CN109602715A - Erlotinib Hydrochloride tablet and preparation method thereof - Google Patents
Erlotinib Hydrochloride tablet and preparation method thereof Download PDFInfo
- Publication number
- CN109602715A CN109602715A CN201910135043.3A CN201910135043A CN109602715A CN 109602715 A CN109602715 A CN 109602715A CN 201910135043 A CN201910135043 A CN 201910135043A CN 109602715 A CN109602715 A CN 109602715A
- Authority
- CN
- China
- Prior art keywords
- erlotinib hydrochloride
- pregelatinized starch
- starch
- added
- piece according
- 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.)
- Pending
Links
Classifications
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
-
- 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
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- 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
- A61K9/2004—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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
Abstract
The present invention provides a kind of erlotinib Hydrochloride tablets and preparation method thereof, which includes label and coating.This product uses dry granulation process, bulk pharmaceutical chemicals granularity increases, preparation section is simple, easily operated, quality controllable, favorable reproducibility, suitable for large-scale industrialized production, dissolves out that difference is small, vivo biodistribution availability is high between gained erlotinib Hydrochloride tablet surface is bright and clean, dissolution rate is high and each batch.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of erlotinib Hydrochloride tablet and its production method.
Background technique
Lung cancer is that the most common malignant tumour and China's city dweller's morbidity and mortality are highest in world wide
Malignant tumour, and with the influence of smoking and various environmental factors, disease incidence and the death rate are also in lasting ascendant trend.In lung cancer
In, non-small cell lung cancer (Non-Small Cell Lung Cancer, NSCLC) accounts for about the 80~85% of lung cancer sum.It is non-small
Cell lung cancer includes squamous carcinoma, gland cancer and large cell carcinoma, compared with small cell carcinoma there is growth of cancer cells to divide slower, diffusion transfer
Relatively late the features such as.Non-small cell lung cancer early stage patient is mostly without obvious sign, and patients with terminal has tired, weight loss, food
It the performance such as is intended to decline and the local symptoms such as expiratory dyspnea, cough, hemoptysis occurs.
Erlotinib Hydrochloride is epidermal growth factor (EGFR) family tyrosine kinase receptor inhibitor, can be inhibited and EGFR
The phosphorylation of the relevant intracellular tyrosine kinase of receptor, Locally Advanced or transfer suitable for the failure of at least one chemotherapy regimen
Non-small cell lung cancer treatment.By Co., Ltd, Roche Group, Switzerland develop, product obtained in March, 2009 CFDA ratify into
Mouthful, after by Shanghai company, Roche Group dispense list marketing.
Erlotinib Hydrochloride chemical name is bis- (2- the methoxyethoxy) -4- quinazoline amine of N- (3- acetylene phenyl) -6,7-
Hydrochloride, molecular formula C22H23N3O4HCl, relative molecular weight are as follows: 429.90, result formula is such as shown in (I).
Erlotinib Hydrochloride is slightly solubility sample, in methyl alcohol slightly soluble, almost insoluble in water or ethyl alcohol.Therefore, it dissolves out
It is the rate-limiting step of preparation body absorption, the technology needed to improve at present is exactly to be needed in production process by designing prescription
And/or preparation process improves the deliquescent purpose of erlotinib Hydrochloride to reach.
Summary of the invention
The purpose of the present invention is to overcome the shortcomings of the existing technology, provides good, the stability that can produce a kind of dissolving out capability
Height, and the erlotinib Hydrochloride tablet and preparation method thereof for the dissolution being able to achieve under each medium.
Specifically, the present invention is achieved through the following technical solutions:
A kind of erlotinib Hydrochloride tablet, label are made of erlotinib Hydrochloride and pharmaceutic adjuvant, and the pharmaceutic adjuvant is
At least one of filler, disintegrating agent, solubilizer, lubricant:
The filler is one of lactose, microcrystalline cellulose, mannitol, cornstarch, pregelatinized starch or a variety of；
The disintegrating agent be one of croscarmellose sodium, sodium carboxymethyl starch, hydroxypropyl cellulose, crospovidone or
It is a variety of；
The solubilizer is one of lauryl sodium sulfate, poloxamer, Tween 80 or a variety of；
The lubricant be magnesium stearate, talcum powder, superfine silica gel powder it is one or more；
It optionally, further include coating, the coating is made of water-soluble coating material and coating solvent, wherein water-soluble packet
Clothing material is selected from Opadry or polyvinylpyrrolidone；Coating solvent is selected from the mixture of ethyl alcohol, water or water and ethyl alcohol.
