CN107080736A - A kind of preparation method of lorazepam tablet - Google Patents
A kind of preparation method of lorazepam tablet Download PDFInfo
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- CN107080736A CN107080736A CN201710173574.2A CN201710173574A CN107080736A CN 107080736 A CN107080736 A CN 107080736A CN 201710173574 A CN201710173574 A CN 201710173574A CN 107080736 A CN107080736 A CN 107080736A
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- Prior art keywords
- lorazepam
- preparation
- tablet
- inclusion compound
- mixed
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
- A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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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)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to medical production technical field, more particularly to a kind of preparation method of lorazepam tablet.The preparation method of the lorazepam tablet, it is characterised in that：Comprise the following steps：（1）Prepare the bag and solution of saturation；（2）Prepare Lorazepam inclusion compound；（3）Crush；（4）Supplementary material is mixed；（5）Tabletting, packaging.Preparation method of the present invention can improve the stability of medicine, disintegration of tablet efficiency is improved, improves the hardness of tablet, increases the dissolution rate of medicine, it is easily absorbed by the body, heighten the effect of a treatment, improve the bioavilability of medicine, avoid the pelletization of complexity, alleviate labor intensity, technique is simple, easy to operate, time saving and energy saving；Product is also avoided simultaneously in process of production because of the excessive risk easily polluted to product of process.
Description
Technical field
The present invention relates to medical production technical field, more particularly to a kind of preparation method of lorazepam tablet.
Background technology
The active ingredient of lorazepam tablet is Lorazepam, and chemistry is entitled：The chloro- 5- of 7-（2- chlorphenyls）- 3- hydroxyls -1,3-
Dihydro -2H-1,4 benzodiazepine -2- ketone belong to national two classes psychotropic substances, and for tranquilizing soporific, wherein the medicine is anti-
Anxiety, which is acted on, acts on most strong in this class medicine.The preparation method of existing lorazepam tablet be by supplementary material it is well mixed after,
Plus ethanol solution softwood, then pelletized, dried, whole grain, the operating procedure such as tabletting, the dissolution rate of its tablet is relatively low, is 80%
~ 90% or so.
The content of the invention
There is provided a kind of dissolution rate is fast, bioavilability is high, good effect for the defect that makes up prior art by the present invention
Lorazepam tablet preparation method.
The present invention is achieved through the following technical solutions：
A kind of preparation method of lorazepam tablet, it is characterised in that：Comprise the following steps：
（1）Prepare the inclusion complex in solution of saturation：The beta-schardinger dextrin of 1 times of amount is added into the 5-6 times of purified water measured, heat temperature raising is stirred
Mix the Benexate Hydrochloride solution that dissolved clarification is made 6-7 times, press filtration while hot after cooling, filtrate clarification, heat preservation for standby use；
（2）Prepare Lorazepam inclusion compound：The Lorazepam of 1 times of amount is taken, the 20-30 times of acetone measured is added, heating dissolved clarification is made
3.3-5% Lorazepam-acetone soln, the step of 25-30 times of addition is measured（1）In the beta-schardinger dextrin saturated solution for preparing, stir
1-2h is mixed, stops heating, is further continued for stirring 3-6h, obtains and rejection filter is carried out after white depositions, standing, wet product is placed in 60-70 DEG C
Vacuum drying chamber in vacuum drying 10h, obtain the 4.5-4.9 times of Lorazepam measured inclusion compound；
（3）Crush：By step（2）Gained Lorazepam inclusion compound is crushed, and crosses 120 mesh sieves, standby；By starch, low-substituted hydroxypropyl
Base cellulose, lactose, magnesium stearate cross 80 mesh sieves respectively, standby；
（4）Supplementary material is mixed：By step（3）Lorazepam inclusion compound after sieving is all added in mixer, add with
The low-substituted hydroxypropyl cellulose of its equivalent, mixes 20min, obtains mixed powder, and 10 times of amounts of Lorazepam inclusion compound are weighed respectively
The step of（2）Starch, the lactose of gained are added in mixed powder, are mixed 40min, are obtained dry powder, then add dry powder total amount
1% magnesium stearate, mixing 10min after, sample examination dry powder content, its limit be labelled amount 100%；
（5）Tabletting, packaging：Carry out direct tablet compressing to dry powder using oblique flat punch die, sample examination, it is qualified after, carry out bubble-cap plastic-aluminum
Packing machine is packed.
Further, step（1）Described heat temperature raising temperature is 60-80 DEG C.
The step（1）Press filtration while hot is cooled to after 40-50 DEG C, and holding temperature is 40-50 DEG C.
Step（2）The Lorazepam is added in acetone, and dissolved clarification is heated to 40-50 DEG C, and whipping temp is 40-50 DEG C.
