CN105343029A - Doxifluridine capsule and preparation method thereof - Google Patents
Doxifluridine capsule and preparation method thereof Download PDFInfo
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- CN105343029A CN105343029A CN201510897618.7A CN201510897618A CN105343029A CN 105343029 A CN105343029 A CN 105343029A CN 201510897618 A CN201510897618 A CN 201510897618A CN 105343029 A CN105343029 A CN 105343029A
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- doxifluridine
- capsule
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- magnesium stearate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
- A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
- A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
- A61K31/7072—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid having two oxo groups directly attached to the pyrimidine ring, e.g. uridine, uridylic acid, thymidine, zidovudine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
Abstract
The invention provides a doxifluridine capsule. The doxifluridine capsule is characterized in that the content in 100 capsules is prepared from, by weight, 200.00 g of doxifluridine, 108.00 g of starch, 70.00 g of low substituted hydroxypropy cellulose, 20.00 g of carboxymethyl starch sodium, 220-300 g of an ethanol aqueous solution with the concentration being 47.5% and 1.50-2.50 g of magnesium stearate. The invention provides the improved doxifluridine capsule and a preparation method thereof. Clinical risk caused by the content difference of products is eliminated, adverse reaction caused by the content difference is reduced, it is guaranteed that the product is safe and effective, and the product is more favorable for clinical use. The method is easy to operate, no new cost is increased, and the doxifluridine capsule is suitable for large-scale industrial production and is large in application value.
Description
Technical field
The present invention relates to pharmaceutical preparation, be specifically related to process for preparing medicine, particularly relate to a kind of doxifluridine capsule and preparation method thereof.
Background technology
The main component of doxifluridine capsule is doxifluridine, is clinically used for the treatment of breast carcinoma, gastric cancer, colorectal carcinoma, nasopharyngeal carcinoma.Doxifluridine is a kind of fluorouracil derivative, changes into fluorouracil (5-Fu) by pyrimidine-nucleoside phosphorylase highly active in tumor tissues, plays its selectivity antitumor action.The therapeutic index of test display doxifluridine is higher than 5-Fu, doxifluridine is as a kind of prodrug, and because it has better targeting, therefore clinical signs is good therapeutic effect, lower toxic and side effects, has significant clinical meaning for the compliance increasing patient.
Existing doxifluridine capsule formula and preparation thereof:
Remarks: doxifluridine capsule principal agent amount calculates by doxifluridine and should be 100.0% of labelled amount.
1, pretreatment: doxifluridine 60 order sieves, low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, starch, magnesium stearate 100 order sieve.
2, prepare: supplementary material presses recipe quantity batching.
3, granulate:
3.1, doxifluridine, starch, carboxymethylstach sodium, low-substituted hydroxypropyl cellulose are dropped into high speed wet granulator and mix, open air compression system, after opening stirring at low speed 2min, open high-speed stirred 3min.
3.2, after adding 47.5% ethanol, stirring at low speed 2min, granulation 1min.
3.3, wet granular wobbler 18 order nylon wire is granulated.
3.4, wet granular enters baking oven, and arranging baking temperature is 60 ~ 70 DEG C, and drying time is 2.5 ~ 4.0 hours.
3.5, the dry rear zinc-plated hard net granulate of granule wobbler 18 order.
4, always mix: dry granule is added in three-dimensional mixer, add magnesium stearate mixing simultaneously.Mixing revolution 50 turns, incorporation time 15 minutes.
5, filling: use full-automatic hard capsule filling machine to carry out filling.Within every 15 minutes, check a loading amount.
6, inner packing.
7, outer package.
