CN104873511A - Medical lansoprazole composition for treating gastric ulcer - Google Patents
Medical lansoprazole composition for treating gastric ulcer Download PDFInfo
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- CN104873511A CN104873511A CN201510245427.2A CN201510245427A CN104873511A CN 104873511 A CN104873511 A CN 104873511A CN 201510245427 A CN201510245427 A CN 201510245427A CN 104873511 A CN104873511 A CN 104873511A
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Abstract
The invention discloses a medical lansoprazole composition for treating gastric ulcer, and belongs to the technical field of medicines. The composition comprises a tablet core, an isolating layer and an enteric coated layer, wherein the tablet core is prepared from a lansoprazole crystal, lactose, microcrystalline cellulose, carboxymethyl starch sodium, calcium hydrophosphate, hydroxypropyl methylcellulose, purified water, lauryl sodium sulfate and silicon dioxide; the isolating layer is prepared by dissolving a film coating premixing agent into 95% ethanol; the enteric coated layer is prepared by dissolving opadry into 95% ethanol. The lansoprazole crystal compound is free of impurity E; the contents of impurity A and impurity B are obviously reduced and changed a little as the storage time goes on; the composition is outstanding in mobility, and the dissolution rate is obviously improved.
Description
Technical field
The invention belongs to medical art, relate to a kind of medicine Lansoprazole composition for the treatment of gastric ulcer, be specifically related to a kind of Lansoprazole enteric coated tablet compositions.
Background technology
The benzimidazoles derivative with antiacid effect that lansoprazole is developed in December, 1991 by Japanese Wu Tian company, it acts on the H+-K+-ATP enzyme of parietal cell, the H+ of parietal cell can not be transported in stomach go, so that gastric acid amount greatly reduces in gastric juice, be used for the treatment of gastric ulcer, duodenal ulcer and reflux esophagitis, and be used for eliminating pylorus.
Lansoprazole is novel proton pump inhibitor, it is the upgraded product of omeprazole, lansoprazole is because importing fluorine at pyridine ring 4 side chains and have trifluoro ethoxy substituent group, make the comparatively omeprazole raising more than 30% of its bioavailability, lipotropy is also better than omeprazole, therefore this product promptly can play drug effect through parietal cell film changes sulfenic acids and time sulfonyl derivative in acid condition, the bacteriostatic activity of HP is risen to four times of omeprazole.
A lot of crystal formations of lansoprazole are disclosed, as the 1.5 crystal types (II type) of the anhydrous crystal forms (I type) and lansoprazole that disclose lansoprazole in CN1355798A in prior art.Describe lansoprazole A crystal formation and B crystal form in US2009/0018339A1, in fact, B crystal form is unstable, is metastable-state crystal, can experience solid-to-solid transition under certain condition, forms A crystal formation.
CN102558154A discloses a kind of lansoprazole crystalline compounds, and the X ray powder diffraction represented with the 2 θ ± 0.2 ° angle of diffraction demonstrates characteristic diffraction peak at 5.8 °, 7.5 °, 9.1 °, 11.8 °, 12.1 °, 12.8 °, 13.3 °, 15.6 °, 16.7 °, 18.3 °, 20.4 °, 25.7 °, 26.8 ° and 31.5 ° of places.
CN102180866A discloses M crystal formation and the N crystal form of lansoprazole, and wherein the X ray powder diffraction of M crystal formation at angle of diffraction 2 θ is: 6.519,9.373,9.989,10.548,13.123,14.298,14.914,15.642,18.104,18.720,19.672,20.231,24.205,25.492,27.899 time there is characteristic peak; The X-ray powder diffraction of N crystal form at angle of diffraction 2 θ is: 5.438,7.062,8.230,9.216,11.022,11.789,12.610,13.541,20.603,21.862,26.242 time there is characteristic peak.
CN1681802A discloses three kinds of crystalline solid form of lansoprazole, and called after D, E and F type, also discloses the preparation method of these crystalline solid form of lansoprazole simultaneously respectively.
