CN108186638A - The pharmaceutical composition of isoniazid - Google Patents
The pharmaceutical composition of isoniazid Download PDFInfo
- Publication number
- CN108186638A CN108186638A CN201810190149.9A CN201810190149A CN108186638A CN 108186638 A CN108186638 A CN 108186638A CN 201810190149 A CN201810190149 A CN 201810190149A CN 108186638 A CN108186638 A CN 108186638A
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- CN
- China
- Prior art keywords
- isoniazid
- composition
- lubricant
- added
- izonid
- Prior art date
- 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
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4409—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 4, e.g. isoniazid, iproniazid
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
Abstract
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of pharmaceutical composition of isoniazid.The composition includes isoniazid, pregelatinized starch, PVP K30, glidant and lubricant.The composition reduces generation of the isoniazid in relation to substance, improves the dissolution rate of isoniazid in tablet, enhance the chemical stability of preparation by the selection of filler and lubricant type.The composition can be prepared into Izonid Tablets, preparation method is simple, it is feasible, be easily achieved the big production of industrialization.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of pharmaceutical composition of isoniazid.
Background technology
Tuberculosis is the chronic infectious disease as caused by mycobacterium tuberculosis infection.Tulase may invade the various devices of Whole Body
Official, but mainly invade lungs, referred to as pulmonary tuberculosis.
Tuberculosis is the incidental a kind of chronic and deferred infectious disease of young people.4~8 weeks incubation periods.Wherein 80%
Lung is happened at, other positions (neck lymph, meninx, peritonaeum, intestines, skin, bone) also can secondary infection.Interpersonal breathing
Road propagation is the major way that this disease infects.The infection sources is the lunger for contacting discharge of bacteria.With environmental pollution and AIDS
Propagation, incidence of tuberculosis is more strong.It is in clinically chronic process in addition to minority morbidity is rapid more.Often there is low-heat, weak
Etc. constitutional symptoms and cough, spitting of blood etc. respiratory systems performance.
Isoniazid is anti-mycobacterium tuberculosis medicine, for pulmonary tuberculosis, cutaneous tuberculosis etc..A kind of conjunction with bactericidal effect in isoniazid
Into antimicrobial, for this product only to mycobacteria, the bacterium of mainly growth and breeding phase is effective.Its mechanism of action not yet illustrates, may
Inhibit the synthesis of sensitive bacterial mycolic acid and make cell wall rupture.
Isoniazid bulk pharmaceutical chemicals are the crystalline powder of colourless crystallization, white or off-white color, odorless；Its fusing point is 170~173
DEG C, readily soluble in water, slightly soluble in ethyl alcohol is almost insoluble in ether.The molecular formula of isoniazid is C6H7N3O, and molecular weight is
137.14 structural formula is as follows：
In addition to above physical property, stability has also been carried out under the conditions of acid, alkali, oxygen, illumination, high temperature etc. to isoniazid
Research.The result shows that the light degradation in lighting box of the solution and solid of isoniazid, the acid degradation of 1.0mol/L hydrochloric acid solutions,
Under the conditions of the alkaline degradation of 0.1mol/L sodium hydroxide solutions, the oxidative degradation of 30% hydrogen peroxide, hydrolytic degradation, have in various degree
Degradation, quality is unstable；Stable quality under high temperature (60 DEG C), high humidity (RH92.5%)；The related object under the conditions of high temperature and humidity
Matter slightly increases.
By the information announced it is found that containing lactose in reference preparation composition, with isoniazid U.S. can occur for lactose
Maillard reaction, the substance of generation do not absorb in vivo, influence the bioavilability of product.
It finds to have disclosed a pharmaceutical composition containing isoniazid by retrieving, is that Kamp Pharmaceuticals Co., Ltd. is special
The sharp composition of 201510876951.X (in examining) containing isoniazid and preparation method thereof.It has used antioxidant in prescription,
And the magnesium stearate that Maillard reaction occurs with isoniazid is added in, have an impact to the stabilization of product.Although using certain preparation
Mode avoids reacting, but preparation method is compared with usual manner for isoniazid and metal ion, more complicated.
Therefore a kind of pharmaceutical composition for improving Izonid Tablets chemical stability is developed, conventional tablet preparation process's
On the basis of improve Izonid Tablets quality.
Invention content
In view of this, one of the objects of the present invention is to provide a kind of medicine groups for improving Izonid Tablets chemical stability
Object is closed, auxiliary material is customary adjuvant, and the generation impurity that do not react with isoniazid, improves the utilization rate of isoniazid.
