A lansoprazole and sodium bicarbonate-containing dry suspension and its preparation method

Abstract

The present invention relates to a dry suspension containing lansoprazole and sodium bicarbonate and a preparation method thereof. By strictly controlling the dosage of sodium bicarbonate and the ratio of each component, the prepared dry suspension has good acid resistance and stability. The active ingredient sodium bicarbonate in the product can quickly neutralize gastric acid, thereby relieving symptoms such as excessive gastric acid and stomach pain. After neutralizing gastric acid, it can reduce the degradation of the drug by gastric acid, improve the stability of lansoprazole in the human gastric environment, ensure the rapid dissolution and high bioavailability of this product in the stomach, so as to achieve the purpose of rapid onset. At the same time, during the research process of the present invention, it was unexpectedly found that through a specific mixing sequence, not only can the stability and mixing uniformity of the product be further improved, but also a better taste masking effect can be achieved. In addition, being prepared as a dry suspension is particularly suitable for the elderly, children and patients with difficulty in swallowing, and has clinical compliance that cannot be compared with tablets or capsules of the same specification. The preparation method of this product is simple, highly operable, and has great clinical significance.

Description

Technical Field

[0001] The present invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a lansoprazole and sodium bicarbonate-containing dry suspension and a preparation method thereof. Background Art

[0002] Lansoprazole is a new type of proton pump inhibitor. After entering parietal cells from the blood, it is converted into an active sulfinamide derivative, which is connected to the sulfhydryl group of H + , K + -adenosine triphosphate (ATP) enzyme (the last step in the process of H ＋ , K ＋ -ATP enzyme catalyzes the secretion of gastric acid), so it inactivates H ＋ , K ＋ -ATP enzyme and inhibits the gastric acid secretion regulated by both the central and peripheral nervous systems. It has a continuous inhibitory effect on the gastric acid secretion caused by all known stimuli, and can effectively maintain the gastric pH above 4 for a long time.

[0003] The physical and chemical properties of lansoprazole are extremely unstable and are easily affected by various factors such as light, heavy metal ions, oxidizing and reducing components, etc. Especially in acidic conditions, its chemical structure undergoes destructive changes, resulting in the degradation of lansoprazole and reducing the drug's onset speed and bioavailability. At present, the preparation technology to avoid the release of active ingredients in gastric acid is mainly to prepare lansoprazole into enteric-coated preparations, such as lansoprazole enteric-coated sustained-release capsules (trade name: PREVACID®) of Takeda Pharmaceutical Company, and dexlansoprazole sustained-release capsules (trade name: DEXILANT®); or prepare them into injections (trade name: PREVACID® I.V.). However, lansoprazole enteric-coated preparations also inhibit its initial inhibitory effect on gastric acid. Generally, it can be detected in the blood about 1 hour after oral administration and reaches the peak at 3.6 hours, with a relatively long onset time. At the same time, it also increases the technical difficulty and production cost. Injections obviously bring problems of medication compliance and higher safety risks.

[0004] Patent CN 103006654 A provides a pharmaceutical composition containing lansoprazole, which is made into tablets or capsules from lansoprazole, sodium bicarbonate, lactose, croscarmellose sodium, 2% povidone, and magnesium stearate. The amount of sodium bicarbonate added is very limited, making it difficult to quickly neutralize gastric acid and thus quickly relieve symptoms such as excessive gastric acid and stomach pain; moreover, its dissolution effect is not good and the bioavailability is low; the tablets or capsules prepared by this method have a relatively large specification, which is not conducive to the elderly and children to take, and the clinical compliance is poor.

[0005] Patent CN 106619520 A discloses a lansoprazole sodium dry suspension, which contains a new crystal form A of lansoprazole sodium, sodium bicarbonate, a solubilizer, gastric-soluble and rapid-release pellets A, enteric-coated and sustained-release pellets B, a filler, a suspending agent, a flavoring agent and other pharmaceutically acceptable excipients. It can relieve symptoms such as excessive gastric acid and stomach pain. However, the preparation process is too complex and it is difficult to maintain the stability of this product in an acidic environment.

