CN115887451B - Levamisole hydrochloride tablet and preparation method thereof - Google Patents
Levamisole hydrochloride tablet and preparation method thereof Download PDFInfo
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- CN115887451B CN115887451B CN202310009476.0A CN202310009476A CN115887451B CN 115887451 B CN115887451 B CN 115887451B CN 202310009476 A CN202310009476 A CN 202310009476A CN 115887451 B CN115887451 B CN 115887451B
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Abstract
The invention provides a levamisole hydrochloride tablet and a preparation method thereof, which solve the technical problems that the existing levamisole hydrochloride suspension oral liquid has poor stability, is easy to generate precipitation, needs to be fully and uniformly mixed before use, is easy to cause excessive poisoning due to improper use, and is easy to deteriorate to cause degradation of active ingredients 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 garlicin, 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 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 a levamisole hydrochloride tablet and a preparation method thereof.
Background
The levamisole hydrochloride is hydrochloride of levamisole, is a broad-spectrum, high-efficiency and low-toxicity nematicide commonly used in veterinary clinical and animal production, and has curative effects on gastrointestinal nematodes, adult pulmonary nematodes and larvae of various animals. Levamisole also has immunoregulatory and immunostimulating effects, and has good therapeutic effects on roundworm, hookworm, enterobiasis and fecal strongylosis.
The Chinese patent application publication No. CN105769881A discloses a veterinary compound levamisole hydrochloride suspension oral liquid and a preparation method thereof, wherein the compound levamisole hydrochloride suspension oral liquid consists of levamisole hydrochloride, niclosamide, cobalt sulfate, agar powder, a suspending agent, a wetting agent, disodium ethylenediamine tetraacetate, a surfactant and the like. Based on levamisole hydrochloride and niclosamide, wetting with wetting agent, utilizing the dispersion characteristic of surfactant and the suspension assisting characteristic of suspending agent, forming stable and uniform dispersion system under the action of mechanical shearing force to prepare a compound suspension oral liquid, and expelling parasites from cattle, sheep and the like through the ways of mixing materials or mixing drinking water and the like. However, the compound levamisole hydrochloride suspension oral liquid is liquid suspension, has the problems of poor stability, easy generation of precipitation, sufficient and uniform mixing before use, improper use, easy excessive poisoning, easy degradation of active ingredients caused by suspension deterioration, influence on the use effect and the like. The technical problem needs to be solved.
Disclosure of Invention
The invention aims to solve the defects of the technology and provide the levamisole hydrochloride tablet and the preparation method thereof, which have simple process, good absorption effect and convenient use.
The invention provides levamisole hydrochloride tablets, which comprise the following raw materials in parts by weight: 25-50 parts of levamisole hydrochloride, 50-100 parts of garlicin, 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 of the raw materials is 600 parts.
Preferably, the composite material comprises the following raw materials in parts by weight: 25 parts of levamisole hydrochloride, 70 parts of garlicin, 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 composite material comprises the following raw materials in parts by weight: 30 parts of levamisole hydrochloride, 50 parts of garlicin, 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 composite material comprises the following raw materials in parts by weight: 50 parts of levamisole hydrochloride, 100 parts of garlicin, 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 levamisole hydrochloride, garlicin, pregelatinized starch, polyethylene glycol, carboxymethyl starch sodium and microcrystalline cellulose is more than or equal to 60 meshes, and the superfine silica 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 according to any one of the above, which comprises the following steps:
(1) Weighing various raw materials according to parts by weight respectively for standby;
(2) Adding levamisole hydrochloride, garlicin, pregelatinized starch, polyethylene glycol, carboxymethyl starch sodium and microcrystalline cellulose which are prepared in the step (1) into a three-dimensional mixer respectively for mixing, adding the micro powder silica gel prepared in the step (1) for continuous mixing after mixing for a period of time, 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), before the raw materials are respectively weighed according to the parts by weight, levamisole hydrochloride, garlicin, pregelatinized starch, polyethylene glycol, carboxymethyl starch sodium and microcrystalline cellulose are respectively sieved by a 60-mesh sieve, and micro powder silica gel is sieved by a 1000-mesh sieve.
