CN104856994A - Medical pantoprazole sodium composition tablet for treating gastric ulcer - Google Patents
Medical pantoprazole sodium composition tablet for treating gastric ulcer Download PDFInfo
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- CN104856994A CN104856994A CN201510273302.0A CN201510273302A CN104856994A CN 104856994 A CN104856994 A CN 104856994A CN 201510273302 A CN201510273302 A CN 201510273302A CN 104856994 A CN104856994 A CN 104856994A
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Abstract
The invention discloses a medical pantoprazole sodium composition tablet for treating gastric ulcer, and belongs to the technical field of medicines. The tablet consists of a tablet core, an isolating layer and a casing dissolving layer, wherein the tablet core consists of pantoprazole sodium, sodium starch glycolate, dicalcium phosphate, lactose F100, microlite cellulose 102 and magnesium stearate; the isolating layer is compounded by dissolving a film coating pre-mix agent in ethyl alcohol of which the mass concentration is 95%; the casing dissolving layer is compounded by dissolving opadry in the ethyl alcohol; the pantoprazole sodium is a chemical compound in a new crystal form, an X-ray powder diffraction image obtained by using the measurement of a Cu-K alpha-ray is shown in the image 1, and the pantoprazole sodium is different from the pantoprazole sodium reported in the prior art. Tests show that the chemical compound in the structure of the new crystal form is good in flowability and stability; compared with the prior art, the casing dissolving tablet prepared from the chemical compound in the new crystal form of the pantoprazole sodium is high in dissolution, is good in stability, is low in impurity content, and improves the safety of clinical application.
Description
Technical field
The invention belongs to medical art, relate to a kind of medicine Pantoprazole Sodium composition tablet for the treatment of gastric ulcer.
Background technology
Pantoprazole Sodium is proton pump inhibitor, by the H with parietal cell
+-K
+two site covalent bond of ATP enzyme system and final step that gastric acid inhibitory produces.This effect be dose dependent and make basis and stimulation state under gastric acid secretion all suppressed.H
+-K
+the combination of ATP enzyme can cause its anti-gastric acid secretion effect lasts more than 24 hours.Pantoprazole Sodium is the proton pump inhibitor of the 3rd listing after omeprazole and lansoprazole.Due to the substituted radical of Pantoprazole Sodium on pyridine ring and benzimidazole ring and omeprazole and lansoprazole different, thus determine its difference at biochemical, pharmacokinetics and pharmacological property, make it have stronger selectivity and specificity.
In prior art, for crystal formation and the hydrate of Pantoprazole Sodium, there is many research:
Patent application 02109182.X relates to anti-peptic ulcer medicine (±) 5-difluoro-methoxy-[[(3; 4-dimethoxy-2-pyridinyl) methyl] sulfinyl] left-handed (-) of-1H-benzimidazole and the salt of dextrorotation (+) enantiomer, i.e. S (-) pantoprazole potassium, sodium, magnesium, calcium, zinc salt R (+) pantoprazole potassium, sodium, magnesium, calcium, zinc salt.Additionally provide a kind of new preparation process of S (-) pantoprazole and R (+) pantoprazole, with chloroform or acetonitrile as solvents, under Sharpless reagent exists, carry out chiral oxidization obtain, be obtained by reacting with potassium hydroxide, potassium carbonate etc.
ZL201110228921.X discloses a kind of compound of pantoprazole sodium, this compound of pantoprazole sodium is crystal, and in the X-ray powder diffraction pattern using the measurement of Cu-K alpha ray to obtain, characteristic peak is 12.5 °, 12.6 °, 13.2 °, 16.2 °, 17.3 ° displays at 2 θ.
ZL201210306449.1 relates to a kind of pantoprazole sodium crystal, adopt X-diffraction powder diffraction, its collection of illustrative plates is followed successively by 9.5 °, 10.4 °, 11.6 °, 13.1 °, 13.8 °, 14.2 °, 15.0 °, 15.3 °, 15.9 °, 16.5 °, 17.5 °, 18.0 ° and 18.2 ° with the characteristic peak that 2 θ angles represent.