[0006] Therefore, it is of great significance to develop a preparation method of lansoprazole dry suspension with a simple preparation process, stable and controllable process, rapid dissolution of the sample, and the ability to quickly neutralize gastric acid to relieve symptoms such as excessive gastric acid and stomach pain, and to obtain a solid preparation with stable quality. Summary of the Invention

[0007] Aiming at the problems existing in the prior art, the present invention provides a lansoprazole sodium bicarbonate dry suspension and a preparation method thereof. The lansoprazole sodium bicarbonate dry suspension prepared by the present invention can quickly neutralize gastric acid to relieve symptoms such as excessive gastric acid and stomach pain. By neutralizing the acidic environment in the stomach, the stability of lansoprazole in the human stomach environment is improved, ensuring rapid dissolution and high bioavailability of this product in the stomach, so as to achieve the purpose of rapid onset.

[0008] The technical solution of the present invention is as follows:

[0009] A lansoprazole sodium bicarbonate dry suspension includes the following components by weight: 15 - 30 parts of lansoprazole, 1680 - 2100 parts of sodium bicarbonate, 3000 - 4200 parts of a diluent, 50 - 70 parts of a suspending agent, 80 - 90 parts of a flavoring agent and 40 - 60 parts of a solubilizer.

[0010] In some embodiments, the lansoprazole sodium bicarbonate dry suspension includes the following components by weight: 15 - 30 parts of lansoprazole, 1680 - 2100 parts of sodium bicarbonate, 3710 - 4130 parts of a diluent, 60 parts of a suspending agent, 90 parts of a flavoring agent and 40 - 60 parts of a solubilizer.

[0011] In some embodiments, the diluent is selected from one or more of glucose, lactose, xylitol, sucrose, mannitol, sorbitol or pregelatinized starch, and preferably lactose and xylitol.

[0012] In some embodiments, the suspending agent is selected from one or more of hydroxypropyl cellulose, hypromellose, microcrystalline cellulose - sodium carboxymethylcellulose, xanthan gum, carbomer, poloxamer or tragacanth gum; preferably xanthan gum.

[0013] In some embodiments, the flavoring agent is selected from one or more of sucralose, essence, glycyrrhizin, maltitol, aspartame, stevioside or acesulfame potassium; preferably sucralose and essence.

[0014] In some embodiments, the solubilizer is selected from one or more of sodium dodecyl sulfate, Tween 80 or sodium taurocholate; preferably sodium dodecyl sulfate.

[0015] In some embodiments, the particle size D90 of lansoprazole is less than 20 μm, preferably the particle size D90 is less than 10 μm.

[0016] In some typical embodiments, the lansoprazole dry suspension is prepared from the following components in parts by weight: 15 parts of lansoprazole, 1680 parts of sodium bicarbonate, 2065 parts of lactose, 2065 parts of xylitol, 60 parts of xanthan gum, 30 parts of sucralose, 60 parts of essence and 40 parts of sodium dodecyl sulfate.

[0017] In some typical embodiments, the lansoprazole dry suspension is prepared from the following components in parts by weight: 15 parts of lansoprazole, 2100 parts of sodium bicarbonate, 1855 parts of lactose, 1855 parts of xylitol, 60 parts of xanthan gum, 30 parts of sucralose, 60 parts of essence and 40 parts of sodium dodecyl sulfate.

[0018] In some typical embodiments, the lansoprazole dry suspension is prepared from the following components in parts by weight: 30 parts of lansoprazole, 1680 parts of sodium bicarbonate, 2065 parts of lactose, 2065 parts of xylitol, 60 parts of xanthan gum, 30 parts of sucralose, 60 parts of essence and 40 parts of sodium dodecyl sulfate.

[0019] In some typical embodiments, the lansoprazole dry suspension is prepared from the following components in parts by weight: 30 parts of lansoprazole, 2100 parts of sodium bicarbonate, 1855 parts of lactose, 1855 parts of xylitol, 60 parts of xanthan gum, 30 parts of sucralose, 60 parts of essence and 40 parts of sodium dodecyl sulfate.

[0020] In some typical embodiments, the lansoprazole dry suspension is prepared from the following components in parts by weight: 30 parts of lansoprazole, 1680 parts of sodium bicarbonate, 2055 parts of lactose, 2055 parts of xylitol, 60 parts of xanthan gum, 30 parts of sucralose, 60 parts of essence and 60 parts of sodium dodecyl sulfate.

