CN1739648A - Antidepressant Chinese medicine prepn and its prepn process and quality control method - Google Patents
Antidepressant Chinese medicine prepn and its prepn process and quality control method Download PDFInfo
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Abstract
The antidepressant Chinese medicine preparation is prepared with bupleurum root, angelica, Chuanxiong rhizome, tuckahoe, hooked uncaria and other three kinds of Chinese medicinal materials as main material and may be prepared into dripping pill, micro pill, capsule, granule or soft capsule. The preparation process includes water extracting the materials, mixing, adding supplementary material, and other steps to prepare dripping pill, micro pill, capsule, granule or soft capsule. The quality control method includes identification and content measurement. The preparation has high bioavailability, high curative effect, etc.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation and preparation method thereof and method of quality control, relate in particular to a kind of antidepressant Chinese medicine preparation and preparation method thereof and method of quality control.
Background technology:
Drop pill in the Chinese medicine preparation or micropill or pellet capsule or granule or soft capsule, change dosage form or technology and manage as new drug research according to the relevant laws and regulations of China's drug control as a kind of pharmaceutical dosage form.
Existing ANLE PIAN has been listed Chinese traditional patent formulation preparation promulgated by the ministries or commissions of the Central Government (second) in, and its technology features is hook taking rattan, Radix Bupleuri half and half amount, is ground into fine powder, sieves; Six-elements such as second half and all the other Poria decoct with water.Decocting liquid filters, and filtrate is concentrated into clear paste, adds above-mentioned powder mixing, makes granule, drying, and tabletting, sugar coating, promptly.
Existing ANLE PIAN has shortcomings such as disintegration is long, and produce effects is slow, and dose is big, and bioavailability is low.
Summary of the invention:
The purpose of this invention is to provide a kind of antidepressant Chinese medicine preparation and preparation method thereof and method of quality control, overcome the above-mentioned drawback of prior art, improve quality, curative effect, the bioavailability of product, satisfy the needs of medical treatment better.
The objective of the invention is to be achieved through the following technical solutions.
A kind of antidepressant Chinese medicine preparation, it is that main constituent is peaceful and comfortable drop pill or micropill or pellet capsule or granule or the soft capsule of Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Poria, Ramulus Uncariae Cum Uncis, Caulis Polygoni Multiflori, the Rhizoma Atractylodis Macrocephalae (stir-fry), Radix Glycyrrhizae.
Its preparation method is:
(1) medicine constituent and percentage by weight thereof are as follows:
Radix Bupleuri, Rhizoma Chuanxiong each 5～12%, Radix Angelicae Sinensis 10～20%, Poria, Ramulus Uncariae Cum Uncis, Caulis Polygoni Multiflori, the Rhizoma Atractylodis Macrocephalae (stir-frys) respectively 12～25%, Radix Glycyrrhizae 4～10%;
Medicine constituent optimum weight percentage ratio is:
Radix Bupleuri, Rhizoma Chuanxiong each 8.16%, Radix Angelicae Sinensis 12.2%, Poria, Ramulus Uncariae Cum Uncis, Caulis Polygoni Multiflori, the Rhizoma Atractylodis Macrocephalae (stir-frys) respectively 16.3%, Radix Glycyrrhizae 6.16%;
(2) get eight flavor medical materials and decoct with water 1～3 time, each 1～5 hour, collecting decoction filtered, and it is 1.15～1.40 clear paste that filtrate is concentrated into relative density, and drying is ground into fine powder, and is standby;
(3) with one or more of stearic acid or glyceryl monostearate or insect wax or Cera Flava or Polyethylene Glycol (PEG4000 or PEG6000) or sodium stearate or glycerin gelatine or polyoxyethylene monostearate (S-40) or Poloxamer188 or other suitable adjuvant, use with by arbitrary proportion, be heated to the fine powder that adds (2) gained after whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 70～100 ℃, under heat-retaining condition, go in the liquid coolant (liquid paraffin or methyl-silicone oil or vegetable oil or water or ethanol) by dropping-pill machine, condensation cured becomes ball, coolant is use up and removed to the drop pill drop of molding, dry, coating or coating not promptly get drop pill.
