CN101219130B - Compound pharmaceutical composition, preparation method and use of the same - Google Patents

Compound pharmaceutical composition, preparation method and use of the same Download PDF

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Publication number
CN101219130B
CN101219130B CN2007103019029A CN200710301902A CN101219130B CN 101219130 B CN101219130 B CN 101219130B CN 2007103019029 A CN2007103019029 A CN 2007103019029A CN 200710301902 A CN200710301902 A CN 200710301902A CN 101219130 B CN101219130 B CN 101219130B
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injection
preparation
compound
dissolving
stirring
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CN101219130A (en
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田玲
莫云
刘彤
郭致君
王海良
布仁阿古达木
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BEIJING DABEINONG ANIMAL HEALTH TECHNOLOGY Co Ltd
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BEIJING DABEINONG ANIMAL HEALTH TECHNOLOGY Co Ltd
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    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A40/00Adaptation technologies in agriculture, forestry, livestock or agroalimentary production
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Abstract

The invention relates to a medical composition used for the febrifuge, analgesia and anti-inflammation of the animals, a preparation method and the application thereof. The medical composition comprises diclophenac sodium and naproxen. The weight proportion of the diclophenac sodium and the naproxen is 1:10-10:1 while the preferred scope is 1:5-5:1. The invention also provides the preparation method of the injection of the medical composition and the application in the control of livestock and poultry pyrexia. The invention has more thorough febrifuge effect than any single preparation with the characteristics of fast action and uneasy rebound relative to the oral preparation.

Description

A kind of compound medicament composition and preparation method thereof and purposes
The application is 200610076344.6 divides an application, the applying date of original application: 2006.4.21, the title of invention: a kind of compound medicament composition and preparation method thereof and purposes
Technical field
The invention belongs to poultry with analgesic, analgesia, anti-inflammatory drug, be specifically related to a kind of compound medicament composition of diclofenac sodium and naproxen or barbital composition and preparation method thereof.
Background technology
Be subjected to antibacterial, virus, mycoplasma invasion and attack and during morbidity, in most cases clinical symptoms influences normal diet, activity and the healthy growth of demand all with inflammatory symptom (heating, pain) poultry.So no matter be the angle of producing from animal welfare or animal, it all is necessary carrying out antiinflammatory (analgesic, analgesia) when using antibiotic, antiviral drugs.
In China, the livestock and poultry pestilence control is the important assurance that animal husbandry develops in a healthy way.China is vast in territory, each department weather, production custom difference, and livestock and poultry species is numerous, has brought difficulty for the control of livestock and poultry pestilence.Diseases such as swine eperythrozoonosis, mycoplasma, escherichia coli, Salmonella, pasteurellosis bacillus constantly take place, and the effective antiinflammatory medicine that is used for veterinary clinic seldom.Existing antipyretic analgesics effect is slow, and action time is short, separates thermal effect and easily rebounds, and can not satisfy clinical needs.Therefore we have invented this kind compound medicament composition, and are significant to ensureing animal health, animal husbandry development.
NSAID (non-steroidal anti-inflammatory drug) (NSAIDs) is that a class has medicine analgesic, analgesic activity by suppressing the epoxidase (COX) in the arachidonic acid metabolic process, makes that prostaglandin (PGE) is synthetic to be reduced.Make the temperature recovery of heating animal normal, normal body temperature is not had obvious influence.NSAID (non-steroidal anti-inflammatory drug) can be alleviated disease symptoms, and crucial effects is being brought into play in the process and even the prognosis of disease.
Diclofenac sodium (Diclofenac Sodium) has another name called diclofenac.Be the potent NSAIDS (nonsteroidal anti-inflammatory drugs) of the third generation, the effect link of cyclooxygenase in the alternative blocking-up arachidonic acid metabolic process, the route of synthesis of blocking-up PGE1 (PGE1) has antiinflammatory, analgesia, refrigeration function.
Naproxen is a non-steroidal class antipyretic analgesic, and the experiment proved that with diclofenac sodium has collaborative refrigeration function; Barbital can also strengthen the refrigeration function of diclofenac sodium.
Summary of the invention
The objective of the invention is to: the compound medicament composition that the heating of a kind of efficient treatment poultry, pain, inflammation disease are provided.
Another object of the present invention is to: the injection liquid formulation preparation method that this compound medicament composition is provided.
A further object of the present invention is: provide this compound medicament composition being used for analgesic, the analgesia of poultry, antiphlogistic purposes.
