CN103638025B - Stable compound omeprazole pharmaceutical composition - Google Patents
Stable compound omeprazole pharmaceutical composition Download PDFInfo
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- CN103638025B CN103638025B CN201310725892.7A CN201310725892A CN103638025B CN 103638025 B CN103638025 B CN 103638025B CN 201310725892 A CN201310725892 A CN 201310725892A CN 103638025 B CN103638025 B CN 103638025B
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- omeprazole
- pharmaceutical composition
- domperidone
- sodium
- histidine
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Abstract
The invention relates to a stable compound omeprazole pharmaceutical composition consisting of omeprazole, domperidone, a cosolvent histidine and an excipient selected from mannitol and sorbitol, wherein pH value of the solution is 10-11. The composition, which adopts histidine as the cosolvent, not only improves solubility of omeprazole but also functions as a stabilizing agent; and the composition can stabilize the omeprazole through a stabilizing agent such as ethylene diamine tetraacetic acid (EDTA) and salt thereof.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, be specifically related to the pharmaceutical composition of a kind of stable omeprazole and domperidone, more particularly, relate to a kind of freeze dried injection containing omeprazole and domperidone.
Background technology
Omeprazole is a kind of proton pump inhibitor (PPI) developed by Astra company, goes on the market, optionally with H in March, 1988 in Europe
+, K
+-ATP enzyme combines and suppresses it active, the clinical treatment being applicable to gastric ulcer, duodenal ulcer, stress ulcer.
Though form of omeprazole salts is a kind of excellent acid inhibitor, because its stability is bad, residual solvent toxicity is comparatively large, and its clinical practice is affected.Chinese patent ZL95111640.1 discloses Aomeilazole salt hydrate for gastric acid inhibitor and preparation method thereof, this Aomeilazole salt hydrate for gastric acid inhibitor, good stability, purity are high, not containing toxicity residual solvent, can be used for preparation freeze dried powder used for intravenous injection and oral formulations, treatment gastric ulcer and duodenal ulcer.
Domperidone is a kind of dopamine-receptor antagonist, and specific effect, in upper digestive tract, can remove upper gastrointestinal dyskinesis symptom effectively, more obvious to symptom treatment effects such as acid regurgitation, anti-food, abdominal distention, belch especially.
Domperidone and other active constituents of medicine make compound preparation, reaches some therapeutic use.Chinese patent ZL98802318.0 discloses ibuprofen or its salt by using to patient containing the upper effective dose for the treatment of and treats the domperidone of upper effective dose or the Pharmaceutical composition treatment migraine of its salt.Chinese patent application ZL200410014337.4 discloses a kind of Chinese medicine composition for the treatment of bowel dysfunction, can comprise the extract of Radix Bupleuri, the Radix Paeoniae Alba, Radix Pseudostellariae and Radix Glycyrrhizae etc. in said composition; Medicine or its extracts such as the Rhizoma Atractylodis Macrocephalae, Rhizoma Chuanxiong, Poria, Radix Puerariae, Ramulus Uncariae Cum Uncis, Fructus Aurantii Immaturus can also be increased; Or increase the compound such as dioctahedral smectite, domperidone.
Oral domperidone, due to " first pass effect " of liver, the bioavailability of administration on an empty stomach only has 13 ~ 17%.If when changing administration in 90 minutes after meal into by empty stomach administration, its bioavailability can be increased to 23% by 13%; If injection gives domperidone, its bioavailability improves greatly, is about 90%.After Omeprazole Sodium oral administration, its bioavailability is comparatively large because of individual variation difference, is generally 35 ~ 50%, and to be that Omeprazole Sodium is oral easily destroyed by acid degradation its reason.And drug administration by injection is without the intestines and stomach, can not be destroyed by acid degradation, its bioavailability will improve greatly.
Chinese patent CN1736378 discloses the composite injection of a kind of omeprazole and domperidone, this composite injection can be the form of freeze-dried powder (lyophilized formulations), comprise omeprazole sodium salt or potassium salt, domperidone, be selected from the excipient of mannitol, pregelatinized Starch, sucrose, lactose, microcrystalline Cellulose, glucose, fructose or its mixture, with the stabilizing agent of sodium salt being selected from ethylenediaminetetraacetic acid, the sodium salt of ethylenediaminetetraacetic acid, malonic acid and malonic acid, its pH is 11-12.