(4) get the fine powder of (2) gained, add an amount of adjuvant, mix homogeneously is granulated, and coating or coating are not made the micropill of diameter less than 2.5mm; Maybe, incapsulate, promptly get pellet capsule the micropill that makes;
Micropill or pellet capsule adjuvant are following one or more combinations or other suitable adjuvant, use with by arbitrary proportion: ethyl cellulose (EC), the polypropylene polysiloxanes, the wax class, Polyethylene Glycol (PEG), stearic acid, Lac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, cellulose propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, propylene glycol, glycerol, triacetin, acetyl list monoglyceride, phthalic acid ester, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, lactose, fructose, sucrose.
(5) get (2) gained fine powder, add appropriate amount of auxiliary materials, mixing is granulated, drying, and granulate is promptly made granule;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion: stevioside, protein sugar, xylitol, high fructose, cyclamate, beta-schardinger dextrin-, dextrin, lactose, saccharin sodium, ethanol, water.
(6) get (2) gained fine powder, add appropriate amount of auxiliary materials, mix homogeneously is suppressed or is dripped and makes soft capsule;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion:
PEG400, vegetable oil, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, tween.
Its peaceful and comfortable micropill or pellet capsule or granule or preparation of soft capsule method can also be:
(1) medicine constituent and percentage by weight thereof are as follows:
Radix Bupleuri, Rhizoma Chuanxiong each 5～12%, Radix Angelicae Sinensis 10～20%, Poria, Ramulus Uncariae Cum Uncis, Caulis Polygoni Multiflori, the Rhizoma Atractylodis Macrocephalae (stir-frys) respectively 12～25%, Radix Glycyrrhizae 4～10%;
Medicine constituent optimum weight percentage ratio is:
Radix Bupleuri, Rhizoma Chuanxiong each 8.16%, Radix Angelicae Sinensis 12.2%, Poria, Ramulus Uncariae Cum Uncis, Caulis Polygoni Multiflori, the Rhizoma Atractylodis Macrocephalae (stir-frys) respectively 16.3%, Radix Glycyrrhizae 6.16%.
(2) 40～60% of each hook taking rattan, Radix Bupleuri percentage by weight, be ground into fine powder, sieve; Six-elements such as remainder and all the other Poria decoct with water 1～3 time, and each 1～5 hour, collecting decoction filtered, and it is 1.15～1.40 clear paste that filtrate is concentrated into relative density, adds above-mentioned fine powder mixing, and drying is pulverized, mixing fine powders, standby;
(3) get the mixing fine powders of (2) gained, add an amount of adjuvant, mix homogeneously is granulated, and coating or coating are not made the micropill of diameter less than 2.5mm; Maybe, incapsulate, promptly get pellet capsule the micropill that makes;
Micropill or pellet capsule adjuvant are following one or more combinations or other suitable adjuvant, use with by arbitrary proportion: ethyl cellulose (EC), the polypropylene polysiloxanes, the wax class, Polyethylene Glycol (PEG), stearic acid, Lac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, cellulose propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, propylene glycol, glycerol, triacetin, acetyl list monoglyceride, phthalic acid ester, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, lactose, fructose, sucrose.
(4) get (2) gained mixing fine powders, add appropriate amount of auxiliary materials, mixing is granulated, drying, and granulate is promptly made granule;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion: stevioside, protein sugar, xylitol, high fructose, cyclamate, beta-schardinger dextrin-, dextrin, lactose, saccharin sodium, ethanol, water.
(5) get (2) gained mixing fine powders, add appropriate amount of auxiliary materials, mix homogeneously is suppressed or is dripped and makes soft capsule;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion:
PEG400, vegetable oil, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, tween.
