CN107224428A - Parenteral solution containing naproxen sodium and preparation method thereof - Google Patents
Parenteral solution containing naproxen sodium and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to a kind of parenteral solution containing naproxen sodium and preparation method thereof, per in 1000mL parenteral solutions, raw material components include：1.0~5.0g of naproxen sodium, 6.0~10.0g of sodium chloride, 0.5~0.8g of valine, 0.5~1.5g of meptazinol hydrochloride, surplus is water for injection；Preparation method comprises the following steps：Sodium chloride and water for injection are well mixed, reflux and filter after activated carbon is added, it is clear and bright to solution；Then other surplus stock components are added, regulation pH value is adjusted to 6.5~7.5 after being well mixed, and obtains the parenteral solution containing naproxen sodium.The parenteral solution containing naproxen sodium that the present invention is provided, stability is good, long shelf-life, instant effect and evident in efficacy；Venoclysis is used directly for, medical personnel is reduced and compatibility step is diluted in Clinical practice, it is to avoid the secondary pollution of medicine, improve the operating efficiency of clinical staff.
Description
Technical field
The present invention relates to field of medicine preparing technology, and in particular to a kind of containing the parenteral solution of naproxen sodium and its preparation side
Method.
Background technology
Sterile solution that what injection (injection) meant that medicine is made confession be injected in vivo (including emulsion and suspension
Liquid) and for the aseptic powdery or concentrated solution of wiring solution-forming or suspension before use.Injection effect is rapid reliable, not by pH,
Enzyme, food etc. influence, no first pass effect, can play whole body or local positioning effect, it is adaptable to unsuitable oral drugs and can not mouth
The patient of clothes, but injection development and production process are complicated, and security and organism adaptation are poor, and cost is higher.Naproxen sodium has
Have very strong anti-inflammatory and antalgic efficiency, its be used to treating rheumatic and rheumatoid arthritis, osteoarthritis, ankylosing spondylitis,
Gout, arthritis, myotenositis, also available for the pain caused by alleviation musculoskeletal sprains, contusion, damage and dysmenorrhoea etc.；Fortune
Dynamic system is (such as：Joint, muscle and tendon) easing pain and diminishing inflammation, the also symptomatic treatment for pain caused by a variety of diseases.But
Anaprox of the prior art, mostly tablet, powder-injection etc., and rarely have the presence of injection, affect naproxen sodium
Widely application.The water stability of naproxen sodium is poor, and light, air, pH value have considerable influence to its stability, so opening
Volatility is stable, the parenteral solution evident in efficacy containing naproxen sodium is the problem of needing to solve.
The content of the invention
For defect of the prior art, present invention aims at provide a kind of parenteral solution and its preparation containing naproxen sodium
Method, to improve parenteral solution stability, extends the shelf life, and shortens instant effect and improves curative effect；And it can be directly used for vein
Infusion, reduces medical personnel and compatibility step is diluted during Clinical practice, it is to avoid the secondary pollution of medicine, improve clinical medical and nursing
The operating efficiency of personnel.
To achieve the above object, the technical scheme that provides of the present invention is：
In a first aspect, the invention provides a kind of parenteral solution containing naproxen sodium, in every 1000mL parenteral solutions, raw material components
Including：1.0~5.0g of naproxen sodium, 6.0~10.0g of sodium chloride, 0.5~0.8g of valine, meptazinol hydrochloride 0.5~
1.5g, surplus is water for injection.
In the further embodiment of the present invention, parenteral solution also includes：PH value regulator, the consumption of pH value regulator is
The pH value of parenteral solution is adjusted to 6.0~8.0.
In the further embodiment of the present invention, pH value regulator is hydrochloric acid, sulfuric acid, phosphoric acid, acetic acid, lactic acid, citron
Acid, tartaric acid, malic acid, sodium hydroxide, sodium carbonate, sodium acid carbonate, sodium phosphate, disodium hydrogen phosphate, sodium dihydrogen phosphate, acetic acid
One or more in sodium, sodium lactate, sodium citrate, sodium tartrate and natrium malicum.
In the further embodiment of the present invention, per in 1000mL parenteral solutions, raw material components also include：Bent
0.1~0.2g, 0.5~1g of sorbierite, 1.0~2.0g of 0.5~1.5g of mannitol and pummelo peel extract.