The filler is one of lactose, microcrystalline cellulose, mannitol, cornstarch, pregelatinized starch or more
Kind, the mixture of preferably microcrystalline cellulose and pregelatinized starch, microcrystalline cellulose with weight be 100-150 parts,
Pregelatinized starch is with weight for 40-60 parts.
The disintegrating agent is croscarmellose sodium, in sodium carboxymethyl starch, hydroxypropyl cellulose, crospovidone
One or more, preferred sodium carboxymethyl starch, with weight for 24-36.2 parts.
The solubilizer is one of lauryl sodium sulfate, poloxamer, Tween 80 or a variety of, preferably poloxamer
188, with weight are as follows: 3-4.6 parts.
The lubricant be magnesium stearate, talcum powder, superfine silica gel powder it is one or more, preferentially select magnesium stearate, with weight
Amount percentage composition is calculated as 3.8-5.8 parts.
The water solubility coating material is selected from Opadry or polyvinylpyrrolidone, preferably Opadry, is contained with weight percent
Amount is calculated as 9.0-13.5 parts；Coating solvent is selected from the mixture of ethyl alcohol, water or water and ethyl alcohol, preferentially selects the mixing of water and ethyl alcohol
Object, with weight for 119.57-179.36 parts.
Preferably, a kind of prescription of erlotinib Hydrochloride piece is as follows:
Preferably, a kind of prescription of erlotinib Hydrochloride piece is as follows:
| Specification | 0.1g | 0.15g |
| Title | Quality (mg/ piece) | Quality (mg/ piece) |
| Erlotinib Hydrochloride (in terms of Tarceva) | 100 | 300 |
| Microcrystalline cellulose | 100 | 150 |
| Pregelatinized starch (premix I) | 20 | 30 |
| Pregelatinized starch (premix II) | 20 | 30 |
| PLURONICS F87 | 3 | 4.5 |
| Sodium carboxymethyl starch (interior to add) | 15 | 22.5 |
| Magnesium stearate | 3 | 6 |
| Sodium carboxymethyl starch (additional) | 9 | 13.5 |
Preferably, the sodium carboxymethyl starch is added by the additional mode of interior adduction, wherein the weight that interior adduction is additional
Than for 1:0.5~1, preferably 1:0.5~0.6.
Preferably, the weight ratio of the microcrystalline cellulose, pregelatinized starch and poloxamer is 15~20:5~10:1, excellent
Select 20:5~7:1.
Preferably, the erlotinib Hydrochloride granularity is 50 μm≤d (0.9)≤200 μm.
Preferably, the pregelatinized starch and poloxamer partial size are 10 μm≤d (0.9)≤50 μm, preferably 15 μm≤d
(0.9)≤35μm。
Preferably, the pregelatinized starch is by premix, and equivalent is added in two times.
Another object of the present invention is to provide a kind of preparations of erlotinib Hydrochloride tablet being adapted with aforementioned schemes
Method.
It is described the preparation method is as follows:
(1) pregelatinized starch and poloxamer micronization is spare.
(2) pregelatinized starch (premix I) is placed in 10~30rpm in hopper mixing machine, mixes 15~30min.
(3) by erlotinib Hydrochloride, microcrystalline cellulose, sodium carboxymethyl starch (interior to add), pregelatinized starch (premix II), pool
Luo Shamu 188 is added to 10~30rpm mixing 30min~1h in step (2) hopper mixing machine.
(4) intermediate obtained by step (3) is added in dry granulation and is pelletized 1 time.
(5) intermediate obtained by step (4) is added in hopper mixing machine, sodium carboxymethyl starch (additional) and stearic acid is added
Magnesium (additional), 10~30rpm mix 30min~1h.
(6) tabletting in tablet press machine is added in intermediate obtained by step (5), controls plain piece hardness are as follows: 2.00~10.00kgf.
(7) optionally, intermediate obtained by step (6) is added in seed-coating machine and is coated, until coating solution has been sprayed.
Specific embodiment
In order to further illustrate the present invention, the present invention is specifically addressed below in conjunction with specific embodiment, but this hair
Bright protection scope is not limited to specific embodiment.
