CN105343029B - A kind of doxifluridine capsule and preparation method thereof - Google Patents
A kind of doxifluridine capsule and preparation method thereof Download PDFInfo
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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
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- 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
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- 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
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- 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
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Abstract
The present invention provides a kind of doxifluridine capsules, which is characterized in that the capsule 's content by following weight proportion at being grouped as, every 1000：Doxifluridine 200.00g, starch 108.00g, low-substituted hydroxypropyl cellulose 70.00g, carboxyrnethyl starch sodium 20.00g, 47.5% ethanol water, 220 300g, 1.50 2.50g of magnesium stearate.The present invention provides improved doxifluridine capsule and preparation method thereof, eliminates product clinical risk caused by content uniformity, reduces the adverse reaction caused by content uniformity, it is ensured that product it is safe and effective, so that product is more advantageous to Clinical practice.The method of the present invention is easy to operate, does not increase new cost, is suitable for scale industrial production, there is larger application value.
Description
Technical field
The present invention relates to pharmaceutical preparations, and in particular to process for preparing medicine more particularly to a kind of doxifluridine capsule and
Preparation method.
Background technology
The main component of doxifluridine capsule is doxifluridine, is clinically used for treatment breast cancer, gastric cancer, colorectum
Cancer, nasopharyngeal carcinoma.Doxifluridine is a kind of fluorouracil derivative, by the pyrimidine nucleoside phosphorylase of high activity in tumor tissues
Enzymatic conversion plays its selective antitumor action at fluorouracil (5-Fu).Experiment shows that the therapeutic index of doxifluridine is high
In 5-Fu, doxifluridine is preferable since it has better targeting, clinical signs as a kind of pro-drug
Therapeutic effect, lower toxic side effect, the compliance for increasing patient have significant clinical meaning.
Existing doxifluridine capsule formula and its preparation：
Remarks：Doxifluridine capsule main ingredient amount should be the 100.0% of labelled amount by doxifluridine calculating.
1, it pre-processes：60 mesh of doxifluridine is sieved, low-substituted hydroxypropyl cellulose, carboxyrnethyl starch sodium, starch, magnesium stearate
100 mesh are sieved.
2, it prepares：Supplementary material presses recipe quantity dispensing.
3, it pelletizes：
3.1, doxifluridine, starch, carboxyrnethyl starch sodium, low-substituted hydroxypropyl cellulose input high speed wet granulator are mixed
With, open air compression system, after opening stirring at low speed 2min, open high-speed stirred 3min.
3.2, after 47.5% ethanol being added, stirring at low speed 2min, pelletize 1min.
3.3, wet granular is pelletized with 18 mesh nylon wire of wobbler.
3.4, wet granular enters baking oven, and setting drying temperature is 60~70 DEG C, and drying time is 2.5~4.0 hours.
3.5, the particle zinc-plated hard net whole grain of 18 mesh of wobbler after drying.
4, total mixed：Dry particl is added in three-dimensional mixer, while magnesium stearate mixing is added.50 turns of revolution is mixed, is mixed
Close 15 minutes time.
5, it fills：It is filled using full-automatic hard capsule filling machine.Check a loading amount within every 15 minutes.
6, inner packing.
7, outer packing.
Since doxifluridine is insoluble drug, bioavilability is relatively low, therefore adds when existing design is formulated
Having entered more disintegrant, (low-substituted hydroxypropyl cellulose accounts for about the 17.5% of recipe quantity；Carboxyrnethyl starch sodium accounts for about recipe quantity
5%) dissolution rate of drug is improved with this.But the addition of a large amount of disintegrants makes particle lack cohesive force, in the drying process
Fine powder is more after a large amount of particles are broken, therefore often discovery is dry in process of production, and mobility is bad.Due to doxifluridine
For raw material in threadiness or acicular texture, compressibility is poor, and above-mentioned factor causes the granulate intermediate mobility of production gained poor,
The filling content uniformity of capsule is larger.Although can slightly improve this feelings by glidants such as additional magnesium stearate, silica
Condition, but bottom can not be surveyed and solve the problems, such as that mobility is bad, bring certain influence to the production of continuous-stable, it would be highly desirable to improve.
Invention content
Technical problem to be solved by the present invention lies in above-mentioned shortcoming is overcome, research and design content uniformity is in controllable model
The formula and preparation method thereof of stable, the safer effective clinic doxifluridine capsule of processing quality in enclosing.
The present invention provides a kind of doxifluridine capsules.
The capsule 's content is by following weight proportion at being grouped as (every 1000)：
Remarks：Doxifluridine capsule main ingredient amount should be the 100.0% of labelled amount by doxifluridine calculating.