A kind of method of quality control of antidepressant Chinese medicine preparation:
Differentiate that the thin layer of the Rhizoma Atractylodis Macrocephalae is differentiated: get this product content 2～10g, porphyrize adds normal hexane 5～20ml, supersound process 5～40 minutes filters, and filtrate is concentrated into 2ml, as need testing solution; Other gets Rhizoma Atractylodis Macrocephalae control medicinal material 0.2～2g, with the method operation, makes control medicinal material solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 5～40 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with petroleum ether (60～90 ℃)-ethyl acetate (40～60: 0.5～5) be developing solvent, launch, take out, dry, spray is with 2～8% vanillin sulfuric acid solutions, it is clear to be heated to the speckle colour developing, in the test sample chromatograph, on the corresponding position of control medicinal material, show the speckle of same color;
Assay, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Methanol-1% glacial acetic acid (20～40: 60～80) be mobile phase; Flow velocity 0.5～1.5ml/mol; Detect wavelength 290～330nm; Theoretical cam curve is calculated by the ferulic acid peak should be no less than 3000;
It is an amount of that the preparation of reference substance solution, precision take by weighing the ferulic acid reference substance, adds methanol and make the solution that every 1ml contains 0.02～0.06mg, in contrast product solution;
This medicine 1～5g is got in the preparation of need testing solution, and accurate the title decides, put in the tool plug conical flask, the accurate methanol 20～80ml that adds claims to decide weight, supersound process 20～50 minutes is put and is chilled to room temperature, claims to decide weight again, supply the weight that subtracts mistake with methanol, shake up, centrifugal, leave standstill, get supernatant, filter, filter with microporous filter membrane, get filtrate as need testing solution;
Algoscopy, accurate respectively reference substance solution and each 10～30ul of need testing solution of drawing injects chromatograph of liquid, measures.
Specific embodiments:
The present invention further specifies in conjunction with specific embodiments, can be for reference, do not limit the scope of the invention:
A kind of antidepressant Chinese medicine preparation, it is that main constituent is peaceful and comfortable drop pill or micropill or pellet capsule or granule or the soft capsule of Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Poria, Ramulus Uncariae Cum Uncis, Caulis Polygoni Multiflori, the Rhizoma Atractylodis Macrocephalae (stir-fry), Radix Glycyrrhizae.
A kind of antidepressant Chinese medicine preparation energy soothing liver-QI for relieving depression, arresting convulsion is calmed the nerves.Be mainly used in spirit depressing, terrified insomnia, discomfort uncomfortable in chest, the anorexia Mental fatigue also can use neurosis, climacteric syndrome and the nocturnal fretfulness in infants, symptom such as grind one's teeth in sleep.
A kind of antidepressant Chinese medicine preparation drop pill or micropill or pellet capsule or granule or soft capsule preparation method are:
(1) medicine constituent and weight consumption are as follows:
Radix Bupleuri, each 90g of Rhizoma Chuanxiong, Radix Angelicae Sinensis 135g, Poria, Ramulus Uncariae Cum Uncis, Caulis Polygoni Multiflori, each 180g of the Rhizoma Atractylodis Macrocephalae (stir-fry), Radix Glycyrrhizae 68g;
(2) get eight flavor medical materials and decoct with water 2 times, each 2 hours, collecting decoction filtered, and filtrate is concentrated into relative density and is about 1.28 clear paste, and drying is ground into fine powder, and is standby;
(3) a kind of antidepressant Chinese medicine preparation drop pill is peaceful and comfortable drop pill, its preparation method is taking polyethylene glycol PEG6000200g, stearic acid 80g, Poloxamer188 50g, treat that Polyethylene Glycol PEG6000, stearic acid, Poloxamer188 are heated to the fine powder that adds above-mentioned (2) gained after whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 80 ℃, at heat-retaining condition by splashing in the liquid paraffin, be condensed into ball, with the drop pill drop of molding to the greatest extent and the erasing liquor paraffin body, cold drying promptly gets drop pill.