1 disintegrating agent adding manner of embodiment and dosage are investigated
Table 1
| Batch | Batch 1 | Batch 2 | Batch 3 | Batch 4 |
| Erlotinib Hydrochloride | 164mg | 164mg | 164mg | 164mg |
| Pregelatinized starch | 112.5mg | 112.5mg | 112.5mg | 112.5mg |
| Microcrystalline cellulose | 124.1mg | 124.1mg | 124.1mg | 124.1mg |
| Carboxyrnethyl starch sodium (interior to add) | 36.0mg | 28.5mg | 22.5mg | 24mg |
| Carboxyrnethyl starch sodium (additional) | / | 7.5mg | 13.5mg | 12mg |
| Poloxamer | 4.5mg | 4.5mg | 4.5mg | 4.5mg |
| Magnesium stearate | 6.0mg | 6.0mg | 6.0mg | 6.0mg |
| Disintegration time limited (s) | 122 | 120 | 110 | 107 |
Conclusion:
The investigation of disintegrating agent adding manner: in formulation study, using the disintegration time limited of preparation as main indicator, to disintegrating agent
Adding manner is investigated, the results showed that, carboxyrnethyl starch sodium as disintegrating agent using it is interior it is additional by the way of than all use in
The disintegration effect of prescription prepared by the mode added is more preferable, and disintegration time limited is short, thus using it is interior it is additional by the way of disintegrating agent is added.
2 filler of embodiment and solubilizer dosage are investigated
Table 2
By the type and dosage screening to filler and solubilizer, disintegration time limited is significantly improved.
Embodiment 3
Table 3
| Erlotinib Hydrochloride | 164.00mg |
| Microcrystalline cellulose | 150.00mg |
| Pregelatinized starch (premix I) | 30.00mg |
| Pregelatinized starch (premix II) | 30.00mg |
| PLURONICS F87 | 4.50mg |
| Carboxyrnethyl starch sodium (interior to add) | 22.50mg |
| Magnesium stearate (interior to add) | 1.0mg |
| Carboxyrnethyl starch sodium (additional) | 13.50mg |
| Magnesium stearate (additional) | 4.50mg |
| Angle of repose (°) | 28.63 |
| Friability (%) | 0.12 |
| Tabletting average hardness (kgf) | 6.3 |
Operating procedure:
(1) erlotinib Hydrochloride, pregelatinized starch and PLURONICS F87 are micronized.
(2) pregelatinized starch (premix I) is placed in 25rpm in hopper mixing machine, mixes 25min.
(3) by erlotinib Hydrochloride, microcrystalline cellulose, sodium carboxymethyl starch (interior to add), pregelatinized starch (premix II), pool
Luo Shamu 188 is added to 25rpm mixing 40min in step (2) hopper mixing machine.
(4) intermediate obtained by step (3) is added in dry granulation and is pelletized 1 time.
(5) intermediate obtained by step (4) is added in hopper mixing machine, sodium carboxymethyl starch (additional) and stearic acid is added
Magnesium (additional), 25rpm mix 35min.
(6) tabletting in tablet press machine is added in intermediate obtained by step (5), controls plain piece hardness are as follows: 6.00kgf.
(7) intermediate obtained by step (6) is added in seed-coating machine and is coated, until coating solution has been sprayed.
Conclusion:
The magnesium stearate dosage added in reducing, and the dosage of microcrystalline cellulose is adjusted to keep slice weight, it adjusts as the result is shown
The indices such as prescription mobility of particle, tabletting hardness and dissolution rate afterwards can reach target value, be able to satisfy production requirement.
Embodiment 4
Table 4
| Erlotinib Hydrochloride | 164.00mg |
| Microcrystalline cellulose | 150.00mg |
| Pregelatinized starch (premix I) | 25.00mg |
| Pregelatinized starch (premix II) | 25.00mg |
| PLURONICS F87 | 4.50mg |
| Carboxyrnethyl starch sodium (interior to add) | 18.0mg |
| Magnesium stearate | 6.0mg |
| Carboxyrnethyl starch sodium (additional) | 18.0mg |
Preparation method reference implementation example 3, difference are that magnesium stearate passes through additional addition.