To achieve the above object, the technical scheme is that：
A kind of pharmaceutical composition of isoniazid, is counted in parts by weight, and the composition includes 30~70 parts of isoniazid, pre- glue
Change 25~65 parts of starch, 0.2~2 part of povidone, 0.5~3 part of glidant, 0.5~3 part of lubricant.
As a preferred option, above-mentioned composition includes 40~60 parts of isoniazid, 35~57.5 parts of pregelatinized starch, poly- dimension
0.5~1 part of ketone, 1~2 part of glidant, 1~2 part of lubricant.
As a preferred option, above-mentioned povidone is PVP K30.
As a preferred option, above-mentioned lubricant for stearic acid, Compritol 888 ATO it is one or more.
As a preferred option, the model PC-10 of above-mentioned pregelatinized starch.
As a preferred option, above-mentioned glidant for colloidal silicon dioxide, silica it is one or more.
By the present invention in that while increasing the chemical stability of product, do not increased with the type of filler, lubricant
The difficulty of preparation process.
The filler selected as pregelatinized starch of the present invention, compared with original is ground, the present invention program is not used to be sent out with isoniazid
The lactose of raw reaction, can guarantee the bioavilability and stability of product.
Compared with patent 201510876951.X, technical scheme of the present invention is formed using common material, conventional tablet, no
The functional auxiliary material antioxidant for needing to monitor is introduced, and does not use the lubrication containing metal ion easily to react with isoniazid
Agent, using conventional easy tablet manufacturing technique, you can the product being had good stability.
The Izonid Tablets chemical stability prepared using the composition of the present invention is improved, and is generated related substance and is reduced, carries
The high utilization rate of isoniazid.
The second object of the present invention is to provide a kind of composition of purpose one in the purposes for being used to prepare Izonid Tablets,
Its preparation process is simple, and obtained Izonid Tablets chemical stability improves.
The high isoniazid of chemical stability can be prepared using conventional method in the isoniazid pharmaceutical composition of purpose one
Tablet.
The third object of the present invention is to provide a kind of method that composition of purpose one is used to prepare Izonid Tablets,
Preparation method is conventional tablet preparation process, it can be achieved that large-scale production.
To achieve the above object, the technical scheme is that：
The composition of purpose one is used to prepare the tablet of isoniazid, includes the following steps：
1) water is added to prepare wetting agent the povidone of formula ratio；
2) wetting agent granulation, the drying of step 1) by the isoniazid of formula ratio, pregelatinized starch after mixing, are added in；
3) glidant of formula ratio and mix lubricant uniformly rear tabletting are added in.
The fourth object of the present invention is to provide the tablet that a kind of method of purpose three is prepared.
To achieve the above object, the technical scheme is that：
The tablet of isoniazid is prepared using the method for purpose three for the pharmaceutical composition of the isoniazid of the present invention, stablizes
Property is strong, reduces the production in relation to substance, and be prepared only with common process, customary adjuvant.
The beneficial effects of the present invention are：
1st, pharmaceutical composition provided by the invention by Selective filling agent and the type of lubricant, is effectively reduced different cigarette
Growth in relation to substance in hydrazine tablet enhances the stability of Izonid Tablets.Efficiently solve isoniazid in Izonid Tablets
The problem of influence utilization ratio of drug is reacted with auxiliary material.And selected filler and lubricant are common auxiliary material.
2nd, pharmaceutical composition provided by the invention, preparation process is simple, is conventional tablet preparation process, it can be achieved that scale metaplasia
It produces, component is simple in prescription, cheap to commonly use auxiliary material, has saved production cost.
3rd, it is detected and found by the tablet chromatography to the present invention, isoniazid pharmaceutical composition provided by the invention is prepared different
Related content of material is substantially reduced in cigarette hydrazine tablet.
Specific embodiment
It detailed description of a preferred embodiment of the present invention will be given below.The reality of actual conditions is not specified in preferred embodiment
Proved recipe method, usually according to normal condition, illustrated embodiment are to preferably be illustrated to present disclosure, but are not
Present disclosure is only limitted to illustrated embodiment.So those skilled in the art according to foregoing invention content to embodiment party
Case carries out nonessential modifications and adaptations, still falls within protection scope of the present invention.