Because doxifluridine is insoluble drug, bioavailability is relatively low, and therefore add more disintegrating agent (low-substituted hydroxypropyl cellulose, accounts for 17.5% of recipe quantity when existing component design; Carboxymethylstach sodium, accounts for 5% of recipe quantity) dissolution of medicine is improved with this.But adding of a large amount of disintegrating agent makes granule lack cohesiveness, and in dry run, a large amount of granule is easily broken, therefore often find that dry rear fine powder is many in process of production, mobility is not good.Because doxifluridine raw material is in threadiness or acicular texture, compressibility is poor, and above-mentioned factor causes the granulate intermediate mobility of producing gained poor, and the content uniformity of capsule fill is larger.Although this situation slightly can be improved by fluidizer such as additional magnesium stearate, silicon dioxide, the problem that end solution mobility is not good cannot be surveyed, bring certain influence to the production of continous-stable, urgently improve.
Summary of the invention
Technical problem to be solved by this invention is to overcome above-mentioned weak point, and the processing quality of research design content uniformity in controlled range is stablized, the formula of safer effective clinical doxifluridine capsule and preparation method thereof.
The invention provides a kind of doxifluridine capsule.
Described capsule 's content is grouped into (every 1000) by the one-tenth of following weight proportion:
Remarks: doxifluridine capsule principal agent amount calculates by doxifluridine and should be 100.0% of labelled amount.
Another object of the present invention there is provided the preparation method of described doxifluridine capsule, and the method comprises the following steps:
(1), pretreatment: doxifluridine 60 order sieves; Low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, starch, magnesium stearate 100 order sieve;
(2), prepare: supplementary material presses formula ratio batching;
(3), granulate:
(3.1), by the doxifluridine sieved, starch, carboxymethylstach sodium, low-substituted hydroxypropyl cellulose drop into high speed wet granulator and mix, open air compression system, after opening stirring at low speed 2min, open high-speed stirred 3min;
(3.2), add 47.5% alcoholic solution after, stirring at low speed, granulation;
(3.3), wet granular wobbler 18 order nylon wire is granulated;
(3.4), wet granular enters baking oven, drying;
(3.5), the dry rear zinc-plated hard net granulate of granule wobbler 18 order;
(4), always mix: dry granule is added in three-dimensional mixer, add magnesium stearate mixing, mixing, incorporation time 15 minutes simultaneously;
(5), filling: use full-automatic hard capsule filling machine to carry out filling, check a loading amount in every 15 minutes;
(6), inner packing;
(7), outer package.
Step of the present invention (3.1) stirring at low speed rotating speed is 120 rev/min, and high-speed stirred rotating speed is 180 rev/min.
It is 220g-300g that step of the present invention (3.2) adds 47.5% alcoholic solution; Preferably add 47.5% alcoholic solution 260g.Described 47.5% alcoholic solution is obtained by the mixing of the weight such as 95% ethanol and purified water.
Step of the present invention (3.2) the stirring at low speed time is 3min-6min, and Granulation time is 2min-5min; The preferred stirring at low speed time is 3min-4min, and Granulation time is 2min-3min.
Step of the present invention (3.4) baking temperature is 60 DEG C ~ 70 DEG C, and drying time is 2.5 hours ~ 4.0 hours.
It is 1.50-2.50g that step of the present invention (4) adds magnesium stearate; Preferably add 2.00g magnesium stearate.
Doxifluridine capsule that the invention provides improvement and preparation method thereof, eliminates the clinical risk that product causes because of content uniformity, reduces the untoward reaction because content uniformity causes, guarantees the safe and effective of product, make product more be conducive to Clinical practice.The inventive method is simple to operate, does not increase new cost, is suitable for large-scale industrial to be produced, and has larger using value.
Detailed description of the invention
Following examples are raw materials used commercially availablely to be obtained.
Example 1 prepares doxifluridine capsule:
Remarks: doxifluridine capsule principal agent amount calculates by doxifluridine and should be 100.0% of labelled amount.
1, pretreatment: doxifluridine 60 order sieves, low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, starch, magnesium stearate 100 order sieve.
2, prepare: supplementary material presses formula ratio batching.
47.5% alcoholic solution is obtained by the mixing of the weight such as 95% ethanol and purified water.
3, granulate:
3.1, doxifluridine, starch, carboxymethylstach sodium, low-substituted hydroxypropyl cellulose are dropped into high speed wet granulator (GHL-120) and mix; open air compression system; open after low speed (120 rev/min) stirs 2min, open (180 rev/min) at a high speed and stir 3min.