It is a further object of the present invention to provide the preparation method of the doxifluridine capsule, this method includes following step
Suddenly：
(1), it pre-processes：60 mesh of doxifluridine is sieved；Low-substituted hydroxypropyl cellulose, carboxyrnethyl starch sodium, starch, stearic acid
100 mesh of magnesium is sieved；
(2), it prepares：Supplementary material presses formula ratio dispensing；
(3), it pelletizes：
(3.1), the doxifluridine of sieving, starch, carboxyrnethyl starch sodium, low-substituted hydroxypropyl cellulose are put into high speed wet method
Granulator mixes, and opens air compression system, after opening stirring at low speed 2min, opens high-speed stirred 3min；
(3.2), after 47.5% ethanol solution being added, stirring at low speed, granulation；
(3.3), wet granular is pelletized with 18 mesh nylon wire of wobbler；
(3.4), wet granular enters baking oven, drying；
(3.5), the particle zinc-plated hard net whole grain of 18 mesh of wobbler after drying；
(4), total mixed：Dry particl is added in three-dimensional mixer, while magnesium stearate mixing is added, is mixed, incorporation time
15 minutes；
(5), it fills：It is filled using full-automatic hard capsule filling machine, checks a loading amount within every 15 minutes；
(6), inner packing；
(7), outer packing.
Step (3.1) stirring at low speed rotating speed of the present invention is 120 rev/min, high-speed stirred rotating speed is 180 turns/it is every
Minute.
It is 220g-300g that 47.5% ethanol solution, which is added, in step (3.2) of the present invention；It is molten to be preferably added to 47.5% ethyl alcohol
Liquid 260g.47.5% ethanol solution is mixed to prepare by weight such as 95% ethyl alcohol and purified waters.
Step (3.2) the stirring at low speed time of the present invention is 3min-6min, Granulation time 2min-5min；It is preferred that low
Fast mixing time is 3min-4min, Granulation time 2min-3min.
Step (3.4) drying temperature of the present invention is 60 DEG C~70 DEG C, and drying time is 2.5 hours~4.0 hours.
It is 1.50-2.50g that magnesium stearate, which is added, in step (4) of the present invention；It is preferably added to 2.00g magnesium stearates.
The present invention provides improved doxifluridine capsule and preparation method thereof, and eliminate product causes because of content uniformity
Clinical risk, reduce the adverse reaction caused by content uniformity, it is ensured that product it is safe and effective, so that product is more advantageous to and face
Bed uses.The method of the present invention is easy to operate, does not increase new cost, is suitable for scale industrial production, there is larger application value.
Specific implementation mode
Following embodiment is raw materials used to be commercially available.
Example 1 prepares doxifluridine capsule：
Remarks：Doxifluridine capsule main ingredient amount should be the 100.0% of labelled amount by doxifluridine calculating.
1, it pre-processes：60 mesh of doxifluridine is sieved, low-substituted hydroxypropyl cellulose, carboxyrnethyl starch sodium, starch, magnesium stearate
100 mesh are sieved.
2, it prepares：Supplementary material presses formula ratio dispensing.
47.5% ethanol solution is mixed to prepare by weight such as 95% ethyl alcohol and purified waters.
3, it pelletizes：
3.1, doxifluridine, starch, carboxyrnethyl starch sodium, low-substituted hydroxypropyl cellulose are put into high speed wet granulator
(GHL-120) it mixes, opens air compression system, after opening low speed (120 rev/min) stirring 2min, open high speed (180 rpms
Clock) stirring 3min.
3.2, after 47.5% ethanol solutions of 11.00kg being added, low speed (120 rev/min) stirs 3min, and pelletize 2min.
3.3, wet granular is pelletized with wobbler YK-16018 mesh nylon wires.
3.4, wet granular enters baking oven JCT-C-I, and setting drying temperature is 65 DEG C, and drying time is 2.5 hours.
3.5, the particle zinc-plated hard net whole grain of 18 mesh of wobbler (model YK-160) after drying.
4, total mixed：Dry particl is added in three-dimensional mixer (model GH-200), while it is mixed that magnesium stearate 0.075kg is added
It is even.Incorporation time 15 minutes.
5, it fills：It is filled using full-automatic hard capsule filling machine (model YJF-800).Check within every 15 minutes primary dress
Amount.(detection inner quality standard：± 5%；National standard：± 7.5%；The method of inspection is referring to 2010 editions two annex I of Chinese Pharmacopoeia
A)
6, inner packing.
7, outer packing.
Example 2 prepares doxifluridine capsule：
Remarks：Doxifluridine capsule main ingredient amount should be the 100.0% of labelled amount by doxifluridine calculating.
