CN106619484A - Formula of tinidazole suppository and preparation technology of tinidazole suppository - Google Patents
Formula of tinidazole suppository and preparation technology of tinidazole suppository Download PDFInfo
- Publication number
- CN106619484A CN106619484A CN201710123983.1A CN201710123983A CN106619484A CN 106619484 A CN106619484 A CN 106619484A CN 201710123983 A CN201710123983 A CN 201710123983A CN 106619484 A CN106619484 A CN 106619484A
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- China
- Prior art keywords
- tinidazole
- suppository
- temperature
- substrate
- filling
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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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
- A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
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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)
- Gynecology & Obstetrics (AREA)
- Reproductive Health (AREA)
- Urology & Nephrology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to a formula of tinidazole suppository and preparation technology of the tinidazole suppository. The formula of the tinidazole suppository comprises the following components: 1000g/1000 grains of tinidazole and 2000g/1000 grains of mixed fatty acid glyceride (36-type). The preparation technology comprises the steps of weighing matrix according to a formula ratio, adding the weighed matrix into a matrix melting tank, and controlling the melting temperature to be 70 DEG C; adding the dissolved matrix into an emulsification tank, adding a weighed tinidazole raw material into the matrix, and stirring for 30min for emulsifying; stopping emulsification stirring, replenishing an interlayer with cooling water until the liquid medicine is cooled to 50 DEG C, starting a delivery pump, conveying the liquid medicine to a filling and sealing station and waiting for being filled and sealed; controlling the temperature of a filling barrel to be 50 DEG C, the temperature of a blanking valve to be 45 DEG C, the filling temperature to be 45 DEG C and the grain weight to be 3.0g/grain, and filling to obtain the tinidazole suppository. The tinidazole suppository is higher in main drug concentration, good in uniformity and good in treatment effect.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, is related to the formula and its preparation technology of a kind of tinidazole suppositories.
Background technology
Tinidazole suppositories, its principal agent composition Tinidazole has suppression or killing action to infusorian and most of anaerobe, therefore suitable
For trichomonal vaginitis and bacterial vaginosis.
The content of tinidazole suppositories is that parts by weight are for 5-25, and its preparation method in existing Tinidazole suppository：Will place
Side's amount suppository base and acidulant add heat fusing, when the temperature to 60 DEG C, add the raw material fine powder containing Tinidazole for crossing 80 mesh sieves,
Stir rapidly to solidifying, fill is obtained final product.
It can be seen that, the principal agent concentration of existing Tinidazole suppository is not high, and preparation process is not accurately controlled, and medicinal liquid exists
Easily solidify in pouring process, Tinidazole is susceptible to sedimentation, the lack of homogeneity of principal agent, therefore the final finished product for obtaining, in reality
Use in, absorb it is insufficient, it is impossible to play optimal curative effect.
The content of the invention
In order to overcome the above-mentioned deficiency of prior art, the present invention to provide a kind of formula and its preparation technology of tinidazole suppositories,
It contains, and principal agent concentration is larger, and uniformity is good, and therapeutic effect is good.
The present invention solves the technical scheme of its technical problem employing：
A kind of formula of tinidazole suppositories, is made up of following component：Tinidazole 1000g/1000 grain, mixed fatty glycerides
(36 type) 2000g/1000 grains.
A kind of technique for preparing tinidazole suppositories described in claim 1, step is as follows：First, the mixing-in fat of formula ratio is weighed
Used as in the molten substrate tank of substrate input, 70 DEG C of setting substrate melt temperature makes substrate melting standby to acid glyceride (36 type)；2nd,
Substrate after dissolving is added in emulsion tank, load weighted Tinidazole raw material is added in substrate, close emulsifying tank mouth, setting breast
Change mixing speed and emulsification times, start emulsifying stirring and emulsifying 30 minutes；3rd, emulsifying stirring is closed, interlayer is passed through cooling water extremely
Fluid temperature is down to 50 DEG C, and medicinal liquid is delivered to embedding post and treats embedding by startup delivery pump；4th, filling is set respectively by technological requirement
50 DEG C of barrel temperature of note, baiting valve temperature 45 C, 45 DEG C of filling temperature, grain weight 3.0g/ grains, in injection PVC bolt moulds, rapid cooling,
Edging heat seal, packaging is obtained final product.
Compared to existing technology, the formula and its preparation technology of a kind of tinidazole suppositories of the invention, prepared tinidazole suppositories
Concentration containing principal agent is larger, per piece of grain weight (3g) 1g containing Tinidazole, can more effectively play to infusorian and most of anaerobe
There are suppression or killing action；And the control for passing through preparation process condition, 50 DEG C of barrel temperature of perfusion, baiting valve temperature 45 C, filling
Note temperature 45 C, it is higher 5-10 DEG C than general suppository technological temperature, and the process of medicinal liquid is conveyed, in interlayer cooling water is passed through to medicine
Liquid temp is down to 50 DEG C, keeps suitable and stablizes, and solidifies in pouring process so as to avoid medicinal liquid；Emulsification times are set in 30
Minute, beneficial to uniformity control；Ceaselessly stirring and medicinal liquid circulation, can prevent Tinidazole from settling in pouring process, keep equal
Even property；So final therapeutic effect is more preferably.
Description of the drawings
With reference to the accompanying drawings and examples the present invention is further described.
Fig. 1 is that embodiment of the present invention tinidazole suppositories carry out continuous stability and keep sample the data analysiss curve of investigation.