CN103664889A also discloses a kind of Lansoprazole crystal compound.
Lansoprazole has a chiral centre sulphur atom, therefore has two optical isomers.Research shows that the lansoprazole drug effect of (R)-configuration is obviously better than lansoprazole raceme, and optically active lansoprazole toxic and side effects is lower than raceme.
But according to the chemical constitution feature of lansoprazole, lansoprazole is being produced, is being deposited easy generation following impurity A, impurity B and impurity E in process, and these trace impurities can affect drug quality.Although some crystal formation of above-mentioned lansoprazole improves its hygroscopicity, dissolubility or stability to a certain extent, the present inventor's its result after the impurity of some crystal formation above-mentioned being carried out to investigation is unsatisfactory.
The present inventor starts with from the research of lansoprazole solid chemical substance existence, has prepared a kind of new compound of Lansoprazole crystal through a large amount of tests.
The lansoprazole of prior art, owing to having stronger hygroscopicity, causes its mobility bad, is unfavorable for the operation of production process; And due to almost insoluble in water, belong to low solubility, Thief zone class medicine, dissolution rate is the rate-limiting step that it absorbs.Directly affect the speed of onset, the power of drug effect due to dissolution rate and hold time, therefore, the dissolution rate improving insoluble drug usually becomes the first step improving its oral administration biaavailability.The present invention finds by test the dissolution that Lansoprazole crystal compound provided by the present invention has good mobility and significantly improves further.
Some crystal formation of the lansoprazole that the preparation method that prior art provides obtains improves from stability, hygroscopicity or dissolubility aspect mostly.But according to the chemical constitution feature of lansoprazole, lansoprazole in production, deposit in process and easily produce impurity A, impurity B and impurity E, these trace impurities can affect the quality of medicine, and the impurity A of the lansoprazole that the method for prior art obtains, impurity B and impurity E are not effectively controlled.
The present inventor is after having carried out large quantifier elimination to it, obtain above-mentioned preparation method, and surprisingly find the Lansoprazole crystal compound E free from foreign meter that the above-mentioned preparation method of employing is obtained, and the content of impurity A and impurity B significantly reduces, and along with its changes of contents of prolongation of period of storage less.
The dissolution that Lansoprazole crystal compound provided by the present invention has good mobility and significantly improves is found further by test.
Compared with prior art, tool of the present invention has the following advantages:
Lansoprazole crystal compound provided by the present invention E free from foreign meter, and the content of impurity A and impurity B significantly reduces, and along with its changes of contents of prolongation of period of storage less, and the dissolution that there is good mobility and significantly improve.
Summary of the invention
Goal of the invention of the present invention is to provide a kind of Lansoprazole enteric coated tablet compositions.
In order to complete object of the present invention, the technical scheme of employing is:
The present invention relates to a kind of medicine Lansoprazole composition for the treatment of gastric ulcer, it is characterized in that, described compositions is made up of label, sealing coat and enteric layer; It is crystal that described label comprises lansoprazole, and the X-ray powder diffraction pattern that described lansoprazole crystal uses the measurement of Cu-K alpha ray to obtain as shown in Figure 1.
First optimal technical scheme of the present invention is: with parts by weight, and described label is made up of the lansoprazole crystal of 0.1-0.15 weight portion, the lactose of 0.7-1.1 weight portion, the microcrystalline Cellulose of 1.0-1.10 weight portion, the carboxymethylstach sodium of 0.40-0.50 weight portion, the calcium hydrogen phosphate of 0.05-0.15 weight portion, the hypromellose of 0.07-0.11 weight portion, the purified water of 1.0-1.3 weight portion, the sodium lauryl sulphate of 0.03-0.07 weight portion, the silicon dioxide of 0.3-0.7 weight portion.
