CN1813975A - Chinese medicine preparation of kidney-tonifying bloodczirculation-activating and pain relieving, preparing method and quality control method - Google Patents
Chinese medicine preparation of kidney-tonifying bloodczirculation-activating and pain relieving, preparing method and quality control method Download PDFInfo
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Abstract
The present invention discloses a Chinese medicine preparation with the functions of tonifying kidney, promoting blood circulation and stopping pain, its preparation method and quality control method. It is a Jingkang dripping pills preparation or micropill or micropill capsule or granules or effervescent granules preparation or capsule or soft capsule preparation made up by using 9 Chinese medicinal materials of cooked rehmannia root, flowery knotweed root, pyrola, drynaria root, uncaria stem and thorn, notoginseng and others through a certain preparation process. Its quality control method adopts content determination method. Besides, said invention also provides the concrete steps of said preparation method.
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 invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation and preparation method thereof and method of quality control.
Background technology:
The existing dosage form of neck health is a sheet by retrieval, has listed national standard for traditional Chinese medicines compilation orthopedics department fascicle in.Its technology features is: the flavor of nine in prescription medical material, and get the part Radix Notoginseng powder and be broken into fine powder; Eight flavors such as remaining Radix Notoginseng and Radix Rehmanniae Preparata, water is carried, and is condensed into thick paste, mixes with the Radix Notoginseng fine powder, and drying is ground into fine powder, adds an amount of magnesium stearate and starch, and mixing is made granule, tabletting, sugar coating or film-coat, promptly.
By the patent retrieval of neck health, the relevant patent of no neck health.
Drop pill in the Chinese medicine preparation or micropill or pellet capsule or granule or effervescent granule or capsule 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 neck health sheet has shortcomings such as disintegration is long, and produce effects is slow, and bioavailability is low.Drop pill or micropill or pellet capsule or granule or effervescent granule or capsule or soft capsule can overcome the deficiency of above-mentioned dosage form, satisfy the demand of people's medication better.
Summary of the invention:
The purpose of this invention is to provide a kind of invigorating kidney, promoting blood circulation analgesic 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 invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation, it is that Main Ingredients and Appearance is neck disease treating drop pills or micropill or pellet capsule or granule or effervescent granule or capsule or the soft capsule of Radix Polygoni Multiflori, the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), Ramulus Uncariae Cum Uncis, Radix Puerariae, Radix Notoginseng, Semen Raphani (stir-fry).
Its preparation method is:
(1) medicine Main Ingredients and Appearance and weight proportion thereof are as follows:
50～350 parts of Radix Rehmanniae Preparata, 100～500 parts of Radix Polygoni Multiflori, respectively 40～250 parts of the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), each 10～200 parts of Ramulus Uncariae Cum Uncis, Radix Puerariaes, 5～100 parts of Radix Notoginseng, 10～150 parts of Semen Raphanis (stir-fry);
Medicine Main Ingredients and Appearance preferred weight proportioning is:
100～300 parts of Radix Rehmanniae Preparata, 150～400 parts of Radix Polygoni Multiflori, respectively 60～200 parts of the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), each 50～150 parts of Ramulus Uncariae Cum Uncis, Radix Puerariaes, 25～75 parts of Radix Notoginseng, 40～120 parts of Semen Raphanis (stir-fry);
Medicine Main Ingredients and Appearance optimum weight proportioning is:
204.5 parts of Radix Rehmanniae Preparata, 272.8 parts of Radix Polygoni Multiflori, 136.4 parts of the Cortexs Eucommiae, 136.4 parts of Herba Pyrolaes, 136.4 parts of Rhizoma Drynariae (scalding), 100 parts of Ramulus Uncariae Cum Uncis, 100 parts of Radix Puerariaes, 50 parts of Radix Notoginseng, 86.2 parts of Semen Raphanis (stir-fry);
(2) get above nine flavors, decoct with water 1～4 time, each 1～4 hour, collecting decoction filtered, and filtrate is concentrated into the thick paste of relative density 1.2～1.4 (80 ℃), and drying is pulverized, and gets mixing fine powders, 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, add (2) gained mixing fine powders after being heated to 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 (2) gained mixing fine powders, 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 with the micropill that makes, pack into Capsules or enteric coated capsule promptly get pellet capsule;
