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A kind of stable i crystal form clopidogrel bisulfate tablet and preparation method thereof

A technology of clopidogrel hydrogen sulfate tablet and clopidogrel hydrogen sulfate, applied in the field of medicine, can solve problems such as problems affecting drug effectiveness and safety, and achieve the effect of ensuring safety and effectiveness

Active Publication Date: 2017-01-18
ZHEJIANG JINHUA CONBA BIO PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Drug dissolution affects the effectiveness and safety of drugs in clinical application. When developing I crystalline clopidogrel bisulfate tablets, it is also necessary to solve the problem of consistency between its dissolution behavior in various media and marketed preparations through prescriptions, and this A problem that has not been mentioned in the above-mentioned published patents

Method used

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  • A kind of stable i crystal form clopidogrel bisulfate tablet and preparation method thereof
  • A kind of stable i crystal form clopidogrel bisulfate tablet and preparation method thereof
  • A kind of stable i crystal form clopidogrel bisulfate tablet and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044]

[0045] 1. Pregelatinized starch, colloidal silicon dioxide, 971P passed through a 50-mesh sieve for later use;

[0046] 2. Dry the above-mentioned excipients that have been sieved at 100°C for 1 hour to remove moisture, and check that the moisture content is less than 3%.

[0047] 3. The I crystal form clopidogrel bisulfate, spray-dried lactose monohydrate, 90. Mix the pregelatinized starch evenly.

[0048] 4. Take the above-mentioned part of the material and colloidal silica through a 50-mesh sieve and mix evenly, and then add the sieved material back to the mixed material in the second step and mix evenly.

[0049] 5. Add the prescribed amount of sodium stearate fumarate and talcum powder, mix evenly again, and press into tablets.

[0050] 6. Remove the fine powder from the tablet core and carry out film coating to obtain the finished product.

Embodiment 2

[0052]

[0053] 1. Pass the prescribed amount of pregelatinized starch, colloidal silicon dioxide, and HPC-SL through an 80-mesh sieve for later use;

[0054] 2. Dry the above-mentioned excipients that have been sieved at 60°C for 4 hours to remove moisture, and check that the moisture content is less than 3%.

[0055] 3. The I crystal form clopidogrel bisulfate of prescription amount, 80. Mix the pregelatinized starch evenly.

[0056] 4. Take the above-mentioned part of the material and colloidal silica through a 60-mesh sieve and mix evenly, and then add the sieved material back to the mixed material in the second step and mix evenly.

[0057] 5. Add the prescribed amount of sodium stearate fumarate and talcum powder, mix evenly again, and press into tablets.

[0058] 6. Remove the fine powder from the tablet core and carry out film coating to obtain the finished product.

Embodiment 3

[0060]

[0061] 1. Pass the prescribed amount of pregelatinized starch, colloidal silicon dioxide, and HPC-SSL through a 60-mesh sieve for later use;

[0062] 2. Dry the above-mentioned excipients at 80°C for 2 hours to remove moisture, and check that the moisture content is less than 3%;

[0063] 3. Mix the prescribed amount of clopidogrel bisulfate in crystal form I, spray-dried lactose monohydrate, microcrystalline cellulose, pregelatinized starch, and HPC-SSL.

[0064] 4. Take the above-mentioned part of the material and colloidal silicon dioxide and pass through a 40-mesh sieve to mix evenly, and then add the sieved material back to the mixed material in the second step and mix evenly.

[0065] 5. Add the prescribed amount of sodium stearate fumarate and talcum powder, mix evenly again, and press into tablets.

[0066] 6. Remove the fine powder from the tablet core and carry out film coating to obtain the finished product.

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Abstract

The invention relates to the technical field of medicines and discloses a stable I-crystal-form clopidogrel hydrogen sulfate tablet and a preparation method thereof. The provided I-crystal-form clopidogrel hydrogen sulfate tablet contains a pH-sensitive binder, wherein the digestion behaviors of the binder in media with different pH values are consistent with those of market products, and the stability of the binder in production and storage is good, so that the clinical effectiveness and the safety of the drug during taking are guaranteed. Secondly, the I-crystal-form clopidogrel hydrogen sulfate tablet provided by the invention is simple in preparation process, so that the drug production cost is lowered, and a sticking phenomenon that appears in a tabletting process is also solved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a stable I-crystal form clopidogrel bisulfate tablet and a preparation method thereof. Background technique [0002] Clopidogrel bisulfate (clopidogrel bisulfate), a thienopyridine derivative, is a new generation of platelet inhibitors that can selectively inhibit the binding of adenosine diphosphate (ADP) to its platelet receptor and the secondary ADP-mediated Activation of the glycoprotein GP111b / 111a complex, thus inhibiting platelet aggregation. In addition, clopidogrel bisulfate can also inhibit platelet aggregation induced by other agonists by blocking platelet activation caused by released ADP. Compared with other platelet inhibitors, clopidogrel bisulfate has the advantages of strong curative effect, low cost, and few side effects. After more than ten years of extensive use, this product is currently the first-line drug for the prevention and treatment of a...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K31/4365A61K47/38A61K47/32A61P7/02
Inventor 胡江宁金庆平徐洪明陈梁吴华铃何厚洪徐勇陈菲菲
Owner ZHEJIANG JINHUA CONBA BIO PHARM CO LTD
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