CN103462925A - Capecitabine solid preparation pharmaceutical composition and preparation method thereof - Google Patents
Capecitabine solid preparation pharmaceutical composition and preparation method thereof Download PDFInfo
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- CN103462925A CN103462925A CN 201310438097 CN201310438097A CN103462925A CN 103462925 A CN103462925 A CN 103462925A CN 201310438097 CN201310438097 CN 201310438097 CN 201310438097 A CN201310438097 A CN 201310438097A CN 103462925 A CN103462925 A CN 103462925A
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Abstract
The invention relates to the technical field of medicine dosage form structures, and particularly relates to a capecitabine solid preparation pharmaceutical composition and a preparation method thereof. The best formula and the optimal technology are selected through a great quantity of experiments and prescription screening to provide the capecitabine solid preparation pharmaceutical composition for the patients, thereby filling the domestic vacancy and meeting the clinical pharmaceutical needs.
Description
Technical field
The present invention relates to a kind of pharmaceutical formulation technical field of structures, be specifically related to capecitabine solid preparation pharmaceutical composition and preparation method thereof.
Background technology
Breast carcinoma is one of modal malignant tumor of women, and according to statistics, sickness rate accounts for 7～10% of the various malignant tumor of whole body.Its morbidity is often relevant with heredity, and the women's sickness rate between 40～60 years old, before and after menopause is higher.Only approximately 1～2% patient with breast cancer is the male.Usually occur in the malignant tumor of breast glandular epithelium tissue.Be one of even life-threatening modal malignant tumor of a kind of women's of having a strong impact on physical and mental health, male breast carcinoma is rare.
Colorectal carcinoma is malignant tumor common in gastrointestinal tract, early symptom is not obvious, show along with the increase of cancerous protuberance that bowl evacuation habit changes, has blood in stool, suffers from diarrhoea, diarrhoea and the symptoms such as constipation replaces, local stomachache, the General Symptoms such as show anemia late period, lose weight.Its sickness rate and case fatality rate are only second to gastric cancer, the esophageal carcinoma and primary hepatocarcinoma in alimentary system malignant tumour.
Colorectal carcinoma belongs to low in China than other countries and sends out area, but its incidence rate has the increase trend of varying degree in many areas.Primary disease mostly occurs elderly male, with 40～70 years old the most common, but find that person below 30 years old is also not rare 20 end of the centurys.Men and women's both sexes morbidity ratio is about 2:1.Primary disease is the same with other malignant tumor, and pathogenic factor is still unclear, can occur in any position of colon or rectum, but the most common with rectum, sigmoid colon, all the other see caecum, ascending colon, descending colon and transverse colon successively.The carcinoma great majority are adenocarcinoma, and minority is squamous cell carcinoma and mucinous carcinoma.Primary disease can pass through the approach such as lymph, blood circulation and direct extension, sends out its hetero-organization and internal organs.According to clinical manifestation, X ray barium enema or fibercolonscopy, can make a definite diagnosis.The treatment key be early discovery, in time the diagnosis and surgical radical treatment.Early diagnosis and timely operative treatment are depended in the prognosis of primary disease.General cancerous protuberance is only limited to the intestinal wall, and person's prognosis is better, and infiltration is poor to the prognosis of intestinal epigenesist, and young patient, carcinoma infiltrate extensively, transferrer arranged or the complications prognosis mala is arranged.
The sickness rate of colorectal carcinoma and case fatality rate occupy first of various tumors, and thymidylate synthase is basic medicine, but need intravenous administration, and untoward reaction is strong, and a lot of patients can not adhere to the full course for the treatment of.The pyrimidine antagonistic is to treat the main medicine of the tumor patients such as advanced colorectal cancer over nearly 40 years, but because thymidylate synthase can produce the untoward reaction that the patient can't tolerate, 70～eighties of 20th century, clinical research concentrates on by changing dosage form or combining use with various biochemical regulatings, improve activity, reduce untoward reaction.
Capecitabine is as prodrug, and non-activity own, be woven with targeting to tumor group, and metabolism generation active substance is high than its hetero-organization and plasma concentration, and Orally-administrable, be a kind of safe, effective, economic, adaptable antineoplastic agent in addition.
