CN115887451A - Levamisole hydrochloride tablet and preparation method thereof - Google Patents
Levamisole hydrochloride tablet and preparation method thereof Download PDFInfo
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- CN115887451A CN115887451A CN202310009476.0A CN202310009476A CN115887451A CN 115887451 A CN115887451 A CN 115887451A CN 202310009476 A CN202310009476 A CN 202310009476A CN 115887451 A CN115887451 A CN 115887451A
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- levamisole hydrochloride
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
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Abstract
The invention provides levamisole hydrochloride tablets and a preparation method thereof, and solves the technical problems that the existing levamisole hydrochloride suspension oral liquid is poor in stability, easy to generate precipitates, required to be fully and uniformly mixed before use, easy to cause excessive poisoning due to improper use, easy to deteriorate the suspension, easy to degrade effective components and influence the use effect. The levamisole hydrochloride tablet comprises the following raw materials in parts by weight: 25-50 parts of levamisole hydrochloride, 50-100 parts of allicin, 150-180 parts of pregelatinized starch, 50-75 parts of polyethylene glycol, 75-90 parts of micro powder silica gel, 10-15 parts of carboxymethyl starch sodium and the balance of microcrystalline cellulose; the total weight part of the raw materials is 600 parts; meanwhile, the invention also discloses a preparation method of the levamisole hydrochloride tablet, which can be widely applied to the technical field of biological medicines.
Description
Technical Field
The application relates to the technical field of biological medicines, in particular to levamisole hydrochloride tablets and a preparation method thereof.
Background
Levamisole hydrochloride is levamisole hydrochloride, is a broad-spectrum, high-efficiency and low-toxicity nematicide commonly used in veterinary clinic and animal production, and has curative effects on adult and larva of gastrointestinal nematodes and pulmonary nematodes of various animals. Levamisole also has the functions of immunoregulation and immunity excitation, and also has good curative effects on ascaris, hookworm, pinworm and strongylostomosis.
The Chinese patent with application publication number CN105769881A discloses a veterinary compound levamisole hydrochloride suspension oral liquid and a preparation method thereof, and the compound levamisole hydrochloride suspension oral liquid consists of levamisole hydrochloride, chlorohydroxylamine, cobalt sulfate, agar powder, a suspending agent, a wetting agent, disodium ethylenediamine tetraacetate, a surfactant and the like. The compound oral suspension is prepared by wetting levamisole hydrochloride and chlorhydroxysal with a wetting agent, forming a stable and uniform dispersion system under the action of mechanical shearing force by utilizing the dispersion characteristic of a surfactant and the suspension characteristic of a suspension adjuvant, and expelling parasites of cattle, sheep and the like by means of material mixing or water mixing and the like. However, the compound levamisole hydrochloride suspension oral liquid is a liquid suspension, and has the problems of poor stability, easy generation of precipitates, full and uniform mixing before use, easy excessive poisoning caused by improper use, easy deterioration of the suspension, degradation of effective components, influence on use effect and the like. This technical problem is urgently needed to be solved.
Disclosure of Invention
The invention aims to solve the technical defects and provides the levamisole hydrochloride tablet and the preparation method thereof, and the levamisole hydrochloride tablet has the advantages of simple process, good absorption effect and convenience in use.
Therefore, the invention provides a levamisole hydrochloride tablet which comprises the following raw materials in parts by weight: 25-50 parts of levamisole hydrochloride, 50-100 parts of allicin, 150-180 parts of pregelatinized starch, 50-75 parts of polyethylene glycol, 75-90 parts of micro powder silica gel, 10-15 parts of carboxymethyl starch sodium and the balance of microcrystalline cellulose; and the total weight portion of the raw materials is 600 portions.
Preferably, the feed comprises the following raw materials in parts by weight: 25 parts of levamisole hydrochloride, 70 parts of allicin, 150 parts of pregelatinized starch, 50 parts of polyethylene glycol, 90 parts of micro powder silica gel, 12 parts of carboxymethyl starch sodium and 203 parts of microcrystalline cellulose.
Preferably, the feed comprises the following raw materials in parts by weight: 30 parts of levamisole hydrochloride, 50 parts of allicin, 180 parts of pregelatinized starch, 60 parts of polyethylene glycol, 75 parts of micro powder silica gel, 15 parts of carboxymethyl starch sodium and 190 parts of microcrystalline cellulose.
