CN105769875A - Preparation method of compound olanzapine fluoxetine hydrochloride capsule - Google Patents
Preparation method of compound olanzapine fluoxetine hydrochloride capsule Download PDFInfo
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- CN105769875A CN105769875A CN201410823058.6A CN201410823058A CN105769875A CN 105769875 A CN105769875 A CN 105769875A CN 201410823058 A CN201410823058 A CN 201410823058A CN 105769875 A CN105769875 A CN 105769875A
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Abstract
The invention provides a preparation method of a compound olanzapine fluoxetine hydrochloride capsule. The method consists of: weighing a formulated amount of olanzapine, fluoxetine hydrochloride and pregelatinized starch and performing blending to obtain a mixture, sieving the mixture by a sieve of more than 60 meshes, then conducting mixing by a mixer to prepare an intermediate, taking the mixed powder and detecting the content of olanzapine and fluoxetine hydrochloride, and when the content is accord with the intermediate standard, performing capsule filling. The preparation method of the compound olanzapine fluoxetine hydrochloride capsule provided by the invention realizes preparation of the compound olanzapine fluoxetine hydrochloride capsule, and the solubility of the active ingredients olanzapine and fluoxetine hydrochloride can be significantly increased, thus being conducive to giving play to the efficacy.
Description
Technical field
The preparation method that the present invention relates to a kind of pharmaceutical composition, the preparation method particularly relating to a kind of compound recipe olanzapine fluoxetine hydrochloride capsules.
Background technology
Olanzapine is a kind of atypical antipsychotic, has the multiple antagonism of serotonin, norepinephrine and dopamine.Abroad in Recent Years reports that serious symptom, psychotic disease, refractory depression, depressive anxiety syndrome and bipolar affective disorder, obsession are all had good efficacy by it, especially controls depressive anxiety syndrome rapid-action.
Fluoxetine Hydrochloride is a kind of selective serotonin reuptake inhibitor (SSRI), it can absorb 5-hydroxy tryptamine by inhibitory neuron effectively from synaptic space, increasing this neurotransmitter being available for actual utilization in gap, thus improving affective state, treating depr essive disorder.
It is a recommendable treatment way that small-dose olanzapine merges fluoxetine for treatment major depressive disorder patient, not only rapid-action, overcome that the onset of fluoxetine own is slow and the shortcoming of the benzene phenodiazine easy addiction of azole antianxiety drug, and greatly reduce the expulsion rate in Fluoxetine in Treatment, and sleep and anxiety somatization can be improved rapidly, significantly improving the curative effect of antidepressant and anxiety, compliance is good, and clinic is promoted.
It is SYMBYAX that compound recipe olanzapine fluoxetine hydrochloride capsules former grinds the former name of an article of consulting and deliberating, and is researched and developed by Lilly Co., Eli., and antipsychotic drug olanzapine and antidepressant fluoxetine combined therapy are difficult to the paralepsy of the adult's I type bipolar disorder cured；In in December, 2003 in U.S.'s approval listing, subsequently in Argentina, Mexico and Chile's listing.At present domestic have no import listing, also have no the information of declaring.
Chinese invention patent application 201310139272.5 provides pharmaceutical composition of a kind of bortezomib and preparation method thereof, which employs the technical scheme that bortezomib, the tert-butyl alcohol, sodium chloride and excipient are 1: 0.5: 1～5: 5～20 with mass ratio, the dissolution velocity in water of the lyophilized formulations of gained was at about 20 seconds, relevant content of material is also far below comparison medicament, and stability significantly improves.
But still do not have the medicinal tert-butyl alcohol to provide because of domestic, also without the medicinal standard of the tert-butyl alcohol, more lack its clinical safety data, declare this kind medicine difficulty with this to CFDA also big.Prepare lyophilized injectable powder with the tert-butyl alcohol and be also easy to residual in the formulation, it is also possible to there is clinical drug safety hidden danger.For this, some technical staff have explored and have attempted.
Summary of the invention
The preparation method that it is an object of the present invention to provide a kind of compound recipe olanzapine fluoxetine hydrochloride capsules, to produce olanzapine fluoxetine Hydrochloride compound preparation.
Further object is that the preparation method that a kind of compound recipe olanzapine fluoxetine hydrochloride capsules is provided, to improve the dissolution of compound preparation, be beneficial to the performance of drug effect.
The compound recipe olanzapine fluoxetine hydrochloride capsules that the present invention relates to, including olanzapine and fluoxetine Hydrochloride isoreactivity composition, pregelatinized Starch is major auxiliary burden, substantially has 3 kinds of specifications, is respectively as follows: 3mg/25mg, 6mg/25mg and 12mg/25mg in olanzapine/fluoxetine.Along with going deep into disease research, and the situation of clinical application, its recipe quantity also can change, but must not as the restriction to technical solution of the present invention.