Capecitabine is a kind of novel 5-fluorouracil (5-fluorouracil) prodrug by the development of Switzerland Roche Holding Ag, on August 15th, 1998 in Switzerland's Initial Public Offering, the same year, JIUYUE obtained the further treatment that the U.S. FDA approval is used for the treatment of advanced primary or the metastatic breast cancer invalid to anthracene nucleus medicament chemotherapy such as paclitaxel and doxorubicins, and go on the market at Japan registration with identical indication in April, 2003.Calendar year 2001 FDA approval capecitabine is for the treatment of metastatic colorectal cancer, the European Community, Canada and Australian etc. also all using it as the main medicine for the treatment of metastatic colorectal cancer.At present domesticly by Shanghai Roche Group, produced, still can not meet the clinical application demand, hereby apply for patent of the present invention.
Common name: capecitabine
English name: capecitabine; Ro-9-1978
Trade name: xeloda; Xeloda
Chemical name: the fluoro-N-[(amoxy of 5-deoxidation-5-) carbonyl]-cytidine;
Cytidine,5-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]-[CAS]
Molecular formula: C
15h
22o
6n
3f
Molecular weight: 359.35
CAS accession number: 154361-50-9
Structural formula:
Indication:
Colon cancer adjuvant chemotherapy: after capecitabine is applicable to Dukes ' C phase, primary tumo(u)r radical correction, be suitable for accepting 5-FU class medicine single medicine auxiliary treatment of the colorectal cancer patients for the treatment of separately.The disease free survival phase (DFS) of its treatment is not second to 5-fluorouracil and formyl tetrahydrofolic acid scheme for combining (5-FU/LV).Capecitabine list medicine or all can not extend Overall survival (OS) with the other drug combined chemotherapy, but existing test data shows that capecitabine can improve the disease free survival phase than 5-FU/LV in Combination chemotherapy.When the doctor uses capecitabine list medicine to carry out auxiliary treatment to Dukes ' C phase colon cancer in prescription, can be with reference to above result of study.For supporting the data of this indication from external clinical research (seeing [clinical trial] partial content).
Colorectal cancer: when the first-selected alone 5-FU class Drug therapy of metastatic colorectal cancer patients, capecitabine can be used as First-line chemotherapy.When capecitabine and other drug combined chemotherapy, be better than the mono-medicine chemotherapy of 5-FU/LV life cycle.There is no at present advantage life cycle of proof capecitabine list medicine chemotherapy.Relevant capecitabine in combined chemotherapy, replace 5-FU/LV safety and life cycle advantage also need further research.
The breast carcinoma combined chemotherapy: capecitabine can be combined with docetaxel the metastatic breast cancer that is used for the treatment of the failure of anthracycline-containing pharmaceutical admixtures chemotherapy.The single medicine chemotherapy of breast carcinoma: capecitabine also can be used for the treatment of separately to paclitaxel and the equal drug resistance of anthracycline-containing medicine chemotherapy regimen or for example, to taxol resistance with can not re-use the metastatic breast cancer patient of anthracene nucleus medicament treatment (having accepted accumulated dose 400mg/m2 amycin or amycin congener).Drug resistance is defined as disease during treatment and continues progress (have or alleviate without initial), or completes recurrence in 6 months after the adjuvant chemotherapy that contains anthracene nucleus medicament.
Gastric cancer: capecitabine is applicable to the first-line treatment of inoperable late period or metastatic gastric carcinoma.
Dosage form: tablet, 0.5g
Application number is that CN201210538704.5 discloses a kind of capecitabine dispersible tablet composition and preparation method thereof, and described dispersible tablet is filled a prescription as follows: its accounting example scope of principal agent capecitabine is 70%～80%; Its accounting example scope of polyvinyl pyrrolidone K30 is 3%～7%; Its accounting example scope of disintegrating agent low-substituted hydroxypropyl cellulose sodium is 3%～7%; Its accounting example scope of filler microcrystalline Cellulose is 10%～20%.
Application number is that CN201110189145.7 discloses a kind of capecitabine tablet, described tablet consists of by weight: capecitabine 100-600, microcrystalline Cellulose 10-80, pregelatinized Starch 10-70, low-substituted hydroxypropyl cellulose sodium 30-100,1% PVP K30 50% alcoholic solution 10-70, magnesium stearate 1-10, purified water is appropriate.