CN101961334 discloses a kind of pantoprazole and combines with domperidone with injectable drug, containing pantoprazole, domperidone, and the adjuvant of following weight percent: be selected from as one or more the excipient in next group material: mannitol, pregelatinized Starch, sucrose, lactose, microcrystalline Cellulose, glucose and fructose; Be selected from sodium chloride, sodium bicarbonate, sodium dihydrogen phosphate, calcium chloride, sodium lactate, calcium lactate, glucose and xylose alcohol isoosmotic adjusting agent; Cosolvent polyethylene glycol 6000 or polyvinylpyrrolidone-K30, stabilizing agent 1-3.0%, described stabilizing agent is selected from ethylenediaminetetraacetic acid, the sodium salt of ethylenediaminetetraacetic acid, ethylenediamine tetrapropionic acid, the sodium salt of ethylenediamine tetrapropionic acid, malonic acid, the sodium salt of malonic acid and/or the sodium salt of succinic acid or succinic acid, and pH is 10-12.
Above-mentioned two kinds of compound injections, the gastroenteropathys such as therapeutic alliance gastric ulcer, duodenal ulcer, gastroesophageal reflux disease, functional dyspepsia.But, due to domperidone, dissolubility is better in acid condition, poorly soluble in the basic conditions, therefore, a large amount of water is needed to dissolve domperidone during preparation lyophilizing liquid, comparatively large on the impact of freeze dryer, need Large Copacity ampulla or Large-capacity drier, and consumption can be large, production cost is high.
Summary of the invention
The object of the present invention is to provide a kind of stable compound omeprazole pharmaceutical composition, said composition comprises Omeprazole Sodium, domperidone, cosolvent histidine and is selected from the excipient of mannitol and sorbitol, and the pH of its solution is 10 ~ 11.
The compound omeprazole pharmaceutical composition of the invention described above, described compositions is preferably freeze-dried powder, wherein, the weight ratio of Omeprazole Sodium and domperidone is 8: 1 ~ 2: 1, wherein, the weight of Omeprazole Sodium is in omeprazole, and the weight ratio of domperidone and cosolvent histidine is 5:1 ~ 5.
The compound omeprazole pharmaceutical composition of the invention described above, described excipient is mannitol or sorbitol, and consumption accounts for the 20-60% of composition total weight, is preferably 30-50%.
The compound omeprazole pharmaceutical composition of the invention described above, also can comprise isoosmotic adjusting agent further, and described isoosmotic adjusting agent is sodium chloride, sodium bicarbonate or glucose.
The compound omeprazole pharmaceutical composition of the invention described above, wherein, the weight of Omeprazole Sodium counts 20 ~ 40mg with omeprazole, and domperidone is 5 ~ 10mg.
The compound omeprazole pharmaceutical composition of the invention described above, also can comprise pH adjusting agent, preferred sodium hydroxide or hydrochloric acid.
In one embodiment, a kind of stable compound omeprazole pharmaceutical composition, said composition comprises Omeprazole Sodium, domperidone, cosolvent histidine and is selected from the excipient of mannitol and sorbitol, the pH value of its solution is 10 ~ 11, and wherein, the weight ratio of Omeprazole Sodium and domperidone is 8: 1 ~ 2: 1, wherein, the weight of Omeprazole Sodium is in omeprazole, and the weight ratio of domperidone and cosolvent histidine is 5:1 ~ 5, is preferably 2:1 ~ 2.
In above-mentioned specific embodiments, compound omeprazole pharmaceutical composition of the present invention, described excipient accounts for the 20-60% of composition total weight, is preferably 30-50%.
In above-mentioned specific embodiments, compound omeprazole pharmaceutical composition of the present invention, also can comprise isoosmotic adjusting agent and pH adjusting agent further, described isoosmotic adjusting agent is sodium chloride, sodium bicarbonate or glucose, the preferred sodium hydroxide of described pH adjusting agent or hydrochloric acid.
In above-mentioned specific embodiments, compound omeprazole pharmaceutical composition of the present invention, wherein, the weight of Omeprazole Sodium counts 20 ~ 40mg with omeprazole, and domperidone is 5 ~ 10mg.