1, it pre-processes：60 mesh of doxifluridine is sieved, low-substituted hydroxypropyl cellulose, carboxyrnethyl starch sodium, starch, magnesium stearate
100 mesh are sieved.
2, it prepares：Supplementary material presses formula ratio dispensing.
3, it pelletizes：
3.1, doxifluridine, starch, carboxyrnethyl starch sodium, low-substituted hydroxypropyl cellulose are put into high speed wet granulator
GHL-120 is mixed, and is opened air compression system and is opened 180 rev/min of high-speed stirred after opening 120 rev/min 2min of stirring at low speed
3min。
3.2, after 47.5% ethanol solutions of 13.00kg being added, stirring at low speed 4min120 rev/min, pelletize 3min.
3.3, wet granular is pelletized with wobbler YK-16018 mesh nylon wires.
3.4, wet granular enters baking oven JCT-C-I, and setting drying temperature is 65 DEG C, and drying time is 3.0 hours.
3.5, the particle zinc-plated hard net whole grain of wobbler YK-16018 mesh after drying.
4, total mixed：Dry particl is added in three-dimensional mixer GH-200, while magnesium stearate 0.10kg mixings are added, is mixed
15 minutes time.
5, it fills：It is filled using full-automatic hard capsule filling machine YJF-800.Check a loading amount within every 15 minutes.It is interior
Control standard：± 5%；National standard：± 7.5%；The method of inspection is referring to 2010 editions two annex I A of Chinese Pharmacopoeia
6, inner packing.
7, outer packing.
Example 3 prepares doxifluridine capsule：
Remarks：Doxifluridine capsule main ingredient amount should be the 100.0% of labelled amount by doxifluridine calculating.
1, it pre-processes：60 mesh of doxifluridine is sieved, low-substituted hydroxypropyl cellulose, carboxyrnethyl starch sodium, starch, magnesium stearate
100 mesh are sieved.
2, it prepares：Supplementary material presses formula ratio dispensing.
3, it pelletizes：
3.1, doxifluridine, starch, carboxyrnethyl starch sodium, low-substituted hydroxypropyl cellulose are put into high speed wet granulator
GHL-120 is mixed, and is opened air compression system and is opened 180 rev/min of high-speed stirred after opening 120 rev/min 2min of stirring at low speed
3min。
3.2, after 15.00kg47.5% ethanols being added, 120 rev/min 6min of stirring at low speed, pelletize 5min.
3.3, wet granular is pelletized with wobbler YK-16018 mesh nylon wires.
3.4, wet granular enters baking oven JCT-C-I, and setting drying temperature is 65 DEG C, and drying time is 4.0 hours
3.5, the particle zinc-plated hard net whole grain of wobbler YK-16018 mesh after drying.
4, total mixed：Dry particl is added in three-dimensional mixer GH-200, while magnesium stearate 0.125kg mixings are added, is mixed
Close 15 minutes time.
5, it fills：It is filled using full-automatic hard capsule filling machine YJF-800.Check a loading amount within every 15 minutes.It is interior
Control standard：± 5%；National standard：± 7.5%；The method of inspection is referring to 2010 editions two annex I A of Chinese Pharmacopoeia
6, inner packing.
7, outer packing.
Indices investigation is carried out to the doxifluridine capsule of embodiment 1-3 productions, it is as a result as follows：
As a result illustrate, the doxifluridine capsule indices of embodiment 1-3 productions all comply with standard regulation, and loading amount is poor
Different, labelled amount, dissolution rate, related substance meet Clinical practice requirement, and production process is controllable, meet the life of scale continuous-stable
Production requires.
Example 4 prepares doxifluridine capsule
Composition and preparation are the same as example 1
Example 5 prepares doxifluridine capsule
Composition and preparation are the same as example 2
Example 6 prepares doxifluridine capsule
Composition and preparation are the same as example 3
Doxifluridine capsule prepared by above-described embodiment 1-6 meets doxifluridine capsule quality standard after testing
(the national drug standards WS of state food and drug administration1-(X-121)-2006Z)。
Comparative example 1-3：It is the product produced by existing preparation process below,
Existing doxifluridine formula process of capsule：
Remarks：Doxifluridine capsule main ingredient amount should be the 100.0% of labelled amount by doxifluridine calculating.
1, it pre-processes：60 mesh of doxifluridine is sieved, low-substituted hydroxypropyl cellulose, carboxyrnethyl starch sodium, starch, magnesium stearate
100 mesh are sieved.
2, it prepares：Supplementary material presses formula ratio dispensing.
3, it pelletizes：
3.1, doxifluridine, starch, carboxyrnethyl starch sodium, low-substituted hydroxypropyl cellulose are put into high speed wet granulator
(model GHL-120) is mixed, and opens air compression system, after opening low speed (120 rev/min) stirring 2min, opens (180 turns/every of high speed
Minute) stirring 3min.