The invention provides a kind of compound medicament composition, it is made up of diclofenac sodium and naproxen or barbital.
According to the present invention, the weight ratio of diclofenac sodium and naproxen is 1: 10~10: 1, preferable range 1: 5~5: 1.
According to the present invention, the weight ratio of diclofenac sodium and barbital is 1: 5~10: 1, preferable range 1: 1~7.5: 1.
According to the present invention, the said composition injection preparation contains a certain amount of cosolvent, used cosolvent is selected from liquid preparation or injection adds the solvent that is selected from N-N-methyl-2-2-pyrrolidone N-, ethanol, glycerol formal or its mixture usually, the concentration of N-N-methyl-2-2-pyrrolidone N-in the injection liquid preparation is 10~90% (v/v), is preferably 20~70% (v/v); Concentration of ethanol is 10~70% (v/v), is preferably 10~50% (v/v); The concentration of glycerol formal is 10~70% (v/v), is preferably 10~50% (v/v).
The present invention also provides the preparation method of this compound medicament composition liquid preparation, and is as follows:
(1) measures one or more cosolvents, mix homogeneously;
(2) take by weighing medicine in required ratio combination, add in the cosolvent stirring and dissolving, mix homogeneously;
(3) it is an amount of to get water for injection, adds antioxidant, stirring and dissolving;
(4) merge (2), (3) liquid, adjust pH to 5~8 are settled to 100ml with water for injection, membrane filtration;
(5) embedding, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
The present invention also provides, and this compound medicament composition is being used for analgesic, the analgesia of poultry, antiphlogistic purposes.
The specific embodiment
Embodiment 1
Prescription:
Diclofenac sodium 2g
Naproxen 4g
N-N-methyl-2-2-pyrrolidone N-60ml
Antioxidant is an amount of
Water for injection adds to 100ml
Preparation method:
1. get recipe quantity N-N-methyl-2-2-pyrrolidone N-, add diclofenac sodium, stirring and dissolving; Add naproxen, stirring and dissolving.
2. it is an amount of to get water for injection, adds antioxidant, stirring and dissolving.
3. merge 1,2, adjust pH to 5~8 are settled to 100ml with water for injection, membrane filtration.
4. embedding, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
Embodiment 2
Prescription:
Diclofenac sodium 1g
Naproxen 10g
N-N-methyl-2-2-pyrrolidone N-80ml
Antioxidant is an amount of
Water for injection adds to 100ml
Preparation method:
1. get recipe quantity N-N-methyl-2-2-pyrrolidone N-, add diclofenac sodium, stirring and dissolving; Add naproxen, stirring and dissolving.
2. it is an amount of to get water for injection, adds antioxidant, stirring and dissolving.
3. merge 1,2, adjust pH to 5~8 are settled to 100ml with water for injection, membrane filtration.
4. embedding, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
Embodiment 3
Prescription:
Diclofenac sodium 10g
Naproxen 1g
N-N-methyl-2-2-pyrrolidone N-80ml
Antioxidant is an amount of
Water for injection adds to 100ml
Preparation method:
1. get recipe quantity N-N-methyl-2-2-pyrrolidone N-, add diclofenac sodium, stirring and dissolving; Add naproxen, stirring and dissolving.
2. it is an amount of to get water for injection, adds antioxidant, stirring and dissolving.
3. merge 1,2, adjust pH to 5~8 are settled to 100ml with water for injection, membrane filtration.
4. embedding, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
Embodiment 4
Prescription:
Diclofenac sodium 2g
Naproxen 5g
N-N-methyl-2-2-pyrrolidone N-70ml
Antioxidant is an amount of
Water for injection adds to 100ml
Preparation method:
1. get recipe quantity N-N-methyl-2-2-pyrrolidone N-, add diclofenac sodium, stirring and dissolving; Add naproxen, stirring and dissolving.
2. it is an amount of to get water for injection, adds antioxidant, stirring and dissolving.
3. merge 1,2, adjust pH to 5~8 are settled to 100ml with water for injection, membrane filtration.
4. embedding, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
Embodiment 5
Prescription:
Diclofenac sodium 2g
Naproxen 10g
N-N-methyl-2-2-pyrrolidone N-80ml
Antioxidant is an amount of
Water for injection adds to 100ml
Preparation method:
1. get recipe quantity N-N-methyl-2-2-pyrrolidone N-, add diclofenac sodium, stirring and dissolving; Add naproxen, stirring and dissolving.
2. it is an amount of to get water for injection, adds antioxidant, stirring and dissolving.
