CN105769791B - Section's Lip river knee-piece and preparation method thereof - Google Patents
Section's Lip river knee-piece and preparation method thereof Download PDFInfo
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- CN105769791B CN105769791B CN201610148322.XA CN201610148322A CN105769791B CN 105769791 B CN105769791 B CN 105769791B CN 201610148322 A CN201610148322 A CN 201610148322A CN 105769791 B CN105769791 B CN 105769791B
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- cobratide
- povidone solution
- povidone
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
-
- 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 present invention provides a kind of section Lip river knee-piece preparation method, includes the following steps：(1) povidone is taken, is dissolved in purified water, povidone solution is prepared into；(2) the part povidone solution described in step (1) is taken, Cobratide is added, stirring and dissolving obtains the povidone solution containing Cobratide；(3) tramadol hydrochloride, brufen and excipient are sucked into fluid bed, is uniformly mixed to obtain tramadol hydrochloride, brufen and excipient mixture；(4) tramadol hydrochloride, brufen and the excipient mixture in the step (3) are pelletized, is whitewashed simultaneously, whitewashing sequence is step a：Povidone solution, step b without Cobratide：Povidone solution, step c containing Cobratide：The remaining povidone solution without Cobratide, get Ke Luo song particles；(5) dry Lip river song particle, tabletting.
Description
Technical field
The present invention relates to section's Lip river knee-pieces and preparation method thereof.
Background technology
Section's Lip river knee-piece is NEW TYPE OF COMPOSITE Biologic analgesia agent, and the proportioning of science is pressed by Cobratide, tramadol hydrochloride and brufen
Composition, in prescription Cobratide mainly by inhibiting acetylcholine release from analgesic activity；Tramadol hydrochloride by with maincenter
Opiate receptor in conjunction with and play analgesic activity；Analgesic activity from cloth lives sweet smell by inhibiting Cycloxygenase；Three passes through different
The mechanism of action plays analgesic synergistic effect.Section's Lip river knee-piece is without tolerance, no dependence, non-habituation, acute and chronic toxicity test card
Bright to have high safety, clinic is relatively lighter than adverse reaction with other throe medicines, to be applicable in disease and be mainly used for advanced cancer
Pain, caused by postoperative pain and other reasons in, severe pain.
Cobratide is the low molecule of separating-purifying, single-stranded basic polypeptide from snake venom, and its chemical name is snake venom Nervous toxicities
Plain (neurotoxin), is made of 68 amino acid.Since Cobratide is polypeptide, stability ratio and tramadol hydrochloride and Bu Luo
Sweet smell is compared, and stabilization is poor, and temperature and humidity is higher to cause Cobratide to be denaturalized or decompose, and stringent control is needed in production process
The environment temperature and humidity of Cobratide processed.In addition, in section's Lip river knee-piece, the proportioning of Cobratide, tramadol hydrochloride and brufen is 1
: 150: 300, the content of Cobratide is only 0.16mg every, and Cobratide content is extremely low, only accounts for the 0.05% of tablet total amount, is increased
The difficulty of mixing together with tramadol hydrochloride, brufen and other adjunct ingredients.Therefore, solution section in the production of section Lip river knee-piece
The stability problem and homogeneity question of rich peptide are always the emphasis direction researched and developed.
Invention content
The present invention relates to section's Lip river knee-pieces and preparation method thereof；More specifically, it is rich that the present invention relates to control sections in section's Lip river knee-piece
Peptide quality solves the stability of Cobratide and the preparation method of uniformity.
Section Lip river knee-piece preparation method of the present invention, includes the following steps：
(1) povidone is taken, is dissolved in purified water, povidone solution is prepared into；
(2) the part povidone solution described in step (1) is taken, Cobratide is added, stirring and dissolving is obtained poly- containing Cobratide
Tie up ketone solution；
(3) tramadol hydrochloride, brufen and excipient are sucked into fluid bed, is uniformly mixed to obtain tramadol hydrochloride, brufen
And excipient mixture；
(4) tramadol hydrochloride, brufen and the excipient mixture in the step (3) are pelletized, is whitewashed simultaneously, whitewashed
Sequence is step a：Povidone solution, step b without Cobratide：Povidone solution, step c containing Cobratide：It is remaining not
Povidone solution containing Cobratide, get Ke Luo song particles；
(5) dry Lip river song particle, tabletting.
In the step (1), a concentration of 1-3% of povidone solution；Preferably, in the step (1), povidone solution is dense
Degree is 3%.
