CN108014087A - A kind of preparation method of sertraline hydrochloride capsules - Google Patents
A kind of preparation method of sertraline hydrochloride capsules Download PDFInfo
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- CN108014087A CN108014087A CN201711449595.9A CN201711449595A CN108014087A CN 108014087 A CN108014087 A CN 108014087A CN 201711449595 A CN201711449595 A CN 201711449595A CN 108014087 A CN108014087 A CN 108014087A
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- parts
- sertraline hydrochloride
- preparation
- magnesium stearate
- capsules
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of preparation method of sertraline hydrochloride capsules, count in parts by weight, 40 50 parts of sertraline hydrochloride, 40 60 parts of lactose, 10 20 parts of cornstarch and 0.5 2 parts of magnesium stearate are mixed, dry granulation, additional 0.1 0.5 parts of lauryl sodium sulfate and 0.5 1 parts of magnesium stearate are filled into Capsules after mixing again, to obtain the final product.The preparation method of the sertraline hydrochloride capsules of the present invention, using different prescriptions, by the dry granulation of the application, can make the product similar to existing commercial product dissolution.This method is simple, is more conducive to sample and stablizes, ensures product quality, more conducively play additional auxiliary material disintegrant effect, can corrosion also have partial disintegration, there is good practicality, easily controllable drug quality, beneficial to supply industry metaplasia production, has good economic benefit.
Description
Technical field
The invention belongs to pharmaceutical technology field, and in particular to a kind of preparation method of sertraline hydrochloride capsules.
Background technology
Sertraline hydrochloride capsules, main ingredient are：Sertraline hydrochloride, its chemical name are：(IS- is cis) -4- (3,4- bis-
Chlorphenyl) -1,2,3,4- tetrahydro-N-methyls-naphthalidine hydrochloride；Indication is used for the related disease for treating depression for Sertraline
Shape, including with anxiety, the depression with or without manic history.
In Chinese patent application CN1261793, a kind of slow release formulation of sertraline salts and Sertraline is disclosed, with
The slow release formulation of the Sertraline of speed release Sertraline when 1mgA/ is small to 40mgA/ when small.The formulation can show starting and prolong
Chi Qi, Sertraline is with the speed release less than 1mgA/ when small in the process.Further aim of the present invention is Sertraline
Acetate, Pfansteihl salt and aspartate, its Pharmaceutical composition and with the various diseases of the salts for treating and disorderly method.This
It is to prepare Sertraline acetate that invention, which also has a purpose, the method for Sertraline Pfansteihl salt and Sertraline L-Aspartic acid salt.
In Chinese patent application CN102740842A, disclose transnorsertraline preparation, salt and polymorph and
It is applied, its pharmaceutical composition, includes transnorsertraline or its pharmaceutically acceptable salt or solvate, and mannitol
Or xylitol.Divisional application (application number is proposed based on the patent and with 2015：201510354186.5), and contain original
The full content of case application.
In Chinese patent application CN106309404A, a kind of preparation of the sertraline hydrochloride capsules of high stability is disclosed
Method, described method includes following steps for this：(1) count in parts by weight, by 20-25 parts of sertraline hydrochlorides, 30-38 parts of lactose,
25-30 parts of microcrystalline celluloses, 20-22 parts of low-substituted hydroxypropyl celluloses and 5-10 parts of mannitol mixing；(2) to obtained by step (1)
Thing adds ethanol, softwood processed, sieving granulation；(3) processing is dried to step (2) gains；Whole grain is carried out afterwards；(4) will
Step (3) gains are fitted into hard gelatin capsule shell, to obtain the final product.Gained capsule of the invention has Long-term stability, at 30 DEG C, 70%
Under the conditions of RH, preserve 24 months, total impurities is no more than 0.09%；At 60 DEG C, preserved 60 days under the conditions of 92.5%RH, total impurities is not
More than 0.14%.
The content of the invention
Goal of the invention：For the deficiencies in the prior art, the object of the present invention is to provide a kind of sertraline hydrochloride glue
The preparation method of capsule, has the features such as method is simple, and product is stablized.
Technical solution：In order to realize foregoing invention purpose, the technical solution adopted by the present invention is：
A kind of preparation method of sertraline hydrochloride capsules, is counted in parts by weight, by 40-50 parts of sertraline hydrochloride, 40-60
The lactose, 10-20 parts of cornstarch and the mixing of 0.5-2 parts of magnesium stearate of part, dry granulation, then 0.1-0.5 parts additional
Lauryl sodium sulfate and 0.5-1 parts of magnesium stearate are filled into Capsules after mixing, to obtain the final product.
