dextrin, stir evenly, when adding water move to 60 DEG C, relative density is 1.18 ~ 1.20 g/mL, obtains intermediate product C, for subsequent use;
5. get ball core 100 weight portion, put in micropill machine, spray into intermediate product A and intermediate product C successively, make micropill, coating, 10 ~ 30 mesh sieves select the micropill of 0.55 ~ 2.0mm, then make finished dosage form, obtain described Radix Saposhnikoviae and lead to holy pharmaceutical preparation.
By step 5. gained micropill conveniently tablet making technology tabletted, obtain Radix Saposhnikoviae and lead to holy tablet.
Specific embodiment 3
Radix Saposhnikoviae leads to a preparation method for holy pharmaceutical preparation, and the raw medicinal material weight proportion that described Radix Saposhnikoviae leads to holy pharmaceutical preparation is: Radix Saposhnikoviae 75.5 parts, Herba Schizonepetae 37.8 parts, Herba Menthae 75.5 parts, 75.5 parts, Herba Ephedrae, Radix Et Rhizoma Rhei 75.5 parts, 75.5 parts, Natrii Sulfas, Fructus Gardeniae 37.8 parts, 453 parts, Talcum, Radix Platycodonis 151 parts, 151 parts, Gypsum Fibrosum, Rhizoma Chuanxiong 75.5 parts, Radix Angelicae Sinensis 75.5 parts, the Radix Paeoniae Alba 75.5 parts, Radix Scutellariae 151 parts, Fructus Forsythiae 75.5 parts, 302 parts, Radix Glycyrrhizae, Rhizoma Atractylodis Macrocephalae (parched) 37.8 parts; Prepare according to following steps:
1. take the Radix Saposhnikoviae of described weight portion, Herba Schizonepetae, Herba Menthae, Herba Ephedrae, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Forsythiae, the Rhizoma Atractylodis Macrocephalae, add 10 times amount water distillation and extraction volatile oil 4 hours, fractionate aqueous solutions and volatile oil; By gained volatile oil beta cyclodextrin inclusion, evenly spread in the hydroxypropyl emthylcellulose aqueous solution of 5%, obtain intermediate product A, for subsequent use;
2. by step 1. gained medicinal residues add 4 times of water gagings again, decoct 2 hours, filter, gained filtrate and step 1. separating obtained aqueous solution merge, and obtain intermediate product B, for subsequent use;
3. the Radix Et Rhizoma Rhei of described weight portion, Fructus Gardeniae, Radix Platycodonis, the Radix Paeoniae Alba, Radix Glycyrrhizae is taken, add 10 times of water gagings, decoct 1 hour, filter, medicinal residues add 8 times of water gagings again, decoct 1 hour, filter, merging filtrate and intermediate product B, when being evaporated to 60 DEG C, relative density is 1.04 ~ 1.08 g/mL, under abundant stirring condition, slowly adds 2 times amount 95% ethanol and makes it produce precipitation, stir, 0 ~ 4 DEG C leaves standstill 48 hours, filters, gained filtrate recycling ethanol, and relative density is the thick paste A of 1.20 ~ 1.25 g/mL when being evaporated to 60 DEG C, for subsequent use;
4. take the Natrii Sulfas of described weight portion, add 100 weight parts waters and dissolve to obtain Natrii Sulfas aqueous solution, for subsequent use; Take the Gypsum Fibrosum of described weight portion, Talcum, add 10 times of water gagings, after boiling, add Radix Scutellariae, decoct 1 hour again, filter, gained medicinal residues add 7 times of water gagings again, decoct 1 hour, filter, merge twice filtrate, when being evaporated to 60 DEG C, relative density is the thick paste B of 1.20 ~ 1.25 g/mL, with step 3. gained thick paste A merge, then add described Natrii Sulfas aqueous solution and 30 weight portion dextrin, stir evenly, when adding water move to 60 DEG C, relative density is 1.18 ~ 1.20 g/mL, obtains intermediate product C, for subsequent use;
5. get ball core 100 weight portion, put in micropill machine, spray into intermediate product A and intermediate product C successively, make micropill, coating, 10 ~ 30 mesh sieves select the micropill of 0.55 ~ 2.0mm, then make finished dosage form, obtain described Radix Saposhnikoviae and lead to holy pharmaceutical preparation.
