CN1823897A - Chinese medicinal preparation for antimicrobial and anti inflammation, its preparation method and quality control method - Google Patents
Chinese medicinal preparation for antimicrobial and anti inflammation, its preparation method and quality control method Download PDFInfo
- Publication number
- CN1823897A CN1823897A CN 200510032579 CN200510032579A CN1823897A CN 1823897 A CN1823897 A CN 1823897A CN 200510032579 CN200510032579 CN 200510032579 CN 200510032579 A CN200510032579 A CN 200510032579A CN 1823897 A CN1823897 A CN 1823897A
- Authority
- CN
- China
- Prior art keywords
- preparation
- cellulose
- adjuvant
- radix salviae
- salviae miltiorrhizae
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Medicinal Preparation (AREA)
Abstract
An antibacterial Chinese medicine in the form of pill, dripping pill, micropill, dispersing tablet, particle, etc for relieving inflammation is prepared from red sage root through reflux extracting in alcohol, depositing in water to obtain the extract, mixing with auxiliaries and shaping. Its quality control method is also disclosed.
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 Chinese medicine preparation and preparation method thereof and method of quality control of anti-inflammation.
Background technology:
Ball in the Chinese medicine preparation or drop pill or enteric coated drop pill or micropill or pellet capsule or dispersible tablet or granule or enteric coated particles or effervescent granule, change dosage form and 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.The existing dosage form of this product is a capsule, has listed in the 17 of the national drug ministry standard.
A kind of process characteristic of Chinese medicine preparation tanshinone capsule of anti-inflammation is got Radix Salviae Miltiorrhizae and is processed into through suitable.
The Chinese medicine preparation tanshinone capsule of existing anti-inflammation exists dosage form single, can not satisfy the medication demand of sufferer, and poor stability is not suitable for shortcomings such as old man and children taking.Chinese medicine preparation of the present invention has multiple dosage form, can provide a lot of selections to the patient, satisfies the different demands of extensive patients.
Summary of the invention:
The Chinese medicine preparation and preparation method thereof and the method for quality control that the purpose of this invention is to provide a kind of anti-inflammation overcome the drawback of prior art, improve quality and the curative effect and 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 Chinese medicine preparation of anti-inflammation, it is that Main Ingredients and Appearance is TANSHINONES ball or drop pill or enteric coated drop pill or micropill or pellet capsule or dispersible tablet or granule or the enteric coated particles or the effervescent granule of Radix Salviae Miltiorrhizae.
A kind of preparation method of Chinese medicine preparation of anti-inflammation, it is the preparation method of TANSHINONES ball or drop pill or enteric coated drop pill or micropill or pellet capsule or dispersible tablet or granule or enteric coated particles or effervescent granule:
Get red rooted salvia, extract, get Radix Salviae Miltiorrhizae extract through suitable method, standby;
(1) get Radix Salviae Miltiorrhizae extract, add an amount of adjuvant, pill, drying, coating or coating not promptly get ball;
Adjuvant is one or more mixture or other proper auxiliary materials in the following material, uses with by arbitrary proportion: lactose, 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 or sodium chloride, dextrin, magnesium stearate, hydrogenated vegetable oil, Polyethylene Glycol;
(2) with one or more mixture or other the suitable adjuvant 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, use with by arbitrary proportion, add Radix Salviae Miltiorrhizae extract 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, sugar coating or film-coat or coating not, drying promptly gets drop pill;
(3) with one or more mixture or other the suitable adjuvant 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, use with by arbitrary proportion, add Radix Salviae Miltiorrhizae extract 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, enteric coated, drying promptly gets enteric coated drop pill;
The coating material of its enteric coating is one or more mixture or other suitable material in the following material, uses with by arbitrary proportion: acrylic resin II number, acrylic resin III number, cellulose acetate-phthalate (CAP), Lac, zein, the adjacent benzene diacetate (PVAP) of polyethylene, hydroxypropyl emthylcellulose acetic acid succinate (HPMCAS), ethyl cellulose;
(4) get Radix Salviae Miltiorrhizae extract, add an amount of adjuvant, mix homogeneously is granulated, and coating or coating are not made the micropill of diameter less than 2.5mm, promptly get micropill; Maybe the micropill that makes is incapsulated, promptly get pellet capsule;
Adjuvant is one or more mixture or other proper auxiliary materials in the following material, 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 Radix Salviae Miltiorrhizae extract, add an amount of adjuvant, mix homogeneously, compacting promptly gets dispersible tablet;