Adjuvant is following one or more combinations or other suitable adjuvant, uses 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 mixing fine powders, add an amount of adjuvant, mixing is granulated, drying, and granulate, coating or coating not promptly get 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;
(6) get (2) gained mixing fine powders, add an amount of adjuvant, mixing is granulated, drying, and granulate promptly gets effervescent granule;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion: microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, cane sugar powder, saccharin sodium, polyvidone, citric acid, tartaric acid, fumaric acid, sodium carbonate, sodium bicarbonate, edible essence;
(7) get (2) gained mixing fine powders, add an amount of adjuvant, mix homogeneously is granulated, coating or coating not, and pack into Capsules or enteric coated capsule promptly get capsule;
Adjuvant is one or more combinations or other suitable adjuvant of following material, uses with by arbitrary proportion: starch, carboxymethyl starch sodium, pregelatinized Starch, sucrose, glucose, mannitol, sorbitol, syrup, microcrystalline Cellulose, methylcellulose, carboxymethyl cellulose, ethyl cellulose, hydroxypropyl emthylcellulose, low-substituted hydroxypropyl cellulose, carboxymethylcellulose calcium, calcium sulfate, calcium hydrogen phosphate, calcium phosphate, calcium carbonate, light magnesium oxide, Pulvis Talci, micropowder silica gel, aluminium hydroxide, boric acid, sodium chloride, dextrin, magnesium stearate, hydrogenated vegetable oil, Polyethylene Glycol;
(8) get (2) gained mixing fine powders, add an amount of adjuvant, 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.
Neck disease treating drop pills or micropill or pellet capsule or granule or effervescent granule or capsule or preparation of soft capsule method can also be:
(1) medicine Main Ingredients and Appearance and weight proportion thereof are as follows:
50～350 parts of Radix Rehmanniae Preparata, 100～500 parts of Radix Polygoni Multiflori, respectively 40～250 parts of the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), each 10～200 parts of Ramulus Uncariae Cum Uncis, Radix Puerariaes, 5～100 parts of Radix Notoginseng, 10～150 parts of Semen Raphanis (stir-fry);
Medicine Main Ingredients and Appearance preferred weight proportioning is:
100～300 parts of Radix Rehmanniae Preparata, 150～400 parts of Radix Polygoni Multiflori, respectively 60～200 parts of the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), each 50～150 parts of Ramulus Uncariae Cum Uncis, Radix Puerariaes, 25～75 parts of Radix Notoginseng, 40～120 parts of Semen Raphanis (stir-fry);
Medicine Main Ingredients and Appearance optimum weight proportioning is:
204.5 parts of Radix Rehmanniae Preparata, 272.8 parts of Radix Polygoni Multiflori, 136.4 parts of the Cortexs Eucommiae, 136.4 parts of Herba Pyrolaes, 136.4 parts of Rhizoma Drynariae (scalding), 100 parts of Ramulus Uncariae Cum Uncis, 100 parts of Radix Puerariaes, 50 parts of Radix Notoginseng, 86.2 parts of Semen Raphanis (stir-fry);
(2) get 25～75% of Radix Notoginseng weight proportion in the prescription, be ground into fine powder, standby;
(3) get eight flavors such as remaining Radix Notoginseng and Radix Rehmanniae Preparata, decoct with water 1～4 time, each 1～4 hour, collecting decoction filtered, and filtrate is concentrated into the thick paste of relative density 1.2～1.4 (80 ℃), and drying is pulverized, and gets mixing fine powders, and is standby;
(4) 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, add (3) gained mixing fine powders after being heated to 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;
(5) get (3) gained mixing fine powders, 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 with the micropill that makes, pack into Capsules or enteric hollow capsule promptly get pellet capsule;
Adjuvant is following one or more combinations or other suitable adjuvant, uses 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;
(6) get (3) gained mixing fine powders, add appropriate amount of auxiliary materials, mixing is granulated, drying, and granulate, coating or coating are not 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;
(7) get (3) gained mixing fine powders, add an amount of adjuvant, mixing is granulated, drying, and granulate promptly gets effervescent granule;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion: microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, cane sugar powder, saccharin sodium, polyvidone, citric acid, tartaric acid, fumaric acid, sodium carbonate, sodium bicarbonate, edible essence;
(8) get (3) gained mixing fine powders, add an amount of adjuvant, mix homogeneously is granulated, drying, and coating or coating not divide pack into Capsules or enteric hollow capsule, promptly get capsule;
