CN111388425A - Omeprazole dry suspension and preparation method thereof - Google Patents
Omeprazole dry suspension and preparation method thereof Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
Abstract
The invention provides an omeprazole dry suspension and a preparation method thereof, relating to the field of pharmaceutical preparations, wherein the omeprazole dry suspension comprises the following raw materials in parts by weight: 10-20 parts of omeprazole, 600-900 parts of sodium bicarbonate, 720-1000 parts of cane sugar, 15-25 parts of suspending agent, 12-22 parts of flavoring agent and 5-10 parts of synergistic stabilizer. The dry suspension is prepared by the following steps: (1) sieving omeprazole, mixing sucrose accounting for 30-40% of the total weight of omeprazole and a synergistic stabilizer, adding deionized water, stirring and uniformly mixing, storing for 24 hours at 10-15 ℃, and granulating to obtain a material A; (2) mixing the material A in the step (1) with the rest of cane sugar, suspending agent and flavoring agent to obtain a material B; (3) and (3) mixing the material B in the step (2) with sodium bicarbonate to obtain the omeprazole dry suspension. The preparation method is simple and efficient, and the finally obtained product has good quality and strong stability.
Description
Technical Field
The invention relates to the field of pharmaceutical preparations, and in particular relates to an omeprazole dry suspension and a preparation method thereof.
Background
Omeprazole is a proton pump inhibitor, is mainly used for duodenal ulcer and Zollinger-Ellison syndrome, and can also be used for gastric ulcer and reflux esophagitis; intravenous injection can be used for treating acute hemorrhage of peptic ulcer. Generally, omeprazole is also extremely susceptible to degradation in acidic or alkaline media, and in particular, is destroyed by gastric acid, so enteric omeprazole formulations are frequently used clinically. In addition, the stability of omeprazole is also affected by light, heat, humidity and the like, which leads to degradation of omeprazole and appearance of harmful products, which further threatens human health, so in recent years, the stability of omeprazole is paid extensive attention, and how to improve the stability of omeprazole is always a hot spot of current research. At present, omeprazole enteric preparations are of pills, tablets and capsules, but the omeprazole enteric preparations are not suitable for children or old people to take, so researchers research dry suspensions which are more convenient to take, the dry suspensions are insoluble medicines and are prepared into powder or granular materials with appropriate auxiliary materials, water is added for shaking to disperse into suspension for oral liquid preparations when the omeprazole enteric preparations are used, sodium bicarbonate contained in the omeprazole enteric preparations can neutralize and buffer gastric acid rapidly under the condition of not influencing gastric acid secretion, and then omeprazole is protected from being decomposed by gastric acid, and the stability of the omeprazole enteric preparations is guaranteed.
Chinese patent CN102641286A discloses a compound omeprazole dry suspension and a preparation method thereof, wherein the compound omeprazole dry suspension consists of omeprazole, sodium bicarbonate and a pharmaceutically acceptable medicinal carrier, and the specific components are omeprazole, sodium bicarbonate, sucrose, xylitol, xanthan gum, sucralose and essence. However, the patent does not make further research on the stability of the suspension, and the stability of the prepared dry suspension needs to be further improved.
Chinese patent CN106798750B discloses a preparation method of compound omeprazole dry suspension, which comprises a wet granulation process, a drying process, a total mixing process and a separation process, wherein the dissolution rate, the acid resistance and the maximum impurities of the finally produced compound omeprazole dry suspension are far higher than the national standard, the defective rate is greatly reduced, the product quality is improved, and the curative effect of the product is improved. However, the method is relatively complex and time-consuming, and further increases the cost of the compound omeprazole dry suspension.
Aiming at the problems of poor stability and complex preparation process of the omeprazole dry suspension, it is important to find a simple and efficient preparation method and further prepare the omeprazole dry suspension with strong stability.
Disclosure of Invention
Aiming at the problems in the prior art, the invention provides an omeprazole dry suspension and a preparation method thereof. The preparation method is simple and efficient, and the prepared omeprazole dry suspension has good quality and strong stability.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
the invention provides an omeprazole dry suspension which comprises the following raw materials in parts by weight: 10-20 parts of omeprazole, 600-900 parts of sodium bicarbonate, 720-1000 parts of cane sugar, 15-25 parts of suspending agent, 12-22 parts of flavoring agent and 5-10 parts of synergistic stabilizer.
