CN104606477A - Fire-clearing jasmine and radix ophiopogonis film-coated tablets and preparation method thereof - Google Patents
Fire-clearing jasmine and radix ophiopogonis film-coated tablets and preparation method thereof Download PDFInfo
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Abstract
The invention discloses fire-clearing jasmine and radix ophiopogonis film-coated tablets which comprise main ingredients and auxiliary materials, wherein the main ingredients comprise the following components in parts by weight: 700-900 parts of common andrographis Herb, 80-120 parts of jasmine and 80-120 parts of radix ophiopogonis; and the auxiliary materials comprise the following components in parts by weight: 20-30 parts of starch and 0.1-2 parts of magnesium stearate. The invention also discloses a method for preparing the fire-clearing jasmine and radix ophiopogonis film-coated tablets. The fire-clearing jasmine and radix ophiopogonis tablets are changed from the traditional sugar-coated tablets into the film-coated tablets, the coating time is short, the operation is simple and convenient, the drying speed is high, the medicine is slightly affected by damp-heat, and the service life of the product can be prolonged. Moreover, the process stability is high, the drug quality is high, and the market prospects are wide.
Description
Technical field
The present invention relates to a kind of Qinghuozhimaipian Film coated tablets and preparation method thereof, belong to technical field of medicine.
Background technology
Qinghuozhimaipian is the class Chinese medicine general types that relieves inflammation or internal heat, by 2010 version " Chinese Pharmacopoeia " record, its prescription is Herba Andrographis, Fructus Gardeniae and Radix Ophiopogonis., mainly based on sugar coating sheet, also there is small part manufacturer production Film coated tablets in current most of manufacturer in recent years.The advantage of coated tablet is: the sugar coating material that label top layer parcel is suitable, medicine is isolated from the outside, thus reach the effect of protection against the tide, lucifuge, isolated air oxidation, to strengthen the stability of medicine within the shelf-life, cover the not unpleasant taste of prescription flavour of a drug simultaneously and reduce medicine to the stimulation of human body alimentary canal, taking to facilitate.Due to production practices for many years, Qinghuozhimaipian coated tablet has the production technology of a set of maturation, but also there is certain drawback, such as:
(1) Qinghuozhimaipian coated tablet sugarcoating layer based on the multiple and Drug therapy of Pulvis Talci, sucrose, gelatin milli unallied adjuvant, be attached to the top layer of drug core, coated tablet active drug label is additionally increased weight and reaches 50 ~ 100%, therefore, long-term taking can cause high risks to human body, especially diabetics.
(2) coated tablet is in production operation process, and the dust of generation is large, contaminated environment, and change sugar, change glue, add pigment, the sheet that dries in the air, material are deposited all needs to take workshop larger space.
(3) complex manufacturing, the experience, the feel that mostly rely on operator in operating process control coating quality, are therefore difficult to control product quality homogeneity.
(4) at coating process, easily there is sliver, piebald, mildew, disintegrate time-out, content declines, hygroscopicity is preserved by force, not easily, production time and the problems such as the sheet time of drying in the air is long.
Film coating refers at the more stable high molecular polymer clothing film of drug core top layer outsourcing one deck, because Film coated tablets clothing film is much thinner than coated tablet clothing film, therefore also referred to as film-coat.
Summary of the invention
Technical problem to be solved by this invention is for the deficiencies in the prior art, and provide a kind of Qinghuozhimaipian Film coated tablets and preparation method thereof, Coating times of the present invention is short, easy and simple to handle, rate of drying is fast, and medicine affects less by damp and hot, can extend and improve the life-span of product.
The technical scheme that the present invention solves the problems of the technologies described above is as follows: a kind of Qinghuozhimaipian Film coated tablets, comprise major ingredient and adjuvant, wherein major ingredient comprises the component of following parts by weight: Herba Andrographis 700 ~ 900 parts, Fructus Gardeniae 80 ~ 120 parts, Radix Ophiopogonis 80 ~ 120 parts, adjuvant comprises the component of following parts by weight: starch 20 ~ 30 parts, magnesium stearate 0.1 ~ 2 part.
On the basis of technique scheme, the present invention can also do following improvement.
Further, wherein major ingredient comprises the component of following parts by weight: Herba Andrographis 800 parts, Fructus Gardeniae 100 parts, Radix Ophiopogonis 100 parts, adjuvant comprises the component of following parts by weight: starch 25 parts, magnesium stearate 0.9 part.