Preferably, in the step (2), the rotating speed of the three-dimensional mixer is 30-40 rpm, and levamisole hydrochloride, garlicin, pregelatinized starch, polyethylene glycol, carboxymethyl starch sodium and microcrystalline cellulose are respectively added into the three-dimensional mixer for mixing for 35-50 min; adding the superfine silica 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 is 18-22 KN.
The raw materials play the following roles in the levamisole hydrochloride tablet and the preparation process thereof:
levamisole hydrochloride: the active ingredients are used as raw material medicines;
allicin: the drug effect and the adhesive effect are improved;
pregelatinized starch: binding agent and synergistic lubrication;
polyethylene glycol: the adhesive and the drug effect are improved;
micro silica gel: lubricant and glidant action;
sodium carboxymethyl starch: a disintegrant effect;
microcrystalline cellulose: the filler acts.
The beneficial effects of the invention are as follows: the invention provides a levamisole hydrochloride tablet and a preparation method thereof, which creatively prepares the levamisole hydrochloride tablet, has simple process, good absorption effect and convenient use, and fundamentally solves the technical problems that the existing levamisole hydrochloride suspension oral liquid has poor stability, is easy to generate precipitation, needs to be fully and uniformly mixed before use, is easy to cause excessive poisoning due to improper use, and is easy to deteriorate to cause degradation of active ingredients and influence the use effect.
Detailed Description
In order to make the technical problems, technical schemes and beneficial effects to be solved by the present application more clear, the present application is further described in detail below with reference to examples and comparative examples. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the present application. The method used in the invention is a conventional method unless specified otherwise; the raw materials and devices used, unless otherwise specified, are all conventional commercial products.
Example 1:
the invention provides a preparation method of levamisole hydrochloride tablets, which comprises the following steps:
(1) Weighing various raw materials according to parts by weight: levamisole hydrochloride 25 mg, garlicin 70 mg, pregelatinized starch 150 mg, polyethylene glycol 4000 50 mg, micro powder silica gel 90 mg, carboxymethyl starch sodium 12 mg and microcrystalline cellulose 203 mg for later use;
(2) Adding levamisole hydrochloride, garlicin, pregelatinized starch, polyethylene glycol 4000, carboxymethyl starch sodium and microcrystalline cellulose which are prepared in the step (1) into a three-dimensional mixer respectively for mixing, wherein the mixing speed is 35 rpm, the mixing time is 35 min, and then adding the superfine silica gel powder prepared in the step (1) for continuous mixing for 10 min to obtain a mixed raw material;
(3) And (3) adding the mixed raw materials obtained in the step (2) into a rotary tablet press for tabletting, wherein a round punch with the diameter of 13mm is adopted, and the tabletting pressure is 18 KN, so that the levamisole hydrochloride tablet is finally obtained.
Example 2:
the invention provides a preparation method of levamisole hydrochloride tablets, which comprises the following steps:
(1) Weighing various raw materials according to parts by weight: levamisole hydrochloride 30 mg, garlicin 50 mg, pregelatinized starch 180 mg, polyethylene glycol 4000 60 mg, micro powder silica gel 75 mg, carboxymethyl starch sodium 15 mg and microcrystalline cellulose 190 mg for later use;
(2) Adding levamisole hydrochloride, garlicin, pregelatinized starch, polyethylene glycol 4000, carboxymethyl starch sodium and microcrystalline cellulose which are prepared in the step (1) into a three-dimensional mixer respectively for mixing, wherein the mixing speed is 30 rpm, the mixing time is 50min, and then adding the superfine silica gel powder prepared in the step (1) for continuous mixing for 15min to obtain a mixed raw material;
(3) And (3) adding the mixed raw materials obtained in the step (2) into a rotary tablet press for tabletting, wherein a round punch with the diameter of 13mm is adopted, and the tabletting pressure is 20 KN, so that the levamisole hydrochloride tablet is finally obtained.