Second optimal technical scheme of the present invention is: with parts by weight, and described sealing coat is mixed with in 95% ethanol film coating pre-mix dose of 0.06-0.10 weight portion being dissolved in 1.1-1.42 weight portion.
3rd optimal technical scheme of the present invention is: with parts by weight, and described enteric layer is dissolved in 95% ethanol of 2.5-3.5 weight portion by the Opadry of 0.22-0.26 weight portion and is mixed with.
4th optimal technical scheme of the present invention is: with parts by weight, and described label is made up of the lansoprazole crystal of 0.15 weight portion, the lactose of 0.9 weight portion, the microcrystalline Cellulose of 1.05 weight portions, the carboxymethylstach sodium of 0.45 weight portion, the calcium hydrogen phosphate of 0.1 weight portion, the hypromellose of 0.09 weight portion, the purified water of 1.15 weight portions, the sodium lauryl sulphate of 0.05 weight portion, the silicon dioxide of 0.5 weight portion.
5th optimal technical scheme of the present invention is: with parts by weight, and described sealing coat is mixed with in 95% ethanol film coating pre-mix dose of 0.08 weight portion being dissolved in 1.26 weight portions.
6th optimal technical scheme of the present invention is: with parts by weight, and described enteric layer is dissolved in 95% ethanol of 3 weight portions by the Opadry of 0.24 weight portion and is mixed with.
7th optimal technical scheme of the present invention is: the preparation method of described compositions comprises the following steps:
1) supplementary material process: raw material lansoprazole to be sieved 80 orders with oscillating sieving machine, pulverize calcium hydrogen phosphate with pulverizer and cross 120 mesh sieves;
2) supplementary material is weighed according to recipe quantity;
3) binding agent is prepared: get 70-80 DEG C of purified water and be placed in stainless steel cask, add hypromellose while stirring, be stirred to whole dissolving, treat that temperature is down to room temperature, add sodium lauryl sulphate, stir stand-by; 4) mixing granulation: lansoprazole crystal, lactose, microcrystalline Cellulose, carboxymethylstach sodium, calcium hydrogen phosphate are added in wet mixing pelletizer, open stirring motor and be dry mixed 10 minutes, add the binder solution prepared, wet mixing 90-120 soft material second, selects 16 order nylon wires to be arranged in oscillating granulator and granulates;
5) dry: arranging boiling drier inlet temperature is 50 DEG C, is dried to moisture 1.5-2.5%, select 16 order nylon wires to be arranged on granulate in oscillating granulator after dry;
6) always mix: the dry granule after granulate and silicon dioxide are joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
7) tabletting: select high speed tablet press tabletting, regulate pressure to make the molding of slice, thin piece energy and hardness at 4-8kgf;
8) insulating liquid coating: film coating pre-mix dose is dissolved in 95% ethanol and is mixed with insulating liquid, arranging coating pan inlet temperature is 60 DEG C, coating weight gain 2.0-2.4%;
9) enteric coating: be dissolved in by Opadry in 95% ethanol and be mixed with enteric liquid, arranging coating pan inlet temperature is 60 DEG C, coating weight gain 6.0-7.0%.
According to the chemical constitution feature of lansoprazole, lansoprazole in production, deposit in process and easily produce impurity A, impurity B and impurity E, these trace impurities can affect the quality of medicine.Prior art provide some crystal formation of lansoprazole mostly improve from stability, hygroscopicity or dissolubility aspect, its impurity is not effectively controlled.
The present inventor is after having carried out large quantifier elimination to it, obtain a kind of lansoprazole crystal compound, and surprisingly find described compound of Lansoprazole E free from foreign meter, and the content of impurity A and impurity B significantly reduces, and along with its changes of contents of prolongation of period of storage less.
The dissolution that compound of Lansoprazole provided by the present invention has good mobility and significantly improves is found further by test.