In order to improve the performance of Pantoprazole Sodium further, improve the effect of tablet clinical practice application, special proposition the present invention.
Summary of the invention
Goal of the invention of the present invention is to provide a kind of medicine Pantoprazole Sodium composition tablet for the treatment of gastric ulcer.
The technical solution used in the present invention is:
Treat a medicine Pantoprazole Sodium composition tablet for gastric ulcer, it is characterized in that, described composition tablet is made up of label, sealing coat and enteric layer; Described Pantoprazole Sodium is crystal, and the X-ray powder diffraction pattern that the measurement of use Cu-K alpha ray obtains as shown in Figure 1.
As preferably, with parts by weight, described label is made up of the Pantoprazole Sodium of 0.4 weight portion, the carboxymethylstach sodium of 0.2-0.3 weight portion, the calcium hydrogen phosphate of 0.1-0.18 weight portion, the microcrystalline Cellulose 102 of lactose F100,0.2-0.36 weight portion of 0.2-0.3 weight portion, the magnesium stearate of 0.005-0.015 weight portion.
As preferably, with parts by weight, described sealing coat is formulated in 95% ethanol film coating pre-mix dose of 0.04-0.06 weight portion being dissolved in 0.5-0.74 weight portion.
As preferably, with parts by weight, described enteric layer is formulated in 95% ethanol Opadry of 0.1-0.12 weight portion being dissolved in 1.2-1.24 weight portion.
As preferably, with parts by weight, described label is made up of the magnesium stearate of the calcium hydrogen phosphate of the carboxymethylstach sodium of the Pantoprazole Sodium of 0.4 weight portion, 0.25 weight portion, 0.14 weight portion, the lactose F100 of 0.25 weight portion, microcrystalline Cellulose 102,0.01 weight portion of 0.28 weight portion.
As preferably, with parts by weight, described sealing coat is formulated in 95% ethanol film coating pre-mix dose of 0.05 weight portion being dissolved in 0.62 weight portion.
As preferably, with parts by weight, described enteric layer is formulated in 95% ethanol Opadry of 0.11 weight portion being dissolved in 1.22 weight portions.
As preferably, the preparation method of described composition tablet comprises the following steps:
1) supplementary material process: raw material Pantoprazole Sodium to be sieved 80 orders with oscillating sieving machine;
2) supplementary material is weighed according to prescription;
3) always mix: the Pantoprazole Sodium of recipe quantity, carboxymethylstach sodium, calcium hydrogen phosphate, lactose F100, microcrystalline Cellulose 102 are placed in three-dimensional motion mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes, magnesium stearate is added after having mixed, motor rotation frequency 200r/min is set, opens mixer and mix 5 minutes;
4) tabletting: select high speed tablet press tabletting, regulate pressure to make the molding of slice, thin piece energy and hardness at 5-8kgf;
5) insulating liquid coating: the film coating pre-mix dose of recipe quantity is dissolved in 95% ethanol and is mixed with insulating liquid, arranging coating pan inlet temperature is 55 DEG C, coating weight gain 3.0-3.5%;
6) enteric coating: be dissolved in 95% ethanol by the Opadry of recipe quantity and be mixed with enteric liquid, arranging coating pan inlet temperature is 55 DEG C, coating weight gain 7.0-8.0%.
The preparation method of the pantoprazole sodium crystal in the present composition comprises the following steps:
(1) be that in the methanol of 18 times of Pantoprazole Sodium weight and the mixed solution of carbon tetrachloride, the volume ratio of described methanol and carbon tetrachloride is 4:2.5 to 35 DEG C of volumes by Pantoprazole Sodium dissolving crude product;
(2) add the activated carbon decolorizing that weight is 0.4 times of Pantoprazole Sodium weight, filter, obtain pantoprazole sodium solution;
(3) by Pantoprazole Sodium solution warms to 45 DEG C, in pantoprazole sodium solution, drip the ether of 0 DEG C under the condition of stirring, the volume of ether is 8 times of Pantoprazole Sodium weight, at the uniform velocity dropwises in 0.5h, and described stir speed (S.S.) is 35rmp;
(4) be cooled to-10 DEG C after being added dropwise to complete, continue to stir 1h under the stir speed (S.S.) of 15rmp, leave standstill 2h crystallize out, filter, washing, vacuum drying obtains pantoprazole sodium crystal.