Adjuvant is one or more combinations or other suitable adjuvant of following material, uses with by arbitrary proportion: starch, carboxymethyl starch sodium, pregelatinized Starch, sucrose, glucose, mannitol, sorbitol, syrup, microcrystalline Cellulose, methylcellulose, carboxymethyl cellulose, ethyl cellulose, hydroxypropyl emthylcellulose, low-substituted hydroxypropyl cellulose, carboxymethylcellulose calcium, calcium sulfate, calcium hydrogen phosphate, calcium phosphate, calcium carbonate, light magnesium oxide, Pulvis Talci, micropowder silica gel, aluminium hydroxide, boric acid, sodium chloride, dextrin, magnesium stearate, hydrogenated vegetable oil, Polyethylene Glycol;
(9) get (3) 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 invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation, it is the method for quality control of neck disease treating drop pills or micropill or pellet capsule or granule or effervescent granule or capsule or soft capsule:
According to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; (10～30: 60～90) be mobile phase, the detection wavelength is 240～260nm, and theoretical cam curve is calculated by puerarin peak should be not less than 2000 with methanol-water;
The preparation of reference substance solution, it is an amount of to get the puerarin reference substance, and accurate the title, decide, and adds methanol and make the solution that every 1ml contains 80ug, promptly;
This product or the about 2～10g of this product content are got in the preparation of need testing solution, and accurate the title decides, and puts in the 50ml measuring bottle, adds methanol and is diluted to scale, shakes up, and filters, and gets subsequent filtrate, promptly;
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 invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation, it is that Main Ingredients and Appearance is neck disease treating drop pills or micropill or pellet capsule or granule or effervescent granule or capsule or the soft capsule of Radix Rehmanniae Preparata, Radix Polygoni Multiflori, the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), Ramulus Uncariae Cum Uncis, Radix Puerariae, Radix Notoginseng, Semen Raphani (stir-fry).
It is the kidney invigorating that a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation function cures mainly, invigorate blood circulation, pain relieving.Be used for the cervical spondylosis due to the blood stasis due to renal deficiency, disease is seen: neck distending pain numbness, movable unfavorable, dizziness and tinnitus etc.
A kind of preparation method of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation is:
(1) medicine Main Ingredients and Appearance and weight consumption are as follows:
Radix Rehmanniae Preparata 204.5g, Radix Polygoni Multiflori 272.8g, Cortex Eucommiae 136.4g, Herba Pyrolae 136.4g, Rhizoma Drynariae (scalding) 136.4g, Ramulus Uncariae Cum Uncis 100g, Radix Puerariae 100g, Radix Notoginseng 50g, Semen Raphani (stir-fry) 86.2g;
(2) get above eight flavors, decoct with water 2 times, 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, and filtrate is concentrated into the thick paste of relative density 1.30～1.35 (80 ℃), and drying is pulverized, and gets mixing fine powders, and is standby;
(3) a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation drop pill is the neck disease treating drop pills, its preparation method is taking polyethylene glycol PEG6000 40g, stearic acid 35g, Poloxamer188 30g, treat to add above-mentioned (2) gained mixing fine powders after Polyethylene Glycol PEG6000, stearic acid, Poloxamer188 are heated to 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 invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation micropill is a neck health micropill, its preparation method is to get (2) gained mixing fine powders, with 45g 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 invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation pellet capsule is a neck health pellet capsule, its preparation method is to get (2) gained mixing fine powders, with 45g 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 invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation granule is the neck recovering particles, and its preparation method is: get (2) gained mixing fine powders, add B-cyclodextrin 25g, and mixing, drying adds the 0.5g stevioside, granulates, and drying is promptly made granule.
(7) a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation effervescent granule is a neck health effervescent granule, and its preparation method is to get (2) gained mixing fine powders, adds sodium bicarbonate 5g, citric acid 10g, mixing, add microcrystalline Cellulose 15g again, sucrose 50g, polyvidone 0.5g granulates, drying, quality inspection, packing, promptly.
(8) a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation capsule is the neck recovering capsule, and its preparation method is to get (2) gained mixing fine powders, adds micropowder silica gel, starch is an amount of, granulate, and drying, behind the granulate, the Capsules of packing into promptly gets capsule.
(9) a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation soft capsule is the neck caring 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.