[0021] The present invention also provides a method for preparing the above lansoprazole sodium bicarbonate dry suspension, which comprises the following steps:

[0022] (1) Pretreatment: micronize the active ingredient lansoprazole sodium to control its particle size D90 below 20 μm; sieve sodium bicarbonate through a 60-mesh sieve; sieve other excipients for standby.

[0023] (2) Mixing: uniformly mix the active ingredient lansoprazole sodium, flavoring agent, suspending agent, and solubilizer, then add sodium bicarbonate and mix uniformly again, and finally add the diluent and mix uniformly.

[0024] (3) Subpackaging: package according to the prescribed dose to obtain a dry suspension.

[0025] In some embodiments, in step (1), micronize the active ingredient lansoprazole to control its particle size D90 below 10 μm.

[0026] In some embodiments, in step (2), uniformly mix the active ingredient lansoprazole, flavoring agent, suspending agent, and solubilizer, then add sodium bicarbonate and mix uniformly again, and finally add the diluent and mix uniformly. Package according to the prescribed dose to obtain a dry suspension.

[0027] Advantages of the present invention: The lansoprazole sodium bicarbonate dry suspension provided by the present invention has good acid resistance and stability by strictly controlling the dosage of sodium bicarbonate and the ratio of each component. The active ingredient sodium bicarbonate in the product can quickly neutralize gastric acid, thereby relieving symptoms such as excessive gastric acid and stomach pain. After neutralizing gastric acid, it can reduce the degradation of the drug by gastric acid, improve the stability of lansoprazole in the human gastric environment, ensure high bioavailability when the product rapidly dissolves in the stomach, and thus achieve the purpose of rapid onset. At the same time, during the research process of the present invention, it was unexpectedly found that through a specific mixing sequence, the stability and mixing uniformity of the product can be further improved, and a better taste masking effect can also be achieved. In addition, preparing it into a dry suspension for administration is especially suitable for the elderly, children, and patients with difficulty in swallowing, and has good clinical compliance that cannot be compared with tablets or capsules of the same specification. The preparation method of this product is simple, highly operable, and has great clinical significance. Embodiment

[0028] The following examples can enable those skilled in the art in this field to more comprehensively understand the present invention, but do not limit the present invention to the scope of the described examples.

[0029] In the present invention, it is necessary to strictly control the dosage of sodium bicarbonate in order to rapidly neutralize gastric acid and relieve symptoms such as excessive gastric acid and stomach pain. After neutralizing gastric acid, it can reduce the degradation of drugs by gastric acid. Especially in an acidic environment, lansoprazole has the advantages of slow degradation rate and high stability. If the dosage of sodium bicarbonate is too low, it cannot achieve a good effect of neutralizing gastric acid, which will lead to the degradation of lansoprazole and reduce its bioavailability. If the dosage of sodium bicarbonate is too high, it will lead to a significant increase in dosage and product uneconomy, or poor particle powder properties that do not meet the requirements of sub-packaging.

[0030] The dry suspension of lansoprazole in Examples 1-5 and Comparative Examples 1-2 has the following composition of the formula:

[0031] Table 1 Composition of the formula of the dry suspension in Examples and Comparative Examples

[0032]

[0033] Among them, the preparation method of the dry suspension in Examples 1-5 and Comparative Examples 1-2 includes the following steps:

[0034] (1) Pretreatment: Micronize the active ingredient lansoprazole sodium to control its particle size D90 below 20 μm; sieve sodium bicarbonate through a 60-mesh sieve; sieve other excipients for later use.

[0035] (2) Mixing: Mix the active ingredient lansoprazole, the flavoring agent sucralose and essence, the suspending agent xanthan gum, and the solubilizer sodium lauryl sulfate evenly, then add sodium bicarbonate and mix evenly again, and finally add the diluent and mix evenly.

[0036] (3) Sub-packaging: Package according to the predetermined dose to obtain the dry suspension.

[0037] Comparative Example 3

[0038] The prescription composition refers to Example 3, and the mixing process is adjusted as follows: Mix the active ingredient lansoprazole, the suspending agent xanthan gum, the flavoring agent sucralose and essence, and the solubilizer sodium lauryl sulfate evenly, then add the diluents xylitol, lactose and sodium bicarbonate and mix evenly again, and package according to the predetermined dose to obtain the dry suspension.