In the step (2), the mass ratio of the part povidone solution and total povidone solution is 50%-70%；It is excellent
Choosing, in the step (2), the mass ratio of the part povidone solution and total povidone solution is 63.6%.
In the step (3), the excipient is starch, croscarmellose sodium, crospovidone, carboxymethylstarch
One or more of sodium, lactose, sorbierite.
In the step (4), the whitewashing amount of povidone solutions of the step a without Cobratide is total povidone solution amount
13.6%-27.2%；Preferably, in the step (4), the spray of povidone solutions of the step a without Cobratide
Slurry amount is the 18.2% of total povidone solution amount.
In the step (4), pelletization controls 33-38 DEG C of particle temperature.
Specifically, section Lip river knee-piece preparation method of the present invention, it may include following steps：
(1) povidone is taken, is dissolved in purified water, 3% povidone solution is prepared into；
(2) 3% povidone solution of part described in step (1) is taken, Cobratide is added, stirring and dissolving obtains containing Cobratide
Povidone solution, the mass ratio of 3% povidone solution of part and total povidone solution is 63.6%；
(3) tramadol hydrochloride, brufen, starch, lactose are sucked into fluid bed, is uniformly mixed to obtain tramadol hydrochloride, Bu Luo
Fragrant, starch and milk-sugar mixture；
(4) tramadol hydrochloride, brufen, starch and the milk-sugar mixture in the step (3) are pelletized, are whitewashed simultaneously,
Whitewashing sequence is step a：Povidone solution, step b without Cobratide：Povidone solution, step c containing Cobratide：It is remaining
The povidone solution without Cobratide, get Ke Luo song particles, pelletization control 33-38 DEG C of particle temperature；The step a is not
The whitewashing amount of povidone solution containing Cobratide is the 18.2% of total povidone solution amount.
(5) dry Lip river song particle, tabletting.
Cobratide content is uniform in section's Lip river knee-piece prepared by this method, and the Cobratide rate of recovery is high, solves in section's Lip river knee-piece
The stability and homogeneity question of Cobratide, and it is suitble to industrialized production.
Specific implementation mode
Following embodiment further describes beneficial effects of the present invention, and embodiment is only used for the purpose of illustration, does not limit this
The range of invention, while those of ordinary skill in the art are also contained according to the obvious change of the invention made and modification
Within the scope of the invention.
Embodiment 1
Experimental group A (250,000) (whitewashing three times, normal process)
(1) povidone 1.65kg is taken, is dissolved in purified water, 3% povidone solution is prepared into；
(2) step (1) the 3% povidone solution 35kg is taken, 40g Cobratides are added, stirring and dissolving obtains containing Cobratide
Povidone solution, the mass ratio of 3% povidone solution of part and total povidone solution is 63.6%；
(3) tramadol hydrochloride 6.25kg, brufen 12.5kg, starch 13.75kg, lactose 33.25kg are sucked into fluid bed,
It is uniformly mixed to obtain tramadol hydrochloride, brufen, starch and milk-sugar mixture；
(4) tramadol hydrochloride, brufen, starch and the milk-sugar mixture in the step (3) are pelletized, are whitewashed simultaneously,
Whitewashing sequence is step a：Povidone solution, step b without Cobratide：Povidone solution, step c containing Cobratide：It is remaining
The povidone solution without Cobratide, get Ke Luo song particles, pelletization control 33-38 DEG C of particle temperature；The step a is not
The whitewashing amount of povidone solution containing Cobratide is the 18.2% of total povidone solution amount.
Experimental group B (250,000) (Cobratide is dissolved in whole povidone solutions, primary to whitewash)
(1) povidone 1.65kg is taken, is dissolved in purified water, 3% povidone solution is prepared into；
(2) step (1) the 3% povidone solution 55kg is taken, 40g Cobratides are added, stirring and dissolving obtains containing Cobratide
Povidone solution；
(3) tramadol hydrochloride 6.25kg, brufen 12.5kg, starch 13.75kg, lactose 33.25kg are sucked into fluid bed,
It is uniformly mixed to obtain tramadol hydrochloride, brufen, starch and milk-sugar mixture；
(4) tramadol hydrochloride, brufen, starch and the milk-sugar mixture in the step (3) are pelletized, while sprays and contains section
The povidone solution of rich peptide, get Ke Luo song particles, pelletization control 33-38 DEG C of particle temperature.
