CN100551362C - Double coptis effervescent tablets and preparation method - Google Patents
Double coptis effervescent tablets and preparation method Download PDFInfo
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Abstract
The present invention relates to double coptis effervescent tablets and preparation method thereof.Medicine of the present invention is a raw material with Flos Lonicerae, Fructus Forsythiae, Radix Scutellariae, is prepared into double coptis effervescent tablets through special process, has the effect of heat-clearing and toxic substances removing, be used for the anemopyretic cold heating, cough, pharyngalgia, improved bioavailability, and have be easy to oral, dosage is little, characteristics such as easy to carry.Preferred adjuvant of the present invention and annular effervescent tablet can make the rapid disintegrate of double coptis effervescent tablets.
Description
Technical field
The present invention relates to the fabricating technology field of Chinese patent medicine effervescent tablet, relate in particular to double coptis effervescent tablets and preparation method.
Background technology
At present, the domestic main effervescent tablet of China is health product, as vitamin C effervescent tablet, also has plenty of the effervescent tablet of gynecological external use medicine, as JIEERYIN PAOTENGPIAN, and metronidazole vagina effervescent tablet etc., but the oral Chinese medicine effervescent formulation is less.And pharmacopeia side's SHUANGHUANGLIAN KELI is made the effervescent tablet of oral pure Chinese medicinal preparation, do not appear in the newspapers as yet.In addition, ring segment early has application in food industry, but less in the field of medicaments application, particularly in the effervescent tablet preparation field, does not appear in the newspapers as yet.
The Chinese medicine effervescent tablet is a kind of new dosage form, have that drug release rate is fast, dosage is little, divided dose is accurate, take, advantage such as easy to carry, and the oral administration effervescing sheet is specially adapted to the patient of child, old people and the solid preparation of can not swallowing.SHUANGHUANLIAN class Chinese patent medicine is to have heat-clearing toxin-expelling functions, be used for the anemopyretic cold heating, cough, the common medicine of pharyngalgia, former dosage form have SHUANGHUANGLIAN KOUFUYE (to record in the Drug Standard of Ministry of Public Health of the Peoples Republic of China new drug standard the 9th of becoming a full member, 11), SHUANGHUANGLIAN KOUFUYE (is recorded in National Drug Administration's drug standard new drug standard the 16 of becoming a full member, 20,24), SHUANGHUANGLIAN KOUFUYE (recording) in one one of 2000 editions Chinese Pharmacopoeia, SHUANGHUANGLIAN KELI (record in Drug Standard of Ministry of Public Health of the Peoples Republic of China new drug become a full member the 11 of standard), SHUANGHUANGLIAN KELI (record in National Drug Administration's drug standard new drug become a full member the 25 of standard), SHUANGHUANGLIAN JIAONANG (is recorded in National Drug Administration's drug standard new drug standard the 24 of becoming a full member, 25), SHUANGHUANGLIAN PIAN (is recorded in National Drug Administration's drug standard new drug standard the 25 of becoming a full member, 26), SHUANGHUANLIAN bolt (recording) in one one of 2000 editions Chinese Pharmacopoeia, SHUANGHUANGLIAN KELI (recording) in one one of 2000 editions Chinese Pharmacopoeia, SHUANGHUANGLIAN FENZHENJI (lyophilizing) (is recorded in National Drug Administration's drug standard new drug standard the 18 of becoming a full member, 22), SHUANGHUANGLIAN FENZHENJI (record in National Drug Administration's drug standard new drug become a full member the 18 of standard).
All there are some shortcomings in original dosage form, and oral liquid in the precipitate with ethanol process, has lost many effective ingredient, thereby influenced curative effect in order to keep clarity.Capsule, tablet generally are not suitable for child and old man's medication because of the inconvenience of swallowing; Suppository uses inconvenience, and cost is higher, and China patient is not glad to be accepted; The shortcoming of granule is to take after mixing it with hot water, and dissolving is not exclusively normal, easily produce precipitation, and taking dose is big; The complex process of injectable powder to the requirement height of preparation, and is used inconvenient.
Summary of the invention
The purpose of this invention is to provide a kind of double coptis effervescent tablets and preparation method,, satisfy needs of medical treatment better to overcome the deficiency of present dosage form.