3.2, after 47.5% ethanols of 9.00kg being added, low speed (120 rev/min) stirs 2min, and pelletize 1min.
3.3, wet granular is pelletized with 18 mesh nylon wire of wobbler (model YK160).
3.4, wet granular enters baking oven JCT-C-I, and setting drying temperature is 65 DEG C, and drying time is 2.5 hours
3.5, the particle zinc-plated hard net whole grain of 18 mesh of wobbler (model YK-160) after drying.
4, total mixed：Dry particl is added in three-dimensional mixer (model GH-200), while it is mixed that magnesium stearate 0.10kg is added
It is even.Mix 50 turns of total revolution, incorporation time 15 minutes.
5, it fills：It is filled using full-automatic hard capsule filling machine (model YJF-800).Check within every 15 minutes primary dress
Amount.Inner quality standard：± 5%；National standard：± 7.5%；The method of inspection is referring to 2010 editions two annex I A of Chinese Pharmacopoeia
6, inner packing.
7, outer packing.
The preparation method of comparative example 2-3 is identical as comparative example 1.
It is as follows that 3 batches of sample indices investigate result：
As can be seen from the above table, the content uniformity of three products is larger, internally controlling requirement is not met.Dissolution rate and related substance meet
Inner quality standard.
Example 4 prepares doxifluridine capsule
Composition and preparation are the same as example 1
Example 5 prepares doxifluridine capsule
Composition and preparation are the same as example 2
Example 6 prepares doxifluridine capsule
Composition and preparation are the same as example 3
Doxifluridine capsule prepared by above-described embodiment 1-6 meets doxifluridine capsule quality standard after testing
(the national drug standards WS of state food and drug administration1-(X-121)-2006Z)
The data full inspection result of doxifluridine capsule finished product prepared by examples detailed above 4-6.
Claims (8)
1. a kind of doxifluridine capsule, which is characterized in that the capsule 's content is every at being grouped as by following weight proportion
1000：
Above-mentioned doxifluridine capsule main ingredient amount should be the 100.0% of labelled amount by doxifluridine calculating.
2. the preparation method of doxifluridine capsule as described in claim 1, which is characterized in that this method includes the following steps：
(1), it pre-processes：60 mesh of doxifluridine is sieved；Low-substituted hydroxypropyl cellulose, carboxyrnethyl starch sodium, starch, magnesium stearate
100 mesh are sieved；
(2), it prepares：Supplementary material presses formula ratio dispensing；
(3), it pelletizes：
(3.1), the doxifluridine of sieving, starch, carboxyrnethyl starch sodium, low-substituted hydroxypropyl cellulose are put into high speed wet granulation
Machine mixes, and opens air compression system, after opening stirring at low speed 2min, opens high-speed stirred 3min；
(3.2), after 47.5% ethanol solution being added, stirring at low speed, granulation；
(3.3), wet granular is pelletized with 18 mesh nylon wire of wobbler；
(3.4), wet granular enters baking oven, drying；
(3.5), the particle zinc-plated hard net whole grain of 18 mesh of wobbler after drying；
(4), total mixed：Dry particl is added in three-dimensional mixer, while magnesium stearate mixing is added, is mixed, incorporation time 15 is divided
Clock；
(5), it fills：It is filled using full-automatic hard capsule filling machine, checks within every 15 minutes a loading amount to get deoxidation fluorine urine
Glycosides capsule.
3. the preparation method of doxifluridine capsule according to claim 2, which is characterized in that step (3.1) low speed
Stirring is 120 rev/min of rotating speed, and high-speed stirred is 180 revs/min of rotating speed.
4. the preparation method of doxifluridine capsule according to claim 2, which is characterized in that the step (3.2)
47.5% ethanol solution is mixed to prepare by the weight such as 95% ethyl alcohol and purified water, and 47.5% ethanol solution of addition is 220g-
300g；Stirring at low speed time 3min-6min, Granulation time 2min-5min.
5. the preparation method of doxifluridine capsule according to claim 4, which is characterized in that the step (3.2) is added
47.5% ethanol solution 260g；The stirring at low speed time is 3min-4min, Granulation time 2min-3min.
6. the preparation method of doxifluridine capsule according to claim 2, which is characterized in that the step (3.4) is dry
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, which is characterized in that the step (4) is added hard
Fatty acid magnesium is 1.50-2.50g.
8. the preparation method of doxifluridine capsule according to claim 7, which is characterized in that the step (4) is added hard
Fatty acid magnesium is 2.00g.
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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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| Publication number | Publication date |
|---|---|
| CN105343029A (en) | 2016-02-24 |
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