By step 5. gained micropill load in No. 1 transparent hard capsule by every 0.42g, obtain Radix Saposhnikoviae and lead to holy capsule.
test example 1: the content balance analysis of ephedrine hydrochloride and baicalin in medicine.
ephedrine measures according to high performance liquid chromatography (" Chinese Pharmacopoeia " version in 2010 annex VI D)
Chromatographic condition and system suitability: be filler with octadecylsilane chemically bonded silica; Acetonitrile-0.1% phosphoric acid (5:95) is mobile phase; Determined wavelength is 207nm.Number of theoretical plate should be not less than 3000 by ephedrine hydrochloride.
The preparation of reference substance solution: get ephedrine hydrochloride reference substance appropriate, accurately weighed, add methanol and make the solution of every 1ml containing 10 μ g, product solution in contrast.
The preparation of need testing solution: it is appropriate that the Radix Saposhnikoviae of getting under content uniformity item leads to holy capsule 's content, and porphyrize, gets about 3g, accurately weighed, put in tool plug conical flask, precision adds 50% methanol 50ml, weighed weight, supersound process (power 150w, frequency 50kHz) 45 minutes, lets cool, weighed weight again, supply the weight of less loss with 50% methanol, shake up, centrifugal.Precision measures supernatant 10ml, puts on neutral alumina column (100 ~ 200 orders, 3g, internal diameter 1.5cm), uses 50% methanol-eluted fractions, collects eluent and is about 24ml, put in 25ml volumetric flask, with 50% methanol dilution to scale, shake up, as need testing solution.
Measure: accurate absorption reference substance solution and each 10 μ l of need testing solution respectively, inject high performance liquid chromatograph, measure, to obtain final product.
Lead to holy capsule as a control group with the Radix Saposhnikoviae that existing standard is obtained according to the method described above, lead to holy capsule as experimental group using the present invention according to the Radix Saposhnikoviae that embodiment 1 is obtained, measure respectively.
baicalin measures according to high performance liquid chromatography (" Chinese Pharmacopoeia " version in 2010 annex VI D)
Chromatographic condition and system suitability: be filler with octadecylsilane chemically bonded silica; Methanol-0.4% phosphoric acid (47:53) is mobile phase; Determined wavelength is 280nm.Number of theoretical plate should be not less than 2500 by ephedrine hydrochloride.
The preparation of reference substance solution gets baicalin reference substance in right amount, accurately weighed, adds methanol and makes every 1ml containing 40 μ g solution, in contrast product solution.
The preparation of need testing solution: it is appropriate that the Radix Saposhnikoviae of getting under content uniformity item leads to holy capsule 's content, and porphyrize, gets about 0.2g, accurately weighed, put in tool plug conical flask, precision adds 70% ethanol 50ml, weighed weight, reflux, extract, 3 hours, lets cool, more weighed weight, the weight of less loss is supplied with 70% ethanol, shake up, filter, get subsequent filtrate as need testing solution.
Algoscopy: accurate absorption reference substance solution and each 10 μ l of need testing solution respectively, injection liquid chromatography, measures, to obtain final product.Ephedrine hydrochloride and baicalin measurement result are in table 1.
Lead to holy capsule as a control group with the Radix Saposhnikoviae that existing standard is obtained according to the method described above, lead to holy capsule as experimental group using the present invention according to the Radix Saposhnikoviae that embodiment 1 is obtained, measure respectively.