Application number provides a kind of new capecitabine tablet composition and a kind of quality controllable for CN201310208550.8, guarantee the preparation method of the capecitabine sheet of product stability, adopt wet granule compression tablet technique, can make granule there is good compressibility, and epigranular, good fluidity, wearability is stronger, preparation technology's feasibility is better, do not need raw material is carried out to the micronizing processing, improved the yield of raw material, reduced production process, and in prescription, supplementary product consumption is less, effectively reduces production cost.
But application number is CN201110267016.5, a kind of capecitabine Pharmaceutical composition and application thereof of direct powder compression are disclosed.The capecitabine that described compositions is 100～200 μ m by mean diameter and pharmaceutically acceptable excipient form.But the capecitabine Pharmaceutical composition of direct powder compression of the present invention can be used for the preparation of capecitabine solid preparation, the especially preparation of tablet.Compared with prior art, but the capecitabine Pharmaceutical composition of direct powder compression of the present invention, electrostatic interaction obviously weakens, mobility and compressibility are good, have solved the sticking problem, have simplified the preparation technology of capecitabine solid preparation, and dissolution and the stability of prepared preparation all meet the requirements, guarantee the quality of preparation, reduced preparation cost, met industrialization production requirements.
Application number is that CN200710048137.4 discloses a kind of capecitabine oral sustained-release preparation and preparation method thereof.This oral sustained-release preparation contains following composition by weight percentage: 1) capecitabine, or its pharmaceutically acceptable salt, or the amount of its esters derivative is 50～90%; 2) 10～50% pharmaceutically acceptable adjuvant, comprising the adjuvant of 4～44% pharmaceutically acceptable slow-releasing and controlled-releasing actions.The present invention adopts the pharmaceutic adjuvant gone on the market, and active constituents of medicine content high (percentage by weight > 50%), can delay controlled release 12 to 24 hours.
Application number provides the film coating pharmaceutical composition for CN200780036204.9, described compositions comprises the fluoro-N-[(amoxy of 5 '-deoxidation-5-)-carbonyl]-cytidine (capecitabine) and at least one disintegrating agent, described disintegrating agent is selected from and comprises following group: crospolyvinylpyrrolidone (granular size<15-400 Μ), low-substituted hydroxypropyl cellulose sodium, primojel, low-substituted hydroxypropyl cellulose, PHARMABURST C or these combination in any, form rapid disintegration tablet together with other pharmaceutical excipient.Described tablet is being less than 2 minutes in 37 ℃ of water in USP disintegrate device, preferably disintegrate in 1 minute, and described tablet has the hardness of 8-13SCU.
Application number provides the film coating pharmaceutical composition for CN200980149768.2, described compositions comprises the fluoro-N-[(amoxy of 5 '-deoxidation-5-)-carbonyl]-cytidine (capecitabine) and at least one disintegrating agent, described disintegrating agent is selected from and comprises following group: crospolyvinylpyrrolidone (granularity<15-400 μ), low-substituted hydroxypropyl cellulose sodium, sodium starch glycollate, the low hyprolose replaced, Ludiflash or these combination in any, form rapid disintegration tablet together with other pharmaceutical excipient.
Application number is that CN201110415055.5 relates to a kind of capecitabine fast release micropill and preparation method thereof, and the composition of described capecitabine fast release micropill comprises capecitabine, excipient, disintegrating agent and binding agent, and described micropill particle diameter is 0.1-10mm; The present invention prepares capecitabine fast release micropill direct encapsulating capsule with the extruded type granulating technique, has greatly simplified production process, and described method is simple and reliable, and capecitabine fast release micropill favorable reproducibility, the yield prepared by method of the present invention are high.