Example 3:
the invention provides a preparation method of levamisole hydrochloride tablets, which comprises the following steps:
(1) Weighing various raw materials according to parts by weight: levamisole hydrochloride 50 mg, garlicin 100mg, pregelatinized starch 160 mg, polyethylene glycol 4000 75 mg, micro powder silica gel 80 mg, carboxymethyl starch sodium 10mg and microcrystalline cellulose 125 mg for standby;
(2) Adding levamisole hydrochloride, garlicin, pregelatinized starch, polyethylene glycol 4000, carboxymethyl starch sodium and microcrystalline cellulose which are prepared in the step (1) into a three-dimensional mixer respectively for mixing at a mixing speed of 40rpm for 45min, and adding the superfine silica powder prepared in the step (1) for continuously mixing for 12 min to obtain a mixed raw material;
(3) And (3) adding the mixed raw materials obtained in the step (2) into a rotary tablet press for tabletting, wherein a round punch with the diameter of 13mm is adopted, and the tabletting pressure is 22KN, so that the levamisole hydrochloride tablet is finally obtained.
Comparative example 1:
comparative example 1 provides a method for preparing levamisole hydrochloride tablet, which differs from example 3 only in step (1): weighing various raw materials according to parts by weight: levamisole hydrochloride 50 mg, pregelatinized starch 160 mg, polyethylene glycol 4000 75 mg, micro silica gel 80 mg, carboxymethyl starch sodium 10mg and microcrystalline cellulose 225 mg. The remainder is the same as in example 3 and will not be described here.
Comparative example 2:
comparative example 2 provides a method for preparing levamisole hydrochloride tablet, which differs from example 2 only in step (1): weighing various raw materials according to parts by weight: levamisole hydrochloride 30 mg, pregelatinized starch 180 mg, micro silica gel 75 mg, carboxymethyl starch sodium 15 mg and microcrystalline cellulose 300mg. The remainder is the same as in example 2 and will not be described here.
It should be noted that:
(1) In the above examples 1 to 3, comparative example 1 and comparative example 2, in step (1), before weighing the various raw materials, levamisole hydrochloride, allicin, pregelatinized starch, polyethylene glycol 4000, carboxymethyl starch sodium, microcrystalline cellulose were sieved respectively by a 60 mesh sieve, and micro powder silica gel was sieved by a 1000 mesh sieve, in order to further increase the mixing uniformity between the raw materials and improve the content uniformity of the main drug components. In the production process, the mesh number of the raw materials can be adjusted according to actual requirements.
(2) In the above examples 1 to 3, polyethylene glycol 4000 may be used, and other types of polyethylene glycol such as polyethylene glycol 2000, polyethylene glycol 6000, and the like may be used.
(3) In the actual production process, the rotating speed of the three-dimensional mixer, the mixing time of raw materials, the type of the tablet press, the size of a punch of the rotary tablet press, the size of tablet press pressure and the like can be adjusted according to actual requirements.
For more visual comparison, the following table 1 is now formed for each raw material mass ratio of examples 1 to 3, comparative example 1, and comparative example 2:
comparison of experimental results:
the levamisole hydrochloride tablets prepared in examples 1 to 3, comparative example 1 and comparative example 2 were respectively tested for tablet weight difference, hardness, friability, disintegration time, 45min dissolution according to standard test methods, and the results are shown in table 2 below:
as can be seen from the data in the table 2, the levamisole hydrochloride tablet prepared by the scheme of the invention is obviously superior to comparative examples 1 and 2 in the aspects 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 are generated, the hardness is improved by more than one time, the levamisole hydrochloride tablet has obvious quality advantages, the national standard and the use requirement are met, and the direct tablet compression of powder is realized.