(4) a kind of antidepressant Chinese medicine preparation micropill is peaceful and comfortable micropill, its preparation method is a fine powder of getting (2) gained, with 100g microcrystalline Cellulose mix homogeneously, 5%PVP alcohol liquid is binding agent, at first prepare 60 purpose granules and make parent nucleus, be binding agent with 5%PVP alcohol liquid again, add the mixed powder amplification and make 40 purpose micropills, promptly make micropill.
(5) a kind of antidepressant Chinese medicine preparation pellet capsule is peaceful and comfortable pellet capsule, its preparation method is a fine powder of getting (2) gained, with 100g microcrystalline Cellulose mix homogeneously, 5%PVP alcohol liquid is binding agent, at first preparing 60 purpose granules and make parent nucleus, is binding agent with 5%PVP alcohol liquid again, adds the mixed powder amplification and makes 40 purpose micropills, incapsulate, promptly get pellet capsule.
(6) a kind of antidepressant Chinese medicine preparation granule is peaceful and comfortable granule, and its preparation method is: get (2) gained fine powder, add B-cyclodextrin 150g, add oligomeric lactose 100g and fully stir, and mixing, spray drying adds the 1g stevioside, granulates, and drying is promptly made granule.
(7) a kind of antidepressant Chinese medicine preparation soft capsule is peaceful and comfortable soft capsule, its preparation method is: get (2) gained fine powder, behind water dissolution, the adding adjuvant is the combination of one or more different proportions in PEG400, vegetable oil, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, the tween, suppresses or drips and make soft capsule.
(8) a kind of antidepressant Chinese medicine preparation micropill or pellet capsule or granule or soft capsule, its preparation method is:
1. medicine constituent and weight consumption are as follows:
Radix Bupleuri, each 90g of Rhizoma Chuanxiong, Radix Angelicae Sinensis 135g, Poria, Ramulus Uncariae Cum Uncis, Caulis Polygoni Multiflori, each 180g of the Rhizoma Atractylodis Macrocephalae (stir-fry), Radix Glycyrrhizae 68g;
2. hook taking rattan 90g, Radix Bupleuri 45g are ground into fine powder, and Six-elements such as remainder and all the other Poria decoct with water each 2 hours 2 times, collecting decoction filters, and filtrate is concentrated into relative density and is about 1.28 clear paste, adds above-mentioned fine powder mixing, drying is pulverized, and gets mixing fine powders, and is standby;
3. a kind of antidepressant Chinese medicine preparation micropill is peaceful and comfortable micropill, its preparation method is to get the 2. mixing fine powders of gained, with 80g microcrystalline Cellulose mix homogeneously, 5%PVP alcohol liquid is binding agent, at first preparing 60 purpose granules and make parent nucleus, is binding agent with 5%PVP alcohol liquid again, adds the mixed powder amplification and makes 40 purpose micropills, mixing promptly makes micropill.
4. a kind of antidepressant Chinese medicine preparation pellet capsule is peaceful and comfortable pellet capsule, its preparation method is to get the 2. mixing fine powders of gained, with 80g microcrystalline Cellulose mix homogeneously, 5%PVP alcohol liquid is binding agent, at first prepares 60 purpose granules and makes parent nucleus, and be binding agent with 5%PVP alcohol liquid again, add the mixed powder amplification and make 40 purpose micropills, mixing incapsulates, and promptly gets pellet capsule.
5. a kind of antidepressant Chinese medicine preparation granule is peaceful and comfortable granule, and its preparation method is: get 2. gained mixing fine powders, add B-cyclodextrin 130g, add oligomeric lactose 100g and fully stir, and mixing, spray drying adds the 1g stevioside, granulates, and drying is promptly made granule.
6. a kind of antidepressant Chinese medicine preparation soft capsule is peaceful and comfortable soft capsule, its preparation method is: get 2. gained mixing fine powders, behind water dissolution, the adding adjuvant is the combination of one or more different proportions in PEG400, vegetable oil, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, the tween, suppresses or drips and make soft capsule.