The preparation method of the lansoprazole crystal in the present composition comprises the following steps:
Get lansoprazole bulk drug, the volume adding 15-25 DEG C is that in the mixed solvent of the methanol of lansoprazole weight 8 times, dimethyl formamide, carbon tetrachloride, methanol, dimethyl formamide, carbon tetrachloride volume ratio are 3:2.5:1, obtain solution; Then in the horizontal direction of the liquid level of gained solution, the stationary magnetic field that magnetic field intensity is 0.5T-0.8T is applied, and under the condition of this stationary magnetic field, in solution, dripping the mixed solvent that volume is lansoprazole weight 10 times of acetone, ethyl acetate, ether, the volume ratio of acetone, ethyl acetate and ether is 5:3:2.5; After being added dropwise to complete, leave standstill 4 hours, filter, washing, vacuum drying 3 hours, obtains described compound of Lansoprazole.
Accompanying drawing explanation
Fig. 1 is the X-ray powder diffraction of lansoprazole 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 lansoprazole crystal
Get lansoprazole bulk drug, the volume adding 15-25 DEG C is that in the mixed solvent of the methanol of lansoprazole weight 8 times, dimethyl formamide, carbon tetrachloride, methanol, dimethyl formamide, carbon tetrachloride volume ratio are 3:2.5:1, obtain solution; Then in the horizontal direction of the liquid level of gained solution, the stationary magnetic field that magnetic field intensity is 0.5T-0.8T is applied, and under the condition of this stationary magnetic field, in solution, dripping the mixed solvent that volume is lansoprazole weight 10 times of acetone, ethyl acetate, ether, the volume ratio of acetone, ethyl acetate and ether is 5:3:2.5; After being added dropwise to complete, leave standstill 4 hours, filter, washing, vacuum drying 3 hours, obtains described compound of Lansoprazole.
As shown in Figure 1, its purity of high-performance liquid chromatogram determination is 99.99% to the X-ray powder diffraction pattern that the lansoprazole crystal prepared uses the measurement of Cu-K alpha ray to obtain.
embodiment 2:the preparation of blue rope enteric coatel tablets, step is as follows:
Prescription: with parts by weight
Preparation method:
1) supplementary material process: raw material lansoprazole to be sieved 80 orders with oscillating sieving machine, pulverize calcium hydrogen phosphate with pulverizer and cross 120 mesh sieves;
2) supplementary material is weighed according to recipe quantity;
3) binding agent is prepared: get 70-80 DEG C of purified water and be placed in stainless steel cask, add hypromellose while stirring, be stirred to whole dissolving, treat that temperature is down to room temperature, add sodium lauryl sulphate, stir stand-by; 4) mixing granulation: lansoprazole crystal, lactose, microcrystalline Cellulose, carboxymethylstach sodium, calcium hydrogen phosphate are added in wet mixing pelletizer, open stirring motor and be dry mixed 10 minutes, add the binder solution prepared, wet mixing 90-120 soft material second, selects 16 order nylon wires to be arranged in oscillating granulator and granulates;
5) dry: arranging boiling drier inlet temperature is 50 DEG C, is dried to moisture 1.5-2.5%, select 16 order nylon wires to be arranged on granulate in oscillating granulator after dry;
6) always mix: the dry granule after granulate and silicon dioxide are joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
7) tabletting: select high speed tablet press tabletting, regulate pressure to make the molding of slice, thin piece energy and hardness at 4-8kgf;
8) insulating liquid coating: film coating pre-mix dose is dissolved in 95% ethanol and is mixed with insulating liquid, arranging coating pan inlet temperature is 60 DEG C, coating weight gain 2.0-2.4%;
9) enteric coating: be dissolved in by Opadry in 95% ethanol and be mixed with enteric liquid, arranging coating pan inlet temperature is 60 DEG C, coating weight gain 6.0-7.0%.