Capecitabine is a kind of new oral '-fluoropyrimidine nucleosides class analog, it can be absorbed rapidly by intestinal mucosa with complete molecular forms because containing the mephenesin Carbamate structure, there are three step activation mechanisms in unique body, finally change 5-fluorouracil into through three steps, performance suppresses the effect of tumor: (1) Carboxylesterase in liver changes 5-deoxidation-5-fluorine cytidine (5-DFCR) into; (2) in liver and tumor tissues, active higher cytidine deaminase is converted into 5-DFUR; (3) the gland pyrimi piperidine deoxidating nucleus glycosides phosphorylase (dThdPase) in tumor tissues is converted into activated 5-fluorouracil.Concentration and the specific activity corresponding non-cancer tissue of dThdPase in various entity tumors is high, therefore the antitumor action of capecitabine has targeting, can be in tumor tissues selectivity be activated and produce the competent cell poisonous substance matter of high concentration, thereby improve the tolerance of tumor patient, and active anticancer is maximized; Again because itself does not show biological activity, many untoward reaction of having avoided oral fluorouracil to cause.
Oral capecitabine treatment, the fluorouracil concentration produced in tumor is 127 and 22 times in blood plasma and muscle.Directly the concentration difference of intravenous injection fluorouracil in treatment in tumor, blood plasma and muscle is not remarkable.The capecitabine concentrated in tumor tissues discharges rapidly fluorouracil, then decomposites anti-tumor active substance, significantly reduces the untoward reaction of fluorouracil to the patient, improves toleration, reaches the therapeutic effect of expection.
Summary of the invention
Purpose of the present invention just is according to existing adjuvant and working condition, guaranteeing to have lower production cost and simple preparation technology, be suitable under the prerequisite of large-scale industrial production, being necessary to work out a kind of suitable prescription forms and preparation technology, can produce capecitabine solid preparation pharmaceutical composition, make it there is good bioavailability and stability of drug products.
The object of the present invention is to provide a kind of capecitabine solid preparation pharmaceutical composition and preparation method thereof, it can overcome the deficiency of prior art, efficiently solves the problem of capecitabine solid preparation.
The purpose of this invention is to provide a kind of capecitabine solid preparation pharmaceutical composition.
Capecitabine solid preparation pharmaceutical composition provided by the present invention and preparation method thereof, prepare 1000, and compositing formula is as follows:
Capecitabine solid preparation pharmaceutical composition provided by the present invention and preparation method thereof prepares the preparation method of 1000, following steps:
1) preprocessing raw material and auxiliary material operation: capecitabine, pregelatinized Starch, microcrystalline Cellulose are crossed respectively to 60 mesh sieves.2) granulation process: the preparation of binding agent: in PVP K30: ratio purified water=3:97(W:W) is mixed with 3% solution.To sieve rear capecitabine, pregelatinized Starch, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose sodium adds in wet mixing pelletizer, carries out premix, and premix finishes to add adhesive to be granulated; Atomizing pressure 0.25～0.35Mpa, when obvious granule being arranged in soft material, granulate and finish.By the soft material that makes wet granulate online, mesh size: 3 * 3mm.Start fluid bed, wet granular is transferred to fluid bed online.
3) drying process: use boiling drier to carry out drying, inlet temperature is 60 ℃, and dry air quantity is set 30～40HZ, should make whole granules answer integral body to stir, and adjusts in case of necessity air quantity.Measure moisture with infrared fast tester for water content, moisture≤2.0%, the dry end, rewinding.
4) granulate operation: the dry granule after drying is carried out to online granulate, mesh size 1.2mm.
5) always mix operation: the dry granule after granulate, magnesium stearate, silicon dioxide are mixed 15 minutes in mixer, and sampling detects intermediate content, moisture.Moisture≤3.0%.
6) sheeting process: according to intermediate content, converting standard sheet weight, tabletting.Tablet weight variation controls ± 4.0%; Pressure limit 13～15kg/mm
2.
7) coating operation: in stomach dissolved film coating pre-mix dose: ratio preparation coating solution purified water=1:6.7(W:W).The coating pan engine speed is controlled at 4～7 turn/min.The seed-coating machine hot blast temperature is made as 65 ℃, is preheated to 47 ℃ of leaving air temps and starts coating.Peristaltic pump rotating speed 5～10rpm, atomizing pressure 0.40～0.60Mpa, spray gun is controlled at 20～40cm to sheet bed distance, and spray angle becomes 90 degree with sheet bed plane, and coating process control negative pressure is at 60～100pa.In the coating process, leaving air temp is controlled between 50 ℃～55 ℃.Coating weightening finish approximately 3.0%.