Fig. 2 is that embodiment of the present invention tinidazole suppositories carry out melting the interpretation of result curve for becoming overtime check.
Specific embodiment
To make purpose, technical scheme and the advantage of the embodiment of the present invention clearer, below in conjunction with accompanying drawing of the present invention and
Embodiment, is clearly and completely described to the technical scheme in the embodiment of the present invention, it is clear that described embodiment is this
A part of embodiment of invention, rather than the embodiment of whole.Based on the embodiment in the present invention, those of ordinary skill in the art
The every other embodiment obtained under the premise of creative work is not made, belongs to protection scope of the present invention.
Embodiment：
The first step：According to per 1000 Tinidazole containing 1000g and 2000g mixed fatty glycerides (36 type), weigh and match somebody with somebody
Used as in the molten substrate tank of substrate input, 70 DEG C of setting substrate melt temperature makes base to the mixed fatty glycerides (36 type) of side's amount
Matter melting is standby；
Second step：Substrate after dissolving is added in emulsion tank, load weighted Tinidazole raw material is added in substrate, closed
Emulsifying tank mouth, setting emulsification stirring speed and emulsification times, start emulsifying stirring and emulsifying 30 minutes；
3rd step：Emulsifying stirring is closed, interlayer is passed through cooling water to fluid temperature and is down to 50 DEG C, start delivery pump by medicinal liquid
It is delivered to embedding post and treats embedding；
4th step：50 DEG C of barrel temperature of perfusion, baiting valve temperature 45 C, 45 DEG C of filling temperature are set respectively by technological requirement,
Grain weight 3.0g/ grains, in injection PVC bolt moulds, rapid cooling, edging heat seal, packaging is obtained final product.
Keep sample investigation to carrying out continuous stability by tinidazole suppositories obtained in the embodiment of the present invention, be reported as follows table 1, number
See Fig. 1 according to analysis curve, while also it is carried out to melt change overtime check, as a result such as table 2, interpretation of result curve such as Fig. 2.
The tinidazole suppositories of table 1 carry out continuous stability and keep sample the analysis report of investigation
| Lot number | Investigate month | 0 month | March | June | September | December | 18 months | 24 months |
| 14030901 | Assay | 102.8% | 101.1% | 103.2% | 102.5% | 100.9% | 103.3% | 100.4% |
The tinidazole suppositories of table 2 carry out melting the analysis report for becoming overtime check
| Lot number | Investigate month | 0 month | March | June | September | December | 18 months | 24 months |
| 14030901 | Melt the change time limit | 17 | 17 | 17 | 17 | 18 | 18 | 18 |
Referring to Fig. 1 and Biao 1, the investigation by keeping sample for 0,3,6,9,12,18,24 months to 14030901 batch of tinidazole suppositories finds
Content was maintained at 100 or so before bound, more stable；Referring to Fig. 2 and Biao 2, melt change the time limit be maintained at 15-20
Between, and amplitude of variation is little, it is seen that melt the change time limit more stable.Thus illustrate the product of the embodiment of the present invention in the effect phase
Requirement stable in properties in interior storage process, can reaching quality standards.
The above, is only presently preferred embodiments of the present invention, not does any pro forma restriction to the present invention, it is every according to
According to the technical spirit of the present invention, any simple modification and equal change are made to above example, each fall within the guarantor of the present invention
Within the scope of shield.
Claims (2)
1. a kind of formula of tinidazole suppositories, is characterized in that, is made up of following component：
Tinidazole 1000g/1000 grain,
Mixed fatty glycerides (36 type) 2000g/1000 grains.
2. a kind of technique for preparing tinidazole suppositories described in claim 1, is characterized in that：Step is as follows
First, the mixed fatty glycerides (36 type) for weighing formula ratio are melted in substrate tank as substrate input, setting substrate melting
Temperature 70 C, makes substrate melting standby；
2nd, the substrate after dissolving is added in emulsion tank, load weighted Tinidazole raw material is added in substrate, close emulsion tank
Mouthful, emulsification stirring speed and emulsification times are set, start emulsifying stirring and emulsifying 30 minutes；
3rd, emulsifying stirring is closed, interlayer is passed through cooling water to fluid temperature and is down to 50 DEG C, starts delivery pump and medicinal liquid is delivered to into filling
Treat embedding in envelope post；
4th, 50 DEG C of barrel temperature of perfusion, baiting valve temperature 45 C, 45 DEG C of filling temperature, grain weight 3.0g/ are set respectively by technological requirement
Grain, in injection PVC bolt moulds, rapid cooling, edging heat seal, packaging is obtained final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710123983.1A CN106619484A (en) | 2017-03-03 | 2017-03-03 | Formula of tinidazole suppository and preparation technology of tinidazole suppository |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710123983.1A CN106619484A (en) | 2017-03-03 | 2017-03-03 | Formula of tinidazole suppository and preparation technology of tinidazole suppository |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106619484A true CN106619484A (en) | 2017-05-10 |
Family
ID=58847911
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710123983.1A Pending CN106619484A (en) | 2017-03-03 | 2017-03-03 | Formula of tinidazole suppository and preparation technology of tinidazole suppository |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN106619484A (en) |
-
2017
- 2017-03-03 CN CN201710123983.1A patent/CN106619484A/en active Pending
Non-Patent Citations (1)
| Title |
|---|
| 王克森，徐传新，董珩，谢文耀: "替硝唑栓的研制及临床应用", 《中国医院药学杂志》 * |
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| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20170510 |