embodiment 3:the preparation of blue rope enteric coatel tablets, step is as follows:
Prescription: with parts by weight
Preparation method:
1) supplementary material process: raw material lansoprazole to be sieved 80 orders with oscillating sieving machine, pulverize calcium hydrogen phosphate with pulverizer and cross 120 mesh sieves;
2) supplementary material is weighed according to recipe quantity;
3) binding agent is prepared: get 70-80 DEG C of purified water and be placed in stainless steel cask, add hypromellose while stirring, be stirred to whole dissolving, treat that temperature is down to room temperature, add sodium lauryl sulphate, stir stand-by; 4) mixing granulation: lansoprazole crystal, lactose, microcrystalline Cellulose, carboxymethylstach sodium, calcium hydrogen phosphate are added in wet mixing pelletizer, open stirring motor and be dry mixed 10 minutes, add the binder solution prepared, wet mixing 90-120 soft material second, selects 16 order nylon wires to be arranged in oscillating granulator and granulates;
5) dry: arranging boiling drier inlet temperature is 50 DEG C, is dried to moisture 1.5-2.5%, select 16 order nylon wires to be arranged on granulate in oscillating granulator after dry;
6) always mix: the dry granule after granulate and silicon dioxide are joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
7) tabletting: select high speed tablet press tabletting, regulate pressure to make the molding of slice, thin piece energy and hardness at 4-8kgf;
8) insulating liquid coating: film coating pre-mix dose is dissolved in 95% ethanol and is mixed with insulating liquid, arranging coating pan inlet temperature is 60 DEG C, coating weight gain 2.0-2.4%;
9) enteric coating: be dissolved in by Opadry in 95% ethanol and be mixed with enteric liquid, arranging coating pan inlet temperature is 60 DEG C, coating weight gain 6.0-7.0%.
embodiment 4:the preparation of blue rope enteric coatel tablets, step is as follows:
Prescription: with parts by weight
Preparation method:
1) supplementary material process: raw material lansoprazole to be sieved 80 orders with oscillating sieving machine, pulverize calcium hydrogen phosphate with pulverizer and cross 120 mesh sieves;
2) supplementary material is weighed according to recipe quantity;
3) binding agent is prepared: get 70-80 DEG C of purified water and be placed in stainless steel cask, add hypromellose while stirring, be stirred to whole dissolving, treat that temperature is down to room temperature, add sodium lauryl sulphate, stir stand-by; 4) mixing granulation: lansoprazole crystal, lactose, microcrystalline Cellulose, carboxymethylstach sodium, calcium hydrogen phosphate are added in wet mixing pelletizer, open stirring motor and be dry mixed 10 minutes, add the binder solution prepared, wet mixing 90-120 soft material second, selects 16 order nylon wires to be arranged in oscillating granulator and granulates;
5) dry: arranging boiling drier inlet temperature is 50 DEG C, is dried to moisture 1.5-2.5%, select 16 order nylon wires to be arranged on granulate in oscillating granulator after dry;
6) always mix: the dry granule after granulate and silicon dioxide are joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
7) tabletting: select high speed tablet press tabletting, regulate pressure to make the molding of slice, thin piece energy and hardness at 4-8kgf;
8) insulating liquid coating: film coating pre-mix dose is dissolved in 95% ethanol and is mixed with insulating liquid, arranging coating pan inlet temperature is 60 DEG C, coating weight gain 2.0-2.4%;
9) enteric coating: be dissolved in by Opadry in 95% ethanol and be mixed with enteric liquid, arranging coating pan inlet temperature is 60 DEG C, coating weight gain 6.0-7.0%.
test example 1:determination of foreign matter in stability test
Prepare 3 batch samples according to embodiment 1, be numbered 001,002,003
Reference substance 1: according to " improvement in synthesis of lansoprazole " [Liu Yanfei, Li Yongxin etc. the improvement in synthesis [J] of lansoprazole, fine-chemical intermediate, 2011, the lansoprazole fine work of method synthesis 41(3): 26-28 and 42], m.p.169-171 DEG C (decomposition).
