Duloxetine hydrochloride capsules and preparation method thereof
A technology for duloxetine hydrochloride and capsules, which is applied in the field of duloxetine hydrochloride capsules and its preparation, and can solve the key quality comparison situation that the stability of the product, the bioavailability of Cymbalta capsules, and the equivalence cannot be determined. , hazardous chemicals and other issues
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Embodiment 1
[0040] In this example, duloxetine enteric-coated capsules are composed of a capsule shell, a drug-loaded pill core, a drug, an isolation gown, and an enteric-coated layer. The gel material is dissolved and wrapped on the upper pill to form an isolation coat, and the coating solution is completed in ice water (also known as enteric coating), and the drug-loaded pill core, drug, isolation coat and coating form a coated microcapsule , put the coated microcapsules in the capsule shell to get the finished duloxetine hydrochloride capsules.
[0041] In the present embodiment, the composition of the upper pill is as shown in Table 1.
[0042] Composition of pills on Table 1
[0043]
[0044]
[0045] Among them, blank sugar pill: Hangzhou Gaocheng Bio-Nutrition Technology Co., Ltd. (Model: 20140370), API refers to the main drug duloxetine hydrochloride: Wuhan Dahua Weiye Biomedical Chemical Co., Ltd. (Model: 20140401), HPMC E5: Shanghai Colorcon Coating Technology Co., Ltd. ...
Embodiment 2
[0067] The setting and working principle of this embodiment are the same as that of Embodiment 1, the difference is that:
[0068] (1) The composition of the upper pill is shown in Table 4.
[0069] The composition of the pills on Table 4
[0070] Element
weighing (g)
blank sugar pill
350.1
APIs
180.0
HPMC E5 (2%)
36.0
water
1700
[0071] Wherein, because 3% binder HPMC E5 coating is difficult, so need add the water of 500ml to be diluted to its concentration and be 2%.
[0072] (2) The composition of the gown is shown in Table 5.
[0073] Table 5 Composition of gowns
[0074] Element
weighing (g)
on the pill
400.0
HPMC E5
24.0
water
379.0
ethanol
422.5
[0075] Note: 4.75% weight gain.
[0076] (3) The ingredients of the coating (enteric coating) are shown in Table 6.
[0077] Table 6 Composition of the coating
[0078] Element
weighing (g) ...
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