5 supplementary material granularity of embodiment is investigated
Table 5
After handling supplementary material, Tarceva tablet is prepared according to the prescription of embodiment 3, dissolution in vitro experimental method is such as
Under: take this product according to dissolution method, respectively with the hydrochloric acid solution (pH value 1.0) containing 1% lauryl sodium sulfate, contain
Acetate buffer solution (pH value 4.5) 1000ml of 1% lauryl sodium sulfate be dissolution medium, respectively at 5min, 10min,
10ml is sampled when 15min, 30min, 45min, 60min, is filtered, filtrate is as test solution.Each batch dissolution it is as follows:
It can be seen that Tarceva tablet prepared by the present invention is able to maintain preferable and more consistent dissolution at different conditions.
After handling supplementary material, Tarceva tablet is prepared according to the prescription of embodiment 3, it is consistent with the dissolution data of embodiment 3.
The test of 6 erlotinib Hydrochloride tablet stability of embodiment:
(1) sample prepared by embodiment 3 is placed into 60 DEG C of high temperature, 25 DEG C/RH90% respectively, (total illumination is not less than for illumination
1.2×106Luxhr it under the conditions of), is sampled respectively at 5d, 10d, detection, compared with 0d, test result is as follows:
Table 6
(2) under the conditions of sample being placed 40 DEG C of ± 2 DEG C/RH75% ± 5%, respectively at 1M, 2M, 3M, 6M sample detection, and
Compared with 0M result, test result is as follows:
Table 7
(2) under the conditions of sample being placed 30 DEG C of ± 2 DEG C/RH 65% ± 5%, respectively at 3M, 6M, 9M, 12M sample detection,
And compared with 0M result, test result is as follows:
Table 8
Conclusion:
The result shows that pharmaceutical composition of the invention is related during influence factor, acceleration and long-term stable experiment
Substance, dissolution rate, content results have no significant change compared with 0d.To illustrate erlotinib Hydrochloride piece provided by the present invention
And preparation method thereof obtained by product it is more stable.
Claims (9)
1. a kind of erlotinib Hydrochloride piece, which is characterized in that include at least one in filler, disintegrating agent, solubilizer, lubricant
Kind: the filler is selected from one of lactose, microcrystalline cellulose, mannitol, cornstarch, pregelatinized starch or a variety of, excellent
Select microcrystalline cellulose and pregelatinized starch；The disintegrating agent is selected from croscarmellose sodium, sodium carboxymethyl starch, hydroxypropyl
One of cellulose, crospovidone are a variety of, preferably sodium carboxymethyl starch；The solubilizer is selected from dodecyl sulphate
One of sodium, poloxamer, Tween 80 are a variety of, preferably poloxamer；The lubricant be selected from magnesium stearate, talcum powder,
One or more, the preferred magnesium stearate of differential silica gel.
2. erlotinib Hydrochloride piece according to claim 1, which is characterized in that the weight percentage of each component is as follows:
109-164 parts of erlotinib Hydrochloride, 100-150 parts of microcrystalline cellulose, 40-60 parts of pregelatinized starch, 3-5 parts of poloxamer, carboxylic
24-38 parts of first sodium starch, 3-6 parts of magnesium stearate.
3. erlotinib Hydrochloride piece according to claim 1, which is characterized in that sodium carboxymethyl starch is additional by interior adduction
Mode be added, wherein in the additional weight ratio of adduction be 1:0.5~1, preferably 1:0.5~0.6.
4. erlotinib Hydrochloride piece according to claim 1, which is characterized in that microcrystalline cellulose, pregelatinized starch and pool
The weight ratio of Luo Shamu is 15~20:5~10:1, preferably 20:5~7:1.
5. erlotinib Hydrochloride piece according to claim 1, which is characterized in that the erlotinib Hydrochloride granularity is 50 μm
≤d(0.9)≤200μm。
6. erlotinib Hydrochloride piece according to claim 1, which is characterized in that pregelatinized starch is with poloxamer partial size
10 μm≤d (0.9)≤50 μm, preferably 15 μm≤d (0.9)≤35 μm.
7. erlotinib Hydrochloride piece according to claim 1, which is characterized in that equivalent is added pregelatinized starch in two times.