Adjuvant is one or more mixture or other proper auxiliary materials in the following material, use with by arbitrary proportion: low-substituted hydroxypropyl cellulose, dimension splash form sediment 5000, polyvinylpolypyrrolidone 1NF-10, polyethylene glycols, polyvinylpyrrolidone class, methylcellulose, ethyl cellulose, hydroxypropyl emthylcellulose, cellulose acetate-phthalate, hydroxypropyl methylcellulose phthalate, hydroxymethyl ethyl cellulose, microcrystalline Cellulose, citric acid, cholic acid, fumaric acid, succinic acid, tartaric acid, colloidality silicon dioxide, magnesium stearate, Pulvis Talci;
(6) get Radix Salviae Miltiorrhizae extract, add an amount of adjuvant, mix homogeneously is granulated, drying, and granulate, sugar coating or film-coat or coating not promptly get granule;
Adjuvant is one or more mixture or other proper auxiliary materials in the following material, uses with by arbitrary proportion: starch, dextrin, lactose, sucrose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, mannitol, xylitol, chitosan, SHUANGQITANG, ethanol, polyvinylpyrrolidone (PVP), sodium carboxymethyl cellulose (CMC-Na), low-substituted hydroxypropyl cellulose (L-HPC), Polyethylene Glycol (PEG);
(7) get Radix Salviae Miltiorrhizae extract, add an amount of adjuvant, mix homogeneously is granulated, drying, and granulate, enteric coated, promptly get enteric coated particles;
Adjuvant is one or more mixture or other proper auxiliary materials in the following material, uses with by arbitrary proportion: starch, dextrin, lactose, sucrose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, mannitol, xylitol, chitosan, SHUANGQITANG, ethanol, polyvinylpyrrolidone (PVP), sodium carboxymethyl cellulose (CMC-Na), low-substituted hydroxypropyl cellulose (L-HPC), Polyethylene Glycol (PEG);
The coating material of its enteric coating is one or more mixture or other suitable material in the following material, uses with by arbitrary proportion: acrylic resin II number, acrylic resin III number, cellulose acetate-phthalate (CAP), Lac, zein, the adjacent benzene diacetate (PVAP) of polyethylene, hydroxypropyl emthylcellulose acetic acid succinate (HPMCAS), ethyl cellulose;
(8) get Radix Salviae Miltiorrhizae extract, 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;
A kind of preparation method of Chinese medicine preparation of anti-inflammation, its Radix Salviae Miltiorrhizae extract preparation method can be in the following method any one:
(1) get red rooted salvia with 50%～98% alcohol reflux 1～3 time, each 1～3 hour, merge reflux extracting liquid, filter, filtrate recycling ethanol, concentrate drying is pulverized, Radix Salviae Miltiorrhizae extract;
(2) get red rooted salvia with 50～95% alcohol refluxs 1～3 time, each 1～3 hour, merge extractive liquid, filtered, and reclaims ethanol, concentrate, concentrated solution adds 4～8 times of water gaging water precipitating, leaves standstill 12～36 hours, centrifugal removal precipitation, supernatant is standby, filters, and concentrate drying is pulverized, and gets Radix Salviae Miltiorrhizae extract;
(3) get red rooted salvia with 60%～98% soak with ethanol percolation after 6～24 hours, collect percolate, reclaim ethanol, leave standstill, concentrate drying is pulverized, Radix Salviae Miltiorrhizae extract.
A kind of method of quality control of Chinese medicine preparation of anti-inflammation, it is the method for quality control of TANSHINONES ball or drop pill or enteric coated drop pill or micropill or pellet capsule or dispersible tablet or granule or enteric coated particles or effervescent granule:
Assay, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability experiment are filler with octadecyl silane; With acetonitrile-water (65～75: 20～35) be mobile phase; The detection wavelength is 260～280nm; Number of theoretical plate is pressed Tanshinone I I
AThe peak calculates should be not less than 2000;
The preparation of reference substance solution, precision take by weighing Tanshinone I I
AReference substance 5～12mg puts in the brown measuring bottle of 50ml, with dissolve with methanol and be diluted to scale, shakes up, and precision is measured 5ml, puts in the brown measuring bottle of 25ml, adds methanol to scale, shakes up, and promptly gets (to contain Tanshinone I I among every 1ml
A30～50ug);
The preparation of need testing solution is got this product or this product content, porphyrize, get fine powder 1～3g, the accurate title, decide, and puts in the tool plug triangular flask, the accurate methanol 10～40ml that adds claims to decide weight, supersound process 10～25 minutes, put coldly, claim again to decide weight, supply the weight that subtracts mistake with methanol, shake up, filter, get subsequent filtrate, promptly;
Algoscopy, accurate respectively reference substance and each 5～20ul of need testing solution of drawing injects chromatograph of liquid, measures.
Specific embodiments:
The present invention further specifies in conjunction with specific embodiments, and is only for reference, do not limit the scope of the invention.
A kind of Chinese medicine preparation of anti-inflammation, it is that Main Ingredients and Appearance is TANSHINONES ball or drop pill or enteric coated drop pill or micropill or pellet capsule or dispersible tablet or granule or the enteric coated particles or the effervescent granule of TANSHINONES.