8) packaging process: aluminum-plastic packaged parameter setting: heat-seal temperature is set as 140 ℃, and compressed air pressure 0.6Mpa can suitably adjust design temperature up and down according to the difference of room temperature and aluminum-plastic packaged material, seals qualified being advisable.
In the present invention, through the screening of the test recipes of tens of times and the summary of test data, optimized its recipe quantity, and constant product quality.
Prescription screening
Prescription with reference to the solid preparation routine forms, and considers that principal agent capecitabine specification is larger simultaneously, and in acid, easy degraded and mobility are poor, have increased sodium lauryl sulphate and fluidizer silicon dioxide, and default several prescriptions are composed as follows:
The inventor finds through a large amount of experimental study, and the capecitabine pharmaceutical composition is during for prescription 6 formula, described pharmaceutical composition the best in quality, and stability is best, and yield rate is high, easily industrialized implementation.
Another aspect of the present invention provides the preparation method of capecitabine solid preparation pharmaceutical composition of the present invention, and the method is simple, prepared capecitabine solid preparation pharmaceutical composition good stability.
The specific embodiment
Below in conjunction with specific embodiment, capecitabine solid preparation pharmaceutical composition of the present invention and preparation method thereof structure is illustrated to help understanding content of the present invention.
Embodiment 1
Prepare 1000 capecitabine solid preparation pharmaceutical compositions, compositing formula is as follows:
During making:
1) preprocessing raw material and auxiliary material operation: capecitabine, pregelatinized Starch, microcrystalline Cellulose are crossed respectively to 60 mesh sieves.2) granulation process: the preparation of binding agent: in PVP K30: ratio purified water=3:97(W:W) is mixed with 3% solution.To sieve rear capecitabine, pregelatinized Starch, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose sodium adds in wet mixing pelletizer, carries out premix, and premix finishes to add adhesive to be granulated; Atomizing pressure 0.25～0.35Mpa, when obvious granule being arranged in soft material, granulate and finish.By the soft material that makes wet granulate online, mesh size: 3 * 3mm.Start fluid bed, wet granular is transferred to fluid bed online.
3) drying process: use boiling drier to carry out drying, inlet temperature is 60 ℃, and dry air quantity is set 30～40HZ, should make whole granules answer integral body to stir, and adjusts in case of necessity air quantity.Measure moisture with infrared fast tester for water content, moisture≤2.0%, the dry end, rewinding.
4) granulate operation: the dry granule after drying is carried out to online granulate, mesh size 1.2mm.
5) always mix operation: the dry granule after granulate, magnesium stearate, silicon dioxide are mixed 15 minutes in mixer, and sampling detects intermediate content, moisture.Moisture≤3.0%.
6) sheeting process: according to intermediate content, converting standard sheet weight, tabletting.Tablet weight variation controls ± 4.0%; Pressure limit 13～15kg/mm
2.
7) coating operation: in stomach dissolved film coating pre-mix dose: ratio preparation coating solution purified water=1:6.7(W:W).The coating pan engine speed is controlled at 4～7 turn/min.The seed-coating machine hot blast temperature is made as 65 ℃, is preheated to 47 ℃ of leaving air temps and starts coating.Peristaltic pump rotating speed 5～10rpm, atomizing pressure 0.40～0.60Mpa, spray gun is controlled at 20～40cm to sheet bed distance, and spray angle becomes 90 degree with sheet bed plane, and coating process control negative pressure is at 60～100pa.In the coating process, leaving air temp is controlled between 50 ℃～55 ℃.Coating weightening finish approximately 3.0%.
8) packaging process: aluminum-plastic packaged parameter setting: heat-seal temperature is set as 140 ℃, and compressed air pressure 0.6Mpa can suitably adjust design temperature up and down according to the difference of room temperature and aluminum-plastic packaged material, seals qualified being advisable.