Experimental group C (250,000) (first spray contains Cobratide, then sprays without Cobratide, 2 whitewashings)
(1) povidone 1.65kg is taken, is dissolved in purified water, 3% povidone solution is prepared into；
(2) step (1) the 3% povidone solution 35kg is taken, 40g Cobratides are added, stirring and dissolving obtains containing Cobratide
Povidone solution, the mass ratio of 3% povidone solution of part and total povidone solution is 63.6%；
(3) tramadol hydrochloride 6.25kg, brufen 12.5kg, starch 13.75kg, lactose 33.25kg are sucked into fluid bed,
It is uniformly mixed to obtain tramadol hydrochloride, brufen, starch and milk-sugar mixture；
(4) tramadol hydrochloride, brufen, starch and the milk-sugar mixture in the step (3) are pelletized, are whitewashed simultaneously,
Whitewashing sequence is the povidone solution containing Cobratide and the povidone solution without Cobratide, get Ke Luo song particles, pelletization
Control 33-38 DEG C of particle temperature.
Experimental group D (250,000) (first spray is free of Cobratide, then sprays containing Cobratide, 2 whitewashings)
(1) povidone 1.65kg is taken, is dissolved in purified water, 3% povidone solution is prepared into；
(2) step (1) the 3% povidone solution 35kg is taken, 40g Cobratides are added, stirring and dissolving obtains containing Cobratide
Povidone solution, the mass ratio of 3% povidone solution of part and total povidone solution is 63.6%；
(3) tramadol hydrochloride 6.25kg, brufen 12.5kg, starch 13.75kg, lactose 33.25kg are sucked into fluid bed,
It is uniformly mixed to obtain tramadol hydrochloride, brufen, starch and milk-sugar mixture；
(4) tramadol hydrochloride, brufen, starch and the milk-sugar mixture in the step (3) are pelletized, are whitewashed simultaneously,
Whitewashing sequence is the povidone solution without Cobratide and the povidone solution containing Cobratide, get Ke Luo song particles, pelletization
Control 33-38 DEG C of particle temperature.
Experimental result
When section's Lip river song particle that step (4) described in experimental group A, B and C obtains is placed in granulator, respectively from granulator
The upper, middle and lower position of packed particle respectively takes 4 points, and (top is stacking volume from top to bottom at 1/4, and middle part is stacking volume 1/
At 2, lower part is stacking volume from top to bottom at 3/4) particulate samples of 12 points, Cobratide content data such as table 1 are taken altogether：
Table 1
The RSD of Cobratide content is 0.2% in section's Lip river song particle of experimental group A, and uniformity of dosage units is very good；Cobratide is managed
It is 0.534 μ g/mg, the rate of recovery 102.0% by content.
Cobratide RSD is 0.8% in section's Lip river song particle of experimental group B, and uniformity of dosage units is good；Cobratide theoretical content is
The rate of recovery of 0.534 μ g/mg, Cobratide are only 91.4%.
Cobratide uniformity of dosage units is poor in section's Lip river song particle of experimental group C, RSD% 2.8%；Cobratide theoretical content
The rate of recovery for 0.534 μ g/mg, Cobratide is only 89.7%.
Cobratide uniformity of dosage units is slightly poor in section's Lip river song particle of experimental group D, RSD% 1.6%；Cobratide theoretical content
The rate of recovery for 0.534 μ g/mg, Cobratide is 94.6%.
Experiment conclusion：The preparation process difference of experimental group B and experimental group A is only that Cobratide is dissolved in entirely by experimental group B
In the povidone solution in portion, primary whitewashing is completed；And experimental group A is the povidone solution being prepared for respectively containing Cobratide and does not contain
The povidone solution of Cobratide, and it is divided into 3 whitewashings, the difference of whitewashing results in section's Lip river song particle that experimental group A is obtained
The rate of recovery of Cobratide uniformity of dosage units and Cobratide is all higher than experimental group B.
The preparation process of experimental group C, D and experimental group A are prepared for the povidone solution containing Cobratide and do not contain section respectively
The povidone solution of rich peptide, but experimental group C and D are 2 whitewashings, whitewashing sequence is on the contrary, experimental group A is 3 whitewashings, whitewashing
Difference result in section's Lip river song particle that experimental group A is obtained the rate of recovery of Cobratide uniformity of dosage units and Cobratide be all higher than it is real
Test group C and D.
From the above analysis, it can speculate that the povidone solution containing Cobratide plays vital work in production technology
With the technical solution of, experimental group A can preferably in solution section Lip river knee-piece Cobratide stability and homogeneity question.