8. erlotinib Hydrochloride piece according to claim 1, which is characterized in that the weight ratio of each component is as follows:
。
9. the method for preparing the erlotinib Hydrochloride piece as described in claim 1-8 any one, which is characterized in that comprising as follows
Step:
(1) pregelatinized starch and poloxamer are micronized；
(2) pregelatinized starch (premix I) hopper is placed in mix；
(3) by erlotinib Hydrochloride, microcrystalline cellulose, sodium carboxymethyl starch (interior to add), pregelatinized starch (premix II), Bo Luosha
Nurse 188 is added to the mixing of step (2) hopper mixing machine；
(4) by intermediate dry granulation obtained by step (3)；
(5) sodium carboxymethyl starch (additional) and magnesium stearate (additional) is added；
(6) tabletting in tablet press machine is added in intermediate obtained by step (5)；
(7) optionally, intermediate obtained by step (6) is added in seed-coating machine and is coated, until coating solution has been sprayed.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910135043.3A CN109602715A (en) | 2019-02-21 | 2019-02-21 | Erlotinib Hydrochloride tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910135043.3A CN109602715A (en) | 2019-02-21 | 2019-02-21 | Erlotinib Hydrochloride tablet and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109602715A true CN109602715A (en) | 2019-04-12 |
Family
ID=66022277
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201910135043.3A Pending CN109602715A (en) | 2019-02-21 | 2019-02-21 | Erlotinib Hydrochloride tablet and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109602715A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105362239A (en) * | 2014-09-01 | 2016-03-02 | 深圳信立泰药业股份有限公司 | Medicine composition containing erlotinib hydrochloride and preparation method of medicine composition |
| CN112137979A (en) * | 2020-10-29 | 2020-12-29 | 瑞阳制药股份有限公司 | Terpontinib tablet and preparation method thereof |
Citations (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103110597A (en) * | 2013-02-02 | 2013-05-22 | 浙江华海药业股份有限公司 | Erlotinib hydrochloride tablets and preparation method thereof |
| CN103705477A (en) * | 2013-12-26 | 2014-04-09 | 山东博迈康药物研究有限公司 | Tablets containing erlotinib hydrochloride and preparation method thereof |
| CN104138380A (en) * | 2013-05-09 | 2014-11-12 | 江苏豪森药业股份有限公司 | Composition of angiostatin or its medicinal salt, and preparation method and use thereof |
| CN104288114A (en) * | 2014-10-27 | 2015-01-21 | 成都新恒创药业有限公司 | Erlotinib hydrochloride pharmaceutical composition without containing surfactant |
| CN105030705A (en) * | 2015-06-29 | 2015-11-11 | 孙丽华 | Anti-cancer drug erlotinib hydrochloride tablet and preparation method thereof |
| CN105168172A (en) * | 2015-08-26 | 2015-12-23 | 浙江华义医药有限公司 | Erlotinib hydrochloride tablet with improved dissolution rate and stability and preparation method thereof |
| CN105267163A (en) * | 2014-06-18 | 2016-01-27 | 山东新时代药业有限公司 | Erlotinib hydrochloride tablet, and preparation method thereof |
| CN105362239A (en) * | 2014-09-01 | 2016-03-02 | 深圳信立泰药业股份有限公司 | Medicine composition containing erlotinib hydrochloride and preparation method of medicine composition |
| CN105616374A (en) * | 2014-11-05 | 2016-06-01 | 四川科伦药物研究院有限公司 | Erlotinib hydrochloride tablet and preparation method thereof |
| JP2018115130A (en) * | 2017-01-19 | 2018-07-26 | 沢井製薬株式会社 | Method for producing erlotinib hydrochloride-containing pharmaceutical composition |
-
2019
- 2019-02-21 CN CN201910135043.3A patent/CN109602715A/en active Pending
Patent Citations (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103110597A (en) * | 2013-02-02 | 2013-05-22 | 浙江华海药业股份有限公司 | Erlotinib hydrochloride tablets and preparation method thereof |
| CN104138380A (en) * | 2013-05-09 | 2014-11-12 | 江苏豪森药业股份有限公司 | Composition of angiostatin or its medicinal salt, and preparation method and use thereof |
| CN103705477A (en) * | 2013-12-26 | 2014-04-09 | 山东博迈康药物研究有限公司 | Tablets containing erlotinib hydrochloride and preparation method thereof |
| CN105267163A (en) * | 2014-06-18 | 2016-01-27 | 山东新时代药业有限公司 | Erlotinib hydrochloride tablet, and preparation method thereof |