Below technical scheme of the present invention is made further explanation:
The present invention is by the precise controlling to crystallization condition, and prepared a kind of pantoprazole sodium novel crystal form unlike the prior art, the X-ray powder diffraction pattern of this pantoprazole sodium crystal unlike the prior art.Simultaneously due to the ins and outs of this crystal formation, find through test, the compound flow of this novel crystal forms structure, good stability, the enteric coated tablet prepared of this Pantoprazole Sodium crystal compound comparatively prior art to compare dissolution high, good stability, impurity content is low, improves the safety of clinical practice.
Accompanying drawing explanation
Fig. 1 is the X-ray powder diffraction of pantoprazole sodium crystal prepared by the embodiment of the present invention 1.
Detailed description of the invention
Below by specific embodiment, summary of the invention of the present invention is described in further detail, but does not therefore limit content of the present invention.
embodiment 1:the preparation of pantoprazole sodium crystal
(1) be that in the methanol of 18 times of Pantoprazole Sodium weight and the mixed solution of carbon tetrachloride, the volume ratio of described methanol and carbon tetrachloride is 4:2.5 to 35 DEG C of volumes by Pantoprazole Sodium dissolving crude product;
(2) add the activated carbon decolorizing that weight is 0.4 times of Pantoprazole Sodium weight, filter, obtain pantoprazole sodium solution;
(3) by Pantoprazole Sodium solution warms to 45 DEG C, in pantoprazole sodium solution, drip the ether of 0 DEG C under the condition of stirring, the volume of ether is 8 times of Pantoprazole Sodium weight, at the uniform velocity dropwises in 0.5h, and described stir speed (S.S.) is 35rmp;
(4) be cooled to-10 DEG C after being added dropwise to complete, continue to stir 1h under the stir speed (S.S.) of 15rmp, leave standstill 2h crystallize out, filter, washing, vacuum drying obtains pantoprazole sodium crystal.
The X-ray powder diffraction pattern that the pantoprazole sodium crystal prepared uses the measurement of Cu-K alpha ray to obtain as shown in Figure 1.
embodiment 2:the preparation of pantoprazole sodium enteric tablet:
Prescription: with parts by weight as table 1
Table 1 pantoprazole sodium enteric tablet prescription
1) supplementary material process: raw material Pantoprazole Sodium to be sieved 80 orders with oscillating sieving machine;
2) supplementary material is weighed according to prescription;
3) always mix: the Pantoprazole Sodium of recipe quantity, carboxymethylstach sodium, calcium hydrogen phosphate, lactose F100, microcrystalline Cellulose 102 are placed in three-dimensional motion mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes, magnesium stearate is added after having mixed, motor rotation frequency 200r/min is set, opens mixer and mix 5 minutes;
4) tabletting: select high speed tablet press tabletting, regulate pressure to make the molding of slice, thin piece energy and hardness at 5-8kgf;
5) insulating liquid coating: the film coating pre-mix dose of recipe quantity is dissolved in 95% ethanol and is mixed with insulating liquid, arranging coating pan inlet temperature is 55 DEG C, coating weight gain 3.0-3.5%;
6) enteric coating: be dissolved in 95% ethanol by the Opadry of recipe quantity and be mixed with enteric liquid, arranging coating pan inlet temperature is 55 DEG C, coating weight gain 7.0-8.0%.