The composition of double coptis effervescent tablets of the present invention comprises SHUANGHUANLIAN extract powder, disintegrating agent and other adjuvant.Other adjuvant comprises lubricant, can add binding agent, sweeting agent and/or aromatic again in other adjunct ingredient, to improve taste and mouthfeel.
Another important feature of the present invention is that ring segment is incorporated into the double coptis effervescent tablets preparation field, has invented SHUANGHUANLIAN annular effervescent tablet.Contain various saccharides, polysaccharide macromolecular material in the SHUANGHUANLIAN medical material, so the extract powder that makes after the SHUANGHUANLIAN extract drying has very strong viscosity.After being made into double coptis effervescent tablets, these materials form one deck adhesive film in tablet surface easily when effervescent tablet is met the water disintegrate, influence the disintegration rate of effervescent tablet.After being made into ring segment, increased the contact surface of disintegrating agent and water, made disintegrating agent from about two aspects and water effect.Effervescent tablet is easy to rupture after being subjected to the power of both direction, thereby has increased the contact surface with water more, makes effervescent tablet disintegrate fully in the short time.
Because health care products effervescent dosage form and Western medicine effervescent dosage form are very fast because of self Material Characteristics disintegrate, health care products effervescent dosage form and Western medicine effervescent dosage form are made the technical meaning that ring segment further improves disintegration rate do not give prominence to.But to double coptis effervescent tablets, be made into annular, but can improve disintegration rate greatly, significant, the annular double coptis effervescent tablets of disintegrate had both met national standard in two minutes even in one minute, can satisfy patient's demand easy to use again; Need the disintegrate of 4-5 minute ability to compare with the common double coptis effervescent tablets, the commercial value of annular double coptis effervescent tablets aspect the disintegrate convenience is higher.
Each constituent proportioning (mass percent) of double coptis effervescent tablets of the present invention is: Fructus Forsythiae, Flos Lonicerae extractum powder 30-65 part, Radix Scutellariae extract 3-6.5 part, disintegrating agent comprises sour agent 10-30 part, alkaline agent 10-30 part and auxiliary disintegrating agent 0-30 part, other adjuvant comprises binding agent 0-6 part, lubricant 2-5 part, sweeting agent 0-5 part, aromatic 0-5 part.
Usually, every 100g Fructus Forsythiae, Flos Lonicerae extractum powder are equivalent to Fructus Forsythiae, Chinese medicine honeysuckle 800-1200g, and every 100g Radix Scutellariae extract is equivalent to radix scutellariae medicinal materials 1300-1600g.
The acid agent can be selected from one or more in citric acid, tartaric acid, malic acid, fumaric acid, anhydrous citric acid, citric acid or the sodium dihydrogen citrate salt; Alkaline agent can be selected from one or more in potassium carbonate, potassium bicarbonate, sodium carbonate, sodium bicarbonate, calcium carbonate, the calcium bicarbonate; Auxiliary disintegrating agent can be selected from one or more of low-substituted hydroxypropyl cellulose (L-HPC), microcrystalline Cellulose (MCC), crospolyvinylpyrrolidone (PVPP).
The optional non-aqueous solution (as ethanol, isopropyl alcohol etc.) of binding agent from polyvinylpyrrolidone (PVP) variable concentrations.
Optional in Polyethylene Glycol (PEG) 6000, Polyethylene Glycol (PEG) 4000, sodium lauryl sulphate, magnesium stearate, Pulvis Talci, silicon dioxide one or more of lubricant.
Sweeting agent can be selected from one or more in cyclamate, steviosin, acesulfame potassium, aspartame, protein sugar, sucrose, the saccharin sodium (calcium) etc.
Aromatic can be selected from one or more among orange essence, flavoring orange essence, Herba Menthae essence or Fructus Citri Limoniae essence, the flavoring banana essence etc.