(10) a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation neck disease treating drop pills or micropill or pellet capsule or granule or effervescent granule or capsule or soft capsule, its preparation method is:
1. medicine Main Ingredients and Appearance and weight consumption are as follows:
Radix Rehmanniae Preparata 204.5g, Radix Polygoni Multiflori 272.8g, Cortex Eucommiae 136.4g, Herba Pyrolae 136.4g, Rhizoma Drynariae (scalding) 136.4g, Ramulus Uncariae Cum Uncis 100g, Radix Puerariae 100g, Radix Notoginseng 50g, Semen Raphani (stir-fry) 86.2g;
2. get Radix Notoginseng 25g, be ground into fine powder, standby;
3. get eight flavors such as remaining Radix Notoginseng and Radix Rehmanniae Preparata, get above eight flavors, decoct with water 2～4 times, each 1～4 hour, collecting decoction filtered, and filtrate is concentrated into the thick paste of relative density 1.2～1.4 (80 ℃), and drying is pulverized, and gets mixing fine powders, and is standby;
4. a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation drop pill is the neck disease treating drop pills, its preparation method is taking polyethylene glycol PEG6000 30g, stearic acid 25g, Poloxamer188 20g, treat to add above-mentioned 3. gained mixing fine powders after Polyethylene Glycol PEG6000, stearic acid, Poloxamer188 are heated to 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.
5. a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation micropill is a neck health micropill, its preparation method is to get 3. gained mixing fine powders, with 30g 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.
6. a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation pellet capsule is a neck health pellet capsule, its preparation method is to get 3. gained mixing fine powders, with 30g 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.
7. a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation granule is the neck recovering particles, and its preparation method is: get 3. gained mixing fine powders, add B-cyclodextrin 30g, add oligomeric lactose 20g and fully stir, mixing, spray drying adds the 1g stevioside, granulate, drying is promptly made granule.
8. a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation effervescent granule is a neck health effervescent granule, and its preparation method is to get 3. gained mixing fine powders, adds sodium bicarbonate 5g, citric acid 10g, mixing, add microcrystalline Cellulose 10g again, sucrose 40g, polyvidone 0.5g granulates, drying, quality inspection, packing, promptly.
9. a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation capsule is the neck recovering capsule, and its preparation method is: get 3. gained mixing fine powders, add micropowder silica gel, starch is an amount of, granulate, and drying, behind the granulate, the Capsules of packing into promptly gets capsule.
10. a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation soft capsule is the neck caring soft capsule, its preparation method is: get 3. 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 invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation, it is the method for quality control of neck disease treating drop pills or micropill or pellet capsule or granule or effervescent granule or capsule or soft capsule:
According to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; With methanol-water (25: 75) is mobile phase, and the detection wavelength is 250nm, and theoretical cam curve is calculated by puerarin peak should be not less than 2000;
The preparation of reference substance solution, it is an amount of to get the puerarin reference substance, and accurate the title, decide, and adds methanol and make the solution that every 1ml contains 80ug, promptly;
This product or the about 5g of this product content are got in the preparation of need testing solution, and accurate the title decides, and puts in the 50ml measuring bottle, adds methanol and is diluted to scale, shakes up, and filters, and gets subsequent filtrate, promptly;
Algoscopy, accurate respectively above-mentioned reference substance solution and each 5ul of need testing solution of drawing injects chromatograph of liquid, measures, promptly.
Advantage of the present invention is:
Take, easy to carry, the bioavilability height is applicable to the difference crowd that takes medicine, and is conducive to improve drug effect.
Claims (7)
1, a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation is characterized in that it is that Main Ingredients and Appearance is neck disease treating drop pills or micropill or pellet capsule or granule or effervescent granule or capsule or the soft capsule of Radix Rehmanniae Preparata, Radix Polygoni Multiflori, the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), Ramulus Uncariae Cum Uncis, Radix Puerariae, Radix Notoginseng, Semen Raphani (stir-fry).