Another object of the present invention is to provide a kind of method preparing compound omeprazole pharmaceutical composition, comprise the following steps:
(1) take the Omeprazole Sodium of recipe quantity, domperidone, mannitol or sorbitol and histidine, be dissolved in water for injection, heated and stirred makes it clearly molten;
(2) add hydrochloric acid or sodium hydroxide solution, regulate pH value to be 10 ~ 11, then add active carbon, coarse filtration takes off charcoal, injects water to enough, mixing, with 0.22 μm of filtering with microporous membrane, and fill, lyophilization and get final product.
Method of the present invention, also can add isoosmotic adjusting agent, in step (1) as sodium chloride or glucose etc.
Compound omeprazole pharmaceutical composition of the present invention, be preferably the compound lyophilized powder of Omeprazole Sodium and domperidone, be used for the treatment of functional dyspepsia, wherein, omeprazole, as proton pump inhibitor (PPI), can stop the gastric acid secretion that a variety of causes causes, after entering human body, its acid suppression intensity is large, and the time is long, thus can alleviate rapidly the symptoms such as stomachache, acid regurgitation; Meanwhile, omeprazole also has direct anti-Hp effect, can suppress attack factor, strengthens protective factors.Domperidone is then dopamine D 2 receptor antagonists, alternative blocking-up d2 dopamine receptor, and specific effect is in upper digestive tract, and increase gastric emptying, also can increase esophageal peristalsis and lower esophagus expands about muscular tension, and efficient solution is except upper digestive tract dyskinesis disease.Because functional dyspepsia clinical symptoms is more complicated, use in conjunction omeprazole and domperidone can significantly improve gastrointestinal indigestion symptom.
Compound omeprazole pharmaceutical composition of the present invention, adopts water for injection in use or injects after reconstructing containing the normal saline of 0.9%NaCl or the glucose injection use water of 5% or instil.
Advantageous Effects of the present invention is embodied in: compound omeprazole pharmaceutical composition of the present invention, only just can dissolve with a small amount of water, decrease the amount of water for injection, thus reduce the volume of lyophilizing liquid, improve lyophilizing production capacity, effectively reduce production cost to a certain extent.Amazing, owing to adopting histidine to be cosolvent, not only can improve the dissolubility of domperidone, but also can stabilizer function be played, the stabilizing agent such as EDTA and salt thereof can not be used just can to make omeprazole stable sodium.Histidine has anti-ulcer effect simultaneously, can protect gastrointestinal damage.
Detailed description of the invention
Following examples are used for understanding essence of the present invention further, but can not limit the scope of the invention.
Embodiment 1
The injection prescription of freeze-drying powder of Omeprazole Sodium and domperidone
Its preparation technology: take the Omeprazole Sodium of recipe quantity, domperidone, mannitol and histidine, is dissolved in the water for injection of 1600ml, and a control temperature 30-50 DEG C stirring makes it clearly molten; Add hydrochloric acid or sodium hydroxide solution, regulate pH value to be 10, then add the active carbon of 0.1% (W/V), be incubated 20 minutes, coarse filtration takes off charcoal, injects water to 2000ml, mixing, with 0.22 μm of filtering with microporous membrane, under 100 grades of environment, fill 1000 bottles, partly jumps a queue, and puts lyophilization in freeze drying box, tamponade outlet, rolls lid.
Embodiment 2
The injection prescription of freeze-drying powder of Omeprazole Sodium and domperidone
Its preparation technology: take the Omeprazole Sodium of recipe quantity, domperidone, mannitol and histidine, is dissolved in the water for injection of 1600ml, and a control temperature 30-50 DEG C stirring makes it clearly molten; Add hydrochloric acid or sodium hydroxide solution, regulate pH value to be 11, then add the active carbon of 0.1% (W/V), be incubated 20 minutes, coarse filtration takes off charcoal, injects water to 2000ml, mixing, with 0.22 μm of filtering with microporous membrane, under 100 grades of environment, fill 1000 bottles, partly jumps a queue, and puts lyophilization in freeze drying box, tamponade outlet, rolls lid.