3. merge 1,2, adjust pH to 5~8 are settled to 100ml with water for injection, membrane filtration.
4. embedding, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
Embodiment 6
Prescription:
Diclofenac sodium 10g
Naproxen 2g
N-N-methyl-2-2-pyrrolidone N-70ml
Antioxidant is an amount of
Water for injection adds to 100ml
Preparation method:
1. get recipe quantity N-N-methyl-2-2-pyrrolidone N-, add diclofenac sodium, stirring and dissolving; Add naproxen, stirring and dissolving.
2. it is an amount of to get water for injection, adds antioxidant, stirring and dissolving.
3. merge 1,2, adjust pH to 5~8 are settled to 100ml with water for injection, membrane filtration.
4. embedding, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
Embodiment 7
Prescription:
Diclofenac sodium 4g
Naproxen 2g
N-N-methyl-2-2-pyrrolidone N-80ml
Antioxidant is an amount of
Water for injection adds to 100ml
Preparation method:
1. get recipe quantity N-N-methyl-2-2-pyrrolidone N-, add diclofenac sodium, stirring and dissolving; Add naproxen, stirring and dissolving.
2. it is an amount of to get water for injection, adds antioxidant, stirring and dissolving.
3. merge 1,2, adjust pH to 5~8 are settled to 100ml with water for injection, membrane filtration.
4. embedding, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
Embodiment 8
Prescription:
Diclofenac sodium 10g
Naproxen 4g
N-N-methyl-2-2-pyrrolidone N-70ml
Antioxidant is an amount of
Water for injection adds to 100ml
Preparation method:
1. get recipe quantity N-N-methyl-2-2-pyrrolidone N-, add diclofenac sodium, stirring and dissolving; Add naproxen, stirring and dissolving.
2. it is an amount of to get water for injection, adds antioxidant, stirring and dissolving.
3. merge 1,2, adjust pH to 5~8 are settled to 100ml with water for injection, membrane filtration.
4. embedding, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
Embodiment 9
Prescription:
Diclofenac sodium 4g
Barbital 2g
Ethanol 30ml
Glycerol formal 20ml
Antioxidant is an amount of
Water for injection adds to 100ml
Preparation method:
1. get ethanol, the glycerol formal of recipe quantity, mixing; Add diclofenac sodium, stirring and dissolving; Add barbital, stirring and dissolving.
2. it is an amount of to get water for injection, adds antioxidant, stirring and dissolving.
3. merge 1,2, adjust pH to 5~8 are settled to 100ml with water for injection, membrane filtration.
4. embedding, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
Embodiment 10
Prescription:
Diclofenac sodium 1g
Barbital 5g
Ethanol 30ml
Glycerol formal 20ml
Antioxidant is an amount of
Water for injection adds to 100ml
Preparation method:
1. get ethanol, the glycerol formal of recipe quantity, mixing; Add diclofenac sodium, stirring and dissolving; Add barbital, stirring and dissolving.
2. it is an amount of to get water for injection, adds antioxidant, stirring and dissolving.
3. merge 1,2, adjust pH to 5~8 are settled to 100ml with water for injection, membrane filtration.
4. embedding, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
Embodiment 11
Prescription:
Diclofenac sodium 10g
Barbital 1g
Ethanol 40ml
Glycerol formal 20ml
Antioxidant is an amount of
Water for injection adds to 100ml
Preparation method:
1. get ethanol, the glycerol formal of recipe quantity, mixing; Add diclofenac sodium, stirring and dissolving; Add barbital, stirring and dissolving.
2. it is an amount of to get water for injection, adds antioxidant, stirring and dissolving.
3. merge 1,2, adjust pH to 5~8 are settled to 100ml with water for injection, membrane filtration.
4. embedding, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
Embodiment 12
Prescription:
Diclofenac sodium 2g
Barbital 2g
Ethanol 30ml
Glycerol formal 20ml
Antioxidant is an amount of
Water for injection adds to 100ml
Preparation method:
1. get ethanol, the glycerol formal of recipe quantity, mixing; Add diclofenac sodium, stirring and dissolving; Add barbital, stirring and dissolving.
2. it is an amount of to get water for injection, adds antioxidant, stirring and dissolving.
3. merge 1,2, adjust pH to 5~8 are settled to 100ml with water for injection, membrane filtration.