The preparation method of a kind of compound recipe olanzapine fluoxetine hydrochloride capsules provided by the invention, comprises the steps:
Weigh recipe quantity olanzapine, fluoxetine Hydrochloride and pregelatinized Starch and carry out blended mixture, mixture is sieved more than 60 orders, then through mixer mix (as: 20 minutes), prepare into intermediate (i.e. compound recipe olanzapine fluoxetine Hydrochloride), after taking mixed powder detection olanzapine and fluoxetine Hydrochloride content, carry out capsule filling.
The preparation method of another kind of compound recipe olanzapine fluoxetine hydrochloride capsules provided by the invention, comprises the steps:
Weigh recipe quantity olanzapine to mix with the pregelatinized Starch of part recipe quantity, mix with the fluoxetine Hydrochloride of recipe quantity again, the pregelatinized Starch being eventually adding remaining recipe quantity mixes, then the screening more than 60 orders, then through mixer mix (as: 20 minutes), prepare into intermediate (i.e. compound recipe olanzapine fluoxetine Hydrochloride), take mixed powder detection olanzapine and fluoxetine Hydrochloride content, after meeting intermediate standard, carry out capsule filling.
The preparation method of various compound recipe olanzapine fluoxetine hydrochloride capsules provided by the invention, the ratio that olanzapine mixes with pregelatinized Starch is mass ratio 1/20～1/1, wherein prioritizing selection 1/10.
The beneficial effect that technical solution of the present invention realizes:
Preparation method provided by the invention achieves producing compound recipe olanzapine fluoxetine hydrochloride capsules agent, take adjustment is produced the multiple means such as scheme and adjuvant, the dissolubility making active component olanzapine and fluoxetine Hydrochloride is dramatically increased than conventional technical scheme, be conducive to the performance of drug effect, related data is suitable with commercial like product, and entirety is better than commercial like product.
Detailed description of the invention
Technical scheme described in detail below.The embodiment of the present invention is only in order to illustrate technical scheme and unrestricted, although the present invention being described in detail with reference to preferred embodiment, it will be understood by those within the art that, the technical scheme of invention can be modified or equivalent replacement, without deviating from the spirit and scope of technical solution of the present invention, it all should be encompassed in scope of the presently claimed invention.
Embodiment 1.
Weigh recipe quantity olanzapine 60.46g respectively, fluoxetine Hydrochloride 279.6g, each three parts of pregelatinized Starch 1660.5g, three parts of recipe quantity olanzapine 60.46g are all mixed with the pregelatinized Starch 166.05g of 1/10 recipe quantity, mix with the fluoxetine Hydrochloride of 279.6g recipe quantity again, every part of remaining 1494.45g pregelatinized Starch finally adds mixed powder mix, cross 60 orders, 100 orders and 160 mesh sieves respectively, mix 20 minutes then through mixer, prepare into intermediate, detect its dissolution (referring to table 1).
Table 1
Embodiment 2
Weigh recipe quantity olanzapine 60.46g respectively, fluoxetine Hydrochloride 279.6g, each three parts of pregelatinized Starch 1660.5g, three parts of recipe quantity olanzapine 60.46g are mixed with pregelatinized Starch 83.03g, 166.05g, 1660.5g of 1/20,1/10 and 1 part of recipe quantity respectively, mix with the fluoxetine Hydrochloride of 279.6g recipe quantity again, finally every part of remaining 1577.47g, 1494.45g and 0g pregelatinized Starch are added mixed powder and mix, mixed powder is crossed 60 mesh sieves, mix 20 minutes then through mixer, prepare into intermediate, detect its dissolution (referring to table 2).
Table 2
Embodiment 3
Weigh recipe quantity olanzapine 60.46g respectively, fluoxetine Hydrochloride 279.6g, each three parts of pregelatinized Starch 1660.5g, the pregelatinized Starch 166.05g of first part of recipe quantity olanzapine 60.46g and 1/10 recipe quantity is mixed, mix with the fluoxetine Hydrochloride of 279.6g recipe quantity again, be eventually adding remaining 1494.45g pregelatinized Starch and mix；The fluoxetine Hydrochloride of second part of recipe quantity olanzapine 60.46g and 279.6g recipe quantity is mixed, then mixes with the pregelatinized Starch 166.05g of 1/10 recipe quantity, be eventually adding remaining 1494.45g pregelatinized Starch and mix；The pregelatinized Starch 166.05g of the fluoxetine Hydrochloride of the 3rd part of recipe quantity 279.6g recipe quantity and 1/10 recipe quantity is mixed, then mixes with recipe quantity olanzapine 60.46g, be eventually adding remaining 1494.45g pregelatinized Starch and mix；Mixed powder is crossed 60 mesh sieves, mixes 20 minutes then through mixer, prepare into intermediate, detection dissolution (referring to table 3).