In the further embodiment of the present invention, the preparation method of pummelo peel extract comprises the following steps：S101：By shaddock
Skin is soaked in water, is then heated, and the mixture after heating is squeezed into shaddock ped slurry；S102：Adjust the pH value of shaddock ped slurry to 5.0~
5.5, pectase, cellulase and naringinase are then added, is well mixed, then 45~55 DEG C of 3~5h of enzymolysis heat；
S103：The product coarse filtration that S102 is obtained, collects filtrate, then filtrate is decolourized, concentrated, obtained concentrate is used into 0.22
μm membrane filtration, obtains pummelo peel extract.It should be noted that in S101, the shaddock ped after heating is squeezed into shaddock ped slurry, Ke Yishi
Carried out from juice extractor or beater, other equipment can also be selected, shaddock ped is preferably the shaddock ped after drying；In S102, pectin
Enzyme can select (100,000 U/g) pectase of Shandong Kang Qin bio tech ltd, and cellulase can select Shandong Kang Qin
The cellulase of bio tech ltd, naringinase can be from Shanghai Yi Ka Bioisystech Co., Ltd (800U/g)
Naringinase；Pectase, cellulase, naringinase enzymolysis pH value range be respectively 3.5~6.5,4.0~5.5 and 2~
8。
In the further embodiment of the present invention, in S101, the temperature of heating is 55~65 DEG C, and the time of heating is 30
The mass ratio of~40min, shaddock ped and water is 1:(1~3).
In the further embodiment of the present invention, in S102, the mass ratio that pectase and shaddock ped are starched for (0.28~
0.3):100, cellulase is (0.15~0.2) with the mass ratio that shaddock ped is starched:100, the mass ratio that naringinase is starched with shaddock ped is
(0.05~0.1):100, the temperature of heating is 55~65 DEG C, and the time of heating is 85~95min；In S103, concentrate is 25
DEG C determine relative density be 1.2~1.3.
Second aspect, the invention provides the preparation method of the parenteral solution containing naproxen sodium, comprises the following steps：S1：Will
Sodium chloride and water for injection are well mixed, obtain sodium chloride solution；S2：Flowed back after adding activated carbon in sodium chloride solution
Filter, it is clear and bright to sodium chloride solution；S3：Other surplus stock components are added in the product that S2 is obtained, are well mixed, pH value is adjusted
It is adjusted to 6.5~7.5；S4：The product that S3 is obtained obtains the parenteral solution containing naproxen sodium using 0.22 μm of filter element filtering.Need
Illustrate that other surplus stock components in S3 refer to naproxen sodium, or refer to naproxen sodium, bent, sorb
Alcohol, mannitol and pummelo peel extract；In S4,0.22 μm of filter core is preferably 0.22 μm of high molecular filter element；S1-S4 was entirely prepared
Cheng Jun is carried out preferably under conditions of lucifuge, and it is stable to the parenteral solution of the sodium chloride containing naproxen sodium that lucifuge operation can reduce illumination
The influence of property.
In the further embodiment of the present invention, in S2, the ratio of the quality of activated carbon and the volume of sodium chloride solution
For (0.01~0.05) g:100mL.
In the further embodiment of the present invention, step S5 is also included after S4：Parenteral solution containing naproxen sodium is filled
Loaded in infusion bottle or infusion bag, after sealing, sterilize 20~45min at 115 DEG C~121 DEG C.It should be noted that infusion bottle is excellent
Elect glass or polypropylene material as, the material of infusion bag is preferably PP TYPE or upright polypropylene blend film.
The parenteral solution usage and dosage for the sodium chloride containing naproxen sodium that the present invention is provided：Drip-feed, adult one time 250~
500mL, 1 times a day, slow to instil, the time of instiling must not be less than 30 minutes, 5~10mL of children's per kilogram of body weight or follow the doctor's advice.