Double coptis effervescent tablets of the present invention can be by following three kinds of methods preparation, and concrete steps are:
Method one: (1) spray-dried Fructus Forsythiae that obtains, the airtight preservation of Flos Lonicerae extractum powder are standby, and be standby through extracting the airtight preservation of Radix Scutellariae extract that drying and crushing obtains; Sour agent, alkaline agent, other disintegrating agent pulverize separately are crossed the 80-100 mesh sieve, and airtight preservation is standby; Sweeting agent and aromatic were pulverized the 100-120 mesh sieve, and lubricant was pulverized the 140-200 mesh sieve; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; (2) press required proportioning with Fructus Forsythiae, Flos Lonicerae extractum powder, Radix Scutellariae extract and sour agent mix homogeneously, or add sweeting agent again or/and the aromatic mix homogeneously gets powders A 1; (3), get powder B1 with the alkaline agent mix homogeneously; (4) powders A 1 is mixed with powder B1, add lubricant, add or do not add other disintegrating agent, fully mixing; (5) with the 4th step gained mixed-powder tabletting, obtain required double coptis effervescent tablets.
Method two: (1) spray-dried Fructus Forsythiae that obtains, the airtight preservation of Flos Lonicerae extractum powder are standby, and be standby through extracting the airtight preservation of Radix Scutellariae extract that drying and crushing obtains; Sour agent, alkaline agent, other disintegrating agent pulverize separately are crossed the 80-100 mesh sieve, and airtight preservation is standby; Sweeting agent and aromatic were pulverized the 100-120 mesh sieve, and lubricant was pulverized the 140-200 mesh sieve; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; (2) press required proportioning with Fructus Forsythiae, Flos Lonicerae extractum powder, Radix Scutellariae extract and sour agent mix homogeneously, or add sweeting agent again, get granule A2 or/and the aromatic mix homogeneously is granulated; (3), granulate with the alkaline agent mix homogeneously; Get granule B2; (4) granule A2 is mixed with granule B2, add lubricant, add or do not add other disintegrating agent, fully mixing; (5) with the 4th step gained hybrid particles tabletting, obtain required double coptis effervescent tablets.
Method three: (1) spray-dried Fructus Forsythiae that obtains, the airtight preservation of Flos Lonicerae extractum powder are standby, and be standby through extracting the airtight preservation of Radix Scutellariae extract that drying and crushing obtains; Sour agent, alkaline agent, other disintegrating agent pulverize separately are crossed the 80-100 mesh sieve, and airtight preservation is standby; Sweeting agent and aromatic were pulverized the 100-120 mesh sieve, and lubricant was pulverized the 140-200 mesh sieve; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; (2) press required proportioning with Fructus Forsythiae, Flos Lonicerae extractum powder, Radix Scutellariae extract and sour agent mix homogeneously, or add sweeting agent again or/and the aromatic mix homogeneously gets powders A 3; (3), get powder B3 with the alkaline agent mix homogeneously; (4) powders A 3 is mixed with powder B3, add lubricant, add or do not add other disintegrating agent, fully mixing; (5) the 4th step gained mixed-powder is added non-aqueous solution (as ethanol, isopropyl alcohol etc.) pelletizing press sheet, obtain required double coptis effervescent tablets.
The profile of double coptis effervescent tablets done circularize.
The Fructus Forsythiae that the spray drying of learning from else's experience respectively obtains, Flos Lonicerae extractum powder 98g, the Radix Scutellariae extract 10g that obtains through extraction, pulverized citric acid 30g, sodium bicarbonate 34g, the acesulfame potassium 2g of 100 mesh sieves, essence 1g, the PEG6000 10g that pulverized 140 mesh sieves, low-substituted hydroxypropyl cellulose (L-HPC) 15g, make the double coptis effervescent tablets of about 2g/ sheet by above-mentioned three kinds of preparation methoies, in the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%.Prepared double coptis effervescent tablets is with reference to " 2000 editions one appendix XII A of Chinese pharmacopoeia inspection technique disintegration detects, and the result is up to specification, sees Table 1.
Check result disintegration of three kinds of preparation method gained of table 1 double coptis effervescent tablets
Another important feature of the present invention is to have added in the pelletization other tablet disintegrating agent commonly used such as low-substituted hydroxypropyl cellulose (L-HPC), as can be seen from the table, prepare double coptis effervescent tablets by above-mentioned three kinds of methods, the effervescent tablet that adds L-HPC is shorter than the effervescent tablet disintegration time that does not add L-HPC, and can significantly improve disintegration rate after making annular effervescent tablet.In three kinds of methods, the same terms adopts the double coptis effervescent tablets disintegration time of method two preparation the shortest down, is preferred technology.
