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Floating type pulse release capsule in stomach

A technology of pulse release and gastric flotation, applied in the field of medicine, can solve the problems of large difference in time lag of drug release in vivo and inability to guarantee the bioavailability of preparations.

Inactive Publication Date: 2004-02-11
SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For the above-mentioned pulse preparations, if the pulse "time lag" is too long, it will lead to tablet discharge (the drug is not released, the tablet has been excreted) or the difference in the release time lag in the body is large. Therefore, the bioavailability of the preparation cannot be guaranteed.

Method used

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  • Floating type pulse release capsule in stomach
  • Floating type pulse release capsule in stomach
  • Floating type pulse release capsule in stomach

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1, Preparation of Verapamil Gastric Floating Pulse Release Capsules

[0026] a) Preparation of capsules

[0027] 11g of ethyl cellulose (EC) was dissolved in 100ml of dichloromethane solution, and 3ml of castor oil was used as a plasticizer to prepare an EC solution with a mass concentration of 11%, and then a capsule body was made in a No. 0 capsule mold.

[0028] b) Preparation of drugs

[0029] After mixing 40g verapamil with 10g lactose and 15g sodium carboxymethyl starch auxiliary materials, use 5% polyvinylpyrrolidone ethanol solution as a binding agent to make a soft material, pass through a 16-mesh sieve for granulation, and dry at 55°C for 45 Minutes, sieve and granulate, add 0.5g magnesium stearate and mix well, punch with a standard diameter of 6 mm, press each tablet containing 40mg verapamil, a total of 1000 tablets.

[0030] c) Preparation of Capsule Plugs

[0031] Mix 60mg of low-viscosity hydroxypropylmethylcellulose (HPMC) with 40mg of lactos...

Embodiment 2

[0034] Embodiment 2, preparation of the capsule plug of gastric floating pulse release capsule

[0035] According to the preparation method of embodiment 1c) capsule plug, prepare erodible capsule plug with hydroxypropyl methylcellulose HPMC-E5 and hydroxypropyl methylcellulose HPMC-E50 and lactose respectively, and each weight is 100mg, and its composition And the control time (delay) is as follows:

[0036] Table 1. Composition and time lag of time-controlled capsule plugs

[0037] No. HPMC-E50 HPMC-E5 Lactose Time lag (min)

[0038] 1 12% 88% 196

[0039] 2 18% 82% 247

[0040] 3 20% 80% 305

[0041] 4 60% 40% 186

[0042] 5 70% 30% 239

[0043] 6 99% 1% 300

Embodiment 3

[0044] Embodiment 3, capsule pulse release test of the present invention

[0045] For the three capsule plugs numbered 4, 5, and 6 in Table 1, gastric floating pulse-release capsules were prepared according to the preparation method of Example 1. Carry out release test according to "Chinese Pharmacopoeia" 2000 edition appendix XC dissolution test method second method paddle method, release condition: take 900ml artificial gastric juice as release medium, rotating speed (100 ± 1) r / min, temperature (37 ± 0.5) ℃. Put the capsules into the settling basket, sink to the bottom of the container, turn on the rotary switch, and time. Regularly sample 6ml, filter with a 0.8 μm microporous membrane, and supplement with the same amount of dissolution medium. After the filtrate is diluted, measure the absorbance at 229 nm, calculate the medium concentration according to the standard curve, and further calculate the dissolution percentage. release curve as image 3 As shown, ● is number...

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Abstract

The present invention relates to medicine technology, and is a kind of stomach floating pulse releasing capsule. The capsule includes water insoluble capsule, controlled releasing capsule plug, floating aid and medicine set inside the capsule. Owing to the specific weight of the floating aid lower than 1, the capsule will be floated in gastric juice without entering intestinal tract. The capsule plug made of dissolving eroded or swelling material and lactose or other inertial material is dissolved or swelled in digestive fluid in some period for controlled release of medicine. The capsulemay be opened in one or two ends, and may be designed based on different human rhythm time to prevent rhythm disease.

Description

Technical field: [0001] The invention relates to the technical field of medicine, and relates to a stomach-floating pulse-release capsule which can float in gastric juice and release drug active ingredients at regular intervals. Background technique: [0002] In recent years, studies of chronobiology and chronopharmacology have shown that the physiological functions of the human body and the onset of certain diseases show obvious rhythmic changes, that is, they have a circadian rhythm, and the therapeutic effects, toxic reactions and internal processes of drugs are also consistent. There is a time rhythm. Traditional slow / controlled release preparations with zero-order rate and first-order rate release can meet the requirements of maintaining a relatively stable blood drug concentration in the body, ensuring sustained release or long-term effect of the drug, and play an active role in clinical treatment. As time goes by, sustained / controlled release preparations have also b...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K9/52
Inventor 邹豪卢文芸蒋雪涛高申
Owner SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY
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