3.2, after adding 11.00kg47.5% alcoholic solution, low speed (120 rev/min) stirs 3min, granulation 2min.
3.3, wet granular wobbler YK-16018 order nylon wire is granulated.
3.4, wet granular enters baking oven JCT-C-I, and arranging baking temperature is 65 DEG C, and drying time is 2.5 hours.
3.5, the dry rear zinc-plated hard net granulate of granule wobbler (model YK-160) 18 order.
4, always mix: dry granule is added in three-dimensional mixer (model GH-200), add magnesium stearate 0.075kg mixing simultaneously.Incorporation time 15 minutes.
5, filling: use full-automatic hard capsule filling machine (model YJF-800) to carry out filling.Within every 15 minutes, check a loading amount.(detect inner quality standard: ± 5%; National standard: ± 7.5%; The method of inspection is see Chinese Pharmacopoeia 2010 editions two annex IA)
6, inner packing.
7, outer package.
Example 2 prepares doxifluridine capsule:
Remarks: doxifluridine capsule principal agent amount calculates by doxifluridine and should be 100.0% of labelled amount.
1, pretreatment: doxifluridine 60 order sieves, low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, starch, magnesium stearate 100 order sieve.
2, prepare: supplementary material presses formula ratio batching.
3, granulate:
3.1, doxifluridine, starch, carboxymethylstach sodium, low-substituted hydroxypropyl cellulose are dropped into high speed wet granulator GHL-120 and mix, open air compression system, after opening stirring at low speed 120 rev/min 2min, open high-speed stirred 180 rev/min 3min.
3.2, after adding 13.00kg47.5% alcoholic solution, stirring at low speed 4min120 rev/min, granulation 3min.
3.3, wet granular wobbler YK-16018 order nylon wire is granulated.
3.4, wet granular enters baking oven JCT-C-I, and arranging baking temperature is 65 DEG C, and drying time is 3.0 hours.
3.5, the dry rear zinc-plated hard net granulate of granule wobbler YK-16018 order.
4, always mix: dry granule is added in three-dimensional mixer GH-200, add magnesium stearate 0.10kg mixing, incorporation time 15 minutes simultaneously.
5, filling: use full-automatic hard capsule filling machine YJF-800 to carry out filling.Within every 15 minutes, check a loading amount.Inner quality standard: ± 5%; National standard: ± 7.5%; The method of inspection is see Chinese Pharmacopoeia 2010 editions two annex IA
6, inner packing.
7, outer package.
Example 3 prepares doxifluridine capsule:
Remarks: doxifluridine capsule principal agent amount calculates by doxifluridine and should be 100.0% of labelled amount.
1, pretreatment: doxifluridine 60 order sieves, low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, starch, magnesium stearate 100 order sieve.
2, prepare: supplementary material presses formula ratio batching.
3, granulate:
3.1, doxifluridine, starch, carboxymethylstach sodium, low-substituted hydroxypropyl cellulose are dropped into high speed wet granulator GHL-120 and mix, open air compression system, after opening stirring at low speed 120 rev/min 2min, open high-speed stirred 180 rev/min 3min.
3.2, after adding 15.00kg47.5% ethanol, stirring at low speed 120 rev/min 6min, granulation 5min.
3.3, wet granular wobbler YK-16018 order nylon wire is granulated.
3.4, wet granular enters baking oven JCT-C-I, and arranging baking temperature is 65 DEG C, and drying time is 4.0 hours
3.5, the dry rear zinc-plated hard net granulate of granule wobbler YK-16018 order.
4, always mix: dry granule is added in three-dimensional mixer GH-200, add magnesium stearate 0.125kg mixing, incorporation time 15 minutes simultaneously.
5, filling: use full-automatic hard capsule filling machine YJF-800 to carry out filling.Within every 15 minutes, check a loading amount.Inner quality standard: ± 5%; National standard: ± 7.5%; The method of inspection is see Chinese Pharmacopoeia 2010 editions two annex IA
6, inner packing.