Embodiment 1
Preparation method is as follows
(1) prescription (weight ratio)：
Isoniazid 40.0%
Pregelatinized starch PC-10 57.5%
PVP K30 0.5%
Silica 1 .0%
Compritol 888 ATO 1.0%
Purified Water q. s
(2) it prepares：PVP K30 is added in a certain proportion of water, prepares wetting agent.Isoniazid, pregelatinated are formed sediment
Powder PC-10 after mixing, adds in wetting agent granulation, drying.Then it adds in silica and Compritol 888 ATO is uniformly mixed
Tabletting afterwards.
Embodiment 2：
(1) prescription (weight ratio)：
Isoniazid 60.0%
Pregelatinized starch PC-10 37.5%
PVP K30 0.5%
Silica 1 .0%
Compritol 888 ATO 1.0%
Purified Water q. s
(2) it prepares：PVP K30 is added in a certain proportion of water, prepares wetting agent.Isoniazid, pregelatinated are formed sediment
Powder PC-10 after mixing, adds in wetting agent granulation, drying.Then it adds in silica and Compritol 888 ATO is uniformly mixed
Tabletting afterwards.
Embodiment 3：
(1) prescription (weight ratio)：
Isoniazid 50.0%
Pregelatinized starch PC-10 47.5%
PVP K30 0.5%
Colloidal silicon dioxide 1.0%
Compritol 888 ATO 1.0%
Purified Water q. s
(2) it prepares：PVP K30 is added in a certain proportion of water, prepares wetting agent.Isoniazid, pregelatinated are formed sediment
Powder PC-10 after mixing, adds in wetting agent granulation, drying.Then colloidal silicon dioxide and Compritol 888 ATO mixing are added in
Tabletting after uniformly.
Embodiment 4：
(1) prescription (weight ratio)：
Isoniazid 50.0%
Pregelatinized starch PC-10 47.5%
PVP K30 0.5%
Silica 1 .0%
Compritol 888 ATO 1.0%
Purified Water q. s
(2) it prepares：PVP K30 is added in a certain proportion of water, prepares wetting agent.Isoniazid, pregelatinated are formed sediment
Powder PC-10 after mixing, adds in wetting agent granulation, drying.Then it adds in silica and Compritol 888 ATO is uniformly mixed
Tabletting afterwards.
Embodiment 5：
(1) prescription (weight ratio)：
Isoniazid 50.0%
Pregelatinized starch PC-10 45.0%
PVP K30 1.0%
Silica 2.0%
Stearic acid 2.0%
Purified Water q. s
(2) it prepares：PVP K30 will be added in a certain proportion of water, and prepare wetting agent.By isoniazid, pregelatinated
Starch PC-10 after mixing, adds in wetting agent granulation, drying.Then it adds in silica and stearic acid is pressed after mixing
Piece.
Embodiment 6：
(1) prescription (weight ratio)：
Isoniazid 50.0%
Pregelatinized starch PC-10 45.0%
PVP K30 1.0%
Silica 2.0%
Compritol 888 ATO 2.0%
Purified Water q. s
(2) it prepares：PVP K30 is added in a certain proportion of water, prepares wetting agent.Isoniazid, pregelatinated are formed sediment
Powder PC-10 after mixing, adds in wetting agent granulation, drying.Then it adds in silica and Compritol 888 ATO is uniformly mixed
Tabletting afterwards.
Comparative example 1：
(1) prescription (weight ratio)：
Isoniazid 50.0%
Lactose 10%
Pregelatinized starch PC-10 37.5%
PVP K30 0.5%
Silica 1 .0%
Compritol 888 ATO 1.0%
Purified Water q. s
(2) it prepares：PVP K30 is added in a certain proportion of water, prepares wetting agent.By isoniazid, lactose, pre- glue
Change starch PC-10 after mixing, add in wetting agent granulation, drying.Then silica and Compritol 888 ATO mixing are added in
Tabletting after uniformly.
Related content of material measures in Izonid Tablets
1. experimental method：
It completes to measure according to high performance liquid chromatography (Chinese Pharmacopoeia version general rule 0512 in 2015).
(1) chromatographic condition and system suitability
With chromatographic column that octadecyl silane is filler (Inertsil ODS-3v 4.6mm × 250mm, 5um or
The comparable chromatographic column of performance)；With phosphate buffer (potassium dihydrogen phosphate 13.6g is taken, water 1000ml is added to make dissolving, uses 10mol/L
Sodium hydroxide solution adjusts pH value to 6.9, adds in 30mg triethanolamines)-methanol (95: 5) is mobile phase, flow velocity is per minute
1.5ml；Detection wavelength is 254nm；Column temperature is 30 DEG C.Number of theoretical plate based on the peak of isoniazid not less than 5000, isoniazid peak and phase
Adjacent impurity should meet the requirements.