Preferably, the feed comprises the following raw materials in parts by weight: 50 parts of levamisole hydrochloride, 100 parts of allicin, 160 parts of pregelatinized starch, 75 parts of polyethylene glycol, 80 parts of micro-powder silica gel, 10 parts of carboxymethyl starch sodium and 125 parts of microcrystalline cellulose.
Preferably, the mesh number of the levamisole hydrochloride, the allicin, the pregelatinized starch, the polyethylene glycol, the carboxymethyl starch sodium and the microcrystalline cellulose is more than or equal to 60 meshes, and the mesh number of the superfine silica gel powder is more than or equal to 1000 meshes.
Preferably, the polyethylene glycol is one of polyethylene glycol 2000, polyethylene glycol 4000 and polyethylene glycol 6000.
The invention also provides a method for preparing the levamisole hydrochloride tablet, which comprises the following steps:
(1) Weighing various raw materials according to parts by weight for later use;
(2) Respectively adding levamisole hydrochloride, allicin, pregelatinized starch, polyethylene glycol, sodium carboxymethyl starch and microcrystalline cellulose which are prepared in the step (1) into a three-dimensional mixer for mixing, adding the superfine silica powder which is prepared in the step (1) after mixing for a period of time, continuously mixing, and uniformly mixing to obtain a mixed raw material;
(3) And (3) adding the mixed raw materials obtained in the step (2) into a tablet press for tabletting to obtain levamisole hydrochloride tablets.
Preferably, in the step (1), the levamisole hydrochloride, the allicin, the pregelatinized starch, the polyethylene glycol, the sodium starch glycolate and the microcrystalline cellulose are respectively sieved by a 60-mesh sieve, and the micro silica gel is sieved by a 1000-mesh sieve before the raw materials are respectively weighed according to the parts by weight.
Preferably, in the step (2), the rotating speed of the three-dimensional mixer is 30-40 rpm, levamisole hydrochloride, allicin, pregelatinized starch, polyethylene glycol, sodium carboxymethyl starch and microcrystalline cellulose are respectively added into the three-dimensional mixer to be mixed, and the mixing time is 35-50 min; adding the micro silica gel powder and continuously mixing for 10-15 min to obtain the mixed raw material.
Preferably, in the step (3), the tablet press is a rotary tablet press, and the tablet pressing pressure of the rotary tablet press is 18-22 KN.
The levamisole hydrochloride tablet and the preparation process thereof have the following functions:
levamisole hydrochloride: as a raw material medicine, is a medicine active component;
allicin: the drug effect and the bonding effect are increased;
pregelatinized starch: adhesive, synergistic lubrication;
polyethylene glycol: adhesive, increase the effect of the drug;
silica gel micropowder: lubricant and glidant;
sodium starch glycolate: the function of a disintegrating agent;
microcrystalline cellulose: the function of the filling agent.
The invention has the beneficial effects that: the invention provides levamisole hydrochloride tablets and a preparation method thereof, which creatively prepare levamisole hydrochloride tablets, have simple process, good absorption effect and convenient use, and fundamentally solve the technical problems that the existing levamisole hydrochloride suspension oral liquid has poor stability, is easy to generate precipitate, needs to be fully and uniformly mixed before use, is easy to cause excessive poisoning due to improper use, and is easy to deteriorate the suspension to cause degradation of effective components, thereby influencing the use effect.
Detailed Description
In order to make the technical problems, technical solutions and advantageous effects to be solved by the present application more clear, the present application is further described in detail below with reference to the following examples and comparative examples. It should be understood that the specific embodiments described herein are merely illustrative of the present application and are not intended to limit the present application. The method used in the invention is a conventional method if not specially specified; the raw materials and the apparatus used are, unless otherwise specified, conventional commercially available products.
Example 1:
the invention provides a preparation method of levamisole hydrochloride tablets, which comprises the following steps:
(1) Weighing the following raw materials in parts by weight: levamisole hydrochloride 25 mg, allicin 70 mg, pregelatinized starch 150 mg, polyethylene glycol 4000 mg, aerosil 90 mg, carboxymethyl starch sodium 12 mg, microcrystalline cellulose 203 mg for later use;
(2) Respectively adding levamisole hydrochloride, allicin, pregelatinized starch, polyethylene glycol 4000, sodium carboxymethyl starch and microcrystalline cellulose which are prepared in the step (1) into a three-dimensional mixer for mixing at the mixing speed of 35 rpm for 35 min, adding the superfine silica gel powder prepared in the step (1) and continuously mixing for 10 min to obtain a mixed raw material;
(3) And (3) adding the mixed raw material obtained in the step (2) into a rotary tablet press for tabletting, adopting a circular punch with the diameter of 13mm, and obtaining levamisole hydrochloride tablets with the tabletting pressure of 18 KN.