7, outer package.
Carry out indices investigation to the doxifluridine capsule that embodiment 1-3 produces, result is as follows:
Result illustrates, the doxifluridine capsule indices that embodiment 1-3 produces is conformance with standard regulation all, and content uniformity, labelled amount, dissolution, related substance all meet Clinical practice requirement, and production process is controlled, meet the requirement of scale continuous and stable production.
Example 4 prepares doxifluridine capsule
Composition and preparation are with example 1
Example 5 prepares doxifluridine capsule
Composition and preparation are with example 2
Example 6 prepares doxifluridine capsule
Composition and preparation are with example 3
Doxifluridine capsule prepared by above-described embodiment 1-6 all meets the doxifluridine capsule quality standard (national drug standards WS of state food and drug administration after testing
1-(X-121)-2006Z).
Comparative example 1-3: be the product produced by existing preparation technology below,
Existing doxifluridine formula process of capsule:
Remarks: doxifluridine capsule principal agent amount calculates by doxifluridine and should be 100.0% of labelled amount.
1, pretreatment: doxifluridine 60 order sieves, low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, starch, magnesium stearate 100 order sieve.
2, prepare: supplementary material presses formula ratio batching.
3, granulate:
3.1, doxifluridine, starch, carboxymethylstach sodium, low-substituted hydroxypropyl cellulose are dropped into high speed wet granulator (model GHL-120) and mix; open air compression system; open after low speed (120 rev/min) stirs 2min, open (180 rev/min) at a high speed and stir 3min.
3.2, after adding 9.00kg47.5% ethanol, low speed (120 rev/min) stirs 2min, granulation 1min.
3.3, wet granular wobbler (model YK160) 18 order nylon wire is granulated.
3.4, wet granular enters baking oven JCT-C-I, and arranging baking temperature is 65 DEG C, and drying time is 2.5 hours
3.5, the dry rear zinc-plated hard net granulate of granule wobbler (model YK-160) 18 order.
4, always mix: dry granule is added in three-dimensional mixer (model GH-200), add magnesium stearate 0.10kg mixing simultaneously.Mix total revolution 50 turns, incorporation time 15 minutes.
5, filling: use full-automatic hard capsule filling machine (model YJF-800) to carry out filling.Within every 15 minutes, check a loading amount.Inner quality standard: ± 5%; National standard: ± 7.5%; The method of inspection is see Chinese Pharmacopoeia 2010 editions two annex IA
6, inner packing.
7, outer package.
The preparation method of comparative example 2-3 is identical with comparative example 1.
It is as follows that 3 batch sample indices investigate result:
Find out from upper table, the content uniformity of three products is comparatively large, does not meet internally controlling requirement.Dissolution and related substance meet inner quality standard.
Example 4 prepares doxifluridine capsule
Composition and preparation are with example 1
Example 5 prepares doxifluridine capsule
Composition and preparation are with example 2
Example 6 prepares doxifluridine capsule
Composition and preparation are with example 3
Doxifluridine capsule prepared by above-described embodiment 1-6 all meets the doxifluridine capsule quality standard (national drug standards WS of state food and drug administration after testing
1-(X-121)-2006Z)
The data of doxifluridine capsule finished product prepared by above-mentioned example 4-6 examine result entirely.
Claims (8)
1. a doxifluridine capsule, is characterized in that, described capsule 's content is grouped into every 1000 by the one-tenth of following weight proportion:
Above-mentioned doxifluridine capsule principal agent amount calculates by doxifluridine and should be 100.0% of labelled amount.
