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Saccharose containing roflumilast tablets and preparation method thereof

A technology of roflumilast tablet and roflumilast, which is applied in the field of medicine and can solve the problems of sticking to the wall of the pulverizing machine, easily blocking the feeding port and the discharging port, etc.

Inactive Publication Date: 2016-03-02
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Jet milling of roflumilast can control the particle size below 30 μm, which can solve the problem of rapid dissolution of roflumilast, but the electrostatic effect generated by jet milling makes roflumilast very easy to block the inlet and outlet , and adhere to the crushing machine wall

Method used

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  • Saccharose containing roflumilast tablets and preparation method thereof
  • Saccharose containing roflumilast tablets and preparation method thereof
  • Saccharose containing roflumilast tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Mix roflumilast and sucrose powder passed through the 80-mesh sieve at a ratio of 1:40, 1:20:, 1:10, and 1:6, respectively, and add each mixture to the In the sugar outlet of the centrifugal spinning machine (cotton candy machine), the heating temperature is about 186°C. When the powder starts to melt, the centrifugal device is turned on, and the mixture of roflumilast and sucrose is thrown out at a speed of about 3500r / min. into filaments and collected with a glass rod to obtain roflumilast-sucrose filaments with a weight ratio of roflumilast to sucrose of 1:40, 1:20:, 1:10, and 1:6, respectively.

[0033]Weigh 5 mg of roflumilast through a 200-mesh sieve and roflumilast-sucrose silk containing the same amount of roflumilast, and place them in a 500ml beaker, and then add 500ml of distilled water to the beaker. Turn on the ultrasonic instrument, put the beaker with the raw material drug and the roflumilast-sucrose silk in the ultrasonic water bath, and ultrasonically f...

Embodiment 2

[0036] Prescription of Roflumilast Tablets Containing Roflumilast 0.5mg (1000 Tablets)

[0037]

[0038] Preparation method 1: crush roflumilast and pass through a 200-mesh sieve, and crush sucrose and pass through a 80-mesh sieve. Mix the prescribed amount of roflumilast (200 mesh) with the prescribed amount of sucrose evenly, then add the prescribed amount of pregelatinized starch, direct-pressed mannitol and microcrystalline cellulose PH102, and then add the prescribed amount of stearic acid Magnesium, mixed evenly, press according to the theoretical tablet weight to obtain roflumilast tablets containing roflumilast 0.5mg with an average tablet weight of about 66.2mg.

[0039] Preparation method 2 Pass roflumilast through an 80-mesh sieve, crush sucrose and pass through an 80-mesh sieve. Mix roflumilast and sucrose through a 80-mesh sieve evenly in a weight ratio of 1:10, and add the mixture to the sugar discharger of the centrifugal spinning machine (cotton candy machi...

Embodiment 3

[0045] Prescription of Roflumilast Tablets Containing Roflumilast 0.5mg (1000 Tablets)

[0046]

[0047] Preparation method Pass roflumilast through 80-mesh sieve, crush sucrose and pass through 80-mesh sieve. Mix roflumilast and sucrose passing through a 80-mesh sieve evenly in a weight ratio of 1:30, and add the mixture to the sugar discharger of the centrifugal spinning machine (cotton candy machine) in a dry environment at 5°C, and the heating temperature is about At 186°C, when the powder starts to melt, turn on the centrifuge device, and at a speed of about 3500r / min, spin out the mixture of roflumilast and sucrose into silk and collect it with a glass rod. In a dry environment at 12°C, add the prescribed amount of corn starch to the prescribed amount of roflumilast-sucrose silk and mix, so that the roflumilast-sucrose silk is fully broken and mixed evenly with the corn starch. At room temperature, mix the above mixture with the prescribed amount of direct-compressed...

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Abstract

The invention belongs to the technical field of medicine, and particularly relates to a saccharose containing roflumilast solid preparation and a preparation method thereof. Roflumilast is adopted as a medicinal active ingredient and mixed with saccharose, then centrifugal spinning is carried out, the mixture and proper pharmaceutic adjuvant are mixed and tableted, and a quick release preparation is prepared so that the problem of fast digestion of the indissolvable drug roflumilast can be solved. The tablets are suitable for treating the chronic obstructive pulmonary disease and asthma, and disease attacks and exacerbation are relieved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a sucrose-containing roflumilast tablet and a preparation method thereof. Background technique [0002] Chronic Obstructive Pulmonary Disease (COPD for short) is a preventable and treatable disease characterized by airflow limitation. Airflow limitation is not fully reversible, progressive, and associated with an abnormal inflammatory response of the lungs to the inhalation of noxious gases or particles such as tobacco smoke. COPD mainly involves the lungs, but it can also cause systemic (or extrapulmonary) adverse effects. Pulmonary function tests are important to determine whether there is airflow limitation. After inhalation of a bronchodilator, if the forced expiratory volume in one second takes up the percentage of forced vital capacity (FEV 1 / FVC%) < 70%, indicating that there is airflow limitation that is not fully reversible. According to FEV 1 / FVC,...

Claims

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Application Information

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IPC IPC(8): A61K31/44A61K47/26A61K9/20A61P11/00A61P11/06
Inventor 尹东东王杏林张赫然张俊伟杨志强
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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