The concrete operations of the dry granulation are：
(1) sertraline hydrochloride is crushed, crosses 100 mesh sieves；
(2) sertraline hydrochloride, lactose, cornstarch and magnesium stearate are crossed 100 mesh sieves to be uniformly mixed；
(3) powder that step (2) is uniformly mixed is pelletized on dry granulating machine.
The prescription of the sertraline hydrochloride capsules is：40-50 parts of sertraline hydrochloride, 40-60 parts of lactose, 10-15
The cornstarch of part, 0.5-2 parts of magnesium stearate, 0.1-0.5 parts of lauryl sodium sulfate.
The preparation method of the sertraline hydrochloride capsules：Count in parts by weight, by 40-50 parts of sertraline hydrochloride, 40-
60 parts of lactose, 10-20 parts of cornstarch and the mixing of 0.5-1 parts of magnesium stearate, dry granulation, then it is 0.1-0.5 parts additional
Lauryl sodium sulfate and 0.5-1 parts magnesium stearate mix after be filled into Capsules, to obtain the final product.
The parameter of dry granulation is：Feeding frequency 12-16HZ, tabletting frequency 20-25HZ, granulation frequency 8-14HZ.
The prescription of the sertraline hydrochloride capsules is：40-50 parts of sertraline hydrochloride, 40-50 parts of lactose, 10-15
The cornstarch of part, 0.5-1.5 parts of magnesium stearate, 0.1-0.5 parts of lauryl sodium sulfate.
Beneficial effect：Compared with prior art, the preparation method of sertraline hydrochloride capsules of the invention, it is steady beneficial to sample
It is fixed, ensure product quality, there is good practicality, easily controllable drug quality, beneficial to industrialized production, has warp well
Ji benefit.
Embodiment
With reference to specific embodiment, the present invention is described further.
Embodiment 1
Count in parts by weight, by 40-50 parts of sertraline hydrochloride, 40-60 parts of lactose, 10-20 parts of cornstarch and
0.5-2 parts of magnesium stearate mixing, (dry granulating machine manufacturer starts the limited public affairs of machine-building to dry granulation for Zhangjiagang
Department, model GL2-25, operating parameter are feeding frequency 12-16HZ, tabletting frequency 20-25HZ, and pelletize frequency 8-14HZ), then
Lauryl sodium sulfate 0.1-0.5 parts additional and 0.5-1 parts of magnesium stearate are filled into Capsules after mixing, to obtain the final product.
The method as defined in this area, measures Zoloft (English trade name Zoloft, the salt of pfizer inc
Sour sertraline capsules) and the application obtained by stripping curve of the finished product in four kinds of media.
1) stripping quantity data in water, as shown in table 1.
Stripping quantity data in 1 water of table
2) the stripping quantity data in pH1.2 dissolution mediums, as shown in table 2.
Stripping quantity data of the table 2 in pH1.2 dissolution mediums
3) the stripping quantity data in pH4.5 dissolution mediums, as shown in table 3.
Stripping quantity data of the table 3 in pH4.5 dissolution mediums
4) the stripping quantity data in pH6.8 dissolution mediums, as shown in table 4.
Stripping quantity data of the table 4 in pH6.8 dissolution mediums
The prescription using the application is can be seen that from the result in table 1-4, by the dry granulation of the application, can be made
The product similar to Zoloft product dissolution.This method is more conducive to sample stabilization, ensures product quality.
Claims (6)
- A kind of 1. preparation method of sertraline hydrochloride capsules, it is characterised in that：Count in parts by weight, 40-50 parts of hydrochloric acid is given up Qu Lin, 40-60 parts of lactose, 10-20 parts of cornstarch and the mixing of 0.5-2 parts of magnesium stearate, dry granulation, then it is additional The magnesium stearate of 0.1-0.5 parts of lauryl sodium sulfate and 0.5-1 part is filled into Capsules after mixing, to obtain the final product.
- 2. the preparation method of sertraline hydrochloride capsules according to claim 1, it is characterised in that：The dry granulation Concrete operations are：（1）Sertraline hydrochloride is crushed, crosses 100 mesh sieves；（2）Sertraline hydrochloride, lactose, cornstarch and magnesium stearate are crossed 100 mesh sieves to be uniformly mixed；（3）By step（2）Uniformly mixed powder is pelletized on dry granulating machine.