Table 3
Embodiment 4
With reference to two annex XIXC crude drug of " Chinese Pharmacopoeia " version in 2010 and pharmaceutical preparation stability test guideline, we have carried out influence factor's experiment with same specification commercial samples at centering test agent specification 2 (olanzapine/fluoxetine is calculated as: 6mg/25mg), the results detailed in Table 4 and table 5.
Table 4 olanzapine fluoxetine hydrochloride capsules influence factor's result of the test (specification 2)
Table 5 olanzapine fluoxetine hydrochloride capsules influence factor's result of the test (commercial samples)
From table 4 and table 5, the olanzapine fluoxetine Hydrochloride preparation that technical solution of the present invention is produced, related data is suitable with commercial like product, and entirety is better than commercial like product.
Claims (5)
1. the preparation method of a compound recipe olanzapine fluoxetine Hydrochloride, it is characterized in that weighing recipe quantity olanzapine, fluoxetine Hydrochloride and pregelatinized Starch and carry out blended mixture, mixture is sieved more than 60 orders, mixes then through mixer, obtain compound recipe olanzapine fluoxetine Hydrochloride.
2. the preparation method of a compound recipe olanzapine fluoxetine Hydrochloride, it is characterized in that weighing recipe quantity olanzapine mixes with the pregelatinized Starch of part recipe quantity, mix with the fluoxetine Hydrochloride of recipe quantity again, the pregelatinized Starch being eventually adding remaining recipe quantity mixes, then the screening more than 60 orders, mix then through mixer, obtain compound recipe olanzapine fluoxetine Hydrochloride.
3. the preparation method of compound recipe olanzapine fluoxetine Hydrochloride according to claim 1 and 2, it is characterised in that the ratio that described olanzapine mixes with described pregelatinized Starch is mass ratio 1/20～1/1.
4. the preparation method of compound recipe olanzapine fluoxetine Hydrochloride according to claim 1 and 2, it is characterised in that the ratio that described olanzapine mixes with described pregelatinized Starch is mass ratio 1/10.
5. the preparation method of a compound recipe olanzapine fluoxetine hydrochloride capsules, it is characterised in that the compound recipe olanzapine fluoxetine Hydrochloride that the preparation method of the compound recipe olanzapine fluoxetine Hydrochloride described in claim 1 or 2 prepares is carried out capsule filling, prepares capsule.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111084778A (en) * | 2019-12-31 | 2020-05-01 | 北京鑫开元医药科技有限公司 | Olanzapine fluoxetine hydrochloride capsule and preparation method thereof |
| CN112741819A (en) * | 2020-12-11 | 2021-05-04 | 山西仟源医药集团股份有限公司 | Fluoxetine hydrochloride capsule and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1311681A (en) * | 1998-05-22 | 2001-09-05 | 伊莱利利公司 | combination therepy for treatment of refractory depression |
| CN101987090A (en) * | 2009-08-07 | 2011-03-23 | 上海秀新臣邦医药科技有限公司 | Fluoxetine capsule and preparation method thereof |
| CN102440974A (en) * | 2011-12-27 | 2012-05-09 | 天津市嵩锐医药科技有限公司 | Olanzapine orally disintegrating pharmaceutical composition |
-
2014
- 2014-12-22 CN CN201410823058.6A patent/CN105769875A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1311681A (en) * | 1998-05-22 | 2001-09-05 | 伊莱利利公司 | combination therepy for treatment of refractory depression |
| CN101987090A (en) * | 2009-08-07 | 2011-03-23 | 上海秀新臣邦医药科技有限公司 | Fluoxetine capsule and preparation method thereof |
| CN102440974A (en) * | 2011-12-27 | 2012-05-09 | 天津市嵩锐医药科技有限公司 | Olanzapine orally disintegrating pharmaceutical composition |
Non-Patent Citations (1)
| Title |
|---|
| FDA: "SYMBYAX", 《FDA APPROVED DRUG PRODUCTS》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111084778A (en) * | 2019-12-31 | 2020-05-01 | 北京鑫开元医药科技有限公司 | Olanzapine fluoxetine hydrochloride capsule and preparation method thereof |
| CN112741819A (en) * | 2020-12-11 | 2021-05-04 | 山西仟源医药集团股份有限公司 | Fluoxetine hydrochloride capsule and preparation method thereof |
| CN112741819B (en) * | 2020-12-11 | 2022-07-22 | 山西仟源医药集团股份有限公司 | Fluoxetine hydrochloride capsule and preparation method thereof |
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