Further, the omeprazole dry suspension comprises the following raw materials in parts by weight: 12-18 parts of omeprazole 700-800 parts of sodium bicarbonate, 800-900 parts of cane sugar, 18-22 parts of suspending agent, 15-20 parts of flavoring agent and 5-9 parts of synergistic stabilizer.
Preferably, the omeprazole dry suspension comprises the following raw materials in parts by weight: 16 parts of omeprazole 778 parts of sodium bicarbonate, 860 parts of cane sugar, 20 parts of suspending agent, 18 parts of flavoring agent and 8 parts of synergistic stabilizer.
Further, the weight ratio of the omeprazole to the synergistic stabilizer is 12-18: 6-8.
Preferably, the weight ratio of the omeprazole to the synergistic stabilizer is 2: 1.
Further, the suspending agent is xanthan gum or croscarmellose sodium.
Further, the flavoring agent is one or more of stevioside, glycerol, sorbitol or mannitol.
Further, the synergistic stabilizer is tween-20, bamboo leaf polysaccharide and pachyman.
Preferably, the weight ratio of the tween-20 to the bamboo leaf polysaccharide to the pachyman is 1-2:3-5: 2-4.
Preferably, the weight ratio of the tween-20 to the bamboo leaf polysaccharide to the pachyman is 1:2: 1.
Further, the weight ratio of the bamboo leaf polysaccharide to the pachyman is 4-5: 2.
Preferably, the weight ratio of the bamboo leaf polysaccharide to the pachyman is 2: 1.
The invention also provides a preparation method of the omeprazole dry suspension, which comprises the following steps:
(1) sieving omeprazole, mixing with sucrose and a synergistic stabilizer which account for 30-40% of the total weight, adding deionized water, stirring and uniformly mixing, storing at 10-15 ℃ for 24 hours, granulating and drying to obtain a material A;
(2) mixing the material A in the step (1) with the rest of cane sugar, suspending agent and flavoring agent to obtain a material B;
(3) and (3) mixing the material B in the step (2) with sodium bicarbonate to obtain the omeprazole dry suspension.
Further, the particle size of the granules prepared in the step (1) is 30-40 meshes.
Further, the deionized water is added in the step (1) in an amount of 6-8% by weight of the total mixture (i.e. omeprazole, sucrose in an amount of 30-40% by weight, synergistic stabilizer and deionized water).
The technical effects obtained by the invention are as follows:
1. the product is a dry suspension, is suitable for children and the old who are difficult to take pills, tablets or capsules, has wide audience groups and universality;
2. the preparation method of the omeprazole dry suspension is simple and efficient, and the prepared omeprazole dry suspension has good quality and high stability, can effectively treat gastric ulcer and has no sensitization reaction.
Detailed Description
It should be noted that the raw materials used in the present invention are all common commercial products, and thus the sources thereof are not particularly limited.
Example 1
The omeprazole dry suspension comprises the following raw materials in parts by weight: 10 parts of omeprazole, 600 parts of sodium bicarbonate, 720 parts of cane sugar, 15 parts of suspending agent, 12 parts of flavoring agent and 5 parts of synergistic stabilizer. Wherein the suspending agent is xanthan gum, the flavoring agent is stevioside, glycerol and mannitol in a weight ratio of 1:1:1, and the synergistic stabilizer is tween-20, bamboo leaf polysaccharide and pachyman in a weight ratio of 1:3: 2.
The preparation method of the omeprazole dry suspension comprises the following steps:
(1) sieving omeprazole, mixing with sucrose and a synergistic stabilizer which account for 30 percent of the total weight, adding deionized water which accounts for 6 percent of the weight of the total mixed material, stirring and uniformly mixing, preserving at 10 ℃ for 24 hours, granulating and drying to obtain a material A with the particle size of 30 meshes;
(2) mixing the material A in the step (1) with the rest of cane sugar, suspending agent and flavoring agent to obtain a material B;
(3) and (3) mixing the material B in the step (2) with sodium bicarbonate to obtain the omeprazole dry suspension.
Example 2
The omeprazole dry suspension comprises the following raw materials in parts by weight: 20 parts of omeprazole, 900 parts of sodium bicarbonate, 1000 parts of cane sugar, 25 parts of suspending agent, 22 parts of flavoring agent and 10 parts of synergistic stabilizer. Wherein the suspending agent is croscarmellose sodium, the flavoring agent is stevioside, glycerol and sorbitol in a weight ratio of 1:1:1, and the synergistic stabilizer is tween-20, bamboo leaf polysaccharide and pachyman in a weight ratio of 2:5: 4.
