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A technology for cyclobenzaprine and benzalkonium is applied in the field of medicine and achieves the effects of simple preparation process and stable product quality
Inactive Publication Date: 2020-08-07
CP PHARMA QINGDAO CO LTD +1
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Problems solved by technology
Cyclobenzaprine was first developed by Merk Company. Cyclobenzaprine hydrochloride tablets were launched in the U.S. under the trade name: Flexeril®, with specifications of 5mg and 10mg. One of the most commonly used muscle relaxants, but it has not been marketed in China
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preparation example Construction
[0024] A preparation method of cyclobenzaprine enteric-coated capsules, comprising the following steps:
[0025] (1) Get cyclobenzaprine and filler to mix evenly, take 85% ethanol as binder, make 20-30 object cyclobenzaprine pellets, for subsequent use;
[0026] (2) Dissolve enteric-coated material, plasticizer and lubricant with 80% ethanol, make enteric-coated liquid;
[0027] (3) Evenly spray the enteric coating solution prepared in step (2) on the surface of the cyclobenzaprine pellets prepared in step (1), and obtain cyclobenzaprine enteric-coated pellets after drying;
[0028] (4) Filling cyclobenzaprine enteric-coated pellets into capsule shells to obtain cyclobenzaprine enteric-coated capsules.
Embodiment 1-6
[0029] Example 1-6 Preparation of Cyclobenzaprine Enteric-Coated Capsules
[0030] Cyclobenzaprine enteric-coated capsules were prepared according to the raw and auxiliary materials in the following prescription and the above-mentioned preparation method. Among them, " / " means not used.
[0031]
Embodiment 7-11
[0040] Example 7-11 Preparation of cyclobenzaprine enteric-coated capsules
[0041] Cyclobenzaprine enteric-coated capsules were prepared according to the raw and auxiliary materials in the following prescription and the above-mentioned preparation method.
[0042]
[0043] Test Example 2 Determination of Dissolution of Cyclobenzaprine Enteric-Coated Capsules Gained in Examples 7-11
[0044] The measurement method is the same as that of Test Example 1, and the measurement results are shown in Table 3 and Table 4.
[0045] Table 3 Dissolution of cyclobenzaprine enteric-coated capsules obtained in Examples 7-11 in artificial gastric juice
[0046]
[0047] As can be seen from Table 3, the cyclobenzaprine enteric-coated capsule of embodiment 8 dissolves the slowest in the pH1.2 artificial gastric juice, indicating that when the weight of the enteric-coated material methacrylic acid copolymer and hydroxypropyl methylcellulose phthalate When the ratio is 2:1, the prepared c...
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Abstract
The invention discloses a cyclobenzaprine enteric capsule and a preparation method thereof. The cyclobenzaprine enteric capsule disclosed by the invention is prepared by loading cyclobenzaprine enteric pellets into a capsule shell, the cyclobenzaprine enteric pellet is composed of a cyclobenzaprine pellet and an enteric coating layer wrapping the cyclobenzaprine pellet, the cyclobenzaprine pelletcomprises cyclobenzaprine and filler, the enteric coating layer comprises an enteric material, a plasticizer and a lubricant, and the preparation method includes: wrapping the cyclobenzaprine pellet with the enteric coating layer and then loading the product into a capsule to obtain the cyclobenzaprine enteric capsule. The cyclobenzaprine enteric capsule provided by the invention is convenient totake, the enteric effect is ideal, the bioavailability of cyclobenzaprine is improved, the preparation process is simple, the obtained product is stable in quality and is suitable for large-scale production.
Description
technical field [0001] The invention relates to a western medicine preparation technology, in particular to a cyclobenzaprine enteric-coated capsule, which belongs to the technical field of medicine. Background technique [0002] Musculoskeletal system diseases are more common in clinical practice, involving bones, intervertebral discs, nerves, muscles, joints, soft tissues and other diseases. There are also many causes of musculoskeletal pain, such as inflammation, mechanical injury, immune reasons, tumors, etc. The International Society for Pain (IASP) pointed out that musculoskeletal pain is the pain with the highest incidence and the largest range of impact among all pains, and even about half of the population suffers from musculoskeletal pain for more than 3 months in a year. Musculoskeletal pain occurs frequently and is classified into neck pain, back and lower back pain, joint pain, etc. depending on the site of attack. Often cause long-term, chronic injury to the p...
Claims
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