A kind of method of quality control of antidepressant Chinese medicine preparation:
Differentiate that the thin layer of the Rhizoma Atractylodis Macrocephalae is differentiated: get this product 5g, porphyrize adds n-hexane 10ml, supersound process 30 minutes filters, and filtrate is concentrated into 2ml, as need testing solution; Other gets Rhizoma Atractylodis Macrocephalae control medicinal material 0.5g, with the method operation, makes control medicinal material solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), drawing each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, is developing solvent with petroleum ether (60～90 ℃)-ethyl acetate (50: 1), launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, it is clear to be heated to the speckle colour developing, in the test sample chromatograph, on the corresponding position of control medicinal material, show the speckle of same color;
Assay, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Methanol-1% glacial acetic acid (30: 70) is a mobile phase; Flow velocity 1.0ml/mol; Detect wavelength 320nm; Theoretical cam curve is calculated by the ferulic acid peak should be no less than 3000;
It is an amount of that the preparation of reference substance solution, precision take by weighing the ferulic acid reference substance, adds methanol and make the solution that every 1ml contains 0.05mg, in contrast product solution;
This medicine 2g is got in the preparation of need testing solution, and accurate the title decides, put in the tool plug conical flask, the accurate methanol 50ml that adds claims to decide weight, supersound process 30 minutes is put and is chilled to room temperature, claims to decide weight again, supply the weight that subtracts mistake with methanol, shake up, centrifugal, leave standstill, get supernatant, filter, filter with microporous filter membrane, get filtrate as need testing solution;
Algoscopy, accurate respectively reference substance solution and each 20ul of need testing solution of drawing injects chromatograph of liquid, measures.
Advantage of the present invention is:
Take, easy to carry, the bioavilability height is conducive to improve drug effect.
Claims (6)
1, a kind of antidepressant Chinese medicine preparation is characterized in that it is that main constituent is peaceful and comfortable drop pill or micropill or pellet capsule or granule or the soft capsule of Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Poria, Ramulus Uncariae Cum Uncis, Caulis Polygoni Multiflori, the Rhizoma Atractylodis Macrocephalae (stir-fry), Radix Glycyrrhizae.
2, a kind of preparation method of antidepressant Chinese medicine preparation, it is peaceful and comfortable drop pill or micropill or pellet capsule or granule or preparation of soft capsule method, it is characterized in that:
(1) medicine constituent and percentage by weight thereof are as follows:
Radix Bupleuri, Rhizoma Chuanxiong each 5～12%, Radix Angelicae Sinensis 10～20%, Poria, Ramulus Uncariae Cum Uncis, Caulis Polygoni Multiflori, the Rhizoma Atractylodis Macrocephalae (stir-frys) respectively 12～25%, Radix Glycyrrhizae 4～10%;
(2) get eight flavor medical materials and decoct with water 1～3 time, each 1～5 hour, collecting decoction filtered, and it is 1.15～1.40 clear paste that filtrate is concentrated into relative density, and drying is ground into fine powder, and is standby;
(3) get (2) gained fine powder, add suitable adjuvant after, make drop pill or micropill or pellet capsule or granule or soft capsule;
The preparation method of its drop pill is: with one or more of stearic acid or glyceryl monostearate or insect wax or Cera Flava or Polyethylene Glycol (PEG4000 or PEG6000) or sodium stearate or glycerin gelatine or polyoxyethylene monostearate (S-40) or Poloxamer188 or other suitable adjuvant, use with by arbitrary proportion, be heated to the fine powder that adds (2) gained after whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 70～100 ℃, under heat-retaining condition, go in the liquid coolant (liquid paraffin or methyl-silicone oil or vegetable oil or water or ethanol) by dropping-pill machine, condensation cured becomes ball, coolant is use up and removed to the drop pill drop of molding, dry, coating or coating not promptly get drop pill;
The preparation method of its micropill or pellet capsule is: get the fine powder of (2) gained, add an amount of adjuvant, mix homogeneously is granulated, and coating or coating are not made the micropill of diameter less than 2.5mm; Maybe, incapsulate, promptly get pellet capsule the micropill that makes;
Micropill or pellet capsule adjuvant are following one or more combinations or other suitable adjuvant, use with by arbitrary proportion: ethyl cellulose (EC), the polypropylene polysiloxanes, the wax class, Polyethylene Glycol (PEG), stearic acid, Lac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, cellulose propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, propylene glycol, glycerol, triacetin, acetyl list monoglyceride, phthalic acid ester, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, lactose, fructose, sucrose;
Its particulate preparation method is: get (2) gained fine powder, add appropriate amount of auxiliary materials, mixing is granulated, drying, and granulate is promptly made granule;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion: stevioside, protein sugar, xylitol, high fructose, cyclamate, beta-schardinger dextrin-, dextrin, lactose, saccharin sodium, ethanol, water;
Its preparation of soft capsule method is: get (2) gained fine powder, add appropriate amount of auxiliary materials, mix homogeneously is suppressed or is dripped and makes soft capsule;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion:
PEG400, vegetable oil, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, tween.