As shown in Table 1, the difference between the mass ratios of the raw materials in example 3 and comparative example 1 is that no allicin was added in comparative example 1, and 100mg of microcrystalline cellulose was added in addition; as shown by the physical property detection results in Table 2, the weight difference of the tablets of comparative example 1 was increased by 2.4%, the hardness was reduced by 39N, the friability was increased by 3.2%, the disintegration time was shortened by 2.7min, and the dissolution rate was 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 no allicin and polyethylene glycol 4000 were added in comparative example 2, and 110mg of microcrystalline cellulose was added in more; as shown by the physical property detection results in Table 2, the weight difference of the tablets of comparative example 2 was increased by 4.5%, the hardness was reduced by 37N, the friability was 3 tablets, the disintegration time was shortened by 1.4min, and the dissolution rate was reduced by 10%.
The invention provides a levamisole hydrochloride tablet and a preparation method thereof, which creatively prepares the levamisole hydrochloride tablet, has simple process, good absorption effect and convenient use, and fundamentally solves the technical problems that the existing levamisole hydrochloride suspension oral liquid has poor stability, is easy to generate precipitation, needs to be fully and uniformly mixed before use, is easy to cause excessive poisoning due to improper use, and is easy to deteriorate to cause degradation of active ingredients and influence the use effect.
In addition, the levamisole anthelmintic drug is mostly injection and solution in the market, and is quite troublesome to use in livestock production, and the levamisole hydrochloride tablet and the preparation method thereof are developed and provided.
The foregoing description of the preferred embodiment of the present invention is not intended to limit the invention to the particular form disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.
Claims (8)
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 garlicin, 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 part of the raw materials is 600 parts;
the polyethylene glycol is one of polyethylene glycol 2000, polyethylene glycol 4000 and polyethylene glycol 6000;
the preparation method of the levamisole hydrochloride tablet comprises the following steps:
(1) Weighing various raw materials according to parts by weight respectively for standby;
(2) Respectively adding levamisole hydrochloride, garlicin, pregelatinized starch, polyethylene glycol, carboxymethyl starch sodium and microcrystalline cellulose weighed in the step (1) into a three-dimensional mixer for mixing, adding the superfine silica powder weighed in the step (1) after mixing for a period of time, and continuously mixing, so as 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 the levamisole hydrochloride tablet.
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 garlicin, 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 garlicin, 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 garlicin, 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 of any of claims 1-4, wherein the mesh size of levamisole hydrochloride, garlicin, pregelatinized starch, polyethylene glycol, carboxymethyl starch sodium, microcrystalline cellulose is greater than or equal to 60 mesh, and the micro silica gel is greater than or equal to 1000 mesh.
6. The method for preparing the levamisole hydrochloride tablet according to claim 1, wherein in the step (1), before the raw materials are respectively weighed according to parts by weight, levamisole hydrochloride, garlicin, pregelatinized starch, polyethylene glycol, sodium carboxymethyl starch and microcrystalline cellulose are respectively sieved by a 60-mesh sieve, and superfine silica powder is sieved by a 1000-mesh sieve.
7. The method for preparing the levamisole hydrochloride tablet according to claim 1, wherein in the step (2), the rotation speed of the three-dimensional mixer is 30-40 rpm, and levamisole hydrochloride, garlicin, pregelatinized starch, polyethylene glycol, carboxymethyl starch sodium and microcrystalline cellulose are respectively added into the three-dimensional mixer for mixing for 35-50 min; adding the superfine silica powder, and continuously mixing for 10-15 min to obtain the mixed raw material.
8. A method for preparing levamisole hydrochloride tablets according to claim 1, wherein in the step (3), the tablet press is a rotary tablet press with a tabletting pressure of 18-22 KN.
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CN101342148B (en) * | 2008-07-03 | 2012-09-05 | 姚英 | Quick-effective antimicrobial, anti-inflammation, antiviral hyperconcentrated natural allicin tablet and preparation method thereof |
CN101601670B (en) * | 2009-06-30 | 2014-06-04 | 青岛蔚蓝生物股份有限公司 | Compound niclosamide parasite-expelling tablet used for pet and preparation method thereof |
CN105379966B (en) * | 2015-10-20 | 2017-06-27 | 李德昌 | A kind of 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 |
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