In the above-mentioned preparation method, granulating process can adopt methods such as wet granulation, dry granulation, one-step palletizing when big production.
Used Fructus Forsythiae, Flos Lonicerae extractum powder and the Radix Scutellariae extract of said method prepares by the following method:
(1) selection of crude drug: (by weight)
The proportioning of crude drug of the present invention is: (by weight)
1 part of Flos Lonicerae, 1 part of Radix Scutellariae, 2 parts of Fructus Forsythiaes;
(2) above three flavor medical materials are cleaned respectively, remove impurity, it is standby to be up to the standards: get the Radix Scutellariae section, water decocts three times, and 2 hours for the first time, second and third time each 1 hour, collecting decoction filters, and filtrate is concentrated into relative density 1.05-1.10 (80 ℃ of surveys), in the time of 80 ℃, add the 2mol/L hydrochloric acid solution and regulate pH value, be incubated 1 hour, left standstill 24 hours to 1.0-2.0, filter, precipitation washes with water to pH value 5.0, and continuing and being washed till pH value with 70% ethanol is 7.0, cold drying is ground into fine powder, and is standby; Get Fructus Forsythiae, Flos Lonicerae powder and be broken into fine powder/be ground into coarse powder/be cut into decoction pieces, decoct with water each 1-3 hour 2-3 time, collecting decoction filters, and filtrate is concentrated to relative density and is about 1.15-1.30 (70-80 ℃), wait to be chilled to 40 ℃, add ethanol and make and contain alcohol amount and reach 75%, left standstill 6-24 hour, it is an amount of that leaching supernatant, residue add 75% ethanol, left standstill 6-24 hour, filter, merge ethanol liquid, reclaim ethanol to there not being the alcohol flavor, and be concentrated into relative density 1.05-1.20 (60-65 ℃), be dried to extract powder.
To adopt be drying under reduced pressure or spray drying to the drying of extract in the technology.The drying under reduced pressure temperature is controlled at 50-80 ℃, and the best is 60 ℃.
The present invention uses the modern pharmaceutical technology, it is carried out the dosage form process modification, thereby obtain a kind of double coptis effervescent tablets, many weak points of original dosage form have been remedied, and make it become a kind of production technology by optimization more to become fully rationally, quality is easy to control, and drug release rate is fast, the bioavailability height carries, the SHUANGHUANLIAN new formulation of taking convenience.
Specific embodiment
Embodiment 1
1, the preparation of Fructus Forsythiae, Flos Lonicerae extractum powder and Radix Scutellariae extract
(1) proportioning of crude drug is:
Flos Lonicerae 1500g Radix Scutellariae 1500g Fructus Forsythiae 3000g
(2) above three flavor medical materials are cleaned respectively, remove impurity, it is standby to be up to the standards: get the Radix Scutellariae section, water decocts three times, 2 hours for the first time, second and third time each 1 hour, collecting decoction filters, and filtrate is concentrated into relative density 1.05-1.10 (80 ℃ of surveys), in the time of 80 ℃, add the 2mol/L hydrochloric acid solution and regulate pH value to 1.0-2.0, be incubated 1 hour, left standstill 24 hours, filter, precipitation washes with water to pH value 5.0, continuing and being washed till pH value with 70% ethanol is 7.0, and cold drying is ground into fine powder, get 103g, yield 6.9%; Get Fructus Forsythiae, Flos Lonicerae powder and be broken into fine powder/be ground into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, filtrate is concentrated to relative density and is about 1.15-1.30 (70-80 ℃), wait to be chilled to 40 ℃, add ethanol and make and contain alcohol amount and reach 75%, left standstill 6-24 hour, the leaching supernatant, it is an amount of that residue adds 75% ethanol, left standstill 6-24 hour, filters, merge ethanol liquid, reclaim ethanol and do not distinguish the flavor of, and be concentrated into relative density 1.08-1.15 (60-65 ℃), be dried to extract powder to there being alcohol, obtain Fructus Forsythiae, Flos Lonicerae extractum powder 487g altogether, yield 10.8%.