Embodiment 2
(1) povidone 1.65kg is taken, is dissolved in purified water, 3% povidone solution is prepared into；
(2) by tramadol hydrochloride 6.25kg, brufen 12.5kg, starch 13.75kg, microcrystalline cellulose 22.0kg, hydroxypropyl
Cellulose 11.25kg sucks fluid bed, is uniformly mixed to obtain tramadol hydrochloride, brufen, starch, microcrystalline cellulose and hydroxypropyl fiber
Plain mixture；
(3) tramadol hydrochloride, brufen, starch, microcrystalline cellulose and the hydroxypropylcellulose in the step (2) are mixed
Object is pelletized, and is whitewashed simultaneously, and blank granules are obtained, and pelletization controls 33-38 DEG C of particle temperature.
(4) Cobratide 40g is taken, the blank granules 40g in (3) is taken, mixes 15 minutes, section's Lip river song particle is added after mixing
80g is mixed 15 minutes, and gradually mixing is progressively increased to 1.28kg particles.
(5) 1.28kg particles in (4) are added in (3) in remaining blank granules, are mixed 15 minutes, it is bent to obtain section Lip river
Particle.
Example 2 obtain section's Lip river song particle, respectively upper, middle and lower take 12 points, Cobratide content data such as table 2 altogether：
Table 2
| Sample position | The Cobratide content (μ g/mg) of embodiment 2 |
| 1 | 0.511 |
| 2 | 0.463 |
| 3 | 0.533 |
| 4 | 0.547 |
| 5 | 0.469 |
| 6 | 0.487 |
| 7 | 0.500 |
| 8 | 0.464 |
| 9 | 0.455 |
| 10 | 0.544 |
| 11 | 0.481 |
| 12 | 0.491 |
Experiment conclusion：(1) Cobratide uniformity of dosage units is poor in section's Lip river song particle of embodiment 2, RSD% 3.1%；Section
Rich peptide theoretical content is 0.534 μ g/mg, and the rate of recovery of Cobratide is 92.7%.
(2) although equivalent dilution method of progressively increasing is the low solid pharmaceutical preparation conventional process of active constituent, but due in the present invention
Cobratide content is extremely low, needs to increase the step of progressively increasing dilution, take very much；And it needs artificial repeatedly to accurately control addition
Blank auxiliary is not only easy error, but also also increases cost of labor.
Equivalent progressively increase dilution method be not suitable for the present invention in section's Lip river knee-piece preparation.
Embodiment 3
(1) povidone 1.65kg is taken, is dissolved in purified water, 1% povidone solution is prepared into；
(2) step (1) the 1% povidone solution 35kg is taken, 40g Cobratides are added, stirring and dissolving obtains containing Cobratide
Povidone solution, the mass ratio of 1% povidone solution of part and total povidone solution is 63.6%；
(3) tramadol hydrochloride 6.25kg, brufen 12.5kg, starch 13.75kg, lactose 33.25kg are sucked into fluid bed,
It is uniformly mixed to obtain tramadol hydrochloride, brufen, starch and milk-sugar mixture；
(4) tramadol hydrochloride, brufen, starch and the milk-sugar mixture in the step (3) are pelletized, are whitewashed simultaneously,
Whitewashing sequence is step a：Povidone solution, step b without Cobratide：Povidone solution, step c containing Cobratide：It is remaining
The povidone solution without Cobratide, get Ke Luo song particles, pelletization control 33-38 DEG C of particle temperature；The step a is not
The whitewashing amount of povidone solution containing Cobratide is the 18.2% of total povidone solution amount.
(5) dry Lip river song particle, tabletting.
Embodiment 4
(1) povidone 1.65kg is taken, is dissolved in purified water, 3% povidone solution is prepared into；
(2) step (1) the 3% povidone solution 35kg is taken, 40g Cobratides are added, stirring and dissolving obtains containing Cobratide
Povidone solution, the mass ratio of 3% povidone solution of part and total povidone solution is 50.0%；
(3) tramadol hydrochloride 6.25kg, brufen 12.5kg, starch 13.75kg, lactose 33.25kg are sucked into fluid bed,
It is uniformly mixed to obtain tramadol hydrochloride, brufen, starch and milk-sugar mixture；
(4) tramadol hydrochloride, brufen, starch and the milk-sugar mixture in the step (3) are pelletized, are whitewashed simultaneously,
Whitewashing sequence is step a：Povidone solution, step b without Cobratide：Povidone solution, step c containing Cobratide：It is remaining
The povidone solution without Cobratide, get Ke Luo song particles, pelletization control 33-38 DEG C of particle temperature；The step a is not
The whitewashing amount of povidone solution containing Cobratide is the 27.2% of total povidone solution amount.