2. the preparation method of doxifluridine capsule as claimed in claim 1, it is characterized in that, the method comprises the following steps:
(1), pretreatment: doxifluridine 60 order sieves; Low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, starch, magnesium stearate 100 order sieve;
(2), prepare: supplementary material presses formula ratio batching;
(3), granulate:
(3.1), by the doxifluridine sieved, starch, carboxymethylstach sodium, low-substituted hydroxypropyl cellulose drop into high speed wet granulator and mix, open air compression system, after opening stirring at low speed 2min, open high-speed stirred 3min;
(3.2), add 47.5% alcoholic solution after, stirring at low speed, granulation;
(3.3), wet granular wobbler 18 order nylon wire is granulated;
(3.4), wet granular enters baking oven, drying;
(3.5), the dry rear zinc-plated hard net granulate of granule wobbler 18 order;
(4), always mix: dry granule is added in three-dimensional mixer, add magnesium stearate mixing, mixing, incorporation time 15 minutes simultaneously;
(5), filling: use full-automatic hard capsule filling machine to carry out filling, check a loading amount, obtain doxifluridine capsule for every 15 minutes.
3. the preparation method of doxifluridine capsule according to claim 2, it is characterized in that, described step (3.1) stirring at low speed is rotating speed 120 rev/min, and high-speed stirred is rotating speed 180 revs/min.
4. the preparation method of doxifluridine capsule according to claim 2, is characterized in that, described step (3.2) 47.5% alcoholic solution is mixed by weight such as 95% ethanol and purified water and obtains, and adding 47.5% alcoholic solution is 220g-300g; Stirring at low speed time 3min-6min, Granulation time is 2min-5min.
5. the preparation method of doxifluridine capsule according to claim 4, it is characterized in that, described step (3.2) adds 47.5% alcoholic solution 260g; The stirring at low speed time is 3min-4min, and Granulation time is 2min-3min.
6. the preparation method of doxifluridine capsule according to claim 2, it is characterized in that, described step (3.4) baking temperature is 60 DEG C ~ 70 DEG C, and drying time is 2.5 hours ~ 4.0 hours.
7. the preparation method of doxifluridine capsule according to claim 2, it is characterized in that, it is 1.50-2.50g that described step (4) adds magnesium stearate.
8. the preparation method of doxifluridine capsule according to claim 7, it is characterized in that, it is 2.00g that described step (4) adds magnesium stearate.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510897618.7A CN105343029B (en) | 2015-12-08 | 2015-12-08 | A kind of doxifluridine capsule and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510897618.7A CN105343029B (en) | 2015-12-08 | 2015-12-08 | A kind of doxifluridine capsule and preparation method thereof |
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| CN105343029B CN105343029B (en) | 2018-10-12 |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4071680A (en) * | 1976-12-20 | 1978-01-31 | Hoffmann-La Roche Inc. | 5'-Deoxy-5-fluoropyrimidine nucleosides |
| EP0189755A1 (en) * | 1985-01-30 | 1986-08-06 | F. Hoffmann-La Roche Ag | Pharmaceutical composition |
| CN1634117A (en) * | 2004-08-30 | 2005-07-06 | 鲁南制药股份有限公司 | Dispersible tablet of doxifluridine |
| CN1712016A (en) * | 2005-06-28 | 2005-12-28 | 董泽贤 | Injection liquid of doxifluoridine |
| CN1943559A (en) * | 2006-10-19 | 2007-04-11 | 胡传良 | Deoxyuridine powder injection and its preparing method |
-
2015
- 2015-12-08 CN CN201510897618.7A patent/CN105343029B/en active Active
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4071680A (en) * | 1976-12-20 | 1978-01-31 | Hoffmann-La Roche Inc. | 5'-Deoxy-5-fluoropyrimidine nucleosides |
| EP0189755A1 (en) * | 1985-01-30 | 1986-08-06 | F. Hoffmann-La Roche Ag | Pharmaceutical composition |
| CN1634117A (en) * | 2004-08-30 | 2005-07-06 | 鲁南制药股份有限公司 | Dispersible tablet of doxifluridine |
| CN1712016A (en) * | 2005-06-28 | 2005-12-28 | 董泽贤 | Injection liquid of doxifluoridine |
| CN1943559A (en) * | 2006-10-19 | 2007-04-11 | 胡传良 | Deoxyuridine powder injection and its preparing method |
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