Example 2:
the invention provides a preparation method of levamisole hydrochloride tablets, which comprises the following steps:
(1) Weighing the following raw materials in parts by weight: levamisole hydrochloride 30 mg, allicin 50 mg, pregelatinized starch 180 mg, polyethylene glycol 4000 mg, micropowder silica gel 75 mg, carboxymethyl starch sodium 15 mg, microcrystalline cellulose 190 mg for later use;
(2) Respectively adding levamisole hydrochloride, allicin, pregelatinized starch, polyethylene glycol 4000, sodium carboxymethyl starch and microcrystalline cellulose which are prepared in the step (1) into a three-dimensional mixer for mixing at the mixing speed of 30 rpm for 50min, adding the superfine silica gel powder prepared in the step (1), and continuously mixing for 15min to obtain a mixed raw material;
(3) And (3) adding the mixed raw material obtained in the step (2) into a rotary tablet press for tabletting, adopting a circular punch with the diameter of 13mm, and obtaining levamisole hydrochloride tablets with the tabletting pressure of 20 KN.
Example 3:
the invention provides a preparation method of levamisole hydrochloride tablets, which comprises the following steps:
(1) Weighing the following raw materials in parts by weight: levamisole hydrochloride 50 mg, allicin 100mg, pregelatinized starch 160 mg, polyethylene glycol 4000 mg, aerosil 80 mg, carboxymethyl starch sodium 10mg, and microcrystalline cellulose 125 mg for later use;
(2) Respectively adding levamisole hydrochloride, allicin, pregelatinized starch, polyethylene glycol 4000, sodium carboxymethyl starch and microcrystalline cellulose which are prepared in the step (1) into a three-dimensional mixer for mixing, wherein the mixing speed is 40 rpm, the mixing time is 45min, adding the superfine silica gel powder prepared in the step (1), and continuously mixing for 12 min to obtain a mixed raw material;
(3) And (3) adding the mixed raw material obtained in the step (2) into a rotary tablet press for tabletting, adopting a circular punch with the diameter of 13mm, and obtaining levamisole hydrochloride tablets with the tabletting pressure of 22KN.
Comparative example 1:
comparative example 1 provides a method for preparing levamisole hydrochloride tablets, which differs from example 3 only in step (1): weighing the following raw materials in parts by weight: levamisole hydrochloride 50 mg, pregelatinized starch 160 mg, polyethylene glycol 4000 mg, aerosil 80 mg, carboxymethyl starch sodium 10mg, microcrystalline cellulose 225 mg. The rest is the same as in example 3, and will not be described again here.
Comparative example 2:
comparative example 2 provides a method for preparing levamisole hydrochloride tablets, which differs from example 2 only in the step (1): weighing the following raw materials in parts by weight: levamisole hydrochloride 30 mg, pregelatinized starch 180 mg, aerosil 75 mg, carboxymethyl starch sodium 15 mg, microcrystalline cellulose 300mg. The rest is the same as in example 2, and will not be described again here.
It should be noted that:
(1) In the step (1) of the above examples 1 to 3, comparative examples 1 and 2, before weighing the raw materials, levamisole hydrochloride, allicin, pregelatinized starch, polyethylene glycol 4000, sodium carboxymethyl starch and microcrystalline cellulose are respectively sieved by a 60-mesh sieve, and the micro silica gel is sieved by a 1000-mesh sieve, so as to further increase the mixing uniformity among the raw materials and improve the content uniformity of the main drug component. In the production process, the mesh number of the raw materials can be adjusted according to the actual requirements.
(2) In the above embodiments 1 to 3, in addition to polyethylene glycol 4000, other types of polyethylene glycol, such as polyethylene glycol 2000 and polyethylene glycol 6000, may be used.
(3) In the actual production process, the rotating speed of the three-dimensional mixer, the raw material mixing time, the type of the tablet press, the size of a punch of the rotary tablet press, the tablet pressing pressure and the like can be adjusted according to actual requirements.