2, preparation double coptis effervescent tablets (100)
The prescription proportioning:
Fructus Forsythiae, Flos Lonicerae 98g Radix Scutellariae extract 10g
Citric acid 35g steviosin 3g
Essence 1g sodium bicarbonate 25g
Sodium carbonate 10g low-substituted hydroxypropyl cellulose 12g
PEG?6000 6g
3, preparation method
The spray-dried Fructus Forsythiae that obtains, Flos Lonicerae extractum powder, the airtight preservation of Radix Scutellariae extract are standby; Citric acid, sodium bicarbonate, sodium carbonate, low-substituted hydroxypropyl cellulose pulverize separately are crossed 100 mesh sieves, and airtight preservation is standby; Steviosin and essence were pulverized 100 mesh sieves, and PEG 6000 pulverized 200 mesh sieves; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; With Fructus Forsythiae, Flos Lonicerae extractum powder, Radix Scutellariae extract and citric acid mix homogeneously, add steviosin and essence mix homogeneously by required proportioning again, get powders A; With sodium bicarbonate, sodium carbonate mix homogeneously, get powder B; Powders A is mixed with powder B, add PEG 6000, low-substituted hydroxypropyl cellulose, fully mixing; Gained mixed-powder direct compression gets 100 of double coptis effervescent tablets.
The average sheet of gained double coptis effervescent tablets heavily is 2.00 ± 0.04g, any surface finish, exquisiteness.With reference to " 2000 editions one appendix XII A of Chinese pharmacopoeia inspection technique disintegration is checked this product, 25 ℃ of a slice effervescent tablet inputs are filled in the 250ml beaker of 200ml water, there are a large amount of bubbles to emit immediately, tablet dissolves, is scattered in the water rapidly, formed the yellowish-brown clear solution in 5 minutes, it is left not have accumulative granule.Check 6 all qualified, the result is up to specification.
Embodiment 2
1, the preparation of Fructus Forsythiae, Flos Lonicerae extractum powder and Radix Scutellariae extract: with embodiment 1.
2, SHUANGHUANLIAN annular effervescent tablet (100)
The prescription proportioning:
Fructus Forsythiae, Flos Lonicerae extractum powder 98g Radix Scutellariae extract 10g
Tartaric acid 30g cyclamate 3g
Essence 1g potassium bicarbonate 25g
Crospolyvinylpyrrolidone 16g PEG 4000 16g
PVP 1g
3, preparation method
The spray-dried Fructus Forsythiae that obtains, Flos Lonicerae extractum powder, the airtight preservation of Radix Scutellariae extract are standby; Tartaric acid, potassium bicarbonate, crospolyvinylpyrrolidone pulverize separately are crossed 100 mesh sieves, and airtight preservation is standby; Cyclamate and essence were pulverized 100 mesh sieves, and PEG 4000 pulverized 200 mesh sieves; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; With Fructus Forsythiae, Flos Lonicerae extractum powder, Radix Scutellariae extract and tartaric acid mix homogeneously, add cyclamate and essence mix homogeneously by required proportioning again, get powders A; With the potassium bicarbonate mix homogeneously, get powder B; Powders A is mixed with powder B, add PEG 4000, crospolyvinylpyrrolidone, fully mixing; The gained mixed-powder is granulated with the alcoholic solution of 5% PVP, tabletting, 100 of SHUANGHUANLIAN annular effervescent tablets.
The average sheet of gained SHUANGHUANLIAN annular effervescent tablet heavily is 1.99 ± 0.03g, any surface finish, exquisiteness.With reference to " 2000 editions one appendix XII A of Chinese pharmacopoeia inspection technique disintegration is checked this product, 25 ℃ of a slice effervescent tablet inputs are filled in the 250ml beaker of 200ml water, there are a large amount of bubbles to emit immediately, tablet dissolves, is scattered in the water rapidly, formed the yellowish-brown clear solution in 5 minutes, it is left not have accumulative granule.Check 6 all qualified, the result is up to specification.
Embodiment 3
1, the preparation of Fructus Forsythiae, Flos Lonicerae extractum powder and Radix Scutellariae extract: with embodiment 1.
