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Compound dihydralazine sulfate preparation, preparation method and application thereof

A dihydralazine sulfate preparation technology, which is applied in the field of compound dihydralazine sulfate preparation and its preparation, can solve the problems affecting the treatment effect and fluid retention, so as to improve the treatment effect, promote the drop of blood pressure and reduce adverse reactions Effect

Active Publication Date: 2019-02-01
CHANGZHOU PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, long-term use of these two drugs can produce fluid retention, which can affect the therapeutic effect

Method used

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  • Compound dihydralazine sulfate preparation, preparation method and application thereof
  • Compound dihydralazine sulfate preparation, preparation method and application thereof

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preparation example Construction

[0032] The present invention also provides a preparation method for any of the above-mentioned compound dihydralazine sulfate preparations, which includes: mixing dissolved clonidine hydrochloride with hydrochlorothiazide and some auxiliary materials; mixing dihydralazine sulfate with some auxiliary materials; The two mixtures are mixed with the remaining auxiliary materials to obtain the compound dihydralazine sulfate preparation;

[0033] Because dihydralazine sulfate is more sensitive to acidic substances in the raw materials of the preparation of the present invention, calcium hydrogen phosphate is selected as a functional adjuvant to provide an alkaline environment during prescription design to improve the stability of the finished product. However, hydrochlorothiazide in the prescription is easily affected by alkaline substances, and hydrolysis can occur in an alkaline environment, thereby reducing the stability of the finished product. For addressing this problem, speci...

Embodiment 1

[0048] 1.1 Tablet composition (mg / tablet)

[0049] composition

Dosage (mg)

Clonidine Hydrochloride

0.015

Hydrochlorothiazide

5.3

Dihydralazine Sulfate

8.3

corn starch

42

Croscarmellose Sodium

2

lactose

13.88

Calcium hydrogen phosphate

16.5

Low-substituted hydroxypropyl cellulose

12.8

microcrystalline cellulose

35.75

10% starch slurry

5.4

Magnesium stearate

1.1

[0050] 1.2 Preparation

[0051] According to the composition of the tablet in 1.1 above, weigh corresponding amounts of each raw material.

[0052] (1) Add clonidine hydrochloride into 50% ethanol solution, stir and dissolve evenly for later use.

[0053] (2) Weigh the starch and cold purified water at a ratio of 1:1, add the starch into the purified water, and then add water for injection to prepare a starch slurry with a concentration of 10% for later use.

[0054] (3) Put hydrochlorothiaz...

Embodiment 2

[0062] 1.1 Tablet composition (mg / tablet)

[0063] composition

[0064] Then, according to the method for embodiment 1, obtain the compound recipe dihydralazine sulfate tablet of embodiment 2.

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Abstract

The invention provides a compound dihydralazine sulfate preparation, a preparation method and application thereof. The compound preparation of the invention contains clonidine hydrochloride, dihydralazine sulfate and hydrochlorothiazide. By combining the three pharmacodynamic substances, a significant synergistic effect can be achieved, and blood pressure is reduced. Meanwhile, hydrochlorothiazidecan effectively reduce the side effect of fluid retention caused by long-term use of clonidine hydrochloride and dihydralazine sulfate, and the treatment effect is improved.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a compound dihydralazine sulfate preparation and its preparation method and application. Background technique [0002] Clonidine hydrochloride is an α-receptor agonist, which directly acts on the α2 receptor of the peripheral sympathetic nerve presynaptic membrane, and enhances its negative feedback effect, thereby reducing the release of norepinephrine from the peripheral nerve, reducing the peripheral vascular and renal vascular resistance, The effect of slowing the heart rate and lowering blood pressure. However, long-term use of clonidine hydrochloride will lead to fluid retention and blood volume expansion, resulting in drug resistance and weakening of its antihypertensive effect. At the same time, dihydralazine sulfate is also a common antihypertensive drug. Its antihypertensive effect is mainly to expand arterioles, has little effect on veins, and redu...

Claims

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Application Information

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IPC IPC(8): A61K31/4168A61K31/585A61K31/549A61P9/12A61K9/20
CPCA61K9/2059A61K31/4168A61K31/549A61K31/585A61P9/12A61K2300/00
Inventor 茅为赵海涛吴沉巫美金
Owner CHANGZHOU PHARMA FACTORY