Reference substance 2: according to the lansoprazole form D that the method for CN1681802A embodiment 2 is obtained;
Reference substance 3: commercially available lansoprazole bulk drug
Determination of foreign matter method: with reference to " in lansoprazole intestine dissolving capsule the structural identification of impurity, inspection and control " [Xia Guimin, Deng. the structural identification of impurity, inspection and control in lansoprazole intestine dissolving capsule. pharmaceutical analysis impurity, 2012,32(6): 1022-1027] in method measure each impurity content in each sample.The results are shown in Table shown in 1:
Determination of foreign matter in table 1, lansoprazole stability test
test example 2: fluidity test
Method: prepare 3 batch samples according to embodiment 1, be numbered 001,002,003, sample respectively, adopt fixed funnel method, funnel is placed in the suitable height on graph paper, lansoprazole is freely flowed down from bell mouth, until the cone top formed contacts with bell mouth, measures hypotenuse and the horizontal angle (θ angle of repose) of lansoprazole accumulation horizon.The results are shown in Table shown in 2:
The fluidity test result of table 2, lansoprazole
test example 3: Dissolution Rate Testing
Prepare 3 batch samples according to embodiment 1, be numbered 001,002,003
Reference substance 1: according to " improvement in synthesis of lansoprazole " [Liu Yanfei, Li Yongxin etc. the improvement in synthesis [J] of lansoprazole, fine-chemical intermediate, 2011, the lansoprazole fine work of method synthesis 41(3): 26-28 and 42], m.p.169-171 DEG C (decomposition).
Reference substance 2: according to the lansoprazole form D that the method for CN1681802A embodiment 2 is obtained;
Reference substance 3: commercially available lansoprazole bulk drug
Method: different lansoprazoles is investigated dissolution according to Pharmacopoeia of the People's Republic of China version in 2010 two annex X C method second methods.With pH6.8 phosphate buffer 900mL for dissolution medium, temperature is 37 DEG C, and rotating speed is 75rmin
-1, the medication amount in each testing sample is 30mg.Adopt ultraviolet spectrophotometry to carry out dissolution determination respectively at 5,10,15,20,30,45 and 60min sampling, determined wavelength is 284nm, at 5-25mgL
-1internal linear relation is good, and the response rate, Precision Experiment all meet methodology requirement.The results are shown in Table 3:
The dissolution of table 3, lansoprazole investigates result
Claims (8)
1. treat a medicine Lansoprazole composition for gastric ulcer, it is characterized in that: described compositions is made up of label, sealing coat and enteric layer; It is crystal that described label comprises lansoprazole, and the X-ray powder diffraction pattern that described lansoprazole crystal uses the measurement of Cu-K alpha ray to obtain as shown in Figure 1.
2. the medicine Lansoprazole composition for the treatment of gastric ulcer according to claim 1, it is characterized in that: with parts by weight, described label is made up of the lansoprazole crystal of 0.1-0.15 weight portion, the lactose of 0.7-1.1 weight portion, the microcrystalline Cellulose of 1.0-1.10 weight portion, the carboxymethylstach sodium of 0.40-0.50 weight portion, the calcium hydrogen phosphate of 0.05-0.15 weight portion, the hypromellose of 0.07-0.11 weight portion, the purified water of 1.0-1.3 weight portion, the sodium lauryl sulphate of 0.03-0.07 weight portion, the silicon dioxide of 0.3-0.7 weight portion.
3. the medicine Lansoprazole composition for the treatment of gastric ulcer according to claim 1, it is characterized in that: with parts by weight, described sealing coat is mixed with in 95% ethanol film coating pre-mix dose of 0.06-0.10 weight portion being dissolved in 1.1-1.42 weight portion.
4. the medicine Lansoprazole composition for the treatment of gastric ulcer according to claim 1, is characterized in that: with parts by weight, and described enteric layer is dissolved in 95% ethanol of 2.5-3.5 weight portion formulated by the Opadry of 0.22-0.26 weight portion.
