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Compound capsule containing aspirin and proton pump inhibitor

A technology of proton pump inhibitors and aspirin, which is applied in the field of compound capsules containing aspirin and proton pump inhibitors, can solve the problems of instability of proton pump inhibitors, loss of protection of proton pump inhibitors in gastrointestinal mucosa, and short half-life, etc. Achieve the effect of being conducive to industrialized large-scale production, convenient for quality control, and simple process

Inactive Publication Date: 2015-12-09
杭州成邦医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] ②Proton pump inhibitors are very unstable in acidic gastric juice, and are easily destroyed by contact with gastric acid, but their absorption site is in the intestinal tract. Therefore, for proton pump inhibitors, they also need to be prepared into enteric-coated preparations
However, the half-life of proton pump inhibitors is short, with an average of 0.7-1.6 hours, while the half-life of aspirin is about 4 hours, which will make the gastrointestinal mucosa lose the protection of proton pump inhibitors when aspirin takes effect in the later stage.

Method used

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  • Compound capsule containing aspirin and proton pump inhibitor
  • Compound capsule containing aspirin and proton pump inhibitor
  • Compound capsule containing aspirin and proton pump inhibitor

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preparation example Construction

[0068] The preparation method of the compound capsule containing aspirin and proton pump inhibitor of the present invention comprises the following steps:

[0069] The first part: Mix aspirin, stabilizer, porogen and skeleton material according to the prescription ratio, add an appropriate amount of adhesive to prepare a soft material, extrude through an extruder, and place the strip in a spheronizer to spheroidize. After the spheronized pellets are heat-treated and dried, they are sieved for later use. Prepare HPMC solution and add anti-adhesive agent and opacifier according to the prescription ratio to prepare a coating solution for the isolation layer, and place the prepared aspirin pill core in a fluidized bed to coat the isolation coating. Prepare the enteric coating solution according to the prescription ratio and wrap it on the above-mentioned isolation coat.

[0070] The second part: mix the proton pump inhibitor, stabilizer and filler of the prescribed amount evenly,...

Embodiment 1

[0075] first part

[0076]

[0077]

[0078] the second part

[0079]

[0080] the third part

[0081]

[0082] Preparation:

[0083] ① Mix aspirin, tartaric acid, lactose, stearic acid and ethyl cellulose evenly according to the prescription ratio, add 10% starch slurry to prepare a soft material, extrude through an extruder, and place the strip in a spheronizer to spheroidize. The pellets after spheronization are dried in an oven and sieved for later use. Prepare HPMC solution (100mL) and add talcum powder and titanium dioxide according to the prescription ratio to prepare the isolation layer coating liquid, and place the prepared aspirin-containing pill core in a fluidized bed to coat the isolation coat. Prepare the enteric coating solution (50 mL) according to the prescription ratio and wrap it on the above-mentioned isolation coat.

[0084] 2. Pantoprazole, sodium bicarbonate, and sucrose are mixed homogeneously with prescription quantity, prepare pantopra...

Embodiment 2

[0088] first part

[0089]

[0090]

[0091] the second part

[0092]

[0093] the third part

[0094]

[0095]

[0096] Preparation method ①, ②, ③ are the same as in Example 1.

[0097] Preparation method ④: Weigh about 700 mg of the first part, about 40 mg of the second part, and about 150 mg of the third part, mix them evenly, and fill them in gelatin capsule shells to obtain compound capsules containing aspirin and esomeprazole.

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Abstract

The invention discloses a compound capsule containing aspirin and a proton pump inhibitor. According to the compound capsule, the proton pump inhibitor with certain concentration can be provided first, synergetic release of the aspirin and the proton pump inhibitor can be controlled, and meanwhile, the stability and safety of a preparation can be ensured. Besides a gelatin capsule shell, the compound capsule mainly comprises three parts, wherein the first part is an aspirin enteric-coated and sustained-release pellet, the second part is a proton pump inhibitor enteric-coated and immediate-release pellet, and the third part is a proton pump inhibitor enteric-coated and sustained-release pellet. The aspirin and the proton pump inhibitor exist in two preparation units respectively, and therefore quality control in production is facilitated. Furthermore, the technology is simple, and industrial production is facilitated.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a compound capsule containing aspirin and proton pump inhibitors. Background technique [0002] Since low-dose (30-325mg / day) aspirin was first confirmed to prevent and treat thrombosis in 1977, the results of more than 300 large-scale randomized clinical studies around the world have established its role in the prevention and treatment of ischemic stroke and cardiovascular events. cornerstone status. And from the perspective of economic benefits, it is the cheapest of various cardiovascular disease prevention and treatment drugs. However, the gastrointestinal side effects associated with aspirin cannot be ignored, especially ulcers and bleeding, which will cause patients to discontinue treatment. Therefore, it is very important to control gastrointestinal side effects while using low-dose aspirin for long-term antithrombotic of. [0003] Proton pump inhibitors, incl...

Claims

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Application Information

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IPC IPC(8): A61K45/00A61K9/52A61K9/62A61K31/616A61K31/4439A61P7/02A61P1/04
Inventor 戈震
Owner 杭州成邦医药科技有限公司
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