Its function of Chinese medicine preparation of the present invention cures mainly and is anti-inflammation.Be used for osteomyelitis, acne, tonsillitis, otitis externa, furuncle, carbuncle, trauma infection contamination, burn infection, mastitis, cellulitis etc.
Specific embodiment one:
Get red rooted salvia 800g and measured 95% alcohol refluxs 1.5 hours, measured 50% alcohol refluxs 1.5 hours with 8 times for the second time, merge reflux extracting liquid, filter with 10 times, filtrate recycling ethanol, concentrate drying is pulverized, and adds suitable quantity of water or refined honey, mixing, pill, drying promptly gets the TANSHINONES ball.
Specific embodiment two:
Get red rooted salvia 800g and measured 75% alcohol refluxs 1.5 hours with 10 times, measured 50% alcohol reflux 1.5 hours for 8 times for the second time, merge reflux extracting liquid, filter, filtrate recycling ethanol, concentrate drying is pulverized, with Polyethylene Glycol PEG6000 200g, stearic acid 100g, Poloxamer188 30g treats Polyethylene Glycol PEG6000, stearic acid, Poloxamer188 adds in the above-mentioned gained fine drug powder after being heated to whole fusions, is transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 80 ℃, by splashing in the liquid paraffin, be condensed into ball at heat-retaining condition, to the greatest extent and the erasing liquor paraffin body with the drop pill drop of molding, cold drying promptly gets Tanshinoue dropping pills.
Specific embodiment three:
Get red rooted salvia 800g and measured 75% alcohol refluxs 2 hours with 10 times, measured 50% alcohol reflux 1.5 hours for 6 times for the second time, merge reflux extracting liquid, filter, filtrate recycling ethanol, concentrate drying is pulverized, with Polyethylene Glycol PEG6000 200g, stearic acid 100g, Poloxamer188 30g, treat Polyethylene Glycol PEG6000, stearic acid, Poloxamer188 adds in the above-mentioned gained fine drug powder after being heated to whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 80 ℃, by splashing in the liquid paraffin, be condensed into ball at heat-retaining condition, with the drop pill drop of molding to the greatest extent and the erasing liquor paraffin body, acrylic resin is used in cold drying, phthalic acid diethyl ester, the mixed liquor coating that the Semen Ricini wet goods is made promptly gets the TANSHINONES enteric coated drop pill.
Specific embodiment four:
Get red rooted salvia 800g and measured 75% alcohol refluxs 1.5 hours with 8 times, measured 50% alcohol reflux 1.5 hours for 6 times for the second time, merge reflux extracting liquid, filter, filtrate recycling ethanol, concentrate drying is pulverized, and adds 200g dextrin mix homogeneously, and 5%PVP alcohol liquid is binding agent, at first prepare 40 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 get the TANSHINONES micropill.
Specific embodiment five:
Get red rooted salvia 800g and measured 75% alcohol refluxs 1.5 hours, measured 50% alcohol reflux 1.5 hours for 6 times for the second time, merge reflux extracting liquid with 8 times, filter, filtrate recycling ethanol, concentrate drying is pulverized, and adds 200g dextrin mix homogeneously, 5%PVP alcohol liquid is binding agent, at first preparing 40 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, the micropill of making is incapsulated, promptly get the TANSHINONES pellet capsule.
Specific embodiment six:
Get red rooted salvia 800g and measured 95% alcohol refluxs 1.5 hours, measured 50% alcohol reflux 1.5 hours for 8 times for the second time, merge reflux extracting liquid with 10 times, filter, filtrate recycling ethanol, concentrate drying is pulverized, add cross-linking polyethylene pyrrolidone 40g, microcrystalline Cellulose 60g, mixing, 20 mesh sieves are granulated, 65 ℃ of dryings, 30 mesh sieve granulate, add 0.5% micropowder silica gel, mixing, tabletting promptly gets the TANSHINONES dispersible tablet.
Specific embodiment seven:
Get red rooted salvia 800g and measured 95% alcohol refluxs 1.5 hours, measured 50% alcohol reflux 1.5 hours for 8 times for the second time, merge reflux extracting liquid with 10 times, filter, filtrate recycling ethanol, concentrate drying is pulverized, and adds B-cyclodextrin 100g, adding oligomeric lactose 60g fully stirs, mixing, spray drying is granulated, drying promptly gets the TANSHINONES granule.
Specific embodiment eight:
Get red rooted salvia 800g and measured 95% alcohol refluxs 1.5 hours, measured 50% alcohol reflux 1.5 hours for 8 times for the second time, merge reflux extracting liquid with 10 times, filter, filtrate recycling ethanol, concentrate drying is pulverized, add B-cyclodextrin 100g, add oligomeric lactose 60g and fully stir mixing, spray drying, granulate, drying, the mixed liquor coating with acrylic resin, phthalic acid diethyl ester, Semen Ricini wet goods are made promptly gets the TANSHINONES enteric coated particles.