The preparation method of the omeprazole dry suspension comprises the following steps:
(1) sieving omeprazole, mixing with sucrose and a synergistic stabilizer which account for 40 percent of the total weight, adding deionized water which accounts for 8 percent of the weight of the total mixed material, stirring and uniformly mixing, storing for 24 hours at 15 ℃, granulating and drying to obtain a material A with the particle size of 40 meshes;
(2) mixing the material A in the step (1) with the rest of cane sugar, suspending agent and flavoring agent to obtain a material B;
(3) and (3) mixing the material B in the step (2) with sodium bicarbonate to obtain the omeprazole dry suspension.
Example 3
The omeprazole dry suspension comprises the following raw materials in parts by weight: 16 parts of omeprazole 778 parts of sodium bicarbonate, 860 parts of cane sugar, 20 parts of suspending agent, 18 parts of flavoring agent and 8 parts of synergistic stabilizer. Wherein the suspending agent is croscarmellose sodium, the flavoring agent is stevioside, glycerol and mannitol in a weight ratio of 1:1:1, and the synergistic stabilizer is tween-20, bamboo leaf polysaccharide and pachyman in a weight ratio of 1:2: 1.
The preparation method of the omeprazole dry suspension comprises the following steps:
(1) sieving omeprazole, mixing with sucrose accounting for 35 percent of the total weight and a synergistic stabilizer, adding deionized water accounting for 7 percent of the total weight of the mixture, stirring and uniformly mixing, storing for 24 hours at the temperature of 12 ℃, granulating and drying to obtain a material A with the particle size of 35 meshes;
(2) mixing the material A in the step (1) with the rest of cane sugar, suspending agent and flavoring agent to obtain a material B;
(3) and (3) mixing the material B in the step (2) with sodium bicarbonate to obtain the omeprazole dry suspension.
Example 4
The omeprazole dry suspension comprises the following raw materials in parts by weight: 12 parts of omeprazole 700 parts of sodium bicarbonate, 800 parts of cane sugar, 18 parts of suspending agent, 15 parts of flavoring agent and 5 parts of synergistic stabilizer. Wherein the suspending agent is xanthan gum, the flavoring agent is stevioside and mannitol in a weight ratio of 1:1, and the synergistic stabilizer is tween-20, bamboo leaf polysaccharide and pachyman in a weight ratio of 1:5: 2.
The preparation method of the omeprazole dry suspension comprises the following steps:
(1) sieving omeprazole, mixing with sucrose and a synergistic stabilizer which account for 30 percent of the total weight, adding deionized water which accounts for 6 percent of the weight of the total mixed material, stirring and uniformly mixing, preserving at 10 ℃ for 24 hours, granulating and drying to obtain a material A with the particle size of 30 meshes;
(2) mixing the material A in the step (1) with the rest of cane sugar, suspending agent and flavoring agent to obtain a material B;
(3) and (3) mixing the material B in the step (2) with sodium bicarbonate to obtain the omeprazole dry suspension.
Example 5
The omeprazole dry suspension comprises the following raw materials in parts by weight: 18 parts of omeprazole, 800 parts of sodium bicarbonate, 900 parts of cane sugar, 22 parts of suspending agent, 20 parts of flavoring agent and 9 parts of synergistic stabilizer. Wherein the suspending agent is croscarmellose sodium, the flavoring agent is mannitol, and the synergistic stabilizer is tween-20, bamboo leaf polysaccharide and pachyman in a weight ratio of 2:3: 4.
The preparation method of the omeprazole dry suspension comprises the following steps:
(1) sieving omeprazole, mixing with sucrose and a synergistic stabilizer which account for 40 percent of the total weight, adding deionized water which accounts for 8 percent of the weight of the total mixed material, stirring and uniformly mixing, storing for 24 hours at 15 ℃, granulating and drying to obtain a material A with the particle size of 40 meshes;
(2) mixing the material A in the step (1) with the rest of cane sugar, suspending agent and flavoring agent to obtain a material B;
(3) and (3) mixing the material B in the step (2) with sodium bicarbonate to obtain the omeprazole dry suspension.