For more intuitive comparison of the raw materials in examples 1 to 3, comparative example 1 and comparative example 2, the following table 1 is formed:
and (3) comparing experimental results:
according to the standard detection method, the levamisole hydrochloride tablets prepared in examples 1 to 3, comparative example 1 and comparative example 2 are respectively tested for tablet weight difference, hardness, friability, disintegration time and 45min dissolution rate, and the results are shown in the following table 2:
as can be seen from the data in the table 2, the levamisole hydrochloride tablets prepared by the scheme of the invention are obviously superior to those in the comparative examples 1 and 2 in terms of tablet weight difference, friability and hardness, wherein the tablet weight difference is reduced by more than 2.4%, the hardness is improved by more than 30N, the friability is reduced by more than 3%, no fragments and fragments exist, the hardness is improved by more than one time, the levamisole hydrochloride tablets have obvious quality advantages, meet the national standard and use requirements, and realize direct powder tabletting.
As shown in Table 1, the difference between the mass ratios of the raw materials of example 3 and comparative example 1 is that no garlicin is added in comparative example 1, and 100mg more microcrystalline cellulose is added; as shown by the physical property detection results of Table 2, the difference of tablet weight of comparative example 1 is increased by 2.4%, the hardness is reduced by 39N, the friability is increased by 3.2%, the disintegration time is shortened by 2.7min, and the dissolution rate is reduced by 13.1%.
As shown in Table 1, the difference between the mass ratios of the raw materials of example 2 and comparative example 2 is that the comparative example 2 does not add allicin and polyethylene glycol 4000 and adds more than 110mg of microcrystalline cellulose; as shown by the physical property detection results in Table 2, the weight difference of comparative example 2 is increased by 4.5%, the hardness is reduced by 37N, the friability is reduced by 3 pieces, the disintegration time is shortened by 1.4min, and the dissolution rate is reduced by 10%.
The invention provides levamisole hydrochloride tablets and a preparation method thereof, which creatively prepare levamisole hydrochloride tablets, have simple process, good absorption effect and convenient use, and fundamentally solve the technical problems that the existing levamisole hydrochloride suspension oral liquid has poor stability, is easy to generate precipitate, needs to be fully and uniformly mixed before use, is easy to cause excessive poisoning due to improper use, and is easy to deteriorate the suspension to cause degradation of effective components, thereby influencing the use effect.
In addition, most of the existing levamisole anthelmintic drugs in the market are injections and solutions, and are troublesome to use in animal production.
The above description is only exemplary of the present application and should not be taken as limiting the present application, as any modification, equivalent replacement, or improvement made within the spirit and principle of the present application should be included in the protection scope of the present application.
Claims (10)
1. The levamisole hydrochloride tablet is characterized by comprising the following raw materials in parts by weight: 25-50 parts of levamisole hydrochloride, 50-100 parts of allicin, 150-180 parts of pregelatinized starch, 50-75 parts of polyethylene glycol, 75-90 parts of micro-powder silica gel, 10-15 parts of carboxymethyl starch sodium and the balance of microcrystalline cellulose; and the total weight portion of the raw materials is 600 portions.
2. The levamisole hydrochloride tablet according to claim 1, which is characterized by comprising the following raw materials in parts by weight: 25 parts of levamisole hydrochloride, 70 parts of allicin, 150 parts of pregelatinized starch, 50 parts of polyethylene glycol, 90 parts of micro powder silica gel, 12 parts of carboxymethyl starch sodium and 203 parts of microcrystalline cellulose.
3. The levamisole hydrochloride tablet according to claim 1, which is characterized by comprising the following raw materials in parts by weight: 30 parts of levamisole hydrochloride, 50 parts of allicin, 180 parts of pregelatinized starch, 60 parts of polyethylene glycol, 75 parts of micro-powder silica gel, 15 parts of carboxymethyl starch sodium and 190 parts of microcrystalline cellulose.
4. The levamisole hydrochloride tablet according to claim 1, which is characterized by comprising the following raw materials in parts by weight: 50 parts of levamisole hydrochloride, 100 parts of allicin, 160 parts of pregelatinized starch, 75 parts of polyethylene glycol, 80 parts of micro-powder silica gel, 10 parts of carboxymethyl starch sodium and 125 parts of microcrystalline cellulose.
5. The levamisole hydrochloride tablet according to any one of claims 1 to 4, wherein the mesh number of levamisole hydrochloride, allicin, pregelatinized starch, polyethylene glycol, sodium carboxymethyl starch and microcrystalline cellulose is not less than 60 meshes, and the mesh number of aerosil is not less than 1000 meshes.
6. The levamisole hydrochloride tablet according to any one of claims 1 to 4, wherein the polyethylene glycol is one of polyethylene glycol 2000, polyethylene glycol 4000 and polyethylene glycol 6000.