embodiment 3:the preparation of pantoprazole sodium enteric tablet:
Prescription: with parts by weight as table 2
Table 2 pantoprazole sodium enteric tablet prescription
1) supplementary material process: raw material Pantoprazole Sodium to be sieved 80 orders with oscillating sieving machine;
2) supplementary material is weighed according to prescription;
3) always mix: the Pantoprazole Sodium of recipe quantity, carboxymethylstach sodium, calcium hydrogen phosphate, lactose F100, microcrystalline Cellulose 102 are placed in three-dimensional motion mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes, magnesium stearate is added after having mixed, motor rotation frequency 200r/min is set, opens mixer and mix 5 minutes;
4) tabletting: select high speed tablet press tabletting, regulate pressure to make the molding of slice, thin piece energy and hardness at 5-8kgf;
5) insulating liquid coating: the film coating pre-mix dose of recipe quantity is dissolved in 95% ethanol and is mixed with insulating liquid, arranging coating pan inlet temperature is 55 DEG C, coating weight gain 3.0-3.5%;
6) enteric coating: be dissolved in 95% ethanol by the Opadry of recipe quantity and be mixed with enteric liquid, arranging coating pan inlet temperature is 55 DEG C, coating weight gain 7.0-8.0%.
embodiment 4:the preparation of pantoprazole sodium enteric tablet:
Prescription: with parts by weight as table 3
Table 3 pantoprazole sodium enteric tablet prescription
1) supplementary material process: raw material Pantoprazole Sodium to be sieved 80 orders with oscillating sieving machine;
2) supplementary material is weighed according to prescription;
3) always mix: the Pantoprazole Sodium of recipe quantity, carboxymethylstach sodium, calcium hydrogen phosphate, lactose F100, microcrystalline Cellulose 102 are placed in three-dimensional motion mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes, magnesium stearate is added after having mixed, motor rotation frequency 200r/min is set, opens mixer and mix 5 minutes;
4) tabletting: select high speed tablet press tabletting, regulate pressure to make the molding of slice, thin piece energy and hardness at 5-8kgf;
5) insulating liquid coating: the film coating pre-mix dose of recipe quantity is dissolved in 95% ethanol and is mixed with insulating liquid, arranging coating pan inlet temperature is 55 DEG C, coating weight gain 3.0-3.5%;
6) enteric coating: be dissolved in 95% ethanol by the Opadry of recipe quantity and be mixed with enteric liquid, arranging coating pan inlet temperature is 55 DEG C, coating weight gain 7.0-8.0%.
experimental example 1:mobility is tested
The mobility of this experimental example to the compound of pantoprazole sodium of the embodiment of the present invention 1 detects, adopt fixed funnel method, funnel is placed in the suitable height on graph paper, compound of pantoprazole sodium is freely flowed down from bell mouth, until the cone top formed contacts with bell mouth, measure hypotenuse and the horizontal angle (θ angle of repose) of compound of pantoprazole sodium accumulation horizon, experimental result is as shown in table 4.
Table 4 mobility experimental result
From interpretation, the mobility of the compound of pantoprazole sodium that the embodiment of the present invention 1 prepares is fine.
test example 2: Dissolution Rate Testing
Comparative example 1: the pantoprazole sodium enteric tablet (manufacturer: doctor Rui Di Laboratories, Inc of India) of India's import
Example 2 and comparative example 1 sample respectively, according to drug release determination method (Chinese Pharmacopoeia version in 2010 two annex X B second methods), adopt dissolution method first method device, (0.1mol/l hydrochloric acid solution and 0.2mol/l sodium radio-phosphate,P-32 solution is got by 3:1 mix homogeneously with phosphate buffer, PH to 6.8 is regulated with hydrochloric acid) 900ml is solvent, through 30 minutes time, get solution, filter, precision measures subsequent filtrate 10ml, puts in 25ml measuring bottle, adds above-mentioned phosphate buffer (PH6.8) and is diluted to scale, shake up, as offerings solution; Separately get pantoprazole reference substance (calculating by anhydride) appropriate, accurately weighed, add phosphate buffer (PH6.8) and dissolve and dilute the solution made about containing 15 μ g in every 1ml, product solution in contrast.Get above-mentioned two kinds of solution, measure trap respectively at the wavelength place of 288nm, calculate the burst size of every sheet, result of the test is in table 5:
Table 5 dissolution determination result
As seen from the experiment, the dissolution of enteric coatel tablets of the present invention is significantly higher than India's imported product.Carried out Dissolution Rate Testing to other embodiments of the present invention, result is similar to embodiment 2.
test example 3: stability test
The pantoprazole sodium enteric tablet (manufacturer: doctor Rui Di Laboratories, Inc of India) of the pantoprazole sodium enteric tablet that Example 2-4 obtains and India's import, under high temperature 40 DEG C, relative humidity 75% ± 5% condition 6 months, carry out accelerated test investigation, result is as table 6:
Table 6 accelerated test investigates result
From above result, accelerated test is after 6 months, not there is significant change in the sample dissolution of embodiment of the present invention 2-4 and related substance, and the pantoprazole sodium enteric tablet dissolution of India's import declines larger, related substance raises obviously, and the pantoprazole sodium enteric tablet good stability that the present invention obtains is described.