Specific embodiment nine:
Get red rooted salvia 800g and measured 95% alcohol refluxs 1.5 hours, measured 50% alcohol reflux 1.5 hours for 8 times for the second time, merge reflux extracting liquid with 10 times, filter, filtrate recycling ethanol, concentrate drying is pulverized, add B-cyclodextrin 20g, add oligomeric lactose 30g, add effervescent citric acid 220g, sodium bicarbonate 150g fully stirs, mixing, spray drying is granulated, and promptly gets the TANSHINONES effervescent granule.
Specific embodiment ten:
Get red rooted salvia 800g and measured 75% alcohol refluxs 1.5 hours with 6 times, 4 times of amounts of 50% ethanol were extracted merge extractive liquid, 1.5 hours, filter, reclaim ethanol, concentrate, add 6 times of water gaging water precipitating, left standstill 24 hours, centrifugal removal precipitation, the supernatant concentration drying and crushing, add entry and honey in right amount, mixing, pill, drying promptly gets the TANSHINONES ball.
Specific embodiment 11:
Get red rooted salvia 800g and measured 75% alcohol refluxs 1.5 hours with 6 times, 4 times of amounts of 50% ethanol were extracted 1.5 hours, merge extractive liquid,, filter, reclaim ethanol, concentrate, add 6 times of water gaging water precipitating, left standstill 24 hours, centrifugal removal precipitation, the supernatant concentration drying and crushing, with Polyethylene Glycol PEG6000 300g, stearic acid 120g, Poloxamer188 50g treats Polyethylene Glycol PEG6000, stearic acid, Poloxamer188 adds above-mentioned gained fine drug powder after being heated to whole fusions, is transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 80 ℃, by splashing in the liquid paraffin, be condensed into ball at heat-retaining condition, to the greatest extent and the erasing liquor paraffin body with the drop pill drop of molding, cold drying promptly gets Tanshinoue dropping pills.
Specific embodiment 12:
Get red rooted salvia 800g and measured 75% alcohol refluxs 1.5 hours with 6 times, 4 times of amounts of 50% ethanol were extracted 1.5 hours, merge extractive liquid,, filter, reclaim ethanol, concentrate, add 6 times of water gaging water precipitating, left standstill 24 hours, centrifugal removal precipitation, the supernatant concentration drying and crushing is with Polyethylene Glycol PEG6000 300g, stearic acid 120g, Poloxamer188 50g treats Polyethylene Glycol PEG6000, stearic acid, Poloxamer188 adds above-mentioned gained fine drug powder after being heated to whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 80 ℃, by splashing in the liquid paraffin, be condensed into ball at heat-retaining condition, with the drop pill drop of molding to the greatest extent and the erasing liquor paraffin body, cold drying, acrylic resin, phthalic acid diethyl ester, the mixed liquor coating that the Semen Ricini wet goods is made promptly gets the TANSHINONES enteric coated drop pill.
Specific embodiment 13:
Get red rooted salvia 800g and measured 75% alcohol refluxs 2 hours with 6 times, 4 times of amounts of 50% ethanol were extracted merge extractive liquid, 2 hours, filter, reclaim ethanol, concentrate, add 6 times of water gaging water precipitating, left standstill 24 hours, centrifugal removal precipitation, the supernatant concentration drying and crushing adds 240g dextrin mix homogeneously, and 5%PVP alcohol liquid is binding agent, at first prepare 40 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 get the TANSHINONES micropill.
Specific embodiment 14:
Get red rooted salvia 800g and measured 75% alcohol refluxs 2 hours with 6 times, 4 times of amounts of 50% ethanol were extracted 2 hours, merge extractive liquid,, filter, reclaim ethanol, concentrate, add 6 times of water gaging water precipitating, left standstill 24 hours, centrifugal removal precipitation, the supernatant concentration drying and crushing adds 240g dextrin mix homogeneously, 5%PVP alcohol liquid is binding agent, at first preparing 40 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, the micropill of making is incapsulated, promptly get the TANSHINONES pellet capsule.
Specific embodiment 15:
Get red rooted salvia 800g and measured 75% alcohol refluxs 1.5 hours with 6 times, 4 times of amounts of 50% ethanol were extracted 1.5 hours, and merge extractive liquid, filters, reclaim ethanol, concentrate, add 6 times of water gaging water precipitating, left standstill 24 hours, centrifugal removal precipitation, the supernatant concentration drying and crushing adds cross-linking polyethylene pyrrolidone 30g, microcrystalline Cellulose 60g, mixing, 20 mesh sieves are granulated, 65 ℃ of dryings, 30 mesh sieve granulate add 0.5% micropowder silica gel, mixing, tabletting promptly gets the TANSHINONES dispersible tablet;
Specific embodiment 16:
Get red rooted salvia 800g and measured 75% alcohol refluxs 1.5 hours with 6 times, 4 times of amounts of 50% ethanol were extracted merge extractive liquid, 1.5 hours, filter, reclaim ethanol, concentrate, add 6 times of water gaging water precipitating, left standstill 24 hours, centrifugal removal precipitation, the supernatant concentration drying and crushing adds B-cyclodextrin 120g, adds oligomeric lactose 80g and fully stirs, mixing, spray drying is granulated, drying promptly gets the TANSHINONES granule.