The content balance of ephedrine hydrochloride and baicalin in table 1 medicine
Ephedrine hydrochloride (mg/g) Baicalin (mg/g)
Matched group 0.435 9.916
Experimental group 0.517 11.214
test example 2: Radix Saposhnikoviae leads to the test of holy capsule for treating acute urticaria clinical observation on the therapeutic effect
one, case selection
Accept patient 144 example altogether for medical treatment, man 76 example, female 68 example, at 18 ~ 65 years old age, 45 years old mean age, is out-patient; Be divided into test group and matched group at random, often group is 72 examples.
two, experimenter selection and exit
(1) acute urticaria Western medicine diagnose standard(formulate with reference to red legend unit " urticaria " (calendar year 2001, Southeast China University published) and " new Chinese medicine guideline of clinical investigations " (version in 1997).)
Skin plays welt suddenly, different, and every day shows effect, and occurs in batch, dermexanthesis and disappear rapidly.Violent pruritus.The course of disease continues to be less than 6 weeks.
(2) exterior cold and interior heat, excess in both the exterior and interior card Standards of Chinese Medical Syndrome Differentiation
Formulate with reference to " new Chinese medicine guideline of clinical investigations " (version in 1997).
Primary symptom: (1) welt color is red, scorching hot; (2) pruritus.
Secondary disease: (1) fever of the body; (2) aversion to cold; (3) constipation; (4) oliguria with reddish urine; (5) have a headache; (6) dry pharynx
Tongue pulse condition: red tongue, yellow fur; Floating and rapid pulse
Above primary symptom is indispensable, secondary disease 3 and above with reference to tongue, pulse condition and diagnosable.
(3) symptom weight grade scale
Skin symptom (doctor trained in Western medicine) grade scale:
1, skin lesion distribution
Normally (0 point): without welt.
Slightly (2 points): welt n≤10.
Moderate (4 points): welt 10 < n≤20.
Severe (6 points): welt n > 20.
2, welt size
Normally (0 point): nothing.
Slightly (2 points): diameter d≤2cm.
Moderate (4 points): diameter 2 < d≤5cm.
Severe (6 points): diameter d > 5cm.
3, pruritus
Normally (0 point): without pruritus.
Slightly (2 points): random thoughts pruritus.
Moderate (4 points): pruritus is done frequently, but does not affect sleep.
Severe (6 points): pruritus is constant, impact sleep.
4, the welt persistent period
Normally (0 point): nothing.
Slightly (2 points): welt persistent period t≤1 hour.
Moderate (4 points): welt persistent period 1 < t≤3 hour.
Severe (6 points): welt persistent period t > 3 hours.
5, seizure frequency
Normally (0 point): nothing.
Slightly (2 points): every day 1 time.
Moderate (4 points): every day 2-3 time.
Severe (6 points): every day >=3 times.
Tcm symptom grade scale:
1, rubella
Normally (0 point): nothing.
Slightly (2 points): rubella color is micro-red.
Moderate (4 points): rubella color is red, slight fever.
Severe (6 points): rubella color is scarlet, scorching hot.
2, pruritus
Normally (0 point): without pruritus.
Slightly (2 points): random thoughts pruritus.
Moderate (4 points): pruritus is done frequently, but does not affect sleep.
Severe (6 points): pruritus is constant, impact sleep.
Secondary disease
1, fever of the body: nothing: 0 point; Have: 1 point
2, aversion to cold: nothing: 0 point; Have: 1 point
3, constipation: nothing: 0 point; Have: 1 point
4, oliguria with reddish urine: nothing: 0 point; Have: 1 point
5, have a headache: nothing: 0 point; Have: 1 point
6, dry pharynx: nothing: 0 point; Have: 1 point
Tongue arteries and veins itemized record, do not score.
three, Therapeutic Method
Test group: capsule prepared by the oral embodiment of the present invention 1 technique, 4 tablets/time, 2 times/day, oral;
Matched group: Radix Saposhnikoviae leads to holy granule, 3g/ time, 2 times/day, oral;
The course for the treatment of: 2 weeks.
four, efficacy assessment standard
(1) skin symptom (doctor trained in Western medicine) efficacy determination
Therapeutic index (n)= × 100%
Clinical recovery: transference cure n >=95%
Effective: symptom disappears substantially.70%≤n<95%
Effective: symptom is extenuated.30%≤n<70%
Invalid: symptom is substantially unchanged.n<30%
(2) tcm syndrome total mark criterion of therapeutical effect
Therapeutic index (n)= × 100%
1, clinical recovery: transference cure n >=95%
2, effective: symptom disappears substantially.70%≤n<95%
3, effective: symptom is extenuated.30%≤n<70%
4, invalid: symptom is substantially unchanged.n<30%
(3) traditional Chinese medical science individual event symptom curative effect
Disappear: the transference cure suffered from before treatment, integration is zero.