Step（2）The static conditions of gained white depositions are：10-20h is stood at 0-10 DEG C of temperature.
Step（3）The Lorazepam inclusion compound crosses 120 mesh sieves, starch, low-substituted hydroxypropyl cellulose, lactose, tristearin
Sour magnesium crosses 80 mesh sieves.
The beneficial effects of the invention are as follows：（1）The present invention is using beta-schardinger dextrin as bag and material, and the Laura with slightly solubility is western
Dissolve raw material and form inclusion complex in solution in acetone, the inclusion compound can improve the stability of medicine, increase the dissolution rate of medicine, increase
Strong curative effect, improves the bioavilability of medicine, reduces excitant and toxic side effect of medicine etc..
（2）From low-substituted hydroxypropyl cellulose as new auxiliary material, low-substituted hydroxypropyl cellulose is new many work(
The pharmaceutic adjuvant of energy, can both make the adhesive of tablet, the disintegrant of tablet can be done again, be a kind of neutral harmless fibre
The plain derivative of dimension.Not only do not play any chemical reaction in itself with medicament, do not affect the treatment, but also can promote pharmaceutical compositions to
Permeated in blood, thus curative effect can be increased substantially；Compared with traditional excipient substance, its good moldability, it is possible to increase tablet
Efficiency is disintegrated, improves the hardness of tablet, accelerates the dissolution rate of medicine, it is easily absorbed by the body, bioavilability is improved, therefore carry
The high curative effect of medicine.
（3）Change traditional operations such as softwood processed after original raw material is mixed with auxiliary material, granulation, dry, dry-mixed, tabletting
Step, using supplementary material dry powder blend, direct tablet compressing avoids the pelletization of complexity, alleviates labor intensity, technique letter
It is single, it is easy to operate, it is time saving and energy saving；Product is also avoided simultaneously in process of production because of the excessive wind easily polluted to product of process
Danger.
Embodiment
Embodiment 1
A kind of preparation method of lorazepam tablet, comprises the following steps：
（1）Prepare the inclusion complex in solution of saturation：8Kg beta-schardinger dextrins are added into 40Kg purified waters, 80 DEG C are heated to, stirred molten
It is clear to be formed after beta-schardinger dextrin saturated solution, it is cooled to press filtration while hot after 50 DEG C, filtrate clarification, in 40-50 DEG C of heat preservation for standby use；
（2）Prepare Lorazepam inclusion compound：2Kg Lorazepams are taken, is added in 40Kg acetone, is heated to dissolved clarification in 50 DEG C and is made 5%
Lorazepam-acetone soln, then add step（1）In prepare 48 DEG C of beta-schardinger dextrin saturated solution 42Kg, in 40-50
DEG C stirring 2h, stop heating, be further continued for stir 6h, obtain white depositions, in 0-10 DEG C stand 10h after carry out rejection filter, by wet product
Vacuum drying 10h in 60-70 DEG C of vacuum drying chamber is placed in, Lorazepam inclusion compound 9.3kg is obtained；
（3）Crush：By step（2）Gained Lorazepam inclusion compound is crushed, and crosses 120 mesh sieves, standby；By starch, low-substituted hydroxypropyl
Base cellulose, lactose, magnesium stearate cross 80 mesh sieves, standby；
（4）Supplementary material is mixed：By step（3）Lorazepam inclusion compound 9.3kg, low-substituted hydroxypropyl cellulose after sieving
9.3kg is added separately in mixer, and mixing 20min obtains mixed powder, by step（2）Gained starch 93kg, lactose 93kg add
Enter in mixed powder, mix 40min, then add after the .1kg of magnesium stearate 2, mixing 10min, sample examination determines dry powder and contained
Amount, limit is the 100% of labelled amount；
（5）Tabletting, packaging：Sample examination, it is qualified after, carry out bubble-cap Aluminium-coating Packer packaging.