2, preparation SHUANGHUANLIAN annular effervescent tablet (100)
The prescription proportioning:
Fructus Forsythiae, Flos Lonicerae extractum powder 98g Radix Scutellariae extract 10g
Malic acid 35g acesulfame potassium 4g
Essence 1g sodium bicarbonate 30g
Microcrystalline Cellulose 14g magnesium stearate 8g
3, preparation method
The spray-dried Fructus Forsythiae that obtains, Flos Lonicerae extractum powder, the airtight preservation of Radix Scutellariae extract are standby; Malic acid, sodium bicarbonate, potassium carbonate, microcrystalline Cellulose pulverize separately are crossed 100 mesh sieves, and airtight preservation is standby; Acesulfame potassium and essence were pulverized 100 mesh sieves, and magnesium stearate was pulverized 140 mesh sieves; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; With Fructus Forsythiae, Flos Lonicerae extractum powder, Radix Scutellariae extract and malic acid mix homogeneously, add acesulfame potassium and essence mix homogeneously by required proportioning again, granulate, get granule A; Sodium bicarbonate is granulated, get granule B; Granule A is mixed with granule B, add microcrystalline Cellulose, magnesium stearate, fully mixing; Tabletting gets 100 of SHUANGHUANLIAN annular effervescent tablets.
The average sheet of gained SHUANGHUANLIAN annular effervescent tablet heavily is 2.01 ± 0.03g, any surface finish, exquisiteness.With reference to " 2000 editions one appendix XII A of Chinese pharmacopoeia inspection technique disintegration is checked this product, 25 ℃ of a slice effervescent tablet inputs are filled in the 250ml beaker of 200ml water, there are a large amount of bubbles to emit immediately, tablet dissolves, is scattered in the water rapidly, formed the yellowish-brown clear solution in 5 minutes, it is left not have accumulative granule.Check 6 all qualified, the result is up to specification.
Embodiment 4
1 part of extracting honeysuckle, 1 part of Radix Scutellariae, 2 parts of Fructus Forsythiaes; Above three flavor medical materials are cleaned respectively, remove impurity, it is standby to be up to the standards: get the Radix Scutellariae section, water decocts three times, and 2 hours for the first time, second and third time each 1 hour, collecting decoction filters, and filtrate is concentrated into relative density 1.05-1.10 (80 ℃ of surveys), in the time of 80 ℃, add the 2mol/L hydrochloric acid solution and regulate pH value, be incubated 1 hour, left standstill 24 hours to 1.0-2.0, filter, precipitation washes with water to pH value 5.0, and continuing and being washed till pH value with 70% ethanol is 7.0, cold drying is ground into fine powder, and is standby; Get Fructus Forsythiae, Flos Lonicerae powder and be broken into fine powder/be ground into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, each 1-3 hour, collecting decoction, filter, filtrate is concentrated to relative density and is about 1.15-1.30 (70-80 ℃), waits to be chilled to 40 ℃, adding ethanol makes and contains alcohol amount and reach 75%, left standstill 6-24 hour, it is an amount of that leaching supernatant, residue add 75% ethanol, left standstill 6-24 hour, filter, merge ethanol liquid, reclaim ethanol to there not being the alcohol flavor, and be concentrated into relative density 1.05-1.20 (60-65 ℃ ℃), be dried to extract powder.
30 parts in Fructus Forsythiae, Flos Lonicerae extractum powder, 3 parts of Radix Scutellariae extracts, disintegrating agent comprise 30 parts of sour agent, 30 parts of alkaline agents, 5 parts of lubricants, 5 parts of aromatic.
Aromatic wherein is selected from 4 parts of orange essences, 1 part of flavoring orange essence.The acid agent is selected from 5 parts of citric acid, 10 parts in tartaric acid, 15 parts of sodium dihydrogen citrate salt; Alkaline agent is selected from 5 parts of potassium carbonate, 5 parts of potassium bicarbonates, 6 parts of sodium carbonate, 4 parts of sodium bicarbonate, 2 parts of calcium carbonate, 8 parts of calcium bicarbonate; Lubricant is selected from 4000,0.5 parts of sodium lauryl sulphates of 6000,0.5 parts of Polyethylene Glycol of 0.5 part of Polyethylene Glycol (PEG) (PEG), 0.5 part of magnesium stearate, 1 part of Pulvis Talci, 2 parts of silicon dioxide.All the other are with embodiment 1.