Improve: the symptom suffered from before treatment alleviates, integration reduces, but non-vanishing.
Invalid: the symptom suffered from before treatment does not alleviate or increases the weight of, and integration does not reduce.
six, therapeutic outcome is in table 2
table 2 acute urticaria Comparison of therapeutic
Group Clinical recovery Effective Effectively Invalid Amount to
Test group 21 32 14 5 72
Matched group 13 23 24 12 72
Test group total number of persons 72 example, wherein clinical recovery 21 example, effective 32 examples, effective 14 examples, invalid 5 examples, total effective rate 93.1%; Matched group 72 example, wherein clinical recovery 13 example, effective 23 examples, effective 24 examples, invalid 12 examples, total effective rate 83.3%; Both compare significant difference.
test example 3: Radix Saposhnikoviae leads to holy capsule for treating upper respiratory tract infection (exterior cold and interior heat, excess in both the exterior and interior is demonstrate,proved) clinical observation on the therapeutic effect test
one, case selection
Accept patient 144 example altogether for medical treatment, man 70 example, female 74 example, at 18 ~ 65 years old age, 41 years old mean age, is out-patient; Be divided into two groups at random, i.e. test group and matched group, often group is 72 examples.
two, experimenter selection and exit
(1) upper respiratory tract infection Western medicine diagnose standard(with reference to " practical internal medicine ", the 12nd edition People's Health Publisher in 2007 publishes)
Upper respiratory tract infection is one group of acute, self-limited disease, and main pathogens is rhinovirus, and other still have parainfluenza virus, adenovirus, echovirus, Coxsackie virus and respiratory syncytial virus etc., and minority is bacteriological infection.Different according to the position according to morbidity, common cold, acute pharynx-larynx-tracheitis, herpangina, bacillary pharynx-tonsillitis can be divided into.
1, clinical manifestation: incubation period is shorter, onset is hurried, often with pharyngeal harsh feeling, drying or pharyngalgia for early symptom, then have sneeze, nasal obstruction, watery nasal discharge etc.If pathological changes develops, involve throat, trachea and bronchus etc. downwards, then can occur hoarseness, cough, the symptoms such as chest pain, body temperature is often no more than 39 DEG C, and after heat on the about 3rd ~ 4 is moved back.In addition, often have the symptoms such as systemic pain, weak, headache, anorexia, abdominal distention, constipation, some patients can occur together herpes simplex
2, physical examination: nasopharynx part or tonsil hyperemia.Herpangina with isthmus faucium portion and near have exanthema vesiculosum, forming ulcer after ulceration is feature.
3, lab testing: routine blood test total white blood cells and neutrophilic granulocyte raise and belong to bacteriological infection more, if normal or on the low side, the probability of viral infection is large.Antibacterial culturing or virus purification, or virus serology inspection, immunofluorescence, elisa, hemagglutination inhibition test etc. can determine etiological diagnosis.
(2) exterior cold and interior heat, excess in both the exterior and interior card Chinese medical discrimination
(with reference to " new Chinese medicine guideline of clinical investigations " (version in 2002) and " Constitution Theory in TCM ")
(1) primary symptom: heating, aversion to cold, constipation.
(2) secondary disease: headache, lossless, nasal obstruction, cough is coughed up phlegm, pharyngalgia, dry pharynx, and hoarseness is thirsty, oliguria with reddish urine.
(3) tongue pulse condition: red tongue, yellow fur, floating and rapid pulse
Possess primary symptom 2 simultaneously, secondary disease 1 and more than, just can diagnose with reference to tongue, arteries and veins.