The technical scheme that the present invention is provided, with following beneficial effect：(1) note containing naproxen sodium that the present invention is provided
Penetrate liquid and can be directly used for venoclysis, reduce medical personnel the step of Clinical practice process dilutes compatibility, it is to avoid medicine
Secondary pollution and the uneven operating efficiency for causing the situation of unsatisfactory curative effect, improving clinical staff of dilution, are added containing naphthalene
The parenteral solution of general raw sodium sodium chloride is applied in clinic, meets need of the different patients to the parenteral solution of the sodium chloride containing naproxen sodium
Ask；(2) the parenteral solution stability containing naproxen sodium that provides of the present invention is good, long shelf-life, instant effect and evident in efficacy；(3)
The preparation method for the parenteral solution containing naproxen sodium that the present invention is provided is simple, and production cost is low.
The additional aspect and advantage of the present invention will be set forth in part in the description, and will partly become from the following description
Obtain substantially, or recognized by the practice of the present invention.
Embodiment
Below in conjunction with the embodiment of the present invention, technical scheme is clearly and completely described.Implement below
Example is only used for clearly illustrating technical scheme, therefore is intended only as example, and can not limit this hair with this
Bright protection domain.
Experimental method in following embodiments, is conventional method unless otherwise specified.Examination used in following embodiments
Material is tested, is to be commercially available from regular shops unless otherwise specified.Quantitative test in following examples, is respectively provided with three
Secondary to repeat to test, data are the average value or mean+SD of three repetition experiments.
The present invention provides a kind of parenteral solution containing naproxen sodium, and per in 1000mL parenteral solutions, raw material components include：Naproxen
1.0~5.0g of sodium, 6.0~10.0g of sodium chloride, 0.5~0.8g of valine, 0.5~1.5g of meptazinol hydrochloride, pH value regulation
Agent, surplus is water for injection；Wherein, the consumption of pH value regulator is that the pH value of parenteral solution is adjusted into 6.0~8.0, pH value regulation
Agent is hydrochloric acid, sulfuric acid, phosphoric acid, acetic acid, lactic acid, citric acid, tartaric acid, malic acid, sodium hydroxide, sodium carbonate, sodium acid carbonate, phosphorus
One kind in sour sodium, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium acetate, sodium lactate, sodium citrate, sodium tartrate and natrium malicum
Or it is a variety of.
Preferably, in addition to：0.1~0.2g of bent, 0.5~1g of sorbierite, 0.5~1.5g of mannitol and shaddock
1.0~2.0g of bark extract；Wherein, the preparation method of pummelo peel extract comprises the following steps：
S101：Shaddock ped is soaked in water, then 55~65 DEG C of 30~40min of heating, the mixture after heating is squeezed into
Shaddock ped is starched；
S102：The pH value of shaddock ped slurry is adjusted to 5.0~5.5, pectase, cellulase and naringinase is then added, mixes
Close uniform, 45~55 DEG C of 3~5h of enzymolysis, then 55~65 DEG C are heated 85~95min；Wherein, the quality that pectase is starched with shaddock ped
Than for (0.28~0.3):100, cellulase is (0.15~0.2) with the mass ratio that shaddock ped is starched:100, naringinase and shaddock ped
The mass ratio of slurry is (0.05~0.1):100；
S103：The product coarse filtration that S102 is obtained, collects filtrate, then filtrate is decolourized, concentrated, and obtains in 25 DEG C of measure
Relative density be 1.2~1.3 concentrate, by concentrate using 0.22 μm of membrane filtration, obtain pummelo peel extract.
In addition, present invention also offers the preparation method of the parenteral solution containing naproxen sodium, comprising the following steps：
S1：Sodium chloride and water for injection are well mixed, sodium chloride solution is obtained；
S2：Reflux and filter after activated carbon is added in sodium chloride solution, it is clear and bright to sodium chloride solution；Wherein, activated carbon
The ratio of quality and the volume of sodium chloride solution is (0.01~0.05) g:100mL；
S3：Other surplus stock components are added in the product that S2 is obtained, are well mixed, regulation pH value is adjusted to 6.5~
7.5；
S4：The product that S3 is obtained obtains the parenteral solution containing naproxen sodium using 0.22 μm of filter element filtering；
S5：Parenteral solution containing naproxen sodium is filling in infusion bottle or infusion bag, after sealing, gone out at 115 DEG C~121 DEG C
20~45min of bacterium.