Embodiment 2
Simulate large production scale, with 30,000 every batch, amplify and produce 3 batches.
| The trial-manufacture of sample lot number | Plan trial-production number | Actual trial-production number | Assay |
| SR20120061 criticizes | 30000 | 27130 | Up to specification |
| SR20120062 criticizes | 30000 | 27180 | Up to specification |
| SR20120063 criticizes | 30000 | 27260 | Up to specification |
Through evidence: product formulation and technology simple possible.Be packaged in 40 ℃ ± 2 ℃ through three batches of products with listing, place under the accelerated test condition of relative humidity 75% ± 5% 6 months and the long term test condition is placed 6 months, result shows, quality is more stable meets production requirement.
Test example 1
Get the capecitabine solid preparation pharmaceutical composition that embodiment 1, embodiment 2 amount to 4 batches of different batches, investigate its release, see the following form:
From above result of the test: capecitabine solid preparation pharmaceutical composition, effectively guarantee clinical demand, between batch, difference is little, steady quality.
Claims (2)
1. a capecitabine solid preparation pharmaceutical composition, is characterized in that, its described capecitabine solid preparation pharmaceutical composition, and every 1000 its formulas consist of:
2. the preparation method of capecitabine solid preparation pharmaceutical composition according to claim 1, is characterized in that, the method comprises the steps:
1) preprocessing raw material and auxiliary material operation: capecitabine, pregelatinized Starch, microcrystalline Cellulose are crossed respectively to 60 mesh sieves.
2) granulation process: the preparation of binding agent: in PVP K30: ratio purified water=3:97(W:W) is mixed with 3% solution.To sieve rear capecitabine, pregelatinized Starch, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose sodium adds in wet mixing pelletizer, carries out premix, and premix finishes to add adhesive to be granulated; Atomizing pressure 0.25～0.35Mpa, when obvious granule being arranged in soft material, granulate and finish.By the soft material that makes wet granulate online, mesh size: 3 * 3mm.Start fluid bed, wet granular is transferred to fluid bed online.
3) drying process: use boiling drier to carry out drying, inlet temperature is 60 ℃, and dry air quantity is set 30～40HZ, should make whole granules answer integral body to stir, and adjusts in case of necessity air quantity.Measure moisture with infrared fast tester for water content, moisture≤2.0%, the dry end, rewinding.
4) granulate operation: the dry granule after drying is carried out to online granulate, mesh size 1.2mm.
5) always mix operation: the dry granule after granulate, magnesium stearate, silicon dioxide are mixed 15 minutes in mixer, and sampling detects intermediate content, moisture.Moisture≤3.0%.
6) sheeting process: according to intermediate content, converting standard sheet weight, tabletting.Tablet weight variation controls ± 4.0%; Pressure limit 13～15kg/mm
2.
7) coating operation: in stomach dissolved film coating pre-mix dose: ratio preparation coating solution purified water=1:6.7(W:W).The coating pan engine speed is controlled at 4～7 turn/min.The seed-coating machine hot blast temperature is made as 65 ℃, is preheated to 47 ℃ of leaving air temps and starts coating.Peristaltic pump rotating speed 5～10rpm, atomizing pressure 0.40～0.60Mpa, spray gun is controlled at 20～40cm to sheet bed distance, and spray angle becomes 90 degree with sheet bed plane, and coating process control negative pressure is at 60～100pa.In the coating process, leaving air temp is controlled between 50 ℃～55 ℃.Coating weightening finish approximately 3.0%.
8) packaging process: aluminum-plastic packaged parameter setting: heat-seal temperature is set as 140 ℃, and compressed air pressure 0.6Mpa can suitably adjust design temperature up and down according to the difference of room temperature and aluminum-plastic packaged material, seals qualified being advisable.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104997744A (en) * | 2015-08-04 | 2015-10-28 | 孙丽华 | High-stability capecitabine tablets and preparation method thereof |
| CN108606972A (en) * | 2018-06-07 | 2018-10-02 | 董贵雨 | It is a kind of using capecitabine as the solid composite medicament of main ingredient ingredient |
-
2013
- 2013-09-23 CN CN 201310438097 patent/CN103462925A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104997744A (en) * | 2015-08-04 | 2015-10-28 | 孙丽华 | High-stability capecitabine tablets and preparation method thereof |
| CN108606972A (en) * | 2018-06-07 | 2018-10-02 | 董贵雨 | It is a kind of using capecitabine as the solid composite medicament of main ingredient ingredient |
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