Specific embodiment 17:
Get red rooted salvia 800g and measured 75% alcohol refluxs 1.5 hours with 6 times, 4 times of amounts of 50% ethanol were extracted merge extractive liquid, 1.5 hours, filter, reclaim ethanol, concentrate, add 6 times of water gaging water precipitating, left standstill 24 hours, centrifugal removal precipitation, the supernatant concentration drying and crushing adds B-cyclodextrin 120g, adds oligomeric lactose 80g and fully stirs, mixing, spray drying is granulated, drying, the mixed liquor coating with acrylic resin, phthalic acid diethyl ester, Semen Ricini wet goods are made promptly gets the TANSHINONES enteric coated particles.
Specific embodiment 18:
Get red rooted salvia 800g and measured 75% alcohol refluxs 1.5 hours with 6 times, 4 times of amounts of 50% ethanol were extracted merge extractive liquid, 1.5 hours, filter, reclaim ethanol, concentrate, add 6 times of water gaging water precipitating, left standstill 24 hours, centrifugal removal precipitation, the supernatant concentration drying and crushing adds B-cyclodextrin 120g, adds oligomeric lactose 80g and fully stirs, mixing, spray drying is granulated, drying, the mixed liquor coating with acrylic resin, phthalic acid diethyl ester, Semen Ricini wet goods are made promptly gets the TANSHINONES enteric coated particles.
Specific embodiment 19:
Get red rooted salvia 800g with 8 times of amount 75% soak with ethanol percolation after 12 hours, collect percolate, reclaim ethanol, leave standstill, concentrate drying is pulverized, and adds suitable quantity of water or refined honey, mixing, and pill, drying promptly gets the TANSHINONES ball.
Specific embodiment 20:
Get red rooted salvia 800g with 8 times of amount 75% soak with ethanol percolation after 12 hours, collect percolate, reclaim ethanol, leave standstill, concentrate drying is pulverized, with Polyethylene Glycol PEG6000 180g, stearic acid 90g, Poloxamer188 20g, treat Polyethylene Glycol PEG6000, stearic acid, Poloxamer188 adds in the above-mentioned gained fine drug powder after being heated to whole fusions, be transferred to rapidly after stirring in the liquid containing bottle, 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 Tanshinoue dropping pills.
Specific embodiment 21:
Get red rooted salvia 800g with 8 times of amount 75% soak with ethanol percolation after 12 hours, collect percolate, reclaim ethanol, leave standstill, concentrate drying is pulverized, with Polyethylene Glycol PEG6000 180g, stearic acid 90g, Poloxamer188 20g, treat Polyethylene Glycol PEG6000, stearic acid, Poloxamer188 adds in the above-mentioned gained fine drug powder after being 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, use acrylic resin, phthalic acid diethyl ester, the mixed liquor coating that the Semen Ricini wet goods is made promptly gets the TANSHINONES enteric coated drop pill.
Specific embodiment 22:
Get red rooted salvia 800g with 8 times of amount 75% soak with ethanol percolation after 12 hours, collect percolate, reclaim ethanol, leave standstill, concentrate drying is pulverized, add 180g dextrin mix homogeneously, 5%PVP alcohol liquid is binding agent, at first prepares 40 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, promptly get the TANSHINONES micropill.
Specific embodiment 23:
Get red rooted salvia 800g with 8 times of amount 75% soak with ethanol percolation after 12 hours, collect percolate, reclaim ethanol, leave standstill, concentrate drying is pulverized, add 180g dextrin mix homogeneously, 5%PVP alcohol liquid is binding agent, at first prepares 40 purpose granules and makes parent nucleus, be binding agent with 5%PVP alcohol liquid again, add the mixed powder amplification and make 40 purpose micropills, the micropill of making is incapsulated, promptly get the TANSHINONES pellet capsule.
Specific embodiment 24:
Get red rooted salvia 800g with 8 times of amount 75% soak with ethanol percolation after 12 hours, collect percolate, reclaim ethanol, leave standstill, concentrate drying is pulverized, and adds cross-linking polyethylene pyrrolidone 60g, microcrystalline Cellulose 120g, mixing, 20 mesh sieves are granulated, 65 ℃ of dryings, 30 mesh sieve granulate add 0.5% micropowder silica gel, mixing, tabletting promptly gets the TANSHINONES dispersible tablet;
Specific embodiment 25:
Get red rooted salvia 800g with 8 times of amount 75% soak with ethanol percolation after 12 hours, collect percolate, reclaim ethanol, leave standstill, concentrate drying is pulverized, and adds B-cyclodextrin 90g, adds oligomeric lactose 50g and fully stirs mixing, spray drying is granulated, and drying promptly gets the TANSHINONES granule.
