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Losartan potassium gastric floating capsule and preparation method thereof

A technology of losartan potassium and gastric floating, which is applied in the direction of medical formulas, medical preparations containing active ingredients, etc., and can solve the problems of increased frequency of taking medicine, lower patient treatment compliance, and hygroscopicity. Strong and other problems, to achieve the effect of small peak and valley fluctuations in blood concentration, reduce the number of medications taken, and increase the release time

Active Publication Date: 2013-05-01
CHENGDU HENGRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] After patients take losartan potassium prepared by traditional technology, losartan potassium has strong hygroscopicity and is particularly sensitive to water, resulting in a short release time of the drug, that is, the drug is completely absorbed by the patient in a short period of time, causing blood drug Concentration peaks and valleys fluctuate greatly, which is prone to some adverse reactions, such as fatigue, facial edema, fever, and even fainting
Moreover, in order to achieve the therapeutic effect, the number of times patients take medicine increases, which indirectly leads to a decrease in the patient's treatment compliance.
Due to the strong hygroscopicity of losartan potassium prepared by the traditional process, the common preparation technology cannot guarantee its stable quality during the storage validity period

Method used

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  • Losartan potassium gastric floating capsule and preparation method thereof
  • Losartan potassium gastric floating capsule and preparation method thereof
  • Losartan potassium gastric floating capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A losartan potassium gastric floating capsule, which comprises the following components, and the parts by weight of each component according to the amount used in 1000 capsules are:

[0022]

[0023] The losartan potassium is the losartan potassium granules obtained by passing through a 100-mesh sieve.

[0024] The preparation of losartan potassium gastric floating capsule is prepared by the following method:

[0025] S1. Mix PEG6000, stearic acid, and stearyl alcohol in proportion, and heat to 64°C until it melts into liquid;

[0026] S2. Raise the temperature of the liquid mixture to 72° C. and keep it for 9 minutes;

[0027] S3. Add a proportional amount of losartan potassium to the liquid mixture obtained in step S2, keep the temperature at 72°C, and stir evenly;

[0028] S4, add precrossified starch and mannitol in a proportional amount, and stir evenly;

[0029] S5. After the uniformity is qualified, fill it while it is hot, cover the capsule cap, and cool t...

Embodiment 2

[0031] A losartan potassium gastric floating capsule, which comprises the following components, and the parts by weight of each component according to the amount used in 1000 capsules are:

[0032]

[0033] The losartan potassium is the losartan potassium granules obtained by passing through a 100-mesh sieve.

[0034] Losartan Potassium Gastric Floating Capsules are prepared by:

[0035] S1. Mix PEG6000, stearic acid, and stearyl alcohol in proportion, and heat to 65°C until it melts into a liquid;

[0036] S2. Raise the temperature of the above liquid mixture to 70° C. and keep it for 10 minutes;

[0037] S3. Add a proportional amount of losartan potassium to the liquid mixture obtained in step S2, keep the temperature at 70° C., and stir evenly;

[0038] S4, add precrossified starch and mannitol in a proportional amount, and stir evenly;

[0039] S5. After the uniformity is qualified, fill it while it is hot, cover the capsule cap, and cool to room temperature.

[004...

Embodiment 3

[0042] A losartan potassium gastric floating capsule, which comprises the following components, and the parts by weight of each component according to the amount used in 1000 capsules are:

[0043]

[0044]

[0045] The losartan potassium is the losartan potassium granules obtained by passing through a 100-mesh sieve.

[0046] Losartan Potassium Gastric Floating Capsules are prepared by:

[0047] S1. Mix PEG6000, stearic acid, and stearyl alcohol in proportion, and heat to 66°C until it melts into a liquid state;

[0048] S2. Raise the temperature of the above-mentioned liquid mixture to 69° C. and keep it for 11 minutes;

[0049] S3. Add a proportional amount of losartan potassium to the liquid mixture obtained in step S2, keep the temperature at 69° C., and stir evenly;

[0050] S4, add precrossified starch and mannitol in a proportional amount, and stir evenly;

[0051] S5. After the uniformity is qualified, fill it while it is hot, cover the capsule cap, and cool ...

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Abstract

The invention relates to a losartan potassium gastric floating capsule, which comprises losartan potassium, PEG6000 (polyethyleneglycol), stearic acid, octodecyl alcohol, pre-gelatinized starch and mannite, wherein the losartan potassium is a powdery substance which is sieved with a 100-mesh sieve. A preparation method of the capsule comprises the following steps of: S1, mixing the PEG6000, the stearic acid and the octodecyl alcohol according to a certain proportion, heating to 64-66 DEG C, and smelting into a liquid; S2, heating the liquid mixture to 69-72 DEG C, and preserving heat for 9-11 minutes; S3, adding a proportional amount of losartan potassium into the mixture obtained in the step S2, keeping the temperature at 69-72 DEG C, and stirring uniformly; S4, adding a proportional amount of the pre-gelatinized starch and the mannite, and stirring uniformly; and S5, after the uniformity is qualified, filling in a hot state, covering a capsule cap, and cooling to the room temperature. The losartan potassium gastric floating capsule has the advantages that the medicament releasing time is long, the medicine taking times of a patient are reduced, the treatment compliance of the patient is enhanced, and the quality in a storage life is stable.

Description

technical field [0001] The invention relates to the technical field of biomedicine, in particular to a losartan potassium gastric floating capsule and a preparation method thereof. Background technique [0002] Losartan potassium (molecular formula: C 22 h 22 ikB 6 O, molecular weight: 461.001) is a synthetic, potent orally active drug used to treat essential hypertension, suitable for patients treated with combination drugs. Binding experiments and pharmacological bioassays have proved that it can selectively bind to AT1 receptors (such as vascular smooth muscle, adrenal gland, kidney and heart), and produce various important biological effects including vasoconstriction and aldosterone release. In vivo studies have shown that losartan potassium and its pharmacologically active carboxylic acid metabolite (E-3174) can block the corresponding physiological effects of angiotensin II synthesized from any source or via any pathway. Compared with other peptide angiotensin Ⅱ a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/4178A61K47/36A61P9/12
Inventor 冯璐朱德其
Owner CHENGDU HENGRUI PHARMA
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