Claims (8)
1. treat a medicine Pantoprazole Sodium composition tablet for gastric ulcer, it is characterized in that, described composition tablet is made up of label, sealing coat and enteric layer; Described Pantoprazole Sodium is crystal, and the X-ray powder diffraction pattern that the measurement of use Cu-K alpha ray obtains as shown in Figure 1.
2. composition tablet according to claim 1, it is characterized in that, with parts by weight, described label is made up of the Pantoprazole Sodium of 0.4 weight portion, the carboxymethylstach sodium of 0.2-0.3 weight portion, the calcium hydrogen phosphate of 0.1-0.18 weight portion, the microcrystalline Cellulose 102 of lactose F100,0.2-0.36 weight portion of 0.2-0.3 weight portion, the magnesium stearate of 0.005-0.015 weight portion.
3. composition tablet according to claim 1, is characterized in that, with parts by weight, described sealing coat is formulated in 95% ethanol film coating pre-mix dose of 0.04-0.06 weight portion being dissolved in 0.5-0.74 weight portion.
4. composition tablet according to claim 1, is characterized in that, with parts by weight, described enteric layer is formulated in 95% ethanol Opadry of 0.1-0.12 weight portion being dissolved in 1.2-1.24 weight portion.
5. composition tablet according to claim 1 and 2, it is characterized in that, with parts by weight, described label is made up of the magnesium stearate of the calcium hydrogen phosphate of the carboxymethylstach sodium of the Pantoprazole Sodium of 0.4 weight portion, 0.25 weight portion, 0.14 weight portion, the lactose F100 of 0.25 weight portion, microcrystalline Cellulose 102,0.01 weight portion of 0.28 weight portion.
6. the composition tablet according to claim 1 or 3, is characterized in that, with parts by weight, described sealing coat is mixed with in 95% ethanol film coating pre-mix dose of 0.05 weight portion being dissolved in 0.62 weight portion.
7. the composition tablet according to claim 1 or 4, is characterized in that, with parts by weight, described enteric layer is mixed with in 95% ethanol Opadry of 0.11 weight portion being dissolved in 1.22 weight portions.
8. composition tablet according to claim 1, is characterized in that, the preparation method of described composition tablet comprises the following steps:
1) supplementary material process: raw material Pantoprazole Sodium to be sieved 80 orders with oscillating sieving machine;
2) supplementary material is weighed according to prescription;
3) always mix: the Pantoprazole Sodium of recipe quantity, carboxymethylstach sodium, calcium hydrogen phosphate, lactose F100, microcrystalline Cellulose 102 are placed in three-dimensional motion mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes, magnesium stearate is added after having mixed, motor rotation frequency 200r/min is set, opens mixer and mix 5 minutes;
4) tabletting: select high speed tablet press tabletting, regulate pressure to make the molding of slice, thin piece energy and hardness at 5-8kgf;
5) insulating liquid coating: the film coating pre-mix dose of recipe quantity is dissolved in 95% ethanol and is mixed with insulating liquid, arranging coating pan inlet temperature is 55 DEG C, coating weight gain 3.0-3.5%;
6) enteric coating: be dissolved in 95% ethanol by the Opadry of recipe quantity and be mixed with enteric liquid, arranging coating pan inlet temperature is 55 DEG C, coating weight gain 7.0-8.0%.
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Cited By (1)
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CN105147616A (en) * | 2015-09-11 | 2015-12-16 | 青岛蓝盛洋医药生物科技有限责任公司 | Medicine namely pantoprazole sodium composition dry suspension for treating gastric ulcer |
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