4. embedding, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
Embodiment 13
Prescription:
Diclofenac sodium 7.5g
Barbital 1g
Ethanol 30ml
Glycerol formal 20ml
Antioxidant is an amount of
Water for injection adds to 100ml
Preparation method:
1. get ethanol, the glycerol formal of recipe quantity, mixing; Add diclofenac sodium, stirring and dissolving; Add barbital, stirring and dissolving.
2. it is an amount of to get water for injection, adds antioxidant, stirring and dissolving.
3. merge 1,2, adjust pH to 5~8 are settled to 100ml with water for injection, membrane filtration.
4. embedding, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
Embodiment 14
Prescription:
Diclofenac sodium 9g
Barbital 2g
Ethanol 30ml
Glycerol formal 20ml
Antioxidant is an amount of
Water for injection adds to 100ml
Preparation method:
1. get ethanol, the glycerol formal of recipe quantity, mixing; Add diclofenac sodium, stirring and dissolving; Add barbital, stirring and dissolving.
2. it is an amount of to get water for injection, adds antioxidant, stirring and dissolving.
3. merge 1,2, adjust pH to 5~8 are settled to 100ml with water for injection, membrane filtration.
4. embedding, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
Observe the analgesic effect observation of example 1 according to the compound diclofenac natrium injection of embodiment 1 making
Test method: choose healthy adult new zealand white rabbit and do experiment.
1. adopt chemical stimulation pyrogenicity method, give rabbit subcutaneous injection Oleum Terebinthinae by the dosage of per kilogram of body weight 0.2ml, cause heating at 18~20h, about 24~36h reaches the peak.
2. choose give Oleum Terebinthinae after 24 hours pyrogenicity reach 12 of the rabbits on peak, be divided into 4 groups at random, be respectively A, B, C, D group, 3 every group.The A group is pressed 0.2ml/kg b.w. intramuscular injection 4% diclofenac sodium injection, and the B group is pressed 0.2ml/kg b.w. intramuscular injection 5% naproxen injection, and the C group is pressed 0.2ml/kg b.w. intramuscular injection embodiment 1 injection, and D organizes negative matched group, not administration.
3. after the administration, respectively 0,20,60,120min observes rabbit body temperature, the method for surveying body temperature is clinical thermometer to be placed on to stop in the test rabbit rectum show numerical value after 5 minutes, and record.
Result of the test: the thermal effect of separating of the compound diclofenac natrium injection of making according to embodiment 1 sees Table 1
The compound diclofenac natrium injection that table 1 is made according to embodiment 1 separate thermal effect
Figure G2007103019029D00091
Figure G2007103019029D00101
Conclusion (of pressure testing): by table 1 as seen, the compound diclofenac natrium injection that uses embodiment 1 to make is better separated thermal effect than using diclofenac sodium injection and naproxen injection to have separately.
Observe the analgesic effect observation of example 2 according to the compound diclofenac natrium injection of embodiment 2 making
Test method: with observation example 1, but the C group is pressed 0.2ml/kg b.w. intramuscular injection embodiment 2 injection.
Result of the test: the thermal effect of separating of the compound diclofenac natrium injection of making according to embodiment 2 sees Table 2.
The compound diclofenac natrium injection that table 2 is made according to embodiment 2 separate thermal effect
Figure G2007103019029D00102
Figure G2007103019029D00111
Conclusion (of pressure testing): by table 2 as seen, the compound diclofenac natrium injection that uses embodiment 2 to make is better separated thermal effect than using diclofenac sodium injection and naproxen injection to have separately.
Observe the analgesic effect observation of example 3 according to the compound diclofenac natrium injection of embodiment 3 making
Test method: with observation example 1, but the C group is pressed 0.2ml/kg b.w. intramuscular injection embodiment 3 injection.
Result of the test: the thermal effect of separating of the compound diclofenac natrium injection of making according to embodiment 3 sees Table 3
The compound diclofenac natrium injection that table 3 is made according to embodiment 3 separate thermal effect
Figure G2007103019029D00112
Figure G2007103019029D00121
Conclusion (of pressure testing): by table 3 as seen, the compound diclofenac natrium injection that uses embodiment 3 to make is better separated thermal effect than using diclofenac sodium injection and naproxen injection to have separately.
Observe the analgesic effect observation of the compound diclofenac natrium injection that example 4 manufactures according to embodiment 4
Test method:
1. choose 12 of the pigs that the natural infection that occurs in the normal feeding process causes heating, be divided into 4 groups at random, be respectively A, B, C, D group, 3 every group.The A group is pressed 0.15ml/kg b.w. intramuscular injection 4% diclofenac sodium injection, and the B group is pressed 0.15ml/kgb.w. intramuscular injection 5% naproxen injection, and the C group is pressed 0.15ml/kg b.w. intramuscular injection embodiment 4 injection, and D organizes negative matched group, not administration.