3, the preparation method of a kind of antidepressant Chinese medicine preparation according to claim 2, it is characterized in that by adding suitable adjuvant, can make other any pharmaceutically useful dosage forms, comprise sheet (plain sheet, coated tablet, Film coated tablets, enteric coatel tablets, effervescent tablet, slow-release tablet, dispersible tablet, fast-release tablet, buccal tablet), ball, loose, capsule, enteric coated capsule, slow, controlled release capsule, effervescent granule, oral liquid, injection etc.
4, the preparation method of a kind of antidepressant Chinese medicine preparation according to claim 2 is characterized in that peaceful and comfortable micropill or pellet capsule or granule or preparation of soft capsule method also can be:
(1) medicine constituent and percentage by weight thereof are as follows:
Radix Bupleuri, Rhizoma Chuanxiong each 5～12%, Radix Angelicae Sinensis 10～20%, Poria, Ramulus Uncariae Cum Uncis, Caulis Polygoni Multiflori, the Rhizoma Atractylodis Macrocephalae (stir-frys) respectively 12～25%, Radix Glycyrrhizae 4～10%;
(2) 40～60% of each hook taking rattan, Radix Bupleuri percentage by weight, be ground into fine powder, sieve; Six-elements such as remainder and all the other Poria decoct with water 1～3 time, and each 1～5 hour, collecting decoction filtered, and it is 1.15～1.40 clear paste that filtrate is concentrated into relative density, adds above-mentioned fine powder mixing, and drying is pulverized, mixing fine powders, standby;
(3) get the mixing fine powders of (2) gained, add suitable adjuvant after, make micropill or pellet capsule or granule or soft capsule;
The preparation method of its micropill or pellet capsule is: get the mixing fine powders of (2) gained, add an amount of adjuvant, mix homogeneously is granulated, and coating or coating are not made the micropill of diameter less than 2.5mm; Maybe, incapsulate, promptly get pellet capsule the micropill that makes;
Micropill or pellet capsule adjuvant are following one or more combinations or other suitable adjuvant, use with by arbitrary proportion: ethyl cellulose (EC), the polypropylene polysiloxanes, the wax class, Polyethylene Glycol (PEG), stearic acid, Lac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, cellulose propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, propylene glycol, glycerol, triacetin, acetyl list monoglyceride, phthalic acid ester, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, lactose, fructose, sucrose;
Its particulate preparation method is: get (2) gained mixing fine powders, add appropriate amount of auxiliary materials, mixing is granulated, drying, and granulate is promptly made granule;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion: stevioside, protein sugar, xylitol, high fructose, cyclamate, beta-schardinger dextrin-, dextrin, lactose, saccharin sodium, ethanol, water;
Its preparation of soft capsule method is: get (2) gained mixing fine powders, add appropriate amount of auxiliary materials, mix homogeneously is suppressed or is dripped and makes soft capsule;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion:
PEG400, vegetable oil, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, tween.
