Meloxicam suspension capsule and preparation method thereof
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A technology of meloxicam and suspension, which is applied in the field of medicine, can solve the problems of slow onset of drug effect, and achieve the effects of fast onset of distribution, high viscosity, and increased suspending properties
Inactive Publication Date: 2021-04-02
SUZHOU CHUNGHWA CHEM & PHARMA IND
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[0005] However, the current dosage forms of nanosuspensions are generally tablets or hard capsules, that is, the suspension needs to be dried into powder before being compressed
Method used
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Embodiment 1-6
[0028] Embodiment 1-6 relates to a meloxicam suspension capsule, which includes a capsule shell and a meloxicam nanosuspension filled in the capsule shell, wherein the meloxicam in embodiment 1-6 The prescription of the loxicam nanosuspension is shown in Table 1, and the content in Table 1 is based on the total amount of the contents of 1000 capsules.
[0029] Table 1. Prescriptions of meloxicam nanosuspensions in Examples 1-6
[0030]
[0031]
[0032] Wherein, embodiment 1 is prepared according to the following steps:
[0033] S1. Prepare meloxicam, bentonite, tris, poloxamer 124, propylene glycol, sodium benzoate, and purified water into a crude water dispersion, and pass it through a high-pressure micro-fluidic homogenizer at 10,000psi, with a flow rate of 50mL / min , circulate 5 times to crush the API particle size into nanometer level, and form a nanosuspension;
[0034] S2. Mix 34.8g gelatin, 17.5g glycerin, 6g PEG400 and 41.7g water to make a film;
[0035] S3....
Embodiment 2-6
[0036] Embodiment 2-6 is prepared according to the following steps:
[0037] S1. Prepare meloxicam, bentonite, tris, poloxamer 124, propylene glycol, sodium benzoate, and purified water into a crude aqueous dispersion, and pass it through a high-pressure micro-fluidic homogenizer at 30,000 psi with a flow rate of 10 mL / min , and circulated 10 times to crush the API particle size into a nanometer level to form a nanosuspension;
[0038] S2. Mix 34.8g gelatin, 17.5g glycerin, 6g PEG400 and 41.7g water to make a film;
[0039] S3. Put the nanosuspension prepared in step S1 into two pieces of films prepared in S2 and compress to form a soft capsule.
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Abstract
The invention relates to the field of medicine, and particularly relates to a meloxicam suspension capsule and a preparation method thereof. The meloxicam suspension capsule comprises a capsule shelland meloxicam nano suspension filled in the capsule shell. By directly filling the meloxicam nano suspension in the capsule shell to form a soft capsule preparation, when the meloxicam suspension capsule preparation is orally taken, after the capsule shell is dissolved, the meloxicam suspension can directly enter a human body to be released; compared with the situation that tablets, hard capsulesand the like need to be wet again after entering the human body, the meloxicam preparation provided by the invention has the advantage of quicker distribution response; and in addition, the wrapping of the soft capsule also can solve the problem of unpleasant taste after meloxicam is dissolved, and solves the problem of poor patient compliance.
Description
technical field [0001] The invention relates to the field of medicine, in particular to a meloxicam suspension capsule and a preparation method thereof. Background technique [0002] Meloxicam is an enoleic acid non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic and antipyretic effects. It is clinically suitable for symptomatic treatment of pain, swelling and soft tissue inflammation, traumatic pain, and postoperative pain in rheumatoid arthritis and osteoarthritis. [0003] Meloxicam is a BCSⅡ drug, which is a low-solubility and hypertonic drug. It is slightly soluble in N-N-dimethylformamide, hardly soluble in acetone, very difficult to dissolve in methanol or ethanol (99.5), almost insoluble in water, slightly soluble in methanol , Solubility is greatly affected by pH, and the solubility increases in strong acid and strong alkali. Therefore, limited by solubility, the dissolution rate of meloxicam in the gastrointestinal tract is slow, resulting in sl...
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