7. A process for the preparation of levamisole hydrochloride tablets according to any one of claims 1 to 4, characterized in that it comprises the following steps:
(1) Weighing various raw materials according to parts by weight for later use;
(2) Respectively adding levamisole hydrochloride, allicin, pregelatinized starch, polyethylene glycol, sodium carboxymethyl starch and microcrystalline cellulose weighed in the step (1) into a three-dimensional mixer for mixing, adding the micro-powder silica gel weighed in the step (1) after mixing for a period of time, continuously mixing, and uniformly mixing to obtain a mixed raw material;
(3) And (3) adding the mixed raw material obtained in the step (2) into a tablet press for tabletting to obtain the levamisole hydrochloride tablet.
8. The method for preparing the levamisole hydrochloride tablet according to claim 7, wherein in the step (1), the levamisole hydrochloride, the allicin, the pregelatinized starch, the polyethylene glycol, the sodium carboxymethyl starch and the microcrystalline cellulose are respectively sieved by a 60-mesh sieve, and the micro silica gel is sieved by a 1000-mesh sieve before the raw materials are respectively weighed according to the parts by weight.
9. The method for preparing levamisole hydrochloride tablets according to claim 7, wherein in the step (2), the rotating speed of the three-dimensional mixer is 30-40 rpm, levamisole hydrochloride, allicin, pregelatinized starch, polyethylene glycol, sodium carboxymethyl starch and microcrystalline cellulose are respectively added into the three-dimensional mixer to be mixed, and the mixing time is 35-50 min; adding the micro silica gel powder and continuously mixing for 10-15 min to obtain the mixed raw material.
10. The method for preparing levamisole hydrochloride tablets according to claim 7, wherein in the step (3), the tablet press is a rotary tablet press, and the tablet pressing pressure is 18-22 KN.
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| CN202310009476.0A CN115887451B (en) | 2023-01-05 | 2023-01-05 | Levamisole hydrochloride tablet and preparation method thereof |
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| CN202310009476.0A CN115887451B (en) | 2023-01-05 | 2023-01-05 | Levamisole hydrochloride tablet and preparation method thereof |
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Citations (5)
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| CN101601670A (en) * | 2009-06-30 | 2009-12-16 | 青岛康地恩药业有限公司 | A kind of compound niclosamide parasite-expelling tablet used for pet and preparation method thereof |
| WO2010000207A1 (en) * | 2008-07-03 | 2010-01-07 | Yao Ying | A natural allicin tablet and preparation method thereof |
| CN105379966A (en) * | 2015-10-20 | 2016-03-09 | 李德昌 | Water-soluble allicin mixture and preparation method thereof |
| CN106420835A (en) * | 2016-12-23 | 2017-02-22 | 郑州莉迪亚医药科技有限公司 | Pharmaceutical composition for curing dental ulcer and preparation method thereof |
| CN107812002A (en) * | 2017-11-24 | 2018-03-20 | 董方 | It is a kind of to be used for ornamental fish bacterium, virus, the medicine of parasite complex treatment |
-
2023
- 2023-01-05 CN CN202310009476.0A patent/CN115887451B/en active Active
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010000207A1 (en) * | 2008-07-03 | 2010-01-07 | Yao Ying | A natural allicin tablet and preparation method thereof |
| US20110212082A1 (en) * | 2008-07-03 | 2011-09-01 | Ying Yao | Method for producing tablet comprising natural allicin |
| CN101601670A (en) * | 2009-06-30 | 2009-12-16 | 青岛康地恩药业有限公司 | A kind of compound niclosamide parasite-expelling tablet used for pet and preparation method thereof |
| CN105379966A (en) * | 2015-10-20 | 2016-03-09 | 李德昌 | Water-soluble allicin mixture and preparation method thereof |
| CN106420835A (en) * | 2016-12-23 | 2017-02-22 | 郑州莉迪亚医药科技有限公司 | Pharmaceutical composition for curing dental ulcer and preparation method thereof |
| CN107812002A (en) * | 2017-11-24 | 2018-03-20 | 董方 | It is a kind of to be used for ornamental fish bacterium, virus, the medicine of parasite complex treatment |
Non-Patent Citations (1)
| Title |
|---|
| MOHAMED, ESSAM ET AL.: "Modulatory effects of levamisole and garlic oil on the immune response of Wistar rats: Biochemical, immunohistochemical, molecular and immunological study" * |
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