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Compound ferrous sulfate sustained release preparation

A slow-release preparation and ferrous sulfate technology, which can be used in pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., and can solve problems such as drug efficacy and stability effects

Active Publication Date: 2018-09-14
安徽省慧灵生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, the folic acid in this product will decompose rapidly when exposed to water, light and heat, which greatly affects the efficacy and stability of this product

Method used

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  • Compound ferrous sulfate sustained release preparation
  • Compound ferrous sulfate sustained release preparation
  • Compound ferrous sulfate sustained release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] Embodiment 1 compound ferrous sulfate slow-release preparation

[0092] prescription

[0093]

[0094]

[0095] Weight of slow release layer: weight of quick release layer: 324.48:229.9=1.41:1.

[0096] Preparation method:

[0097] A, the preparation of dry ferrous sulfate

[0098] After crushing medicinal ferrous sulfate (CP2000 standard, containing 7 crystal waters) with a universal grinder, pass through an 80-mesh sieve, dry with hot air at 40-45°C for 36-48 hours, cool and grind with a universal grinder, pass through 100 Mesh sieve, after passing the test (conforming to the standard of BP1988 version about dry ferrous sulfate), it is ready for use.

[0099] B, preparation of slow-release ferrous sulfate particles

[0100] Dry ferrous sulfate and lactose, HPMC k100 Mix microcrystalline cellulose for later use, carmine 60, povidone K 30 Dissolve with 40% (w / v) ethanol, add to the above-mentioned mixed powder in advance, use a one-step granulator to granula...

Embodiment 5～7

[0115] The influence of embodiment 5~7 retarder dosage

[0116] Adopt the method identical with embodiment 1, wherein use the consumption of the retarder of table 4

[0117] The consumption (gram) of table 4 retarder

[0118]

ferrous sulfate

HPMC K100

HPMC K100

HPMC K100

Example 5

74.5

56(10％)

Example 6

74.5

112(20％)

Example 7

74.5

168(30％)

[0119] The tablet prepared in Examples 5-7 is according to the release rate assay method, with 1000ml of 0.1mol hydrochloric acid as the medium, and the rotating speed is 100 rpm; the measurement data are shown in the following table 5:

[0120] Table 5 release measurement data (%)

[0121]

Embodiment 8

[0123] After the slow-release granules and folic acid inclusion granules were prepared according to the method in Example 1, the two granules were uniformly mixed and compressed conventionally to obtain single-layer tablets.

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PUM

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Abstract

The invention relates to a compound ferrous sulfate sustained release preparation. The sustained release preparation comprises a sustained release layer and a quick release layer, wherein the sustained release layer comprises ferrous sulfate, a release resistance agent and a first excipient; the quick release layer comprises folic acid wrapped with cyclodextrin and a second excipient. The sustained release preparation has good stability, iron ions are released slowly in the intestinal tract, and the stimulation to the stomach is little.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a compound ferrous sulfate sustained-release preparation. Background technique [0002] Pregnant women are more prone to anemia due to the body's increased demand for nutrients. A survey shows that among women of childbearing age in my country, the incidence of anemia is 35.6% among non-pregnant and non-lactating women, 47.6% among breastfeeding women, and 42.1% among pregnant women, and is higher in rural areas than in urban areas. Generally, the occurrence of anemia is mild to moderate, so it is easier to treat it by supplementing iron and folic acid. Anemia, if left untreated, can lead to premature birth, low birth weight infants, and fetal death. Iron deficiency and folic acid deficiency are the main causes of iron deficiency anemia and megaloblastic anemia, so daily supplementation of sufficient iron and folic acid can prevent the occurrence of anemia i...

Claims

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Application Information

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IPC IPC(8): A61K9/24A61K47/69A61K33/26A61K31/519A61P7/06
CPCA61K9/2086A61K31/519A61K33/26A61K47/6951A61P7/06A61K2300/00
Inventor 邢怀阳周义蕊岳喜波李国俊
Owner 安徽省慧灵生物科技有限公司
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