2, a kind of preparation method of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation, it is neck disease treating drop pills or micropill or pellet capsule or granule or effervescent granule or capsule or preparation of soft capsule method, it is characterized in that:
(1) medicine Main Ingredients and Appearance and weight proportion thereof are as follows:
50～350 parts of Radix Rehmanniae Preparata, 100～500 parts of Radix Polygoni Multiflori, respectively 40～250 parts of the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), each 10～200 parts of Ramulus Uncariae Cum Uncis, Radix Puerariaes, 5～100 parts of Radix Notoginseng, 10～150 parts of Semen Raphanis (stir-fry);
(2) get above eight flavors, decoct with water 1～4 time, each 1～4 hour, collecting decoction filtered, and filtrate is concentrated into the thick paste of relative density 1.2～1.4 (80 ℃), and drying is pulverized, and gets mixing fine powders, and is standby;
(3) get the mixing fine powders of (2) gained, add an amount of adjuvant, make neck disease treating drop pills or micropill or pellet capsule or granule or effervescent granule or capsule 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, add (2) gained mixing fine powders after being heated to 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 (2) gained mixing fine powders, 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 with the micropill that makes, pack into Capsules or enteric coated capsule promptly get pellet capsule;
Adjuvant is following one or more combinations or other suitable adjuvant, uses 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 an amount of adjuvant, mixing is granulated, drying, and granulate, coating or coating not promptly get 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;
The preparation method of its effervescent granule is; Get (2) gained mixing fine powders, add an amount of adjuvant, mixing is granulated, drying, and granulate, promptly;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion: microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, cane sugar powder, saccharin sodium, polyvidone, citric acid, tartaric acid, fumaric acid, sodium carbonate, sodium bicarbonate, edible essence;
Its capsular preparation method is: get (2) gained mixing fine powders, add an amount of adjuvant, mix homogeneously is granulated, coating or coating not, and pack into Capsules or enteric coated capsule promptly get capsule;
Adjuvant is one or more combinations or other suitable adjuvant of following material, uses with by arbitrary proportion: starch, carboxymethyl starch sodium, pregelatinized Starch, sucrose, glucose, mannitol, sorbitol, syrup, microcrystalline Cellulose, methylcellulose, carboxymethyl cellulose, ethyl cellulose, hydroxypropyl emthylcellulose, low-substituted hydroxypropyl cellulose, carboxymethylcellulose calcium, calcium sulfate, calcium hydrogen phosphate, calcium phosphate, calcium carbonate, light magnesium oxide, Pulvis Talci, micropowder silica gel, aluminium hydroxide, boric acid, sodium chloride, dextrin, magnesium stearate, hydrogenated vegetable oil, Polyethylene Glycol;
Its preparation of soft capsule method is: get (2) gained mixing fine powders, add an amount of adjuvant, 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 invigorating kidney, promoting blood circulation analgesic 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, oral cavity disintegration tablet, buccal tablet), ball, cream, loose, slow, controlled release capsule, oral liquid, injection etc.
4, the preparation method of a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation according to claim 2 is characterized in that neck disease treating drop pills or micropill or pellet capsule or granule or effervescent granule or capsule or preparation of soft capsule method also can be:
(1) medicine Main Ingredients and Appearance and weight proportion thereof are as follows:
50～350 parts of Radix Rehmanniae Preparata, 100～500 parts of Radix Polygoni Multiflori, respectively 40～250 parts of the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), each 10～200 parts of Ramulus Uncariae Cum Uncis, Radix Puerariaes, 5～100 parts of Radix Notoginseng, 10～150 parts of Semen Raphanis (stir-fry);
(2) get 25～75% of Radix Notoginseng weight proportion in the prescription, be ground into fine powder, standby;
(3) get eight flavors such as remaining Radix Notoginseng and Radix Rehmanniae Preparata, decoct with water 1～4 time, each 1～4 hour, collecting decoction filtered, and filtrate is concentrated into the thick paste of relative density 1.2～1.4 (80 ℃), and drying is pulverized, and gets mixing fine powders, and is standby;
(4) get the mixing fine powders of (3) gained, add an amount of adjuvant, make neck disease treating drop pills or micropill or pellet capsule or granule or effervescent granule or capsule 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, add (3) gained mixing fine powders after being heated to 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 (3) gained mixing fine powders, 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 with the micropill that makes, pack into Capsules or enteric hollow capsule promptly get pellet capsule;