Specific embodiment 26:
Get red rooted salvia 800g with 8 times of amount 75% soak with ethanol percolation after 12 hours, collect percolate, reclaim ethanol, leave standstill, concentrate drying is pulverized, and adds B-cyclodextrin 20g, adds oligomeric lactose 30g, add effervescent citric acid 200g, sodium bicarbonate 140g fully stirs, mixing, spray drying, granulate, promptly get the TANSHINONES effervescent granule.
Specific embodiment 27:
Get red rooted salvia 800g with 8 times of amount 75% soak with ethanol percolation after 12 hours, collect percolate, reclaim ethanol, leave standstill, concentrate drying is pulverized, and adds B-cyclodextrin 100g, adds oligomeric lactose 60g and fully stirs, mixing, spray drying is granulated drying, mixed liquor coating with acrylic resin, phthalic acid diethyl ester, Semen Ricini wet goods are made promptly gets the TANSHINONES enteric coated particles.
The method of quality control of a kind of Chinese medicine preparation TANSHINONES ball of anti-inflammation or drop pill or enteric coated drop pill or micropill or pellet capsule or dispersible tablet or granule or enteric coated particles or effervescent granule is:
Assay, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability experiment are filler with octadecyl silane; With acetonitrile-water (73: 27) is mobile phase; The detection wavelength is 270nm; Number of theoretical plate is pressed Tanshinone I I
AThe peak calculates should be not less than 2000;
The preparation of reference substance solution, precision take by weighing Tanshinone I I
AReference substance 10mg puts in the brown measuring bottle of 50ml, with dissolve with methanol and be diluted to scale, shakes up, and precision is measured 5ml, puts in the brown measuring bottle of 25ml, adds methanol to scale, shakes up, and promptly gets (to contain Tanshinone I I among every 1ml
A40ug);
This product or this product content are got in the preparation of need testing solution, and porphyrize is got fine powder 0.5g, and accurate the title decides, and puts in the tool plug triangular flask, the accurate methanol 25ml that adds claims decide weight, and supersound process 15 minutes is put coldly, and weight decided in title again, supply the weight that subtracts mistake with methanol, shake up, filter, get subsequent filtrate, promptly;
Algoscopy, accurate respectively reference substance and each 10ul of need testing solution of drawing injects chromatograph of liquid, measures.
You point of the present invention is:
The bioavilability height is applicable to the different crowds that takes medicine, controllability and good stability, and You is beneficial to raising Curative effect.
Claims (4)
1, a kind of Chinese medicine preparation of anti-inflammation is characterized in that it is that Main Ingredients and Appearance is TANSHINONES ball or drop pill or enteric coated drop pill or micropill or pellet capsule or dispersible tablet or granule or the enteric coated particles or the effervescent granule of Radix Salviae Miltiorrhizae.
2, a kind of preparation method of Chinese medicine preparation of anti-inflammation, it is the preparation method of TANSHINONES ball or drop pill or enteric coated drop pill or micropill or pellet capsule or dispersible tablet or granule or enteric coated particles or effervescent granule, it is characterized in that:
Get red rooted salvia, extract, get Radix Salviae Miltiorrhizae extract, add suitable adjuvant, make TANSHINONES ball or drop pill or enteric coated drop pill or micropill or pellet capsule or dispersible tablet or granule or enteric coated particles or effervescent granule through suitable method;
The preparation method of its ball is: gets Radix Salviae Miltiorrhizae extract, adds an amount of adjuvant, and pill, drying, coating or coating not, promptly;
Adjuvant is one or more mixture or other proper auxiliary materials in the following material, uses with by arbitrary proportion: lactose, 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 or sodium chloride, dextrin, magnesium stearate, hydrogenated vegetable oil, Polyethylene Glycol;
The preparation method of its drop pill is: with one or more mixture or other the suitable adjuvant 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, use with by arbitrary proportion, add Radix Salviae Miltiorrhizae extract 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, sugar coating or film-coat or coating not, drying, promptly;
The preparation method of its enteric coated drop pill is: with one or more mixture or other the suitable adjuvant 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, use with by arbitrary proportion, add Radix Salviae Miltiorrhizae extract 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, enteric coated, drying, promptly;