Comparative example 1
The omeprazole dry suspension is different from the omeprazole dry suspension in example 3 only in that the omeprazole dry suspension comprises the following raw materials in parts by weight: 8 parts of omeprazole, 920 parts of sodium bicarbonate, 700 parts of cane sugar, 28 parts of suspending agent, 10 parts of flavoring agent and 12 parts of synergistic stabilizer.
Comparative example 2
The omeprazole dry suspension is different from the omeprazole dry suspension in example 3 only in that the omeprazole dry suspension comprises the following raw materials in parts by weight: 22 parts of omeprazole, 560 parts of sodium bicarbonate, 1050 parts of cane sugar, 12 parts of suspending agent, 25 parts of flavoring agent and 3 parts of synergistic stabilizer.
Comparative example 3
The only difference from example 3 is that no synergistic stabilizer was added.
Comparative example 4
The difference from example 3 is only that the weight ratio of omeprazole to the synergistic stabilizer is 22: 4.
Comparative example 5
The only difference from example 3 is that the synergistic stabilizer is tween-20, bamboo leaf polysaccharide and pachyman in a weight ratio of 3:2: 5.
Comparative example 6
The only difference from example 3 is that the weight ratio of the bamboo leaf polysaccharide to the pachyman in the synergistic stabilizer is 2: 5.
Comparative example 7
The difference from the embodiment 3 is that the preparation method comprises the step (1) of directly sieving the omeprazole, mixing the sieved omeprazole with the sucrose and the synergistic stabilizer which are 35 percent of the total weight, adding the deionized water which is 7 percent of the total weight of the mixture, stirring and uniformly mixing, directly granulating and drying to obtain the material A.
Product quality determination and stability acceleration test
The products of examples 1 to 5 and comparative examples 1 to 7 (5 packs of each prepared 20mg) were subjected to accelerated stability tests at 40 ℃ and 75% relative humidity, and the total impurity content, dissolution rate and acid resistance of the products after 0 month and 6 months were examined (see "chinese pharmacopoeia 2015 edition" omeprazole part, wherein release rate and acid resistance were measured with reference to a general formulation under the first method in the 0931 dissolution and release rate measurement test in general regulations), and the results are shown in table 1.
TABLE 1
(Note: the data in the table are mean values.)
As can be seen from table 1, the dry omeprazole suspensions prepared in examples 1 to 5 have low contents of single impurities (0 month or less than 0.044% and 6 months or less than 0.081%) and total impurities (0 month or less than 0.307% and 6 months or less than 0.454%), and have high dissolution rate and high acid resistance, wherein example 3 is the most preferable, the dissolution rate in 0 month can reach 99.34%, the acid resistance can reach 99.80%, the dissolution rate after 6 months accelerated test can reach 96.43%, and the acid resistance can reach 97.51%. Therefore, the omeprazole dry suspension has extremely high stability and excellent quality. Compared with example 3, the single impurity content and the total impurity content of comparative examples 1 to 7 are increased, and the dissolution rate and the acid resistance are reduced, so that the composition, the content and the preparation method of the omeprazole dry suspension have more or less influence on the final quality and the stability of the omeprazole.
Second, product curative effect and anaphylactic reaction condition test
Test animals: SD rat, male, body weight 200g, 130;
the test method comprises the following steps:
(1) model construction (acetic acid cauterization model) rats were fasted for 24h, drinking water was normally supplied, the rats were anesthetized with ether, the abdominal cavity was opened, a glass tube (inner diameter 5mm, length 30mm) was vertically placed on the serosal surface of the stomach, 0.05m L/mouse of 10% acetic acid was injected into the lumen, 1.5min later, acetic acid was cleaned with a cotton swab and the wound was sutured, and the model construction was completed.
(2) After allowing the rats to normally eat for 24 hours, the rats were divided into 13 groups of 10 rats each, one of which was used as a blank control group, the dry suspensions prepared in examples 1 to 5 and comparative examples 1 to 7 were suspended using deionized water and then separately gavaged to the remaining 12 groups of rats, 1m L each, and the blank control group was dosed with an equal amount of deionized water, during which adverse reactions (sneezing, asthma, erythema on the body surface, etc.) were observed in the rats, and after 30 days of continuous dosing, the rats were sacrificed and dissected to measure the area of gastric ulcer, and the following table 2 was obtained.