A preparation method for Qinghuozhimaipian Film coated tablets, comprises following processing step:
(1) pulverize: take Herba Andrographis 120 ~ 200 parts and Fructus Gardeniae 80 ~ 120 parts, pulverize, sieve, namely obtain Herba Andrographis fine powder and Fructus Gardeniae fine powder;
(2) concentrated: to get Herba Andrographis 580 ~ 700 parts, decoct with water with Radix Ophiopogonis 80 ~ 120 parts, decocting liquid is filtered, filtrate is condensed into mastic;
(3) granulate: by step (1) gained Herba Andrographis fine powder, Fructus Gardeniae fine powder, and starch 20 ~ 30 parts, magnesium stearate 0.1 ~ 2 part, join in step (2) gained mastic together, mixing, granule processed, dry, granulate;
(4) tabletting: with tabletting machine, obtain the substrate that sheet is heavily 0.30 ~ 0.33g/ sheet;
(5) coating:
A, preparation coating solution: take coating powder, in proportion, be first added in the liquid reservoir of coating pan by water, turn on agitator, slowly add coating powder while stirring, add rear continuation and stir, obtain coating solution;
B, grinding: step a gained coating solution is placed in colloid mill, grinds, discharging, obtain ground coating solution, for subsequent use;
C, preheating: the hot-air blower opening coating pan, be preheated to 50 ~ 60 DEG C, then be placed in coating pan by step (4) gained substrate, with 60 ~ 65 DEG C of hot blasts by substrate label preheating l5 ~ 30min;
D, hydrojet: start coating pan, the ground coating solution obtained by step b sprays in the preheated substrate surface of step c, and emitted dose is 80 ~ 150g/min, with 50 ~ 60 DEG C of hot air dryings, continuous hydrojet 2 ~ 3 hours, pot speed 8 ~ 15 revs/min, coating is to label weightening finish 3 ~ 5%, stop hydrojet, after continuing to blow 5 ~ 10 minutes with hot blast, turn off hot blast switch, with room temperature wind, tablet is dried up again, be cooled to room temperature, take the dish out of the pot, obtain Qinghuozhimaipian Film coated tablets.
On the basis of technique scheme, the present invention can also do following improvement.
Further, step (1) described Herba Andrographis is 140 parts, and Fructus Gardeniae is 100 parts, and crossing grit number is 80 orders.
Further, step (2) described Herba Andrographis is 660 parts, and Radix Ophiopogonis is 100 parts, decocts 2 times, boils to 100 DEG C at every turn and be incubated 2 hours, and filter with 200 order chinlon wire screen, described mastic is 1.35 ~ 1.40 the relative density of 80 DEG C.
Further, step (3) described starch is 25 parts, and magnesium stearate is 0.9 part.
Further, step (4) described tablet machine is the shallow concave punch tablet machine of 9.0 ~ 10.0mm.
Further, described in step (5) a, the weight ratio of coating powder and water is 1:8, and the rotating speed of described agitator is 500 ~ 800 revs/min, and the described time of continuing to stir is l5 ~ 18min.
Further, the time of grinding described in step (5) b is 30 ~ 35min, the rotating speed of described colloid mill 2800 ~ 3000 revs/min, and the particle diameter of described ground coating solution is 4.0 ~ 7.0 microns.
Further, Qinghuozhimaipian Film coated tablets dosage form, specification are: the heavy 0.32g/ sheet of sheet, outward appearance is circular thin membrane coated tablet, and coated tablet is fruit green.
The invention has the beneficial effects as follows:
(1) fast, the medicine of art for coating time of the present invention short, easy and simple to handle, rate of drying affects less by damp and hot, can extend and improve the life-span of product;
(2) tablet fill weights after film coating, generally only increases by 3 ~ 5% than plain sheet, can reduce the consumption of Pulvis Talci and Icing Sugar in a large number, both can keep former property, and be convenient to swallow and transport, again save packaging material, decrease patient's dose, and diabetes patient also can take;
(3) present invention process stability is high, drug quality good, wide market.
Detailed description of the invention
Be described principle of the present invention and feature below in conjunction with specific embodiment, example, only for explaining the present invention, is not intended to limit scope of the present invention.