5. the medicine Lansoprazole composition for the treatment of gastric ulcer according to claim 1, it is characterized in that: with parts by weight, described label is made up of the lansoprazole crystal of 0.15 weight portion, the lactose of 0.9 weight portion, the microcrystalline Cellulose of 1.05 weight portions, the carboxymethylstach sodium of 0.45 weight portion, the calcium hydrogen phosphate of 0.1 weight portion, the hypromellose of 0.09 weight portion, the purified water of 1.15 weight portions, the sodium lauryl sulphate of 0.05 weight portion, the silicon dioxide of 0.5 weight portion.
6. the medicine Lansoprazole composition for the treatment of gastric ulcer according to claim 1, is characterized in that: with parts by weight, and described sealing coat is mixed with in 95% ethanol film coating pre-mix dose of 0.08 weight portion being dissolved in 1.26 weight portions.
7. the medicine Lansoprazole composition for the treatment of gastric ulcer according to claim 1, is characterized in that: with parts by weight, and described enteric layer is dissolved in 95% ethanol of 3 weight portions by the Opadry of 0.24 weight portion and is mixed with.
8. prepare a method for the medicine Lansoprazole composition for the treatment of gastric ulcer according to claim 1, it is characterized in that comprising the following steps:
1) supplementary material process: raw material lansoprazole to be sieved 80 orders with oscillating sieving machine, pulverize calcium hydrogen phosphate with pulverizer and cross 120 mesh sieves;
2) supplementary material is weighed according to recipe quantity;
3) binding agent is prepared: get 70-80 DEG C of purified water and be placed in stainless steel cask, add hypromellose while stirring, be stirred to whole dissolving, treat that temperature is down to room temperature, add sodium lauryl sulphate, stir stand-by; 4) mixing granulation: lansoprazole crystal, lactose, microcrystalline Cellulose, carboxymethylstach sodium, calcium hydrogen phosphate are added in wet mixing pelletizer, open stirring motor and be dry mixed 10 minutes, add the binder solution prepared, wet mixing 90-120 soft material second, selects 16 order nylon wires to be arranged in oscillating granulator and granulates;
5) dry: arranging boiling drier inlet temperature is 50 DEG C, is dried to moisture 1.5-2.5%, select 16 order nylon wires to be arranged on granulate in oscillating granulator after dry;
6) always mix: the dry granule after granulate and silicon dioxide are joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
7) tabletting: select high speed tablet press tabletting, regulate pressure to make the molding of slice, thin piece energy and hardness at 4-8kgf;
8) insulating liquid coating: film coating pre-mix dose is dissolved in 95% ethanol and is mixed with insulating liquid, arranging coating pan inlet temperature is 60 DEG C, coating weight gain 2.0-2.4%;
9) enteric coating: be dissolved in by Opadry in 95% ethanol and be mixed with enteric liquid, arranging coating pan inlet temperature is 60 DEG C, coating weight gain 6.0-7.0%.
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| CN105213319A (en) * | 2015-09-17 | 2016-01-06 | 青岛华之草医药科技有限公司 | A kind of blood lipid-lowering medicine Pitavastatin calcium composition dry suspension |
| CN105055334A (en) * | 2015-09-18 | 2015-11-18 | 青岛华之草医药科技有限公司 | Postoperative antiemetic tropisetron hydrochloride composition granule |
| CN105055335A (en) * | 2015-09-23 | 2015-11-18 | 青岛华之草医药科技有限公司 | Urapidil composition granule for treating pregnancy-induced hypertension |
| CN107970386A (en) * | 2017-12-29 | 2018-05-01 | 成都恒瑞制药有限公司 | A kind of preparation method of Adjust-blood lipid combination drug |
| CN107970386B (en) * | 2017-12-29 | 2021-04-20 | 成都恒瑞制药有限公司 | Preparation method of blood fat regulating compound medicine |
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Application publication date: 20150902 |