Embodiment 5
1 part of extracting honeysuckle, 1 part of Radix Scutellariae, 2 parts of Fructus Forsythiaes; Above three flavor medical materials are cleaned respectively, remove impurity, it is standby to be up to the standards: get the Radix Scutellariae section, water decocts three times, and 2 hours for the first time, second and third time each 1 hour, collecting decoction filters, and filtrate is concentrated into relative density 1.05-1.10 (80 ℃ of surveys), in the time of 80 ℃, add the 2mol/L hydrochloric acid solution and regulate pH value, be incubated 1 hour, left standstill 24 hours to 1.0-2.0, filter, precipitation washes with water to pH value 5.0, and continuing and being washed till pH value with 70% ethanol is 7.0, cold drying is ground into fine powder, and is standby; Get Fructus Forsythiae, Flos Lonicerae powder and be broken into fine powder/be ground into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, each 1-3 hour, collecting decoction, filter, filtrate is concentrated to relative density and is about 1.15-1.30 (70-80 ℃), waits to be chilled to 40 ℃, adding ethanol makes and contains alcohol amount and reach 75%, left standstill 6-24 hour, it is an amount of that leaching supernatant, residue add 75% ethanol, left standstill 6-24 hour, filter, merge ethanol liquid, reclaim ethanol to there not being the alcohol flavor, and be concentrated into relative density 1.05-1.20 (60-65 ℃ ℃), be dried to extract powder.
65 parts in Fructus Forsythiae, Flos Lonicerae extractum powder, 6.5 parts of Radix Scutellariae extracts, disintegrating agent comprise 30 parts of 10 parts of sour agent, 10 parts of alkaline agents and auxiliary disintegrating agents, 6 parts of binding agents, 2 parts of lubricants, 10 parts of sweeting agents.
Sweeting agent is selected from 2 parts of cyclamates, 1 part of steviosin, 2 parts of acesulfame potassiums, 1 part of aspartame, 2 parts of protein sugar, 1 part of sucrose, 1 part of saccharin sodium; The acid agent is selected from 1 part of malic acid, 1 part of fumaric acid, 8 parts of anhydrous citric acid one sodium salts; Alkaline agent is selected from 2 parts of sodium bicarbonate, 8 parts of calcium bicarbonate; Auxiliary disintegrating agent can be selected from 15 parts of low-substituted hydroxypropyl celluloses (L-HPC), 5 parts of microcrystalline Cellulose (MCC), 10 parts of crospolyvinylpyrrolidone (PVPP); Binding agent is selected from 6 parts of polyvinylpyrrolidones (PVP), and lubricant is selected from 2 parts of Polyethylene Glycol (PEG) 6000.All the other are with embodiment 1.
Embodiment 6
1 part of extracting honeysuckle, 1 part of Radix Scutellariae, 2 parts of Fructus Forsythiaes; Above three flavor medical materials are cleaned respectively, remove impurity, it is standby to be up to the standards: get the Radix Scutellariae section, water decocts three times, and 2 hours for the first time, second and third time each 1 hour, collecting decoction filters, and filtrate is concentrated into relative density 1.05-1.10 (80 ℃ of surveys), in the time of 80 ℃, add the 2mol/L hydrochloric acid solution and regulate pH value, be incubated 1 hour, left standstill 24 hours to 1.0-2.0, filter, precipitation washes with water to pH value 5.0, and continuing and being washed till pH value with 70% ethanol is 7.0, cold drying is ground into fine powder, and is standby; Get Fructus Forsythiae, Flos Lonicerae powder and be broken into fine powder/be ground into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, each 1-3 hour, collecting decoction, filter, filtrate is concentrated to relative density and is about 1.15-1.30 (70-80 ℃), waits to be chilled to 40 ℃, adding ethanol makes and contains alcohol amount and reach 75%, left standstill 6-24 hour, it is an amount of that leaching supernatant, residue add 75% ethanol, left standstill 6-24 hour, filter, merge ethanol liquid, reclaim ethanol to there not being the alcohol flavor, and be concentrated into relative density 1.05-1.20 (60-65 ℃ ℃), be dried to extract powder.
45 parts in Fructus Forsythiae, Flos Lonicerae extractum powder, 5 parts of Radix Scutellariae extracts, disintegrating agent comprise 20 parts of 20 parts of sour agent, 20 parts of alkaline agents and auxiliary disintegrating agents, 3 parts of binding agents, 4 parts of lubricants, 6 parts of sweeting agents, aromatic
Part.