Embodiment 1:
(1) pulverize: take Herba Andrographis 200g and Fructus Gardeniae 80g, pulverize, sieve, namely obtain Herba Andrographis fine powder and Fructus Gardeniae fine powder;
(2) concentrated: get Herba Andrographis 700g, decoct with water 2 times with 80g Radix Ophiopogonis, boil to 100 DEG C at every turn and be incubated 2 hours, filtered by decocting liquid 200 order chinlon wire screen, filtrate is condensed into mastic, described mastic is 1.35 ~ 1.40 the relative density of 80 DEG C;
(3) granulate: by step (1) gained Herba Andrographis fine powder, Fructus Gardeniae fine powder, and starch 20g, magnesium stearate 2g, join in step (2) gained mastic together, mixing, granule processed, dry, granulate;
(4) tabletting: with the shallow concave punch tabletting machine of 9.0 ~ 10.0mm, substrate sheet is heavily 0.30 ~ 0.33g/ sheet, substrate and get final product;
(5) coating:
A, preparation coating solution: take coating powder 15.5g, the ratio of coating powder and water is 1:8, first water is added in the liquid reservoir of coating pan, turn on agitator, the rotating speed of agitator is 500 ~ 800 revs/min, slowly add coating powder while stirring, add rear continuation and stir l5 ~ 18min, obtain coating solution;
B, grinding: step a gained coating solution is placed in colloid mill, the rotating speed of colloid mill 2800 ~ 3000 revs/min, grinding 30 ~ 35min, discharging, obtaining ground particle diameter is 4.0 ~ 7.0 microns of coating solutions, for subsequent use;
C, preheating: the hot-air blower opening coating pan, be preheated to 50 ~ 60 DEG C, then be placed in coating pan by step (4) gained substrate, with 60 ~ 65 DEG C of hot blasts by substrate label preheating l5 ~ 30min;
D, hydrojet: start coating pan, the ground coating solution obtained by step b sprays in the preheated substrate surface of step c, emitted dose is 80 ~ 150g/min, with 50 ~ 60 DEG C of hot air dryings, continuous hydrojet 2 ~ 3 hours, pot speed 8 ~ 15 revs/min, coating is to label weightening finish 3 ~ 5%, stop hydrojet, after continuing to blow 5 ~ 10 minutes with hot blast, turn off hot blast switch, then with room temperature wind, tablet is dried up, be cooled to room temperature, take the dish out of the pot, obtain Qinghuozhimaipian Film coated tablets, sheet is heavily 0.32g/ sheet, outward appearance is circular thin membrane coated tablet, and coated tablet is fruit green.
Embodiment 2:
(1) pulverize: take Herba Andrographis 120g and Fructus Gardeniae 120g, pulverize, sieve, namely obtain Herba Andrographis fine powder and Fructus Gardeniae fine powder;
(2) concentrated: get Herba Andrographis 580g, decoct with water 2 times with 120g Radix Ophiopogonis, boil to 100 DEG C at every turn and be incubated 2 hours, filtered by decocting liquid 200 order chinlon wire screen, filtrate is condensed into mastic, described mastic is 1.35 ~ 1.40 the relative density of 80 DEG C;
(3) granulate: by step (1) gained Herba Andrographis fine powder, Fructus Gardeniae fine powder, and starch 20g, magnesium stearate 2g, join in step (2) gained mastic together, mixing, granule processed, dry, granulate;
(4) tabletting: with the shallow concave punch tabletting machine of 9.0 ~ 10.0mm, substrate sheet is heavily 0.30 ~ 0.33g/ sheet, substrate and get final product;
(5) coating:
A, preparation coating solution: take coating powder 15.5g, the ratio of coating powder and water is 1:8, first water is added in the liquid reservoir of coating pan, turn on agitator, the rotating speed of agitator is 500 ~ 800 revs/min, slowly add coating powder while stirring, add rear continuation and stir l 5 ~ 18min, obtain coating solution;
B, grinding: step a gained coating solution is placed in colloid mill, the rotating speed of colloid mill 2800 ~ 3000 revs/min, grinding 30 ~ 35min, discharging, obtaining ground particle diameter is 4.0 ~ 7.0 microns of coating solutions, for subsequent use;
C, preheating: the hot-air blower opening coating pan, be preheated to 50 ~ 60 DEG C, then be placed in coating pan by step (4) gained substrate, with 60 ~ 65 DEG C of hot blasts by substrate label preheating l5 ~ 30min;
D, hydrojet: start coating pan, the ground coating solution obtained by step b sprays in the preheated substrate surface of step c, emitted dose is 80 ~ 150g/min, with 50 ~ 60 DEG C of hot air dryings, continuous hydrojet 2 ~ 3 hours, pot speed 8 ~ 15 revs/min, coating is to label weightening finish 3 ~ 5%, stop hydrojet, after continuing to blow 5 ~ 10 minutes with hot blast, turn off hot blast switch, then with room temperature wind, tablet is dried up, be cooled to room temperature, take the dish out of the pot, obtain Qinghuozhimaipian Film coated tablets, sheet is heavily 0.32g/ sheet, outward appearance is circular thin membrane coated tablet, and coated tablet is fruit green.