[0039] Comparative Example 4

[0040] The prescription composition refers to Example 3, and the mixing process is adjusted as follows: Mix the active ingredient lansoprazole, the suspending agent xanthan gum, the flavoring agent sucralose and essence, and the solubilizer sodium lauryl sulfate evenly, then add the diluents xylitol and lactose and mix evenly again, and finally add sodium bicarbonate and mix evenly, and package according to the predetermined dose to obtain the dry suspension.

[0041] Comparative Example 5

[0042] Prepare lansoprazole tablets according to the components and preparation method of Formulation 1 in Patent CN 103006654 A. The preparation prescription process is as follows:

[0043] Take 15 g of lansoprazole pulverized through 120 meshes, and mix it with 30 g of sodium bicarbonate, 75 g of lactose, and 38 g of croscarmellose sodium through 80 meshes. Add 14 g of 2% povidone solution (using 95% ethanol as the solvent) to make soft materials, then granulate through 24 meshes; dry the obtained granules at 55 °C and screen and size them through 20 meshes. Then add 5 g of magnesium stearate and mix well, and press into 1000 tablets.

[0044] Comparative Example 6

[0045] Prepare lansoprazole dry suspension according to Example 11 in Patent CN 106619520 A. The preparation prescription process is as follows:

[0046] Mix 2 g of dexlansoprazole sodium, 8 g of sodium bicarbonate, 8 g of sodium tauroglycocholate, 50 g of xylitol, 50 g of lactose, 6 g of xanthan gum, 4 g of peppermint essence, and 4 g of steviol glycoside evenly for standby;

[0047] Mix 8 g of dexlansoprazole sodium, 10 g of magnesium carbonate, 24 g of Plasdone S630, 8 g of Klucel EF, 4 g of glyceryl behenate, 8 g of Soluplus, 3 g of tromethamine, and 0.8 g of crospovidone evenly, and prepare into pellets with a diameter of 0.5 - 0.7 mm by hot melt extrusion process. Use a fluidized bed coater for gastric-soluble pellet coating with a coating weight gain of 10% to obtain gastric-soluble rapid-release pellets A.

[0048] Mix 20 g of dexlansoprazole sodium, 25 g of magnesium carbonate, 60 g of HPMCAS, 20 g of Eudragit RS100, 5 g of glyceryl behenate, 15 g of polyethylene glycol glycerol laurate Gelucire 44 / 14, 5 g of propyl gallate, and 1 g of carbomer evenly, and then prepare into pellets with a diameter of 0.5 - 0.7 mm by hot melt extrusion process for standby; Use a fluidized bed coater for enteric-coated pellet coating with a coating weight gain of 15%. Obtain enteric-coated sustained-release pellets B.

[0049] Mix the above mixed powder and coated pellets evenly and fill them into 1000 bags of dry suspension.

[0050] Acid resistance

[0051] Using the dissolution and release determination method (the second method in General Chapter 0931, Volume IV of the Chinese Pharmacopoeia 2020 Edition), with 250 ml of 0.02 mol / L hydrochloric acid solution as the dissolution medium, the rotation speed is 75 revolutions per minute. Operate according to the law. After 2 minutes, add 0.1 mol / L fresh hydrochloric acid solution (the solution has been preheated to 37 °C + 2 °C) at a speed of 2 ml / min. After 60 minutes, measure the pH value of the sample solution. Then take 15 ml of the sample solution, filter it, accurately measure 3 ml of the continued filtrate, add 6 ml of phosphate buffer solution (pH 11.0), shake well, and use it as the test solution. Determine the content and related substances of the sample solution according to the lansoprazole content and related substances detection method. The results are shown in Table 2 below.

[0052] Table 2 Data of the acid resistance test of the dry suspension in the examples and comparative examples

[0053]

[0054] It can be seen from Table 2 that in the present invention, the dosage of sodium bicarbonate in Examples 1-5 is strictly controlled, so that the prepared dry suspension has good acid resistance. In an acidic environment, the contents of the maximum single impurity and total impurities are low, and it has high stability. When the dosage of sodium bicarbonate is too low (for example, Comparative Examples 1, 5, and 6), the acid resistance of the obtained product is poor, and in an acidic environment, the contents of the maximum single impurity and total impurities are high, and the stability is poor.

[0055] Tablets were prepared according to the components and preparation method of Formulation 1 in Patent CN 103006654 A, and the effect of neutralizing gastric acid is poor. In an acidic environment, the contents of the maximum single impurity and total impurities are high, and the acid resistance and stability of the product are poor.