Embodiment 3
The injection prescription of freeze-drying powder of Omeprazole Sodium and domperidone
Its preparation technology: take the Omeprazole Sodium of recipe quantity, domperidone, mannitol and histidine, is dissolved in the water for injection of 1600ml, and a control temperature 30-50 DEG C stirring makes it clearly molten; Add hydrochloric acid or sodium hydroxide solution, regulate pH value to be 10.5, then add the active carbon of 0.1% (W/V), be incubated 20 minutes, coarse filtration takes off charcoal, injects water to 2000ml, mixing, with 0.22 μm of filtering with microporous membrane, under 100 grades of environment, fill 1000 bottles, partly jumps a queue, and puts lyophilization in freeze drying box, tamponade outlet, rolls lid.
Embodiment 4
The injection prescription of freeze-drying powder of Omeprazole Sodium and domperidone:
Its preparation technology: take the Omeprazole Sodium of recipe quantity, domperidone, mannitol, histidine and sodium chloride, is dissolved in the water for injection of 1600ml, and a control temperature 30-50 DEG C stirring makes it clearly molten; Add hydrochloric acid or sodium hydroxide solution, regulate pH value to be 10.5, then add the active carbon of 0.1% (W/V), be incubated 20 minutes, coarse filtration takes off charcoal, injects water to 2000ml, mixing, with 0.22 μm of filtering with microporous membrane, under 100 grades of environment, fill 1000 bottles, partly jumps a queue, and puts lyophilization in freeze drying box, tamponade outlet, rolls lid.
Embodiment 5
The injection prescription of freeze-drying powder of Omeprazole Sodium and domperidone
Its preparation technology: take the Omeprazole Sodium of recipe quantity, domperidone, sorbitol and histidine, is dissolved in the water for injection of 1600ml, and a control temperature 30-50 DEG C stirring makes it clearly molten; Add hydrochloric acid or sodium hydroxide solution, regulate pH value to be 11, then add the active carbon of 0.1% (W/V), be incubated 20 minutes, coarse filtration takes off charcoal, injects water to 2000ml, mixing, with 0.22 μm of filtering with microporous membrane, under 100 grades of environment, fill 1000 bottles, partly jumps a queue, and puts lyophilization in freeze drying box, tamponade outlet, rolls lid.
Embodiment 6
The injection prescription of freeze-drying powder of Omeprazole Sodium and domperidone
Its preparation technology: take the Omeprazole Sodium of recipe quantity, domperidone, sorbitol and histidine, is dissolved in the water for injection of 1600ml, and a control temperature 30-50 DEG C stirring makes it clearly molten; Add hydrochloric acid or sodium hydroxide solution, regulate pH value to be 10, then add the active carbon of 0.1% (W/V), be incubated 20 minutes, coarse filtration takes off charcoal, injects water to 2000ml, mixing, with 0.22 μm of filtering with microporous membrane, under 100 grades of environment, fill 1000 bottles, partly jumps a queue, and puts lyophilization in freeze drying box, tamponade outlet, rolls lid.
Embodiment 7
The injection prescription of freeze-drying powder of Omeprazole Sodium and domperidone
Its preparation technology: take the Omeprazole Sodium of recipe quantity, domperidone, mannitol and histidine, is dissolved in the water for injection of 1600ml, and a control temperature 30-50 DEG C stirring makes it clearly molten; Add hydrochloric acid or sodium hydroxide solution, regulate pH value to be 11, then add the active carbon of 0.1% (W/V), be incubated 20 minutes, coarse filtration takes off charcoal, injects water to 2000ml, mixing, with 0.22 μm of filtering with microporous membrane, under 100 grades of environment, fill 1000 bottles, partly jumps a queue, and puts lyophilization in freeze drying box, tamponade outlet, rolls lid.
Embodiment 8
Dissolubility improves
Under mensuration following table prescription condition, the dissolubility (room temperature) of domperidone, the results are shown in Table 1.
The dissolubility of table 1 domperidone under different aminoacids condition
From the discovery that the result of upper table is surprised, adopt histidine as cosolvent, the dissolubility of dopan ketone can be significantly improved.
Embodiment 8
Stability test
Comparative example: take the Omeprazole Sodium 21.3g of recipe quantity, domperidone 10g, mannitol 18g and glycine 10g, be dissolved in the water for injection of 10000ml, a control temperature 30-50 DEG C stirring makes it dissolve; Add hydrochloric acid or sodium hydroxide solution, adjustment pH value is 10-11, then adds the active carbon of 0.1% (W/V), be incubated 20 minutes, coarse filtration takes off charcoal, injects water to 15000ml, mixing, with 0.22 μm of filtering with microporous membrane, under 100 grades of environment, fill 1000 bottles, partly jumps a queue, and puts lyophilization in freeze drying box, tamponade outlet, rolls lid.