Embodiment 2
A kind of preparation method of lorazepam tablet, comprises the following steps：
（1）Prepare the inclusion complex in solution of saturation：10Kg beta-schardinger dextrins are added into 55Kg purified waters, 70 DEG C, stirring are heated to
After dissolved clarification formation beta-schardinger dextrin saturated solution, press filtration while hot after 45 DEG C, filtrate clarification, in 40-50 DEG C of heat preservation for standby use are cooled to；
（2）Prepare Lorazepam inclusion compound：2.5Kg Lorazepams are taken, adds in 62.5Kg acetone, dissolved clarification system is heated in 47 DEG C
Into 4% Lorazepam-acetone soln, step is then added（1）In prepare 45 DEG C of beta-schardinger dextrin saturated solution 65Kg, in
40-50 DEG C of stirring 1.5h, stops heating, is further continued for stirring 4h, obtains white depositions, and rejection filter is carried out after standing 15h in 0-10 DEG C,
10h is dried in vacuo in the vacuum drying chamber that wet product is placed in 60-70 DEG C, Lorazepam inclusion compound 11.5kg is obtained；
（3）Crush：By step（2）Gained Lorazepam inclusion compound is crushed, and crosses 120 mesh sieves, standby；By starch, low-substituted hydroxypropyl
Base cellulose, lactose, magnesium stearate cross 80 mesh sieves, standby；
（4）Supplementary material is mixed：By step（3）Lorazepam inclusion compound 11.5kg, low-substituted hydroxypropyl cellulose after sieving
11.5kg is added separately in mixer, and mixing 20min obtains mixed powder, by step（2）Gained starch 115kg, lactose 115kg
Add in mixed powder, mix 40min, then add after magnesium stearate 2.5kg, mixing 10min, sample examination determines dry powder and contained
Amount, limit is the 100% of labelled amount；
（5）Tabletting, packaging：Sample examination, it is qualified after, carry out bubble-cap Aluminium-coating Packer packaging.
Embodiment 3
A kind of preparation method of lorazepam tablet, comprises the following steps：
（1）Prepare the inclusion complex in solution of saturation：12Kg beta-schardinger dextrins are added into 72Kg purified waters, 60 DEG C, stirring are heated to
After dissolved clarification formation beta-schardinger dextrin saturated solution, press filtration while hot after 40 DEG C, filtrate clarification, in 40-50 DEG C of heat preservation for standby use are cooled to；
（2）Prepare Lorazepam inclusion compound：3Kg Lorazepams are taken, is added in 90Kg acetone, is heated to dissolved clarification in 40 DEG C and is made
3.3% Lorazepam-acetone soln, then adds step（1）In prepare 43 DEG C of beta-schardinger dextrin saturated solution 93Kg, in
40-50 DEG C of stirring 1h, stops heating, is further continued for stirring 3h, obtains white depositions, and rejection filter is carried out after standing 20h in 0-10 DEG C, will
Wet product is placed in vacuum drying 10h in 60-70 DEG C of vacuum drying chamber, obtains Lorazepam inclusion compound 13.6kg；
（3）Crush：By step（2）Gained Lorazepam inclusion compound is crushed, and crosses 120 mesh sieves, standby；By starch, low-substituted hydroxypropyl
Base cellulose, lactose, magnesium stearate cross 80 mesh sieves, standby；
（4）Supplementary material is mixed：By step（3）Lorazepam inclusion compound 13.6kg, low-substituted hydroxypropyl cellulose after sieving
13.6kg is added separately in mixer, and mixing 20min obtains mixed powder, by step（2）Gained starch 136kg, lactose 136kg
Add in mixed powder, mix 40min, then add after magnesium stearate 3kg, mixing 10min, sample examination determines dry powder content,
Limit is the 100% of labelled amount；
（5）Tabletting, packaging：Sample examination, it is qualified after, carry out bubble-cap Aluminium-coating Packer packaging.
Claims (6)
1. a kind of preparation method of lorazepam tablet, it is characterised in that：Comprise the following steps：
（1）Prepare the inclusion complex in solution of saturation：The beta-schardinger dextrin of 1 times of amount is added into the 5-6 times of purified water measured, heat temperature raising is stirred
Mix the Benexate Hydrochloride solution that dissolved clarification is made 6-7 times, press filtration while hot after cooling, filtrate clarification, heat preservation for standby use；
（2）Prepare Lorazepam inclusion compound：The Lorazepam of 1 times of amount is taken, the 20-30 times of acetone measured is added, heating dissolved clarification is made
3.3-5% Lorazepam-acetone soln, the step of 25-30 times of addition is measured（1）In the beta-schardinger dextrin saturated solution for preparing, stir
1-2h is mixed, stops heating, is further continued for stirring 3-6h, obtains and rejection filter is carried out after white depositions, standing, wet product is placed in 60-70 DEG C
Vacuum drying chamber in vacuum drying 10h, obtain the 4.5-4.9 times of Lorazepam measured inclusion compound；
（3）Crush：By step（2）Gained Lorazepam inclusion compound is crushed, and crosses 120 mesh sieves, standby；By starch, low-substituted hydroxypropyl
Base cellulose, lactose, magnesium stearate cross 80 mesh sieves respectively, standby；
（4）Supplementary material is mixed：By step（3）Lorazepam inclusion compound after sieving is all added in mixer, add with
The low-substituted hydroxypropyl cellulose of its equivalent, mixes 20min, obtains mixed powder, and 10 times of amounts of Lorazepam inclusion compound are weighed respectively
The step of（2）Starch, the lactose of gained are added in mixed powder, are mixed 40min, are obtained dry powder, then add dry powder total amount
1% magnesium stearate, mixing 10min after, sample examination dry powder content；
（5）Tabletting, packaging：Carry out direct tablet compressing to dry powder using oblique flat punch die, sample examination, it is qualified after, carry out bubble-cap plastic-aluminum
Packing machine is packed.
