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A kind of crocetin solid dispersion and preparation method thereof

A technology of solid dispersion and crocetin, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc. It can solve problems such as toxic side effects, aging, and affecting drug solubilization effects , to achieve the effects of increased solubility, improved stability, and increased bioavailability

Active Publication Date: 2022-05-17
HANGZHOU JIURUTANG BIOTECH
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since the drug exists in a high-energy unstable form such as molecules or crystallites in the solid dispersion, the solid dispersion often faces the problem of "aging", that is, the degradation or precipitation of the drug in the solid dispersion not only affects the Solubilization effect, the degradation products of the drug may also cause toxic side effects

Method used

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  • A kind of crocetin solid dispersion and preparation method thereof
  • A kind of crocetin solid dispersion and preparation method thereof
  • A kind of crocetin solid dispersion and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-6

[0047] table 5

[0048]

[0049] According to Table 5, the meglumine and the hydrophilic polymer carrier material in Examples 1-6 are dissolved in water and ultrasonicated for 1 h, so that the hydrophilic polymer material and meglumine are dissolved and cross-linked to form a carrier polymer I: Add crocetin to the system containing the carrier polymer I, and dissolve the crocetin by ultrasonication or stirring. The solvent is removed by rotary evaporation or spray drying to obtain a solid dispersion of crocetin, which is passed through a 100-mesh sieve. With pH 6.8 phosphate buffer as the dissolution medium, the volume of the dissolution medium is 900mL, and the rotation speed is 75rpm. The dissolution test is carried out by the paddle method, the dissolution results are determined by high performance liquid chromatography, and the cumulative dissolution rate is calculated.

[0050] Table 6

[0051] 15min 30min 45min 60min 120min 240min 480min ...

Embodiment 7

[0054] Crocetin solid dispersion, comprises the composition of following weight ratio:

[0055] Crocetin 10g

[0056] Soluplus 10g

[0057] Meglumine 40g

[0058] The preparation process is as follows:

[0059] (1) Dissolve Soluplus and meglumine in 500 mL of 95% ethanol solution and sonicate for 1 h to obtain carrier polymer I.

[0060] (2) Adding crocetin to the solution system containing carrier polymer I obtained in step (1), and ultrasonically dissolving the crocetin.

[0061] (3) Use a rotary evaporator to evaporate the solvent from the solution obtained in step (2), dry it under reduced pressure at 60°C for 12 hours, collect the solid, crush it and pass it through a 100-mesh sieve to obtain the crocetin solid dispersion.

Embodiment 8

[0063] Crocetin solid dispersion, comprises the composition of following weight ratio:

[0064] Crocetin 10g

[0065] Soluplus 20g

[0066] Meglumine 40g

[0067] The preparation process is as follows:

[0068] Step 1) Soluplus and meglumine were dissolved in 500 mL of purified water and stirred at 300rmp for 1h to obtain carrier polymer I.

[0069] Step 2) Add crocetin to the solution system containing carrier polymer I obtained in step 1), and stir to dissolve the crocetin.

[0070] Step 3) Use the spray drying method to remove moisture from the solution obtained in step 2), the inlet air temperature is 135°C, the outlet air temperature is 60°C, and the air volume is 0.8m 3 / min, the atomization pressure is 8kPa, and the flow rate is 1.5mL / min. During the spray drying process, the temperature of the mixed solution containing the drug is kept at 70°C.

[0071] Step 4) The spray-dried product was dried under reduced pressure at 60° C. for 12 hours, the solid was collected...

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Abstract

The invention provides a crocetin solid dispersion and a preparation method thereof. The formula of the crocetin solid dispersion is as follows: 1 part of insoluble drug crocetin, 1-15 parts of a hydrophilic polymer carrier material, 1-12 parts of solubilizing agent meglumine; the preparation method of the described solid dispersion, the steps are as follows: take the hydrophilic polymer carrier material and meglumine, dissolve them in organic reagents or water, ultrasonically or stir to make the hydrophilic The polymer material and meglumine are cross-linked to form a carrier polymer I, adding crocetin acid to the above solution containing carrier polymer I, ultrasonically or stirring to dissolve the crocetin acid, and using solvent evaporation or spray drying method to prepare solid dispersions. The crocetin solid dispersion prepared by the invention has good solubility and stability, rapid absorption in the body, high bioavailability, simple preparation process and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of pharmacy and relates to a solid dispersion and a preparation method thereof, in particular to a crocetin solid dispersion and a preparation method thereof. Background technique [0002] Saffron is the dry stigma of Crocus sativus L., a plant of the family Iridaceae, which is recorded in the 2020 edition of the Chinese Pharmacopoeia. Saffron is sweet in taste and flat in nature, with heart-guiding and liver meridians, has the effects of promoting blood circulation and removing blood stasis, cooling blood and detoxification, relieving stagnation and calming the nerves. "Compendium of Materia Medica" is recorded in the Ministry of Cao, named saffron, also known as Xiaofulan, and withdrawing method, it is mainly used to treat depression and depression, lingering breath, promoting blood circulation, and also controlling palpitations. Historically, my country has been importing from Western countries, so it is called sa...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K47/34A61K47/18A61K31/202A61P35/00A61P25/00A61P9/00A61P1/16A61P25/24A61P17/02A61P3/06A61P11/06A61P25/28A61P3/10A61P1/00A61P9/10A61P27/02A61P39/06A61P29/00
CPCA61K9/146A61K31/202A61P35/00A61P25/00A61P9/00A61P1/16A61P25/24A61P17/02A61P3/06A61P11/06A61P25/28A61P3/10A61P1/00A61P9/10A61P27/02A61P39/06A61P29/00Y02A50/30
Inventor 王平徐子金林素素李桥桥江山山尤雅姜玉丽朱琳钟情柔
Owner HANGZHOU JIURUTANG BIOTECH
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