Sweeting agent is selected from 1 part of steviosin, 4 parts of sucrose, 4 parts of Calcium o-benzolsulfimides; Aromatic wherein is selected from each 1 part of Herba Menthae essence or Fructus Citri Limoniae essence, flavoring banana essence; The acid agent is selected from 12 parts in tartaric acid, 8 parts of citric acids; Alkaline agent is selected from 5 parts of sodium bicarbonate, 15 parts of calcium bicarbonate; Auxiliary disintegrating agent is selected from 15 parts of microcrystalline Cellulose (MCC), 5 parts of crospolyvinylpyrrolidone (PVPP); Binding agent is selected from 3 parts of polyvinylpyrrolidones (PVP), and lubricant is selected from 2 parts of 2 parts of the sodium lauryl sulphates, silicon dioxide.All the other are with embodiment 1.
Embodiment 7
Get the double coptis effervescent tablets of embodiment 1,2,3, it is prepared into outer ring diameter respectively is 30 millimeters, and interior ring diameter is 3 millimeters a ring segment.
Embodiment 8
Get the double coptis effervescent tablets of embodiment 1,2,3, it is prepared into outer ring diameter respectively is 20 millimeters, and interior ring diameter is 8 millimeters a ring segment.
Embodiment 9
Get the double coptis effervescent tablets of embodiment 1,2,3, it is prepared into outer ring diameter respectively is 25 millimeters, and interior ring diameter is 5 millimeters a ring segment.
Claims (1)
1, a kind of double coptis effervescent tablets, each composition of this effervescent tablet by the quality proportioning is: Fructus Forsythiae, Flos Lonicerae extractum powder 30-65 part, Radix Scutellariae extract 3-6.5 part, sour agent 10-30 part, alkaline agent 10-30 part; Auxiliary disintegrating agent 0-30 part, binding agent 0-6 part, lubricant 2-5 part, sweeting agent 0-5 part, aromatic 0-5 part is characterized in that: the profile of this effervescent tablet is annular; Fructus Forsythiae wherein, Flos Lonicerae extractum powder and Radix Scutellariae extract prepare by the following method: the proportioning of crude drug is by weight: 1 part of Flos Lonicerae, 1 part of Radix Scutellariae, 2 parts of Fructus Forsythiaes, above three flavor medical materials are cleaned respectively, remove impurity, it is standby to be up to the standards: get the Radix Scutellariae section, water decocts three times, 2 hours for the first time, second, three times each 1 hour, collecting decoction filtered, filtrate is concentrated into 80 ℃ and surveys relative density 1.05-1.10, in the time of 80 ℃, add the 2mol/L hydrochloric acid solution and regulate pH value, be incubated 1 hour, left standstill 24 hours to 1.0-2.0, filter, precipitation washes with water to pH value 5.0, and continuing and being washed till pH value with 70% ethanol is 7.0, cold drying, be ground into fine powder, standby; Get Fructus Forsythiae, Flos Lonicerae powder and be broken into fine powder/be ground into coarse powder/be cut into decoction pieces, decoct with water each 1-3 hour 2-3 time, collecting decoction filters, and it is 1.15-1.30 that filtrate is concentrated to 70-80 ℃ of survey relative density, wait to be chilled to 40 ℃, add ethanol and make and contain alcohol amount and reach 75%, left standstill 6-24 hour, it is an amount of that leaching supernatant, residue add 75% ethanol, left standstill 6-24 hour, filter, merge ethanol liquid, reclaim ethanol to there not being the alcohol flavor, and be concentrated into 60-65 ℃ of survey relative density 1.05-1.20, be dried to extract powder.
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| CN105560317A (en) * | 2015-12-08 | 2016-05-11 | 肇庆医学高等专科学校 | Effervescent tablets containing frangipani tea, and preparation method of effervescent tablets |
| CN106074397A (en) * | 2016-08-29 | 2016-11-09 | 河北国金药业有限责任公司 | The preparation method of Compound Jinyinhua Granules |
| CN106387597A (en) * | 2016-08-31 | 2017-02-15 | 重庆市秀山红星中药材开发有限公司 | Instant honeysuckle flower solid beverage and preparation method thereof |
| CN110302166A (en) * | 2019-07-19 | 2019-10-08 | 杨慧慧 | A kind of swap buffers tablet and preparation method thereof |
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