2. the preparation method of lorazepam tablet according to claim 1, it is characterised in that：Step（1）Described heating liter
Temperature is 60-80 DEG C.
3. the preparation method of lorazepam tablet according to claim 1, it is characterised in that：The step（1）It is cooled to 40-
Press filtration while hot after 50 DEG C, holding temperature is 40-50 DEG C.
4. the preparation method of lorazepam tablet according to claim 1, it is characterised in that：Step（2）The Lorazepam
Add in acetone, dissolved clarification is heated to 40-50 DEG C, whipping temp is 40-50 DEG C.
5. the preparation method of lorazepam tablet according to claim 1, it is characterised in that：Step（2）Gained white precipitate
The static conditions of thing are：10-20h is stood at 0-10 DEG C of temperature.
6. the preparation method of lorazepam tablet according to claim 1, it is characterised in that：Step（3）The Lorazepam
Inclusion compound crosses 120 mesh sieves, and starch, low-substituted hydroxypropyl cellulose, lactose, magnesium stearate cross 80 mesh sieves.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710173574.2A CN107080736A (en) | 2017-03-22 | 2017-03-22 | A kind of preparation method of lorazepam tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710173574.2A CN107080736A (en) | 2017-03-22 | 2017-03-22 | A kind of preparation method of lorazepam tablet |
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| CN201710173574.2A Pending CN107080736A (en) | 2017-03-22 | 2017-03-22 | A kind of preparation method of lorazepam tablet |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115737579A (en) * | 2022-11-24 | 2023-03-07 | 华中药业股份有限公司 | Lorazepam tablet and preparation method thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS584715A (en) * | 1981-07-02 | 1983-01-11 | Ota Seiyaku Kk | Solid preparation containing lorazepam |
| EP1004318A2 (en) * | 1991-06-21 | 2000-05-31 | Takeda Chemical Industries, Ltd. | Cyclodextrin composition |
| CN1379047A (en) * | 2002-05-10 | 2002-11-13 | 刘云清 | Match of organic medicine and beta-cyclodextrin derivative and its preparing process |
| CN102006860A (en) * | 2008-04-04 | 2011-04-06 | 荣威·诺伯特 | Pharmaceutical preparation comprising permethylated cyclodextrin |
| CN104546749A (en) * | 2014-12-25 | 2015-04-29 | 海南卫康制药(潜山)有限公司 | Lorazepam composition freeze-dried tablet and preparation method thereof |
-
2017
- 2017-03-22 CN CN201710173574.2A patent/CN107080736A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS584715A (en) * | 1981-07-02 | 1983-01-11 | Ota Seiyaku Kk | Solid preparation containing lorazepam |
| EP1004318A2 (en) * | 1991-06-21 | 2000-05-31 | Takeda Chemical Industries, Ltd. | Cyclodextrin composition |
| CN1379047A (en) * | 2002-05-10 | 2002-11-13 | 刘云清 | Match of organic medicine and beta-cyclodextrin derivative and its preparing process |
| CN102006860A (en) * | 2008-04-04 | 2011-04-06 | 荣威·诺伯特 | Pharmaceutical preparation comprising permethylated cyclodextrin |
| CN104546749A (en) * | 2014-12-25 | 2015-04-29 | 海南卫康制药(潜山)有限公司 | Lorazepam composition freeze-dried tablet and preparation method thereof |
Non-Patent Citations (5)
| Title |
|---|
| CHANTAL HOLVOET ET AL: "Inclusion Complexation of Lorazepam with Different Cyclodextrins Suitable for Parenteral Use", 《DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY》 * |
| N.M.SANGHAVI ET AL: "INCLUSION COMPLEXATION OF LORAZEPAM WITH β-CYCLODEXTRIN", 《DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY》 * |
| RAKESH PATEL ET AL: "Solid-state characterization and in vitro dissolution behavior of lorazepam: Hydroxypropyl- -cyclodextrin inclusion complex", 《DRUG DISCOVERIES & THERAPEUTICS》 * |
| RENATA KOBETIC ET AL: "Study of the lorazepam: cyclodextrin inclusion complexes using electrospray ionization mass spectrometry", 《TETRAHEDRON LETTERS》 * |
| 张炳盛等主编: "《中药药剂学》", 28 February 2013, 中国医药科技出版社 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115737579A (en) * | 2022-11-24 | 2023-03-07 | 华中药业股份有限公司 | Lorazepam tablet and preparation method thereof |
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Application publication date: 20170822 |
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