(3) symptom weight grade scale
1, generate heat
Nothing: remember 0 point.
Light: axillaty temperature 37.1 DEG C ~ 37.9 DEG C.Remember 2 points.
In: axillaty temperature 38 DEG C ~ 38.5 DEG C.Remember 4 points.
Heavy: axillaty temperature more than 38.5 DEG C.Remember 6 points.
2, aversion to cold
Nothing: remember 0 point.
Light: micro evil wind.Remember 2 points.
In: aversion to cold, need add thin clothing.Remember 4 points.
Heavy: aversion to cold, need increase thick clothing or add a cover bedding.Remember 6 points.
3, constipation
Nothing: remember 0 point.
Light: stool is lifted one's head hard, 2-3 day a line.Remember 2 points.
In: be hard and dry, 4-5 day a line.Remember 4 points.
Heavy: constipation due to dry stool is difficult to resolve, and 6 with lastrow.Remember 6 points.
4, have a headache
Disappear after nothing or treatment: remember 0 point.
Have: remember 1 point.
5, lossless
Disappear after nothing or treatment: remember 0 point.
Have: remember 1 point.
6, have a stuffy nose
Disappear after nothing or treatment: remember 0 point.
Have: remember 1 point.
7, cough is coughed up phlegm
Disappear after nothing or treatment: remember 0 point.
Have: remember 1 point.
8, pharyngalgia
Disappear after nothing or treatment: remember 0 point.
Have: remember 1 point.
9, dry pharynx
Disappear after nothing or treatment: remember 0 point.
Have: remember 1 point.
10, hoarseness
Disappear after nothing or treatment: remember 0 point.
Have: remember 1 point.
11, thirsty
Disappear after nothing or treatment.Remember 0 point.
Have.Remember 1 point.
12, oliguria with reddish urine
Disappear after nothing or treatment.Remember 0 point.
Have.Remember 1 point.
Tongue arteries and veins itemized record, do not score.
three, Therapeutic Method
Test group: capsule prepared by the oral embodiment of the present invention 1 technique, 4 tablets/time, 2 times/day, oral;
Matched group: Radix Saposhnikoviae leads to holy granule, 3g/ time, 2 times/day, oral;
The course for the treatment of: 2 weeks.
four, curative effect determinate standard
Therapeutic index (n)= × 100%
Clinical recovery: clinical symptoms, sign disappear or substantially disappear, syndrome integral reduces >=95%.
Effective: clinical symptoms, sign are obviously improved, syndrome integral reduces >=70% but less than 95%.
Effective: clinical symptoms, sign all take a favorable turn, syndrome integral reduces >=30% but less than 70%.
Invalid: clinical symptoms, sign are not improved, even increase the weight of, syndrome integral reduces less than 30%.
six, therapeutic outcome is in table 3
table 3 upper respiratory tract infection Comparison of therapeutic
Group Clinical recovery Effective Effectively Invalid Amount to
Test group 24 30 14 4 72
Matched group 16 22 24 10 72
Test group total number of persons 72 example, wherein clinical recovery 24 example, effective 30 examples, effective 14 examples, invalid 4 examples, total effective rate 94.4%; Matched group 72 example, wherein clinical recovery 16 example, effective 22 examples, effective 24 examples, invalid 10 examples, total effective rate 86.1%; Both compare significant difference.
test example 4: Radix Saposhnikoviae leads to the test of holy capsule for treating subacute eczema clinical observation on the therapeutic effect
one, case selection
Accept patient 144 example altogether for medical treatment, man 75 example, female 69 example, at 18 ~ 65 years old age, 43 years old mean age, is out-patient; Be divided into two groups at random, i.e. test group and matched group, often group is 72 examples.
two, experimenter selection and exit
(1) subacute eczema Western medicine diagnose standard
Formulate with reference to " guideline of clinical investigations of new Chinese medicine treatment eczema " (trial version in 2002) and " clinical dermatology " (April calendar year 2001 the 3rd edition, Zhao distinguishes chief editor, Jiangsu science tech publishing house):
Subacute eczema: be often that acute eczema is treated not in time or malpractice causes a disease caused by journey delay, there is pruritus in various degree.Skin lesion is with erythema, papulovesicle, and incrustation, squama is main, or phlysis or slight erosion are oozed out.
