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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AI-Extracted 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 preparat...
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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.

Application Domain

Technology Topic

Proton pumpSustained release pellets +7

Image

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

Examples

  • Experimental program(5)
  • Effect test(4)

Example Embodiment

[0068] The preparation method of the compound capsule containing aspirin and proton pump inhibitor of the present invention includes the following steps:
[0069] The first part: Mix aspirin, stabilizer, porogen and framework material according to the prescription ratio, add appropriate amount of binder to prepare soft material, extrude it through extruder, and place the bar in the spheronizer to spheronize. The rounded pellets are heat-treated and dried, and then sieved for use. The HPMC solution is prepared and the anti-sticking agent and the sunscreen are added according to the prescription ratio to prepare the isolation layer coating liquid, and the prepared aspirin pill core is placed in a fluidized bed to coat the isolation coating. Prepare the enteric coating liquid according to the prescription ratio and wrap it outside the isolation coating.
[0070] The second part: Mix the prescribed amount of proton pump inhibitor, stabilizer and filler uniformly, prepare proton pump inhibitor drug-loaded pellets in a centrifugal granulator with a binder, and pass the prepared drug-loaded pellets After heat treatment and drying, sieving is reserved for use. The HPMC solution is prepared and the anti-sticking agent and the sunscreen agent are added according to the prescription ratio to prepare the isolation layer coating liquid, and the prepared proton pump inhibitor-containing pellet core is placed in a fluidized bed to coat the isolation coating. Prepare the enteric coating liquid according to the prescription ratio and wrap it outside the isolation coating.
[0071] The third part: Mix the proton pump inhibitor, stabilizer, porogen and framework material according to the prescription ratio, add an appropriate amount of absolute ethanol as a binder to prepare a soft material, extrude it through an extruder, and place the strip Round in the round machine. The rounded pellets are heat-treated and dried, and then sieved for use. The HPMC solution is prepared and the anti-sticking agent and the sunscreen agent are added according to the prescription ratio to prepare the isolation layer coating liquid, and the prepared proton pump inhibitor-containing pellet core is placed in a fluidized bed to coat the isolation coating. Prepare the enteric coating liquid according to the prescription ratio and wrap it outside the isolation coating.
[0072] Finally, these three parts are filled into the gelatin capsule shell with a capsule filler according to an appropriate ratio to obtain a compound capsule containing aspirin and a proton pump inhibitor.

Example Embodiment

[0074] Example 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 according to the prescription ratio, add 10% starch slurry to prepare soft material, extrude it through an extruder, and place the strips in a spheronizer to round. The rounded pellets are dried in an oven and sieved for use. Prepare HPMC solution (100 mL) and add talc powder and titanium dioxide according to the prescription ratio to prepare isolation layer coating liquid, and place the prepared aspirin-containing pill core in a fluidized bed to coat the isolation coating. The enteric coating solution (50 mL) was prepared according to the prescription ratio and wrapped outside the isolation coating.
[0084] ②Mix the prescription amount of pantoprazole, sodium bicarbonate, and sucrose evenly, and prepare pantoprazole drug-loaded pellets with hydroxypropylmethyl cellulose in a centrifugal granulator. The prepared drug-loaded pellets After drying in the oven, sieving for use. Prepare HPMC solution (100 mL) according to the prescription and add talc powder and titanium dioxide to prepare isolation layer coating liquid, and place the prepared pantoprazole-containing pellet core in a fluidized bed to coat isolation coating. The enteric coating solution (50 mL) was prepared according to the prescription ratio and wrapped outside the isolation coating.
[0085] ③Pantoprazole, sodium bicarbonate, lactose, stearic acid and ethyl cellulose are mixed uniformly according to the prescription ratio, and povidone is added to prepare soft material, extruded by an extruder, and the strips are placed in a spheronizer Spheronization. The rounded pellets are dried in an oven and sieved for use. Prepare HPMC solution (100 mL) and add talc and titanium dioxide according to the prescription ratio to prepare isolation layer coating liquid, and place the prepared pantoprazole-containing pellet core in a fluidized bed to coat isolation coating. The enteric coating solution (50 mL) was prepared according to the prescription ratio and wrapped outside the isolation coating.
[0086] ④ Weigh about 271 mg of the first part, about 40 mg of the second part, and about 150 mg of the third part, evenly mixed and filled into the gelatin capsule shell to prepare a compound capsule containing aspirin and pantoprazole.

Example Embodiment

[0087] Example 2
[0088] first part
[0089]
[0090]
[0091] the second part
[0092]
[0093] the third part
[0094]
[0095]
[0096] The preparation methods ①, ②, and 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, and fill them in a gelatin capsule shell after uniformly mixing to prepare a compound capsule containing aspirin and esomeprazole.
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Description & Claims & Application Information

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