(2) measuring method
This product 20, accurately weighed, finely ground mixing are taken, precision weighs appropriate (being approximately equivalent to isoniazid 32mg), puts 100ml
In measuring bottle, add mobile phase 50ml, ultrasound shaking makes dissolving, lets cool, be diluted to scale with mobile phase, shake up, filters, take subsequent filtrate
As test solution, precision measures 20 μ l injection liquid chromatographs, records chromatogram；Separately take isoniazid reference substance appropriate, essence
It is close weighed, with flowing phased soln and the solution for diluting and being made in every 1ml containing about 0.32mg is quantified, is measured in the same method.By external standard method with
Calculated by peak area to get.
2. the measure in relation to substance
Face with newly matching.This product is taken, it is finely ground, appropriate (being approximately equivalent to isoniazid 50mg) is weighed, puts in 50ml measuring bottles, adds flowing
Phase A is appropriate, and ultrasound shaking makes dissolving, lets cool, mobile phase A is added to be diluted to scale, shake up, and filters, and takes subsequent filtrate molten for test sample
Liquid；Precision measures test solution 2ml, puts in 100ml measuring bottles, dilutes scale with mobile phase A, shakes up, precision measures 5ml, puts
In 50ml measuring bottles, scale is diluted to mobile phase A, is shaken up, as contrast solution.According to high performance liquid chromatography (Chinese Pharmacopoeia
Version general rule 0512 in 2015) experiment.With octadecyl silane be filler (Inertsil ODS-3v4.6mm × 250mm,
5um or the comparable chromatographic column of performance)；With phosphate buffer (potassium dihydrogen phosphate 13.6g is taken, water 1000ml is added to make dissolving, is used
10mol/L sodium hydroxide solutions adjust pH value to 6.9, add in 30mg triethanolamines)-methanol (95: 5) is mobile phase A, with methanol
For Mobile phase B, according to the form below carries out linear gradient elution, and flow velocity is 1.5ml per minute；Detection wavelength is 254nm；Column temperature is 30
℃.Impurities of isoniazid quality control product about 5mg, solubilizer 5ml is taken to make dissolving, shake up, measures 20 μ l injection liquid chromatographs, note
Record chromatogram.Impurity A, impurity B, impurity C, impurity D, impurity E are followed successively by by peak sequence, number of theoretical plate is calculated by isoniazid peak
Not less than 5000, isoniazid peak and the separating degree at other impurities peak should meet the requirements.Precision measures test solution and compares molten
Each 20 μ l of liquid, are injected separately into liquid chromatograph, record chromatogram.If any impurity peaks, peak face in the chromatogram of test solution
Product is not greater than contrast solution main peak area (0.2%).
By tablet prepared by above example 1~6 and comparative example 1, take and sample is placed in 60 DEG C of high temperature and is added
It is investigated under the conditions of 40 DEG C of speed, RH75%, using content, related substance as quality index.Product 0 day, 60 DEG C 10 days and accelerate
It is as shown in table 1 to investigate data, the results are shown in Table 2 for product 0 day and 40 DEG C of RH75%1 months, 2 months, March and investigation in June.
1 high temperature of table, 60 DEG C of investigation results
Table 2 accelerates 40 DEG C, RH75% investigation results
In 7 kinds of Izonid Tablets, 10% lactose, remaining prescription are only included in the prescription of the tablet of comparative example 1
In contain only pregelatinized starch and without lactose.The investigation result of Tables 1 and 2 is compared it can be found that prepared by comparative example 1
Compared with six embodiments of the amount of Izonid Tablets impurity and other, the content higher of impurity at 0 day, by 60 DEG C of high temperature and
The content that rear impurity is investigated in 40 DEG C of acceleration, RH75% increases also faster.Therefore, the present invention replaces the lactose in the auxiliary material of isoniazid
It is significant for the stability of Izonid Tablets for pregelatinized starch.
The pharmaceutical composition of isoniazid provided by the invention effectively reduces generation of the isoniazid in relation to substance, increases tablet
The dissolution rate of middle isoniazid improves the chemical stability of preparation.And the auxiliary material of isoniazid is customary adjuvant in the composition, is used
In being prepared into Izonid Tablets, preparation method is simple, it is easy to accomplish the big production of industrialization.
