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Terazosin hydrochloride capsule and preparation method thereof

A technology of terazosin hydrochloride and terazosin, applied in capsule delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve problems such as poor fluidity, poor uniformity of powder mixing, and low dissolution rate of finished products within 15 minutes

Active Publication Date: 2022-04-29
CHONGQING PHARSCIN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The object of the present invention is to provide a kind of terazosin hydrochloride capsule and preparation method thereof, solve the poor uniformity of powder mixing, poor fluidity, thereby cause the situation that finished product loading difference is big and finished product 15min dissolution rate is on the low side; Improved to a certain extent The fluidity of terazosin hydrochloride capsule mixed powder effectively solves the difference in capsule filling volume, ensures product quality, and has simple manufacturing process, low cost, and is convenient for mass production

Method used

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  • Terazosin hydrochloride capsule and preparation method thereof
  • Terazosin hydrochloride capsule and preparation method thereof
  • Terazosin hydrochloride capsule and preparation method thereof

Examples

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preparation example Construction

[0046] The preparation of the contents of each batch of capsules, wherein the terazosin hydrochloride raw material particle size D90 is different, the specific operation: sieve the obtained raw material drug to obtain the raw material drug with different particle sizes; the excipients are all from the same batch of materials , Lactose is lactose monohydrate, D90 is 119.53um; microcrystalline cellulose is 102 type, D90 is 149.98um; crospovidone D90 is 119.81um; magnesium stearate does not need to control its particle size due to its small amount .

[0047] Since the bulk drug of this product is highly soluble, and there is no significant difference in the dissolution rate of different particle sizes under the four media, the dissolution test of the finished product is not carried out in the investigation of the particle size of the bulk drug, and the focus is on the dissolution of the terazosin hydrochloride bulk drug of different particle sizes in the mixture. Mixing uniformit...

Embodiment 1

[0064] Terazosin hydrochloride capsules, made of the following weight ratio: 2 parts of terazosin hydrochloride (in terms of terazosin), 178 parts of lactose monohydrate, 28 parts of microcrystalline cellulose, 14 parts of crospovidone 3 parts, magnesium stearate 3 parts.

[0065] Preferably, the particle size of lactose monohydrate is controlled so that D90 is 119.53um;

[0066] The microcrystalline cellulose is a 102 model, and the D90 is 149.98um; the crospovidone is an XL model, and the D90 is 100.22um.

[0067] Preparation Process:

[0068] (1) Pass the terazosin hydrochloride bulk drug through a 60-mesh sieve, and set aside.

[0069] (2) Weigh spare terazosin hydrochloride crude drug, lactose monohydrate, crospovidone, and microcrystalline cellulose.

[0070] (3) Add the materials weighed in step (2) into the mixer in the following order, and then add about half of the prescription amount of lactose, crospovidone, terazosin raw material medicine, microcrystalline cell...

Embodiment 2

[0075] Terazosin hydrochloride capsules, made of the following weight ratio: 2 parts of terazosin hydrochloride, 160 parts of lactose monohydrate, 31 parts of microcrystalline cellulose, 16 parts of crospovidone, 2.7 parts of magnesium stearate .

[0076] Preferably, the particle size of lactose monohydrate is controlled so that D90 is 119.53um;

[0077] The microcrystalline cellulose is a 102 model, and the D90 is 149.98um; the crospovidone is an XL model, and the D90 is 100.22um.

[0078] Preparation Process:

[0079] (1) Pass the terazosin hydrochloride bulk drug through a 60-mesh sieve, and set aside.

[0080] (2) Weigh spare terazosin hydrochloride crude drug, lactose monohydrate, crospovidone, and microcrystalline cellulose.

[0081] (3) Add the materials weighed in step (2) into the mixer in the following order, and then add lactose, crospovidone, terazosin hydrochloride bulk drug, microcrystalline cellulose and The remaining prescription amount of lactose was mixed...

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Abstract

The invention discloses a terazosin capsule and a preparation method thereof, the capsule comprises the following components in parts by weight: 1-2 parts of terazosin hydrochloride, 160-196 parts of lactose, 25-31 parts of microcrystalline cellulose, 12-16 parts of polyvinylpolypyrrolidone and 2.7-3.3 parts of magnesium stearate, the terazosin hydrochloride is metered by terazosin, the grain size D90 of the lactose is less than or equal to 120 microns, the grain size D90 of the microcrystalline cellulose is less than or equal to 150 microns, and the grain size D90 of the magnesium stearate is less than or equal to 150 microns. D90 of the cross-linked povidone particles is less than or equal to 120 microns. According to the invention, the operation steps are simpler, the powder mixing uniformity is fully ensured, and the finished product loading difference and the finished product dissolution rate in 15 minutes both meet the internal control standard; the terazosin hydrochloride capsule mixed powder has the advantages that the flowability of the terazosin hydrochloride capsule mixed powder is improved to a certain extent, the difference of capsule filling capacity is effectively solved, the product quality is guaranteed, the manufacturing process is simple, the cost is low, and large-batch production is facilitated.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a terazosin hydrochloride composition and a preparation method thereof. Background technique [0002] Terazosin hydrochloride is a congener of prazosin, which has the effect of selectively blocking the post-synaptic α1-adrenal receptors. The drug was first launched in Germany in 1985. It has good oral absorption, fast onset time and long half-life , only need to be taken once a day, for the treatment of mild to moderate hypertension, benign prostatic hyperplasia patients. Terazosin hydrochloride can relax the bladder neck, prostate and its capsule smooth muscle, thereby reducing urethral resistance and pressure, and bladder resistance, so it can be used to treat benign prostatic hyperplasia. However, its blockade of post-synaptic α1 adrenergic receptors can cause peripheral blood vessels to dilate, peripheral resistance decreases, and blood pressure is lowered. Curren...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/517A61K47/38A61K47/32A61K47/26A61P13/08
CPCA61K9/4858A61K9/4866A61K31/517A61P13/08
Inventor 侯玉梅沈浩游雪丹唐刘范林王超程阳
Owner CHONGQING PHARSCIN PHARM CO LTD
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