(2) exterior cold and interior heat, excess in both the exterior and interior card Chinese medical discrimination
Primary symptom: skin erythema, papulovesicle, infiltrate, ooze out, form a scab, squama, conscious scorching hot, with pruritus;
Secondary disease: fever of the body; Aversion to cold; Constipation; Oliguria with reddish urine; Headache; Dry pharynx.
Tongue pulse condition: red tongue, yellow fur; Floating and rapid pulse
Possessing primary symptom more than 3 or 3, doublely to see in time disease more than 3 or 3, can dialectically be assertive evidence with reference to tongue arteries and veins.
(3) symptom weight grade scale
Primary symptom:
Erythema degree:
0 point: nothing
2 points: slight, may be seen indistinctly.
4 points: moderate, obvious, color is redder.
6 points: severe, clearly, color is scarlet.
Papulovesicle degree:
0 point: nothing
2 points: slight, be dispersed in, slightly projection, color is micro-red.
4 points: moderate, comparatively dense, obvious projection, color is red.
6 points: severe, very intensive noncountable, obvious projection, color is scarlet.
Ooze out infiltration degree:
0 point: nothing
2 points: mild infiltration, point-like is oozed out, and mays be seen indistinctly.
4 points: moderate infiltration, some lamellar is oozed out, and part merges mutually.
6 points: severe infiltrates, and multi-disc is oozed out.
Incrustation squama degree:
0 point: nothing
2 points: slight, be dispersed in tiny thin crust or squama.
4 points: moderate, form crust and squama.
6 points: severe, the thicker crust of more mutual fusion.
Pruritus degree:
0 point: without pruritus
2 points: even have pruritus, do not affect daily life.
4 points: paroxysmal pruritus, time heavy time light, impact sleep.
6 points: violent pruritus, have a strong impact on sleep and work.
6, erythra area: by PASI point system:
Area standards of grading are in table 4
Table 4 area standards of grading
Skin lesion area (%) Mark
0 0
1-9 1
10-29 2
30-49 3
50-69 4
70-89 5
90-100 6
Secondary disease:
1, fever of the body: nothing: 0 point; Have: 1 point
2, aversion to cold: nothing: 0 point; Have: 1 point
3, constipation: nothing: 0 point; Have: 1 point
4, oliguria with reddish urine: nothing: 0 point; Have: 1 point
5, have a headache: nothing: 0 point; Have: 1 point
6, dry pharynx: nothing: 0 point; Have: 1 point
Tongue arteries and veins itemized record, do not score.
three, Therapeutic Method
Test group: capsule prepared by the oral embodiment of the present invention 1 technique, 4 tablets/time, 2 times/day, oral;
Matched group: Radix Saposhnikoviae leads to holy granule, 3g/ time, 2 times/day, oral;
four, curative effect determinate standard
(1) skin symptom (doctor trained in Western medicine) efficacy determination
Therapeutic index (n)= × 100%
1, clinical recovery: transference cure n >=95%
2, effective: symptom disappears substantially.70%≤n<95%
3, effective: symptom is extenuated.30%≤n<70%
4, invalid: symptom is substantially unchanged.n<30%
(2) tcm syndrome total mark criterion of therapeutical effect
Therapeutic index (n)= × 100%
1, clinical recovery: transference cure n >=95%
2, effective: symptom disappears substantially.70%≤n<95%
3, effective: symptom is extenuated.30%≤n<70%
4, invalid: symptom is substantially unchanged.n<30%
(3) traditional Chinese medical science individual event symptom curative effect
Disappear: the transference cure suffered from before treatment, integration is zero.
Improve: the symptom suffered from before treatment alleviates, integration reduces, but non-vanishing.