2. after the administration, respectively 0,20,60,120min observes a pig body temperature, the method for surveying body temperature is clinical thermometer to be placed on to stop in the test pig rectum show numerical value after 5 minutes, and record
Result of the test: the thermal effect of separating of the compound diclofenac natrium injection of manufacturing according to embodiment 4 sees Table 4.
The compound diclofenac natrium injection that table 4 is manufactured according to embodiment 4 separate thermal effect
Figure G2007103019029D00131
Conclusion (of pressure testing): by table 4 as seen, the compound diclofenac natrium injection that uses embodiment 4 to make is better separated thermal effect than using diclofenac sodium injection and naproxen injection to have separately.
Observe the analgesic effect observation of example 5 according to the compound diclofenac natrium injection of embodiment 5 making
Test method: with observation example 4, but the C group is pressed 0.15ml/kg b.w. intramuscular injection embodiment 5 injection.
Result of the test: the thermal effect of separating of the compound diclofenac natrium injection of making according to embodiment 5 sees Table 5.
The compound diclofenac natrium injection that table 5 is made according to embodiment 5 separate thermal effect
Figure G2007103019029D00141
Conclusion (of pressure testing): by table 5 as seen, the compound diclofenac natrium injection that uses embodiment 5 to make is better separated thermal effect than using diclofenac sodium injection and naproxen injection to have separately.
Observe the analgesic effect observation of example 6 according to the compound diclofenac natrium injection of embodiment 9 making
Test method:
1. choose 9 of the pigs that the natural infection that occurs in the normal feeding process causes heating, be divided into 3 groups at random, be respectively A, B, C group, 3 every group.The A group is pressed 0.15ml/kg b.w. intramuscular injection 4% diclofenac sodium injection, and the B group is pressed 0.15ml/kg b.w. intramuscular injection embodiment 6 injection, and C organizes negative matched group, not administration.
2. after the administration, respectively 0,20,60,120min observes a pig body temperature, the method for surveying body temperature is clinical thermometer to be placed on to stop in the test pig rectum show numerical value after 5 minutes, and record
Result of the test: the thermal effect of separating of the compound diclofenac natrium injection of making according to embodiment 9 sees Table 6.
The compound diclofenac natrium injection that table 6 is made according to embodiment 9 separate thermal effect
Figure G2007103019029D00151
Figure G2007103019029D00161
Conclusion (of pressure testing): by table 6 as seen, the compound diclofenac natrium injection that uses embodiment 9 to make is better separated thermal effect than using the diclofenac sodium injection to have separately.
Observe the analgesic effect observation of example 7 according to the compound diclofenac natrium injection of embodiment 10 making
Test method: choose healthy adult new zealand white rabbit and do experiment.
1. adopt chemical stimulation pyrogenicity method, give rabbit subcutaneous injection Oleum Terebinthinae by the dosage of per kilogram of body weight 0.2ml, cause heating at 18~20h, about 24~36h reaches the peak.
2. choose give Oleum Terebinthinae after 24 hours pyrogenicity reach 9 of the rabbits on peak, be divided into 3 groups at random, be respectively A, B, C group, 3 every group.The A group is pressed 0.2ml/kg b.w. intramuscular injection 4% diclofenac sodium injection, and the B group is pressed 0.2ml/kg b.w. intramuscular injection embodiment 10 injection, and C organizes not administration.
3. after the administration, respectively 0,20,60,120min observes rabbit body temperature, the method for surveying body temperature is clinical thermometer to be placed on to stop in the test rabbit rectum show numerical value after 5 minutes, and record.
Result of the test: the thermal effect of separating of the compound diclofenac natrium injection of making according to embodiment 10 sees Table 7.
The compound diclofenac natrium injection that table 7 is made according to embodiment 10 separate thermal effect
Figure G2007103019029D00162
Figure G2007103019029D00171
Conclusion (of pressure testing): by table 7 as seen, the compound diclofenac natrium injection that uses embodiment 10 to make is better separated thermal effect than using the diclofenac sodium injection to have separately.
Observe the analgesic effect observation of example 8 according to the compound diclofenac natrium injection of embodiment 11 making
Test method: with observation example 7, but the B group is pressed 0.2ml/kg b.w. intramuscular injection embodiment 11 injection.