The coating material of its enteric coating is one or more mixture or other suitable material in the following material, uses with by arbitrary proportion: acrylic resin II number, acrylic resin III number, cellulose acetate-phthalate (CAP), Lac, zein, the adjacent benzene diacetate (PVAP) of polyethylene, hydroxypropyl emthylcellulose acetic acid succinate (HPMCAS), ethyl cellulose;
The preparation method of its micropill or pellet capsule is: get Radix Salviae Miltiorrhizae extract, add an amount of adjuvant, mix homogeneously is granulated, and coating or coating are not made the micropill of diameter less than 2.5mm, promptly get micropill; Maybe the micropill that makes is incapsulated, promptly get pellet capsule;
Adjuvant is one or more mixture or other proper auxiliary materials in the following material, 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;
The preparation method of its dispersible tablet is: gets Radix Salviae Miltiorrhizae extract, adds an amount of adjuvant, and mix homogeneously, compacting, promptly;
Adjuvant is one or more mixture or other proper auxiliary materials in the following material, use with by arbitrary proportion: low-substituted hydroxypropyl cellulose, dimension splash form sediment 5000, polyvinylpolypyrrolidone 1NF-10, polyethylene glycols, polyvinylpyrrolidone class, methylcellulose, ethyl cellulose, hydroxypropyl emthylcellulose, cellulose acetate-phthalate, hydroxypropyl methylcellulose phthalate, hydroxymethyl ethyl cellulose, microcrystalline Cellulose, citric acid, cholic acid, fumaric acid, succinic acid, tartaric acid, colloidality silicon dioxide, magnesium stearate, Pulvis Talci;
Its particulate preparation method is: get Radix Salviae Miltiorrhizae extract, add an amount of adjuvant, mix homogeneously is granulated, drying, and granulate, sugar coating or film-coat or coating not, promptly;
Adjuvant is one or more mixture or other proper auxiliary materials in the following material, uses with by arbitrary proportion: starch, dextrin, lactose, sucrose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, mannitol, xylitol, chitosan, SHUANGQITANG, ethanol, polyvinylpyrrolidone (PVP), sodium carboxymethyl cellulose (CMC-Na), low-substituted hydroxypropyl cellulose (L-HPC), Polyethylene Glycol (PEG);
The preparation method of its enteric coated particles is: get Radix Salviae Miltiorrhizae extract, add an amount of adjuvant, mix homogeneously is granulated, drying, and granulate, enteric coated, promptly;
Adjuvant is one or more mixture or other proper auxiliary materials in the following material, uses with by arbitrary proportion: starch, dextrin, lactose, sucrose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, mannitol, xylitol, chitosan, SHUANGQITANG, ethanol, polyvinylpyrrolidone (PVP), sodium carboxymethyl cellulose (CMC-Na), low-substituted hydroxypropyl cellulose (L-HPC), Polyethylene Glycol (PEG);
The coating material of its enteric coating is one or more mixture or other suitable material in the following material, uses with by arbitrary proportion: acrylic resin II number, acrylic resin III number, cellulose acetate-phthalate (CAP), Lac, zein, the adjacent benzene diacetate (PVAP) of polyethylene, hydroxypropyl emthylcellulose acetic acid succinate (HPMCAS), ethyl cellulose;
The preparation method of its effervescent granule is: get Radix Salviae Miltiorrhizae extract, 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.
3, the preparation method of the Chinese medicine preparation of a kind of anti-inflammation according to claim 2 is characterized in that the Radix Salviae Miltiorrhizae extract preparation method can be in the following method any one:
(1) get red rooted salvia with 50%～98% alcohol reflux 1～3 time, each 1～3 hour, merge reflux extracting liquid, filter, filtrate recycling ethanol, concentrate drying is pulverized, Radix Salviae Miltiorrhizae extract;
(2) get red rooted salvia with 50～95% alcohol reflux 1～3 time, each 1～3 hour, merge extractive liquid, filtered, reclaim ethanol, concentrate, concentrated solution adds 4～8 times of water gaging water precipitating, leaves standstill 12～36 hours, centrifugal removal precipitation, supernatant liquid filtering, concentrate drying is pulverized, and gets Radix Salviae Miltiorrhizae extract;
(3) get red rooted salvia with 60%～98% soak with ethanol percolation after 6～24 hours, collect percolate, reclaim ethanol, leave standstill, concentrate drying is pulverized, Radix Salviae Miltiorrhizae extract.