Invalid: the symptom suffered from before treatment does not alleviate or increases the weight of, and integration does not reduce.
five, therapeutic outcome is in table 5
table 5 subacute eczema Comparison of therapeutic
Group Clinical recovery Effective Effectively Invalid Amount to
Test group 22 31 13 6 72
Matched group 15 24 22 11 72
Test group total number of persons 72 example, wherein clinical recovery 22 example, effective 31 examples, effective 13 examples, invalid 6 examples, total effective rate 91.7%; Matched group 72 example, wherein clinical recovery 15 example, effective 24 examples, effective 22 examples, invalid 11 examples, total effective rate 84.7%; Both compare significant difference.

Claims (6)

1. Radix Saposhnikoviae leads to a preparation method for holy pharmaceutical preparation, and the raw medicinal material weight proportion that described Radix Saposhnikoviae leads to holy pharmaceutical preparation is: Radix Saposhnikoviae 75.5 parts, Herba Schizonepetae 37.8 parts, Herba Menthae 75.5 parts, 75.5 parts, Herba Ephedrae, Radix Et Rhizoma Rhei 75.5 parts, 75.5 parts, Natrii Sulfas, Fructus Gardeniae 37.8 parts, 453 parts, Talcum, Radix Platycodonis 151 parts, 151 parts, Gypsum Fibrosum, Rhizoma Chuanxiong 75.5 parts, Radix Angelicae Sinensis 75.5 parts, the Radix Paeoniae Alba 75.5 parts, Radix Scutellariae 151 parts, Fructus Forsythiae 75.5 parts, 302 parts, Radix Glycyrrhizae, Rhizoma Atractylodis Macrocephalae (parched) 37.8 parts; It is characterized in that, prepare according to following steps:
1. take the Radix Saposhnikoviae of described weight portion, Herba Schizonepetae, Herba Menthae, Herba Ephedrae, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Forsythiae, the Rhizoma Atractylodis Macrocephalae, add 6 ~ 10 times amount water distillation and extraction volatile oil 4 ~ 8 hours, fractionate aqueous solutions and volatile oil; By gained volatile oil beta cyclodextrin inclusion, evenly spread in the hydroxypropyl emthylcellulose aqueous solution of 0.5% ~ 5%, obtain intermediate product A, for subsequent use;
2. by step 1. gained medicinal residues add 4 ~ 8 times of water gagings again, decoct 1 ~ 2 hour, filter, gained filtrate and step 1. separating obtained aqueous solution merge, and obtain intermediate product B, for subsequent use;
3. the Radix Et Rhizoma Rhei of described weight portion, Fructus Gardeniae, Radix Platycodonis, the Radix Paeoniae Alba, Radix Glycyrrhizae is taken, add 6 ~ 10 times of water gagings, decoct 1 ~ 3 hour, filter, medicinal residues add 4 ~ 8 times of water gagings again, decoct 1 ~ 3 hour, filter, merging filtrate and intermediate product B, when being evaporated to 60 DEG C, relative density is 1.04 ~ 1.08 g/mL, under abundant stirring condition, slowly adds 2 times amount 95% ethanol and makes it produce precipitation, stir, 0 ~ 4 DEG C leaves standstill 48 hours, filters, gained filtrate recycling ethanol, and relative density is the thick paste A of 1.20 ~ 1.25 g/mL when being evaporated to 60 DEG C, for subsequent use;
4. take the Natrii Sulfas of described weight portion, add 100 weight parts waters and dissolve to obtain Natrii Sulfas aqueous solution, for subsequent use; Take the Gypsum Fibrosum of described weight portion, Talcum, add 6 ~ 10 times of water gagings, the Radix Scutellariae of described weight portion is added after boiling, decoct 1 ~ 3 hour again, filter, gained medicinal residues add 5 ~ 7 times of water gagings again, decoct 1 ~ 3 hour, filter, merge twice filtrate, when being evaporated to 60 DEG C, relative density is the thick paste B of 1.20 ~ 1.25 g/mL, with step 3. gained thick paste A merge, then add described Natrii Sulfas aqueous solution and 30 weight portion dextrin, stir evenly, when adding water move to 60 DEG C, relative density is 1.18 ~ 1.20 g/mL, obtains intermediate product C, for subsequent use;
5. get ball core 100 weight portion, put in micropill machine, spray into intermediate product A and intermediate product C successively, make micropill, coating, 10 ~ 30 mesh sieves select the micropill of 0.55 ~ 2.0mm, then make finished dosage form, obtain described Radix Saposhnikoviae and lead to holy pharmaceutical preparation.