TABLE 2
| Examples of the invention | Area of gastric ulcer (mm)2) | Adverse reaction Rate (%) |
| Blank control group | 32.0±8.02 | 0 |
| Example 1 | 17.3±9.31* | 0 |
| Example 2 | 16.9±8.95* | 0 |
| Example 3 | 13.3±6.89** | 0 |
| Example 4 | 14.6±8.10* | 0 |
| Example 5 | 13.9±6.32* | 0 |
| Comparative example 1 | 25.7±10.03 | 10 |
| Comparative example 2 | 26.6±10.15 | 20 |
| Comparative example 3 | 27.4±11.02 | 40 |
| Comparative example 4 | 19.9±8.73* | 10 |
| Comparative example 5 | 18.3±7.68* | 0 |
| Comparative example 6 | 17.0±7.07* | 0 |
| Comparative example 7 | 14.9±7.34* | 0 |
(Note: P < 0.05, P <0.01 in the table)
As can be seen from table 2, the omeprazole dry suspension in examples 1 to 5 of the present invention has excellent therapeutic effect on gastric ulcer, and the prepared omeprazole dry suspension has no sensitization effect on rats. Whereas the therapeutic effects of the omeprazole dry suspensions of comparative examples 1 to 7 on gastric ulcer were all lower than those of example 3, particularly, the omeprazole dry suspensions of comparative examples 1 to 4 produced more or less sensitizing effects on rats. Therefore, the composition, content and preparation method of the omeprazole dry suspension have more or less influence on the final curative effect of the omeprazole on gastric ulcer and the quality of the medicament.
Finally, it should be noted that the above-mentioned contents are only used for illustrating the technical solutions of the present invention, and not for limiting the protection scope of the present invention, and that the simple modifications or equivalent substitutions of the technical solutions of the present invention by those of ordinary skill in the art can be made without departing from the spirit and scope of the technical solutions of the present invention.
Claims (10)
1. An omeprazole dry suspension, which is characterized in that: the composite material comprises the following raw materials in parts by weight: 10-20 parts of omeprazole, 600-900 parts of sodium bicarbonate, 720-1000 parts of cane sugar, 15-25 parts of suspending agent, 12-22 parts of flavoring agent and 5-10 parts of synergistic stabilizer.
2. The dry suspension of omeprazole according to claim 1, characterized in that: the composite material comprises the following raw materials in parts by weight: 12-18 parts of omeprazole 700-800 parts of sodium bicarbonate, 800-900 parts of cane sugar, 18-22 parts of suspending agent, 15-20 parts of flavoring agent and 5-9 parts of synergistic stabilizer.
3. The dry suspension of omeprazole according to claim 1, characterized in that: the weight ratio of the omeprazole to the synergistic stabilizer is 12-18: 6-7.
4. The dry suspension of omeprazole according to claim 1, characterized in that: the suspending agent is xanthan gum or croscarmellose sodium.
5. The dry suspension of omeprazole according to claim 1, characterized in that: the flavoring agent is one or more of stevioside, glycerol, sorbitol or mannitol.
6. The dry suspension of omeprazole according to claim 1, characterized in that: the synergistic stabilizer is Tween-20, bamboo leaf polysaccharide and pachyman.
7. The dry suspension of omeprazole according to claim 6, characterized in that: the weight ratio of the tween-20 to the bamboo leaf polysaccharide to the pachyman is 1-2:3-5: 2-4.
8. The dry suspension of omeprazole according to claim 6, characterized in that: the weight ratio of the bamboo leaf polysaccharide to the pachyman is 4-5: 2.
9. A process for the preparation of omeprazole dry suspension according to any of claims 1-8 characterized in that: the method comprises the following steps:
(1) sieving omeprazole, mixing with sucrose and a synergistic stabilizer which account for 30-40% of the total weight, adding deionized water, stirring and uniformly mixing, storing at 10-15 ℃ for 24 hours, granulating and drying to obtain a material A;
(2) mixing the material A in the step (1) with the rest of cane sugar, suspending agent and flavoring agent to obtain a material B;
(3) and (3) mixing the material B in the step (2) with sodium bicarbonate to obtain the omeprazole dry suspension.
10. The method of claim 9, wherein: the particle size of the granules prepared in the step (1) is 30-40 meshes.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN115252547A (en) * | 2021-04-29 | 2022-11-01 | 雷允上药业集团有限公司 | Antelope pearl powder suspension and its preparation method and use |
| CN115487151A (en) * | 2022-09-19 | 2022-12-20 | 杭州沐源生物医药科技有限公司 | Compound omeprazole dry suspension and preparation method thereof |
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