[0056] A dry suspension was prepared according to Example 11 in Patent CN 106619520 A. In an acidic environment, the contents of the maximum single impurity and total impurities are high, and the product stability is not ideal.

[0057] Dissolution curve

[0058] Referring to the dissolution detection method of the pharmacopoeia, the dissolution curves of the samples in each example and comparative example in 0.01 mol / L hydrochloric acid medium were detected, and the content of lansoprazole was determined by HPLC method. The results are shown in Table 3 below:

[0059] Table 3 Data of the dissolution effect in the examples and comparative examples

[0060]

[0061] As can be seen from Table 3, the dry suspensions prepared in Examples 1-5 of the present invention dissolve rapidly and sufficiently, and can quickly neutralize gastric acid, thus relieving symptoms such as excessive gastric acid and stomach pain. The dissolution rate of Comparative Example 1 is significantly slower than that of Examples 1-5; in Comparative Example 5, the disintegration rate of the tablets is relatively slow, and at the same time, the amount of sodium bicarbonate added is small, which is not sufficient to achieve an ideal acid resistance effect. In Comparative Example 6, the enteric-coated pellets do not dissolve in the stomach, so the dissolution rate within 30 minutes is low, and the product takes effect late and has a delayed onset.

[0062] Comparison of mixing process and intermediate product quality

[0063] Table 4 Comparison of Examples and Comparative Examples

[0064]

[0065] As can be seen from Table 2, for the dry suspensions of Examples 1-5 and Comparative Examples 1 and 3 of the present invention, the mixing uniformity and the fluidity of the total mixed powder are both good. In Comparative Example 2, due to the general fluidity of sodium bicarbonate itself, as the amount of its addition increases, the mixing uniformity of the total mixed powder becomes worse and the fluidity is poor, resulting in a large difference in filling quantity. Due to the different mixing processes in Comparative Examples 3 and 4, there are certain differences in the odor of the total mixed powder.

[0066] Accelerated stability

[0067] The samples in Examples 1-5 and Comparative Examples 2-3 were placed under the accelerated test conditions of 40°C / 75%RH for 6 months, and their related substances and sedimentation volume ratio were detected. The results are shown in Table 5 below:

[0068] Table 5 Results of Accelerated Stability Tests of Examples and Comparative Examples

[0069]

[0070] As can be seen from Table 5, for the dry suspensions obtained in Examples 1-5 of the present invention, when placed at 40°C / 75%RH for 3 months and 6 months, the maximum single impurity and total impurity contents are low, and the growth rate is small, indicating good stability. However, due to the differences in the mixing processes in Comparative Examples 3 and 4, the stability of the products is relatively poor, and when placed at 40°C / 75%RH for 3 months and 6 months, the impurity growth trend is relatively fast.

[0071] The above examples are only used to illustrate the technical solutions of the present invention and are not intended to limit them; although the present invention has been described in detail with reference to the foregoing examples, those of ordinary skill in the art should understand that it is still possible to modify the technical solutions described in the foregoing examples, or perform equivalent replacements for some of the technical features; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A lansoprazole and sodium bicarbonate dry suspension, characterized in that, The lansoprazole and sodium bicarbonate dry suspension is prepared from the following components in parts by weight: 15 parts of lansoprazole, 1680 parts of sodium bicarbonate, 2065 parts of lactose, 2065 parts of xylitol, 60 parts of xanthan gum, 30 parts of sucralose, 60 parts of essence, and 40 parts of sodium lauryl sulfate; the particle size D90 of the lansoprazole is less than 10 μm; The preparation method of the lansoprazole and sodium bicarbonate dry suspension comprises the following steps: 1) Pretreatment: micronize the active ingredient lansoprazole to control its particle size D90 below 10 μm; sieve the sodium bicarbonate through a 60-mesh sieve; sieve the other excipients for standby; 2) Mixing: uniformly mix the active ingredient lansoprazole, sucralose, essence, xanthan gum, and sodium lauryl sulfate, then add sodium bicarbonate and mix uniformly again, and finally add lactose and xylitol and mix uniformly; 3) Sub-packaging: package according to the prescribed dose to obtain the dry suspension.