Finally illustrate, the above embodiments are merely illustrative of the technical solutions of the present invention and it is unrestricted, although with reference to compared with
The present invention is described in detail in good embodiment, it will be understood by those of ordinary skill in the art that, it can be to the skill of the present invention
Art scheme is modified or replaced equivalently, and without departing from the objective and range of technical solution of the present invention, should all be covered at this
In the right of invention.
Claims (9)
1. a kind of pharmaceutical composition of isoniazid, which is characterized in that count in parts by weight, the composition include isoniazid 30~
70 parts, 25~65 parts of pregelatinized starch, 0.2~2 part of povidone, 0.5~3 part of glidant, 0.5~3 part of lubricant.
2. composition according to claim 1, which is characterized in that the composition includes 40~60 parts of isoniazid, pre- glue
Change 35~57.5 parts of starch, 0.5~1 part of povidone, 1~2 part of glidant, 1~2 part of lubricant.
3. composition according to claim 1, which is characterized in that the povidone is PVP K30.
4. composition according to claim 1, which is characterized in that the lubricant is stearic acid, Compritol 888 ATO
It is one or more.
5. composition according to claim 1, characteristic are, the model PC-10 of the pregelatinized starch.
6. composition according to claim 1, which is characterized in that the glidant is colloidal silicon dioxide, silica
It is one or more.
7. composition described in claim 1 is in the purposes for being used to prepare Izonid Tablets.
8. the method that composition described in claim 1 is used to prepare Izonid Tablets, which is characterized in that include the following steps：
1) water is added to prepare wetting agent the povidone of formula ratio；
2) wetting agent granulation, the drying of step 1) by the isoniazid of formula ratio, pregelatinized starch after mixing, are added in；
3) glidant of formula ratio and mix lubricant uniformly rear tabletting are added in.
9. the tablet that method according to any one of claims 8 is prepared.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810190149.9A CN108186638A (en) | 2018-03-08 | 2018-03-08 | The pharmaceutical composition of isoniazid |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810190149.9A CN108186638A (en) | 2018-03-08 | 2018-03-08 | The pharmaceutical composition of isoniazid |
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| Publication Number | Publication Date |
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| CN108186638A true CN108186638A (en) | 2018-06-22 |
Family
ID=62595266
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
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| CN201810190149.9A Pending CN108186638A (en) | 2018-03-08 | 2018-03-08 | The pharmaceutical composition of isoniazid |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112438951A (en) * | 2019-08-28 | 2021-03-05 | 重庆华邦制药有限公司 | Method for preparing isoniazid preparation and preparation thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1602872A (en) * | 2003-09-29 | 2005-04-06 | 浙江可立思安制药有限公司 | Antituberculosis pharmaceutical composition |
| CN105407874A (en) * | 2013-07-26 | 2016-03-16 | 赛诺菲 | Antitubercular composition comprising rifampicin, isoniazid, ethambutol and pyrazinamide, and its process of preparation. |
| CN106822001A (en) * | 2015-12-03 | 2017-06-13 | 康普药业股份有限公司 | A kind of pharmaceutical composition of isoniazid |
-
2018
- 2018-03-08 CN CN201810190149.9A patent/CN108186638A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1602872A (en) * | 2003-09-29 | 2005-04-06 | 浙江可立思安制药有限公司 | Antituberculosis pharmaceutical composition |
| CN105407874A (en) * | 2013-07-26 | 2016-03-16 | 赛诺菲 | Antitubercular composition comprising rifampicin, isoniazid, ethambutol and pyrazinamide, and its process of preparation. |
| CN106822001A (en) * | 2015-12-03 | 2017-06-13 | 康普药业股份有限公司 | A kind of pharmaceutical composition of isoniazid |
Non-Patent Citations (3)
| Title |
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| AVERA MCKENNAN HOSPITAL: "Isoniazid: Package Insert and Label Information", 《HTTPS://DRUGINSERTS.COM/LIB/RX/MEDS/ISONIAZID-31/》 * |
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| 刘小燕等: ""采用多条溶出曲线评价异烟肼片的质量"", 《中国药事》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112438951A (en) * | 2019-08-28 | 2021-03-05 | 重庆华邦制药有限公司 | Method for preparing isoniazid preparation and preparation thereof |
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