2. lead to the preparation method of holy pharmaceutical preparation according to Radix Saposhnikoviae according to claim 1, it is characterized in that, by step 5. gained micropill load in No. 1 transparent hard capsule by every 0.42g, obtain Radix Saposhnikoviae and lead to holy capsule.
3. lead to the preparation method of holy pharmaceutical preparation according to Radix Saposhnikoviae according to claim 1, it is characterized in that, step 1. in, still-process adds 8 times of water gagings, distillating extracting oil 6 hours, fractionate aqueous solutions and volatile oil; By gained volatile oil beta cyclodextrin inclusion, evenly spread in the hydroxypropyl emthylcellulose aqueous solution of 1.5%, obtain intermediate product A.
4. lead to the preparation method of holy pharmaceutical preparation according to Radix Saposhnikoviae according to claim 1, it is characterized in that, step 2. in, by step 1. gained medicinal residues add 6 times of water gagings, decoct 1 hour.
5. the preparation method of holy pharmaceutical preparation is led to according to Radix Saposhnikoviae according to claim 1, it is characterized in that, step 3. in, take the Radix Et Rhizoma Rhei of described weight portion, Fructus Gardeniae, Radix Platycodonis, the Radix Paeoniae Alba, Radix Glycyrrhizae, add 8 times of water gagings, decoct 2 hours, filter, gained medicinal residues add 6 times of water gagings again, decoct 2 hours, filter, merging filtrate and intermediate product B.
6. lead to the preparation method of holy pharmaceutical preparation according to Radix Saposhnikoviae according to claim 1, it is characterized in that, step 4. in, take the Gypsum Fibrosum of described weight portion, Talcum, add 8 times of water gagings, decoct 2 hours, filter, gained medicinal residues add 6 times of water gagings, decoct 2 hours, filtration.
CN201410615232.8A 2014-11-05 2014-11-05 Method for preparing medicine preparation named Fangfengtongsheng Pending CN104435231A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106822312A (en) * 2017-02-17 2017-06-13 成都风靡生物科技有限公司 A kind of Chinese medicine composition and preparation method for treating heat and internal-external sthenia in exogeneous cold

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Publication number Priority date Publication date Assignee Title
CN1363302A (en) * 2001-01-10 2002-08-14 杨孟君 Nano medicine 'Fangfeng Tongsheng' and its preparing process
CN1895408A (en) * 2006-06-27 2007-01-17 天津中新药业集团股份有限公司达仁堂制药厂 Radix saposhnikoviae Tong Sheng capsules, preparation and quality control thereof
CN101480484A (en) * 2008-01-11 2009-07-15 曾雄辉 Method for preparing miraculous powder preparation of ledebouriella

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1363302A (en) * 2001-01-10 2002-08-14 杨孟君 Nano medicine 'Fangfeng Tongsheng' and its preparing process
CN1895408A (en) * 2006-06-27 2007-01-17 天津中新药业集团股份有限公司达仁堂制药厂 Radix saposhnikoviae Tong Sheng capsules, preparation and quality control thereof
CN101480484A (en) * 2008-01-11 2009-07-15 曾雄辉 Method for preparing miraculous powder preparation of ledebouriella

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106822312A (en) * 2017-02-17 2017-06-13 成都风靡生物科技有限公司 A kind of Chinese medicine composition and preparation method for treating heat and internal-external sthenia in exogeneous cold

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