2. A lansoprazole and sodium bicarbonate dry suspension, characterized in that, The lansoprazole and sodium bicarbonate dry suspension is prepared from the following components in parts by weight: 15 parts of lansoprazole, 2100 parts of sodium bicarbonate, 1855 parts of lactose, 1855 parts of xylitol, 60 parts of xanthan gum, 30 parts of sucralose, 60 parts of essence, and 40 parts of sodium lauryl sulfate; the particle size D90 of the lansoprazole is less than 10 μm; The preparation method of the lansoprazole and sodium bicarbonate dry suspension comprises the following steps: 1) Pretreatment: micronize the active ingredient lansoprazole to control its particle size D90 below 10 μm; sieve the sodium bicarbonate through a 60-mesh sieve; sieve the other excipients for standby; 2) Mixing: uniformly mix the active ingredient lansoprazole, sucralose, essence, xanthan gum, and sodium lauryl sulfate, then add sodium bicarbonate and mix uniformly again, and finally add lactose and xylitol and mix uniformly; 3) Sub-packaging: package according to the prescribed dose to obtain the dry suspension.

3. A lansoprazole and sodium bicarbonate dry suspension, characterized in that, The lansoprazole and sodium bicarbonate dry suspension is prepared from the following components in parts by weight: 30 parts of lansoprazole, 1680 parts of sodium bicarbonate, 2065 parts of lactose, 2065 parts of xylitol, 60 parts of xanthan gum, 30 parts of sucralose, 60 parts of essence, and 40 parts of sodium lauryl sulfate; the particle size D90 of the lansoprazole is less than 10 μm; The preparation method of the lansoprazole and sodium bicarbonate dry suspension comprises the following steps: 1) Pretreatment: micronize the active ingredient lansoprazole to control its particle size D90 below 10 μm; sieve the sodium bicarbonate through a 60-mesh sieve; sieve the other excipients for standby; 2) Mixing: uniformly mix the active ingredient lansoprazole, sucralose, essence, xanthan gum, and sodium lauryl sulfate, then add sodium bicarbonate and mix uniformly again, and finally add lactose and xylitol and mix uniformly; 3) Sub-packaging: package according to the prescribed dose to obtain the dry suspension.

4. A lansoprazole and sodium bicarbonate dry suspension, characterized in that, The lansoprazole and sodium bicarbonate dry suspension is prepared from the following components in parts by weight: 30 parts of lansoprazole, 2100 parts of sodium bicarbonate, 1855 parts of lactose, 1855 parts of xylitol, 60 parts of xanthan gum, 30 parts of sucralose, 60 parts of essence, and 40 parts of sodium lauryl sulfate; the particle size D90 of the lansoprazole is less than 10 μm; The preparation method of lansoprazole and sodium bicarbonate dry suspension comprises the following steps: 1) Pretreatment: micronize the active ingredient lansoprazole to control its particle size D90 below 10 μm; sieve sodium bicarbonate through a 60-mesh sieve; sieve other excipients for standby; 2) Mixing: uniformly mix the active ingredient lansoprazole, sucralose, essence, xanthan gum, and sodium lauryl sulfate, then add sodium bicarbonate and mix uniformly again, and finally add lactose and xylitol and mix uniformly; 3) Sub-packaging: package according to the prescribed dose to obtain the dry suspension.

5. A lansoprazole and sodium bicarbonate dry suspension, characterized in that, The lansoprazole and sodium bicarbonate dry suspension is made from the following components in parts by weight: 30 parts of lansoprazole, 1680 parts of sodium bicarbonate, 2055 parts of lactose, 2055 parts of xylitol, 60 parts of xanthan gum, 30 parts of sucralose, 60 parts of essence, and 60 parts of sodium lauryl sulfate; the particle size D90 of the lansoprazole is less than 10 μm; The preparation method of lansoprazole and sodium bicarbonate dry suspension comprises the following steps: 1) Pretreatment: micronize the active ingredient lansoprazole to control its particle size D90 below 10 μm; sieve sodium bicarbonate through a 60-mesh sieve; sieve other excipients for standby; 2) Mixing: uniformly mix the active ingredient lansoprazole, sucralose, essence, xanthan gum, and sodium lauryl sulfate, then add sodium bicarbonate and mix uniformly again, and finally add lactose and xylitol and mix uniformly; 3) Sub-packaging: package according to the prescribed dose to obtain the dry suspension.

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