4, a kind of method of quality control of Chinese medicine preparation of anti-inflammation, it is the method for quality control of TANSHINONES ball or drop pill or enteric coated drop pill or micropill or pellet capsule or dispersible tablet or granule or enteric coated particles or effervescent granule, it is characterized in that:
Assay, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability experiment are filler with octadecyl silane; With acetonitrile-water (65～75: 20～35) be mobile phase; The detection wavelength is 260～280nm; Number of theoretical plate is pressed Tanshinone I I
AThe peak calculates should be not less than 2000;
The preparation of reference substance solution, precision take by weighing Tanshinone I I
AReference substance 5～12mg puts in the brown measuring bottle of 50ml, with dissolve with methanol and be diluted to scale, shakes up, and precision is measured 5ml, puts in the brown measuring bottle of 25ml, adds methanol to scale, shakes up, and promptly gets (to contain Tanshinone I I among every 1ml
A30～50ug);
The preparation of need testing solution is got this product or this product content, porphyrize, get fine powder 1～3g, the accurate title, decide, and puts in the tool plug triangular flask, the accurate methanol 10～40ml that adds claims to decide weight, supersound process 10～25 minutes, put coldly, claim again to decide weight, supply the weight that subtracts mistake with methanol, shake up, filter, get subsequent filtrate, promptly;
Algoscopy, accurate respectively reference substance and each 5～20ul of need testing solution of drawing injects chromatograph of liquid, measures.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510032579 CN1823897A (en) | 2005-12-20 | 2005-12-20 | Chinese medicinal preparation for antimicrobial and anti inflammation, its preparation method and quality control method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510032579 CN1823897A (en) | 2005-12-20 | 2005-12-20 | Chinese medicinal preparation for antimicrobial and anti inflammation, its preparation method and quality control method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1823897A true CN1823897A (en) | 2006-08-30 |
Family
ID=36934837
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510032579 Pending CN1823897A (en) | 2005-12-20 | 2005-12-20 | Chinese medicinal preparation for antimicrobial and anti inflammation, its preparation method and quality control method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1823897A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1939405B (en) * | 2006-09-30 | 2012-03-14 | 北京亚东生物制药有限公司 | Drop pills for treating coronary heart disease and making method thereof |
| CN102954905A (en) * | 2012-11-28 | 2013-03-06 | 康普药业股份有限公司 | Method for stripping enteric coating of tablet |
| CN112007005A (en) * | 2020-09-10 | 2020-12-01 | 金华市人民医院 | Tanshinone sustained-release dropping pill for treating coronary heart disease and preparation method thereof |
-
2005
- 2005-12-20 CN CN 200510032579 patent/CN1823897A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1939405B (en) * | 2006-09-30 | 2012-03-14 | 北京亚东生物制药有限公司 | Drop pills for treating coronary heart disease and making method thereof |
| CN102954905A (en) * | 2012-11-28 | 2013-03-06 | 康普药业股份有限公司 | Method for stripping enteric coating of tablet |
| CN112007005A (en) * | 2020-09-10 | 2020-12-01 | 金华市人民医院 | Tanshinone sustained-release dropping pill for treating coronary heart disease and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1813899A (en) | Anti cancer Chinese medicine for mulation and its preparing method | |
| CN1824178A (en) | Chinese medicinal preparation for treating urinary system disease, its preparation method and quality control method | |
| CN1814157A (en) | Chinese medicine preparation for detoxicating and pain-relieving, preparation method and quality control method | |
| CN1723945A (en) | Novel oral liquor for invigorating spleen, and prepn. method and quality control therefor | |
| CN1709363A (en) | Chinese medicine formulation for tonifying spleen to nourish qi, and its preparing method | |
| CN1823897A (en) | Chinese medicinal preparation for antimicrobial and anti inflammation, its preparation method and quality control method | |
| CN1709369A (en) | Chinese medicine formualtion for waring middle energizer to invigorate spleen, and its preparing method | |
| CN1739601A (en) | Anticancer Chinese medicine prepn and its prepn process | |
| CN1739715A (en) | Chinese medicine prepn for nourishing kidney and liver and its prepn process | |
| CN1813953A (en) | Chinese medicine formulation for promoting blood circulation to arrest pain, and its preparing method and quality control method | |
| CN1686479A (en) | Loquat drip pill for treating cough and its preparation method | |
| CN1698822A (en) | 'Gansu' dripping pills for treating hepatitis and its preparation method | |
| CN1682819A (en) | Sihuang intense heat purging dripping pill and its preparing method | |
| CN1686482A (en) | Kaihoujian drip pill for treating throat disease and its preparation method | |
| CN1724027A (en) | Traditional Chinese medicinal prepn. for treating intestinal tract diseases, and its prepn. method | |
| CN1686452A (en) | Two kinds of oral drip pills for treating tracheitis and its preparation method | |
| CN1686477A (en) | Lonicera flower mango drip pill and its preparation method | |
| CN1307985C (en) | Melastome drip pill and its preparation method | |
| CN1686381A (en) | Jaundice capillaris drip pill and its preparation method | |
| CN1686521A (en) | Psoriasis drip pill and its preparation method | |
| CN1660371A (en) | Oral drop pills in use for treating diseases of bacterial infection and preparation method | |
| CN1660316A (en) | Drop pills preparation in use for treating bronchitis and preparation method | |
| CN1814022A (en) | Chinese medicine preparation for tonifying yin and supplementing blood, and preparing method | |
| CN1709413A (en) | Golden gallbladder-normalizing dropping pill for relaxing-liver and normalizing gallbladder, and its preparing method | |
| CN1709362A (en) | Chinese medicine formulation for promoting blood circulation to remove blood stasis, and its preparing method and quality control method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C12 | Rejection of a patent application after its publication | ||
| RJ01 | Rejection of invention patent application after publication |