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Beta-cyclodextrin/phenylpropanol inclusion and its preparing method

A technology of cyclodextrin and phenylpropanol, which is applied in the direction of active ingredients of hydroxyl compounds, non-active ingredients of polymer compounds, and drug combinations, etc., which can solve the problems of inconvenient use, easy discoloration, and frequent daily use of patients

Inactive Publication Date: 2005-10-19
NANJING NORMAL UNIVERSITY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Capsule-coated oily phenylpropanol is highly irritating after administration, often accompanied by stomach discomfort, which can easily cause nausea, vomiting and other adverse reactions; the stability of the capsule form is poor, it is easy to change color when exposed to light, and it is easy to rupture and contaminate the product, causing serial Quality issues
In addition, the drug action time of capsules is short, and the number of daily doses is high, which is inconvenient for patients to use.

Method used

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  • Beta-cyclodextrin/phenylpropanol inclusion and its preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1, mix 1000 ml of pure water with 200 g of β-cyclodextrin, heat, add 20 g of phenylpropanol at 70°C, mix and stir for 5 hours, then cool at 5°C for 24 hours; filter, The solid was washed twice with water. Dry at 80°C for 24 hours to obtain a white solid clathrate.

[0035] Add the following auxiliary material components (mg) to the clathrate prepared above:

[0036] β-Cyclodextrin 1000

[0037] Microcrystalline Cellulose 120

[0038] Cornstarch 280

[0039] Citric acid 100

[0040] Talc powder q.s

[0041] Sodium starch glycolate q.s

[0042] Stearic acid q.s

[0043] Pass the clathrate through a 100-mesh sieve, and fully mix it with other excipients shown in the above table at a ratio of 1:0.5 (W / W) to prepare a solid preparation raw material. Adopt wet granulation under the condition of 15-30°C, dry at 60°C for 20 hours, press the whole grain into tablets or fill capsules to obtain the product.

Embodiment 2

[0044] Example 2: basically the same as Example 1, but 2000 milliliters of pure water was mixed with 200 grams of β-cyclodextrin, heated, and 40 grams of phenylpropanol was added at a temperature of 35 ° C, and fully mixed and stirred for 15 hours; the added The proportion of auxiliary materials is 1:1 (W / W), and the ingredients of auxiliary materials are:

[0045] β-Cyclodextrin 500

[0046] Pregelatinized starch 160

[0047] Lactose 80

[0048] Mannitol 140

[0049] Crospovidone q.s

[0050] Talc powder q.s

[0051] PEG4000 q.s.

Embodiment 3

[0052] Example 3: basically the same as Example 1, but 400 milliliters of pure water was mixed with 200 grams of β-cyclodextrin, heated, and 30 grams of phenylpropanol was added at a temperature of 80 ° C, and fully mixed and stirred for 0.5 hours; the added The proportion of auxiliary materials is 1:0.8 (W / W), and the ingredients of auxiliary materials are:

[0053] β-Cyclodextrin 1000

[0054] Microcrystalline Cellulose 120

[0055] Cornstarch 280

[0056] Low-substituted hydroxypropyl cellulose 100

[0057] Micronized silica gel q.s

[0058] Carboxymethyl starch sodium q.s

[0059] PEG6000 q.s.

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Abstract

The beta-cyclodextrin / phenyl propanol inclusion includes oily phenyl propanol and beta-cyclodextrin in the mass ratio of 1 to 5-10. The inclusion has supplementary material selected from the following matters: beta-cyclodextrin, microcrystalline cellulose, corn starch, citric acid, talcum powder, sodium carboxymethyl starch, stearic acid, pre-gletinized starch, lactose, mannitol, etc. The preparation process of the beta-cyclodextrin / phenyl propanol inclusion includes the following steps: mixing beta-cyclodextrin and water to form suspension, adding oily phenyl propanol via stirring, cooling, filtering, water washing, and drying to obtain the inclusion. The inclusion is then mixed with supplementary material in the ratio of 1 to 0.5-1, and the mixture is dried and tabletted or capsulized. The present invention has raised medicine stability, less irritability, smooth medicine release, convenient medicine taking and easy carrying about and storing.

Description

technical field [0001] The invention relates to a pharmaceutical composition, a β-cyclodextrin / phenylpropanol inclusion compound, and a preparation method of the β-cyclodextrin / phenylpropanol inclusion compound as a pharmaceutical composition. Background technique [0002] Phenylpropanol (cholesterol) is a bile secretion accelerator, which was first synthesized by Warrb and Cortese in 1927 and first listed in Germany. my country started production in 1977. All editions of the National Pharmacopoeia of this product are recorded. [0003] Phenylpropanol is a white or yellowish oily liquid; it has a slight ester odor and a sweet and pungent taste. It is easily soluble in methanol, ethanol and chloroform, and slightly soluble in water. The current clinical dosage form is capsules (specification: 0.1 g / capsule; dosage: 1-2 capsules / time, 3 times / day). Phenylpropanol has definite curative effect and the market is stable. [0004] Oily phenylpropanol wrapped in capsules is high...

Claims

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Application Information

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IPC IPC(8): A61K31/045A61K47/40A61P1/16
Inventor 任勇杨星昊余书勤李莉娥符义刚周灿刘子列
Owner NANJING NORMAL UNIVERSITY
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