- 3. the preparation method of sertraline hydrochloride capsules according to claim 1, it is characterised in that：The sertraline hydrochloride The prescription of capsule is：40-50 parts of sertraline hydrochloride, 40-60 parts of lactose, 10-15 parts of cornstarch, 0.5-2 parts hard Fatty acid magnesium, 0.1-0.5 parts of lauryl sodium sulfate.
- 4. the preparation method of the sertraline hydrochloride capsules according to claim 1 or 3, it is characterised in that：Count in parts by weight, 40-50 parts of sertraline hydrochloride, 40-60 parts of lactose, 10-20 parts of cornstarch and 0.5-1 parts of magnesium stearate are mixed, Hollow glue is filled into after dry granulation, then lauryl sodium sulfate 0.1-0.5 parts additional and the mixing of 0.5-1 parts of magnesium stearate In capsule, to obtain the final product.
- 5. according to the preparation method of claim 1-3 any one of them sertraline hydrochloride capsules, it is characterised in that：Dry granulation Parameter be：Feeding frequency 12-16HZ, tabletting frequency 20-25 HZ, granulation frequency 8-14HZ.
- 6. the preparation method of the sertraline hydrochloride capsules according to claim 1 or 3, it is characterised in that：The hydrochloric acid house The prescription of bent woods capsule is：40-50 parts of sertraline hydrochloride, 40-50 parts of lactose, 10-15 parts of cornstarch, 0.5-1.5 The magnesium stearate of part, 0.1-0.5 parts of lauryl sodium sulfate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711449595.9A CN108014087A (en) | 2017-12-27 | 2017-12-27 | A kind of preparation method of sertraline hydrochloride capsules |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711449595.9A CN108014087A (en) | 2017-12-27 | 2017-12-27 | A kind of preparation method of sertraline hydrochloride capsules |
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| Publication Number | Publication Date |
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| CN108014087A true CN108014087A (en) | 2018-05-11 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201711449595.9A Pending CN108014087A (en) | 2017-12-27 | 2017-12-27 | A kind of preparation method of sertraline hydrochloride capsules |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108888606A (en) * | 2018-09-14 | 2018-11-27 | 广州市力鑫药业有限公司 | A kind of amoxil capsule and preparation method thereof |
| CN116617189A (en) * | 2023-07-26 | 2023-08-22 | 四川尚锐生物医药有限公司 | Duloxetine hydrochloride sustained-release capsule and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1999001113A1 (en) * | 1997-07-01 | 1999-01-14 | Pfizer Products Inc. | Gelatine encapsulated solution dosage forms of sertraline |
| CN1261273A (en) * | 1997-07-01 | 2000-07-26 | 辉瑞产品公司 | Delayed-release dosage forms of sertraline |
| CN106309404A (en) * | 2016-10-27 | 2017-01-11 | 四川省百草生物药业有限公司 | High-stability sertraline hydrochloride capsule and preparation method thereof |
-
2017
- 2017-12-27 CN CN201711449595.9A patent/CN108014087A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1999001113A1 (en) * | 1997-07-01 | 1999-01-14 | Pfizer Products Inc. | Gelatine encapsulated solution dosage forms of sertraline |
| CN1261273A (en) * | 1997-07-01 | 2000-07-26 | 辉瑞产品公司 | Delayed-release dosage forms of sertraline |
| CN106309404A (en) * | 2016-10-27 | 2017-01-11 | 四川省百草生物药业有限公司 | High-stability sertraline hydrochloride capsule and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 杨宗发: "《药物制剂设备》", 31 August 2014, 人民军医出版社 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108888606A (en) * | 2018-09-14 | 2018-11-27 | 广州市力鑫药业有限公司 | A kind of amoxil capsule and preparation method thereof |
| CN116617189A (en) * | 2023-07-26 | 2023-08-22 | 四川尚锐生物医药有限公司 | Duloxetine hydrochloride sustained-release capsule and preparation method thereof |
| CN116617189B (en) * | 2023-07-26 | 2023-09-26 | 四川尚锐生物医药有限公司 | Duloxetine hydrochloride sustained-release capsule and preparation method thereof |
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Application publication date: 20180511 |