Embodiment 3:
(1) pulverize: take Herba Andrographis 140g and Fructus Gardeniae 100g, pulverize, sieve, namely obtain Herba Andrographis fine powder and Fructus Gardeniae fine powder;
(2) concentrated: get Herba Andrographis 660g, decoct with water 2 times with 100g Radix Ophiopogonis, boil to 100 DEG C at every turn and be incubated 2 hours, filtered by decocting liquid 200 order chinlon wire screen, filtrate is condensed into mastic, described mastic is 1.35 ~ 1.40 the relative density of 80 DEG C;
(3) granulate: by step (1) gained Herba Andrographis fine powder, Fructus Gardeniae fine powder, and starch 25g, magnesium stearate 0.9g, join in step (2) gained mastic together, mixing, granule processed, dry, granulate;
(4) tabletting: with the shallow concave punch tabletting machine of 9.0 ~ 10.0mm, substrate sheet is heavily 0.30 ~ 0.33g/ sheet, substrate and get final product;
(5) coating:
A, preparation coating solution: take coating powder 15.5g, the ratio of coating powder and water is 1:8, first water is added in the liquid reservoir of coating pan, turn on agitator, the rotating speed of agitator is 500 ~ 800 revs/min, slowly add coating powder while stirring, add rear continuation and stir l5 ~ 18min, obtain coating solution;
B, grinding: step a gained coating solution is placed in colloid mill, the rotating speed of colloid mill 2800 ~ 3000 revs/min, grinding 30 ~ 35min, discharging, obtaining ground particle diameter is 4.0 ~ 7.0 microns of coating solutions, for subsequent use;
C, preheating: the hot-air blower opening coating pan, be preheated to 50 ~ 60 DEG C, then be placed in coating pan by step (4) gained substrate, with 60 ~ 65 DEG C of hot blasts by substrate label preheating l5 ~ 30min;
D, hydrojet: start coating pan, the ground coating solution obtained by step b sprays in the preheated substrate surface of step c, emitted dose is 80 ~ 150g/min, with 50 ~ 60 DEG C of hot air dryings, continuous hydrojet 2 ~ 3 hours, pot speed 8 ~ 15 revs/min, coating is to label weightening finish 3 ~ 5%, stop hydrojet, after continuing to blow 5 ~ 10 minutes with hot blast, turn off hot blast switch, then with room temperature wind, tablet is dried up, be cooled to room temperature, take the dish out of the pot, obtain Qinghuozhimaipian Film coated tablets, sheet is heavily 0.32g/ sheet, outward appearance is circular thin membrane coated tablet, and coated tablet is fruit green.
The foregoing is only preferred embodiment of the present invention, not in order to limit the present invention, within the spirit and principles in the present invention all, any amendment done, equivalent replacement, improvement etc., all should be included within protection scope of the present invention.
Claims (9)
1. a Qinghuozhimaipian Film coated tablets, it is characterized in that, comprise major ingredient and adjuvant, wherein major ingredient comprises the component of following parts by weight: Herba Andrographis 700 ~ 900 parts, Fructus Gardeniae 80 ~ 120 parts, Radix Ophiopogonis 80 ~ 120 parts, adjuvant comprises the component of following parts by weight: starch 20 ~ 30 parts, magnesium stearate 0.1 ~ 2 part.