(5) dry Lip river song particle, tabletting.
Embodiment 5
(1) povidone 1.65kg is taken, is dissolved in purified water, 3% povidone solution is prepared into；
(2) step (1) the 3% povidone solution 35kg is taken, 40g Cobratides are added, stirring and dissolving obtains containing Cobratide
Povidone solution, the mass ratio of 3% povidone solution of part and total povidone solution is 70%；
(3) tramadol hydrochloride 6.25kg, brufen 12.5kg, starch 13.75kg, lactose 33.25kg are sucked into fluid bed,
It is uniformly mixed to obtain tramadol hydrochloride, brufen, starch and milk-sugar mixture；
(4) tramadol hydrochloride, brufen, starch and the milk-sugar mixture in the step (3) are pelletized, are whitewashed simultaneously,
Whitewashing sequence is step a：Povidone solution, step b without Cobratide：Povidone solution, step c containing Cobratide：It is remaining
The povidone solution without Cobratide, get Ke Luo song particles, pelletization control 33-38 DEG C of particle temperature；The step a is not
The whitewashing amount of povidone solution containing Cobratide is the 13.6% of total povidone solution amount.
(5) dry Lip river song particle, tabletting.
Claims (4)
1. a kind of section Lip river knee-piece preparation method, includes the following steps：
(1) povidone is taken, is dissolved in purified water, povidone solution is prepared into；
(2) the part povidone solution described in step (1) is taken, Cobratide is added, stirring and dissolving obtains the povidone containing Cobratide
Solution, wherein the mass ratio of the part povidone solution and total povidone solution is 50%-70%；
(3) tramadol hydrochloride, brufen and excipient are sucked into fluid bed, is uniformly mixed to obtain tramadol hydrochloride, brufen and tax
Shape agent composition；
(4) tramadol hydrochloride, brufen and the excipient mixture in the step (3) are pelletized, is whitewashed simultaneously, whitewashing sequence
For step a：Povidone solution, step b without Cobratide：Povidone solution, step c containing Cobratide：It is remaining to be free of section
The povidone solution of rich peptide, get Ke Luo song particles, wherein the whitewashing amount of povidone solutions of the step a without Cobratide is total
The 13.6%-27.2% of povidone solution amount；
(5) dry section Lip river song particle, tabletting；
In the step (1), a concentration of 1-3% of povidone solution；In the step (3), the excipient is starch, crosslinking carboxylic
One or more of sodium carboxymethylcellulose pyce, crospovidone, carboxyrnethyl starch sodium, lactose, sorbierite；In the step (4), system
33-38 DEG C of grain process control particle temperature.
2. section Lip river knee-piece preparation method according to claim 1, it is characterised in that in the step (2), the part is poly-
The mass ratio for tieing up ketone solution and total povidone solution is 63.6%.
3. section Lip river knee-piece preparation method according to claim 1, it is characterised in that the step a is free of the poly- dimension of Cobratide
The whitewashing amount of ketone solution is the 18.2% of total povidone solution amount.
4. section Lip river knee-piece preparation method according to claim 1, it is characterised in that include the following steps：
(1) povidone is taken, is dissolved in purified water, 3% povidone solution is prepared into；
(2) 3% povidone solution of part described in step (1) is taken, Cobratide is added, stirring and dissolving is obtained poly- containing Cobratide
The mass ratio of dimension ketone solution, 3% povidone solution of part and total povidone solution is 63.6%；
(3) tramadol hydrochloride, brufen, starch, lactose are sucked into fluid bed, is uniformly mixed to obtain tramadol hydrochloride, brufen, shallow lake
Powder and milk-sugar mixture；
(4) tramadol hydrochloride, brufen, starch and the milk-sugar mixture in the step (3) are pelletized, is whitewashed simultaneously, whitewashed
Sequence is step a：Povidone solution, step b without Cobratide：Povidone solution, step c containing Cobratide：It is remaining not
Povidone solution containing Cobratide, get Ke Luo song particles, pelletization control 33-38 DEG C of particle temperature；The step a is free of section
The whitewashing amount of the povidone solution of rich peptide is the 18.2% of total povidone solution amount.
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