Adjuvant is following one or more combinations or other suitable adjuvant, uses 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 (3) gained mixing fine powders, add an amount of adjuvant, mixing is granulated, drying, and granulate, coating or coating are not 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;
The preparation method of its effervescent granule is; Get (3) gained mixing fine powders, add an amount of adjuvant, mixing is granulated, drying, and granulate, promptly;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion: microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, cane sugar powder, saccharin sodium, polyvidone, citric acid, tartaric acid, fumaric acid, sodium carbonate, sodium bicarbonate, edible essence;
Its capsular preparation method is: get (3) gained mixing fine powders, add an amount of adjuvant, mix homogeneously is granulated, drying, and coating or coating not divide pack into Capsules or enteric hollow capsule, promptly get capsule;
Adjuvant is one or more combinations or other suitable adjuvant of following material, uses with by arbitrary proportion: starch, carboxymethyl starch sodium, pregelatinized Starch, sucrose, glucose, mannitol, sorbitol, syrup, microcrystalline Cellulose, methylcellulose, carboxymethyl cellulose, ethyl cellulose, hydroxypropyl emthylcellulose, low-substituted hydroxypropyl cellulose, carboxymethylcellulose calcium, calcium sulfate, calcium hydrogen phosphate, calcium phosphate, calcium carbonate, light magnesium oxide, Pulvis Talci, micropowder silica gel, aluminium hydroxide, boric acid, sodium chloride, dextrin, magnesium stearate, hydrogenated vegetable oil, Polyethylene Glycol;
Its preparation of soft capsule method is: get (3) 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 invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation, it is the method for quality control of neck disease treating drop pills or micropill or pellet capsule or granule or effervescent granule or capsule or soft capsule, it is characterized in that:
According to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; (10～30: 60～90) be mobile phase, the detection wavelength is 240～260nm, and theoretical cam curve is calculated by puerarin peak should be not less than 2000 with methanol-water;
The preparation of reference substance solution, it is an amount of to get the puerarin reference substance, and accurate the title, decide, and adds methanol and make the solution that every 1ml contains 80ug, promptly;
This product or the about 2～10g of this product content are got in the preparation of need testing solution, and accurate the title decides, and puts in the 50ml measuring bottle, adds methanol and is diluted to scale, shakes up, and filters, and gets subsequent filtrate, promptly;
Algoscopy, accurate respectively above-mentioned reference substance solution and each 5～15ul of need testing solution of drawing injects chromatograph of liquid, measures, promptly.
6, the preparation method of a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation according to claim 2 is characterized in that the preferred weight proportioning of its Main Ingredients and Appearance is:
100～300 parts of Radix Rehmanniae Preparata, 150～400 parts of Radix Polygoni Multiflori, respectively 60～200 parts of the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), each 50～150 parts of Ramulus Uncariae Cum Uncis, Radix Puerariaes, 25～75 parts of Radix Notoginseng, 40～120 parts of Semen Raphanis (stir-fry).
7, the preparation method of a kind of invigorating kidney, promoting blood circulation analgesic Chinese medicine preparation according to claim 2 is characterized in that the optimum weight proportioning of its Main Ingredients and Appearance is:
204.5 parts of Radix Rehmanniae Preparata, 272.8 parts of Radix Polygoni Multiflori, 136.4 parts of the Cortexs Eucommiae, 136.4 parts of Herba Pyrolaes, 136.4 parts of Rhizoma Drynariae (scalding), 100 parts of Ramulus Uncariae Cum Uncis, 100 parts of Radix Puerariaes, 50 parts of Radix Notoginseng, 86.2 parts of Semen Raphanis (stir-fry).
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200510032466 CN1813975A (en) | 2005-11-30 | 2005-11-30 | Chinese medicine preparation of kidney-tonifying bloodczirculation-activating and pain relieving, preparing method and quality control method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101953940A (en) * | 2010-10-16 | 2011-01-26 | 秦皇岛皇威制药有限公司 | Traditional Chinese medicine having function of tonifying kidney, invigorating blood circulation and relieving pain, preparation method and quality specification thereof |
| CN114617856A (en) * | 2021-09-07 | 2022-06-14 | 辽宁格林希尔医疗科技有限公司 | Solid-liquid suspension traditional Chinese medicine preparation and preparation method thereof |
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2005
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101953940A (en) * | 2010-10-16 | 2011-01-26 | 秦皇岛皇威制药有限公司 | Traditional Chinese medicine having function of tonifying kidney, invigorating blood circulation and relieving pain, preparation method and quality specification thereof |
| CN114617856A (en) * | 2021-09-07 | 2022-06-14 | 辽宁格林希尔医疗科技有限公司 | Solid-liquid suspension traditional Chinese medicine preparation and preparation method thereof |
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