2. a kind of Qinghuozhimaipian Film coated tablets according to claim 1, it is characterized in that, wherein major ingredient comprises the component of following parts by weight: Herba Andrographis 800 parts, Fructus Gardeniae 100 parts, Radix Ophiopogonis 100 parts, adjuvant comprises the component of following parts by weight: starch 25 parts, magnesium stearate 0.9 part.
3. a preparation method for Qinghuozhimaipian Film coated tablets, is characterized in that, comprises following processing step:
(1) pulverize: take Herba Andrographis 120 ~ 200 parts and Fructus Gardeniae 80 ~ 120 parts, pulverize, sieve, namely obtain Herba Andrographis fine powder and Fructus Gardeniae fine powder;
(2) concentrated: to get Herba Andrographis 580 ~ 700 parts, decoct with water with Radix Ophiopogonis 80 ~ 120 parts, decocting liquid is filtered, filtrate is condensed into mastic;
(3) granulate: by step (1) gained Herba Andrographis fine powder, Fructus Gardeniae fine powder, and starch 20 ~ 30 parts, magnesium stearate 0.1 ~ 2 part, join in step (2) gained mastic together, mixing, granule processed, dry, granulate;
(4) tabletting: with tabletting machine, obtain the substrate that sheet is heavily 0.30 ~ 0.33g/ sheet;
(5) coating:
A, preparation coating solution: take coating powder, in proportion, be first added in the liquid reservoir of coating pan by water, turn on agitator, slowly add coating powder while stirring, add rear continuation and stir, obtain coating solution;
B, grinding: step a gained coating solution is placed in colloid mill, grinds, discharging, obtain ground coating solution, for subsequent use;
C, preheating: the hot-air blower opening coating pan, be preheated to 50 ~ 60 DEG C, then be placed in coating pan by step (4) gained substrate, with 60 ~ 65 DEG C of hot blasts by substrate label preheating l5 ~ 30min;
D, hydrojet: start coating pan, the ground coating solution obtained by step b sprays in the preheated substrate surface of step c, and emitted dose is 80 ~ 150g/min, with 50 ~ 60 DEG C of hot air dryings, continuous hydrojet 2 ~ 3 hours, pot speed 8 ~ 15 revs/min, coating is to label weightening finish 3 ~ 5%, stop hydrojet, after continuing to blow 5 ~ 10 minutes with hot blast, turn off hot blast switch, with room temperature wind, tablet is dried up again, be cooled to room temperature, take the dish out of the pot, obtain Qinghuozhimaipian Film coated tablets.
4. the preparation method of a kind of Qinghuozhimaipian Film coated tablets according to claim 3, is characterized in that, step (1) described Herba Andrographis is 140 parts, and Fructus Gardeniae is 100 parts, and crossing grit number is 80 orders.
5. the preparation method of a kind of Qinghuozhimaipian Film coated tablets according to claim 3, it is characterized in that, step (2) described Herba Andrographis is 660 parts, Radix Ophiopogonis is 100 parts, decoct 2 times, boil to 100 DEG C at every turn and be incubated 2 hours, filter with 200 order chinlon wire screen, described mastic is 1.35 ~ 1.40 the relative density of 80 DEG C.
6. the preparation method of a kind of Qinghuozhimaipian Film coated tablets according to claim 3, is characterized in that, step (3) described starch is 25 parts, and magnesium stearate is 0.9 part.
7. the preparation method of a kind of Qinghuozhimaipian Film coated tablets according to claim 3, is characterized in that, step (4) described tablet machine is the shallow concave punch tablet machine of 9.0 ~ 10.0mm.
8. the preparation method of a kind of Qinghuozhimaipian Film coated tablets according to any one of claim 3 to 7, it is characterized in that, described in step (5) a, the weight ratio of coating powder and water is 1:8, the rotating speed of described agitator is 500 ~ 800 revs/min, and the described time of continuing to stir is l5 ~ 18min.
9. the preparation method of a kind of Qinghuozhimaipian Film coated tablets according to any one of claim 3 to 7, it is characterized in that, the time of grinding described in step (5) b is 30 ~ 35min, the rotating speed of described colloid mill 2800 ~ 3000 revs/min, the particle diameter of described ground coating solution is 4.0 ~ 7.0 microns.
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CN109512935A (en) * | 2018-11-29 | 2019-03-26 | 四川旭阳药业有限责任公司 | A kind of Qinghuozhimaipian and preparation method thereof |
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