| CN105362239A (en) * | 2014-09-01 | 2016-03-02 | 深圳信立泰药业股份有限公司 | Medicine composition containing erlotinib hydrochloride and preparation method of medicine composition |
| CN104288114A (en) * | 2014-10-27 | 2015-01-21 | 成都新恒创药业有限公司 | Erlotinib hydrochloride pharmaceutical composition without containing surfactant |
| CN105616374A (en) * | 2014-11-05 | 2016-06-01 | 四川科伦药物研究院有限公司 | Erlotinib hydrochloride tablet and preparation method thereof |
| CN105030705A (en) * | 2015-06-29 | 2015-11-11 | 孙丽华 | Anti-cancer drug erlotinib hydrochloride tablet and preparation method thereof |
| CN105168172A (en) * | 2015-08-26 | 2015-12-23 | 浙江华义医药有限公司 | Erlotinib hydrochloride tablet with improved dissolution rate and stability and preparation method thereof |
| JP2018115130A (en) * | 2017-01-19 | 2018-07-26 | 沢井製薬株式会社 | Method for producing erlotinib hydrochloride-containing pharmaceutical composition |
Non-Patent Citations (3)
| Title |
|---|
| 原继红等: "药用辅料羧甲基淀粉钠用法新探", 《黑龙江医药》 * |
| 孟胜男等: "《药剂学》", 31 January 2012, 上海科学技术出版社 * |
| 药物制剂国家工程研究中心编著: "《药物辅料应用技术》", 31 July 2002, 中国医药科技出版社 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105362239A (en) * | 2014-09-01 | 2016-03-02 | 深圳信立泰药业股份有限公司 | Medicine composition containing erlotinib hydrochloride and preparation method of medicine composition |
| CN112137979A (en) * | 2020-10-29 | 2020-12-29 | 瑞阳制药股份有限公司 | Terpontinib tablet and preparation method thereof |
| CN112137979B (en) * | 2020-10-29 | 2023-08-25 | 瑞阳制药股份有限公司 | Teposinib tablet and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US20140221424A1 (en) | Pharmaceutical compositions for use in the treatment of cystic fibrosis | |
| TWI744224B (en) | Solid preparation | |
| CN109602715A (en) | Erlotinib Hydrochloride tablet and preparation method thereof | |
| CN112220770B (en) | Pharmaceutical composition of selepag and preparation method thereof | |
| EP3216450B1 (en) | Pharmaceutical preparation comprising cyclin inhibitor and preparation method thereof | |
| CN107998097B (en) | A kind of tablet and preparation method thereof containing olmesartan medoxomil | |
| CN106139156B (en) | A kind of pharmaceutical composition containing quinoline or its salt | |
| CN103565773A (en) | Pharmaceutical composition of prasugrel hydrochloride | |
| CN103083273A (en) | Imatinib mesylate tablet cores, coated tablets, and preparation method thereof | |
| CN113412114A (en) | ATR kinase inhibitor BAY1895344 for treating hyperproliferative diseases | |
| CN104138380A (en) | Composition of angiostatin or its medicinal salt, and preparation method and use thereof | |
| CN105168172A (en) | Erlotinib hydrochloride tablet with improved dissolution rate and stability and preparation method thereof | |
| EP3650025A1 (en) | Pharmaceutical composition and method for preparing same | |
| CN108514560A (en) | A kind of lenalidomide stomach retention sustained-release piece and preparation method thereof | |
| CN103800334B (en) | pharmaceutical composition of imatinib mesylate and preparation method thereof | |
| CN106074415B (en) | A kind of aripirazole tablets and preparation method thereof | |
| CN108125918A (en) | Everolimus pharmaceutical composition | |
| EP3378479A1 (en) | Method for preparing pharmaceutical composition comprising quinoline derivative or salt thereof | |
| CN110354093B (en) | Mosapride citrate pharmaceutical composition | |
| CN107913254A (en) | A kind of ticagrelor dispersible tablet and preparation method thereof | |
| CN107080741A (en) | Pirfenidone sustained release preparation and preparation method | |
| CN106943405B (en) | Aripiprazole preparation and preparation method thereof | |
| JP6739289B2 (en) | Process for producing pharmaceutical tablet containing gefitinib as active ingredient | |
| CN115397416B (en) | Pharmaceutical composition containing molecular level of lenvatinib, preparation method and application thereof | |
| CN107744509A (en) | Mosapride Citrate Tablets agent and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 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: 20190412 |