5, a kind of method of quality control of antidepressant Chinese medicine preparation, it is the method for quality control of peaceful and comfortable drop pill or micropill or pellet capsule or granule or soft capsule, it is characterized in that:
Differentiate that the thin layer of the Rhizoma Atractylodis Macrocephalae is differentiated: get this product 2～10g, porphyrize adds normal hexane 5～20ml, supersound process 5～40 minutes filters, and filtrate is concentrated into 2ml, as need testing solution; Other gets Rhizoma Atractylodis Macrocephalae control medicinal material 0.2～2g, with the method operation, makes control medicinal material solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 5～40 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with petroleum ether (60～90 ℃)-ethyl acetate (40～60: 0.5～5) be developing solvent, launch, take out, dry, spray is with 2～8% vanillin sulfuric acid solutions, it is clear to be heated to the speckle colour developing, in the test sample chromatograph, on the corresponding position of control medicinal material, show the speckle of same color;
Assay, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Methanol-1% glacial acetic acid (20～40: 60～80) be mobile phase; Flow velocity 0.5～1.5ml/mol; Detect wavelength 290～330nm; Theoretical cam curve is calculated by the ferulic acid peak should be no less than 3000;
It is an amount of that the preparation of reference substance solution, precision take by weighing the ferulic acid reference substance, adds methanol and make the solution that every 1ml contains 0.02～0.06mg, in contrast product solution;
This product 1～5g is got in the preparation of need testing solution, and accurate the title decides, put in the tool plug conical flask, the accurate methanol 20～80ml that adds claims to decide weight, supersound process 20～50 minutes is put and is chilled to room temperature, claims to decide weight again, supply the weight that subtracts mistake with methanol, shake up, centrifugal, leave standstill, get supernatant, filter, filter with microporous filter membrane, get filtrate as need testing solution;
Algoscopy, accurate respectively reference substance solution and each 10～30ul of need testing solution of drawing injects chromatograph of liquid, measures.
6, the preparation method of a kind of antidepressant Chinese medicine preparation according to claim 2 is characterized in that the optimum weight percentage ratio of its main constituent is:
Radix Bupleuri, Rhizoma Chuanxiong each 8.16%, Radix Angelicae Sinensis 12.2%, Poria, Ramulus Uncariae Cum Uncis, Caulis Polygoni Multiflori, the Rhizoma Atractylodis Macrocephalae (stir-frys) respectively 16.3%, Radix Glycyrrhizae 6.16%.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101981443A (en) * | 2008-04-03 | 2011-02-23 | 株式会社津村 | Method of bioassaying yokukansan |
| CN102210766A (en) * | 2010-04-05 | 2011-10-12 | 葫芦岛国帝药业有限责任公司 | Traditional Chinese medicine composition for treating mental anxiety |
| CN102397518A (en) * | 2011-11-03 | 2012-04-04 | 铜陵市松马食品包装机械制造有限责任公司 | Tea paste for treating insomnia and preparation method thereof |
| CN105168456A (en) * | 2015-09-16 | 2015-12-23 | 韩志强 | Anle tablet |
-
2005
- 2005-09-06 CN CN 200510032118 patent/CN1739648A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101981443A (en) * | 2008-04-03 | 2011-02-23 | 株式会社津村 | Method of bioassaying yokukansan |
| US8497092B2 (en) | 2008-04-03 | 2013-07-30 | Tsumura & Co. | Method of bioassaying yokukansan |
| CN101981443B (en) * | 2008-04-03 | 2014-05-07 | 株式会社津村 | Method of bioassaying yokukansan |
| CN102210766A (en) * | 2010-04-05 | 2011-10-12 | 葫芦岛国帝药业有限责任公司 | Traditional Chinese medicine composition for treating mental anxiety |
| CN102397518A (en) * | 2011-11-03 | 2012-04-04 | 铜陵市松马食品包装机械制造有限责任公司 | Tea paste for treating insomnia and preparation method thereof |
| CN102397518B (en) * | 2011-11-03 | 2014-07-02 | 铜陵市松马食品包装机械制造有限责任公司 | Tea paste for treating insomnia and preparation method thereof |
| CN105168456A (en) * | 2015-09-16 | 2015-12-23 | 韩志强 | Anle tablet |
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