The freeze-drying prods of above-described embodiment 1-5 and comparative example is placed in the environment of RH75%5%, insert in 40 DEG C ± 2 DEG C calorstats, carry out accelerated test, get the sample after 0,1,3,6 month respectively, measure content and the related substance of Omeprazole Sodium and domperidone.The results are shown in Table 2.
Table 2 omeprazole content and relevant thing content of material
By the result of upper table, omeprazole compound medicament composition of the present invention is not when adding stabilizing agent such as kept stable when EDTA, and change histidine into glycine, omeprazole is unstable, does not also clarify after reconstruct.
Claims (9)
1. a stable compound omeprazole pharmaceutical composition, comprise Omeprazole Sodium, domperidone, cosolvent histidine and be selected from the excipient of mannitol and sorbitol, the pH of its solution is 10 ~ 11, the weight ratio of domperidone and cosolvent histidine is 5:1 ~ 5, and described compositions is freeze-dried powder.
2. pharmaceutical composition as claimed in claim 1, wherein, the weight ratio of Omeprazole Sodium and domperidone is 8: 1 ~ 2: 1, and wherein, the weight of Omeprazole Sodium is in omeprazole.
3. pharmaceutical composition as claimed in claim 1, described excipient is mannitol or sorbitol, accounts for the 20-60% of composition total weight.
4. pharmaceutical composition as claimed in claim 3, described excipient is mannitol or sorbitol, accounts for the 30-50% of composition total weight.
5. pharmaceutical composition as claimed in claim 1, also comprises isoosmotic adjusting agent further.
6. pharmaceutical composition as claimed in claim 5, described isoosmotic adjusting agent is sodium chloride or glucose.
7. pharmaceutical composition as claimed in claim 1, wherein, the weight of Omeprazole Sodium counts 20 ~ 40mg with omeprazole, and domperidone is 5 ~ 10mg.
8. pharmaceutical composition as claimed in claim 1, also comprise pH adjusting agent, described pH adjusting agent is sodium hydroxide or hydrochloric acid.
9. prepare the method for the compound omeprazole pharmaceutical composition of claim 1 for one kind, comprise the following steps: (1) takes the Omeprazole Sodium of recipe quantity, domperidone, mannitol or sorbitol and histidine, be dissolved in water for injection, heated and stirred makes it clearly molten; (2) add hydrochloric acid or sodium hydroxide solution, regulate pH value to be 10 ~ 11, then add active carbon, coarse filtration takes off charcoal, injects water to enough, mixing, with 0.22 μm of filtering with microporous membrane, and fill, lyophilization and get final product.
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| CN201310725892.7A CN103638025B (en) | 2013-12-25 | 2013-12-25 | Stable compound omeprazole pharmaceutical composition |
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| CN201310725892.7A CN103638025B (en) | 2013-12-25 | 2013-12-25 | Stable compound omeprazole pharmaceutical composition |
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| CN103638025B true CN103638025B (en) | 2015-04-15 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1279909C (en) * | 2004-12-13 | 2006-10-18 | 李广起 | Freeze dried combination of Lansoprazole available for linjection and preparation method |
| CN1723897A (en) * | 2005-07-18 | 2006-01-25 | 张志生 | Compound medicine contg. omeprazol and |
| CN1736378A (en) * | 2005-07-20 | 2006-02-22 | 张志生 | Injection with omeprazole and domperidone |
| CN101390859B (en) * | 2007-09-21 | 2012-02-29 | 北京德众万全药物技术开发有限公司 | Medicine composition containing omeprazole and domperidone |
| RS57334B1 (en) * | 2010-11-15 | 2018-08-31 | Neuroderm Ltd | Compositions for transdermal delivery of active agents |
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Address after: 430042 Hubei province Dongxihu District of Wuhan City Baiquan Qi Santak No. 1 Applicant after: Fu'an Pharmaceutical Group, Hubei People Pharmaceutical Co., Ltd. Address before: 430042 Hubei province Dongxihu District of Wuhan City Baiquan Qi Santak No. 1 Applicant before: Hubei Renmin Pharmaceutical Co.,Ltd. |
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