Result of the test: the thermal effect of separating of the compound diclofenac natrium injection of making according to embodiment 11 sees Table 8.
The compound diclofenac natrium injection that table 8 is made according to embodiment 11 separate thermal effect
Figure G2007103019029D00172
Conclusion (of pressure testing): by table 8 as seen, the compound diclofenac natrium injection that uses embodiment 11 to make is better separated thermal effect than using the diclofenac sodium injection to have separately.
Observe the analgesic effect observation of example 9 according to the compound diclofenac natrium injection of embodiment 12 making
Test method: with observation example 6, but the B group is pressed 0.15ml/kg b.w. intramuscular injection embodiment 12 injection.
Result of the test: the thermal effect of separating of the compound diclofenac natrium injection of making according to embodiment 12 sees Table 9.
The compound diclofenac natrium injection that table 9 is made according to embodiment 9 separate thermal effect
Figure G2007103019029D00181
Conclusion (of pressure testing): by table 9 as seen, the compound diclofenac natrium injection that uses embodiment 12 to make is better separated thermal effect than using the diclofenac sodium injection to have separately.
Observe the stability observing of example 10 according to the compound diclofenac natrium injection of embodiment 1 making
Test method: making lot number by embodiment 1 is 20050201,20050202,20,050,203 3 batches of test samples, 40 ± 2 ℃ of temperature, places six months under the condition of relative humidity 75 ± 5%.In duration of test sampling in the 0th, 1,2,3,4,5,6 month once, detect by stable high spot reviews project.Stability high spot reviews project: appearance luster, content, pH value, clarity, related substance.Experimental result sees Table 10.
Table 10 is according to the accelerated test result of the compound diclofenac natrium injection of embodiment 1 making
Figure G2007103019029D00201
Conclusion (of pressure testing):
Accelerated test shows, stores under the accelerated test condition according to the preparation that embodiment 1 makes, and appearance luster, content, pH value, clarity, related substance all change not remarkable, so preparation is more stable.
Observe the stability observing of example 11 according to the compound diclofenac natrium injection of embodiment 9 making
Test method: making lot number by embodiment 9 is 20050401,20050402,20,050,403 3 batches of test samples, 40 ± 2 ℃ of temperature, places six months under the condition of relative humidity 75 ± 5%.In duration of test sampling in the 0th, 1,2,3,4,5,6 month once, detect by stable high spot reviews project.Stability high spot reviews project: appearance luster, content, pH value, clarity, related substance.Experimental result sees Table 11.
Table 11 is according to the accelerated test result of the compound diclofenac natrium injection of embodiment 9 making
Figure G2007103019029D00211
Figure G2007103019029D00221
Conclusion (of pressure testing):
Accelerated test shows, stores under the accelerated test condition according to the preparation that embodiment 9 makes, and appearance luster, content, pH value, clarity, related substance all change not remarkable, so preparation stabilization.

Claims (6)

1. poultry are used compound medicament composition, it is characterized in that it is made up of diclofenac sodium and naproxen, and the weight ratio of diclofenac sodium and naproxen is 1: 10~10: 1.
2. poultry according to claim 1 are used compound medicament composition, it is characterized in that the weight ratio of diclofenac sodium and naproxen is preferably 1: 5~5: 1.
3. the injection liquid preparation of the described poultry usefulness of claim 1 compound medicament composition is characterized in that containing a certain amount of cosolvent.
4. poultry according to claim 3 are used the injection liquid preparation of compound medicament composition, it is characterized in that described cosolvent is selected from N-N-methyl-2-2-pyrrolidone N-, ethanol, glycerol formal or its mixture, the concentration of N-N-methyl-2-2-pyrrolidone N-in the injection liquid preparation is 10~70%v/v, concentration of ethanol is 10~70%v/v, and the concentration of glycerol formal is 10~70%v/v.
5. poultry according to claim 4 are used the injection liquid preparation of compound medicament composition, it is characterized in that the concentration of described N-N-methyl-2-2-pyrrolidone N-in the injection liquid preparation is preferably 20~70%v/v, concentration of ethanol is preferably 10~50%v/v, and the concentration of glycerol formal is preferably 10~50%v/v.
Each described poultry of claim 1-2 with compound medicament composition the preparation poultry with the purposes in analgesic, analgesia, the anti-inflammatory drug.
CN2007103019029A 2006-04-21 2006-04-21 Compound pharmaceutical composition, preparation method and use of the same Active CN101219130B (en)

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