Parenteral solution containing naproxen sodium provided with reference to specific embodiment the present invention and preparation method thereof is made into one
Walk explanation.
Embodiment one
The present embodiment provides a kind of parenteral solution containing naproxen sodium, raw material components by weight, including：
Per in 1000mL parenteral solutions, raw material components include：Naproxen sodium 3.0g, sodium chloride 8.0g, valine 0.6g, hydrochloric acid
Meptazinol 1.0g, pH value regulator, surplus is water for injection.
By above-mentioned raw material, the preparation method of the parenteral solution containing naproxen sodium provided using the present invention is prepared and contains Nabumetone
The parenteral solution of raw sodium：
S1：Sodium chloride and water for injection are well mixed, sodium chloride solution is obtained；
S2：Reflux and filter after activated carbon is added in sodium chloride solution, it is clear and bright to sodium chloride solution；Wherein, activated carbon
The ratio of quality and the volume of sodium chloride solution is 0.03g:100mL；
S3：Other surplus stock components are added in the product that S2 is obtained, are well mixed, regulation pH value is adjusted to 7.0；
S4：The product that S3 is obtained obtains the parenteral solution containing naproxen sodium using 0.22 μm of filter element filtering；
S5：Parenteral solution containing naproxen sodium is filling in infusion bottle or infusion bag, after sealing, 115 DEG C of sterilizing 30min.
Embodiment two
The present embodiment provides a kind of parenteral solution containing naproxen sodium, raw material components by weight, including：
Per in 1000mL parenteral solutions, raw material components include：Naproxen sodium 1.0g, sodium chloride 6.0g, valine 0.5g, hydrochloric acid
Meptazinol 0.5g, pH value regulator, surplus is water for injection.
By above-mentioned raw material, the preparation method of the parenteral solution containing naproxen sodium provided using the present invention is prepared and contains Nabumetone
The parenteral solution of raw sodium：
S1：Sodium chloride and water for injection are well mixed, sodium chloride solution is obtained；
S2：Reflux and filter after activated carbon is added in sodium chloride solution, it is clear and bright to sodium chloride solution；Wherein, activated carbon
The ratio of quality and the volume of sodium chloride solution is 0.01g:100mL；
S3：Other surplus stock components are added in the product that S2 is obtained, are well mixed, regulation pH value is adjusted to 6.5；
S4：The product that S3 is obtained obtains the parenteral solution containing naproxen sodium using 0.22 μm of filter element filtering；
S5：Parenteral solution containing naproxen sodium is filling in infusion bottle or infusion bag, after sealing, 115 DEG C of sterilizing 45min.
Embodiment three
The present embodiment provides a kind of parenteral solution containing naproxen sodium, raw material components by weight, including：
Per in 1000mL parenteral solutions, raw material components include：Naproxen sodium 5.0g, sodium chloride 10.0g, valine 0.8g, salt
Sour meptazinol 1.5g, pH value regulator, surplus is water for injection.
By above-mentioned raw material, the preparation method of the parenteral solution containing naproxen sodium provided using the present invention is prepared and contains Nabumetone
The parenteral solution of raw sodium：
S1：Sodium chloride and water for injection are well mixed, sodium chloride solution is obtained；
S2：Reflux and filter after activated carbon is added in sodium chloride solution, it is clear and bright to sodium chloride solution；Wherein, activated carbon
The ratio of quality and the volume of sodium chloride solution is 0.05g:100mL；
S3：Other surplus stock components are added in the product that S2 is obtained, are well mixed, regulation pH value is adjusted to 7.5；
S4：The product that S3 is obtained obtains the parenteral solution containing naproxen sodium using 0.22 μm of filter element filtering；
S5：Parenteral solution containing naproxen sodium is filling in infusion bottle or infusion bag, after sealing, 121 DEG C of sterilizing 20min.
Example IV
The present embodiment provides a kind of parenteral solution containing naproxen sodium, raw material components by weight, including：
Per in 1000mL parenteral solutions, raw material components include：Naproxen sodium 3.0g, sodium chloride 8.0g, valine 0.6g, hydrochloric acid
Meptazinol 1.0g, bent 0.15g, sorbierite 0.7g, mannitol 1.0g, pummelo peel extract 1.5g, pH value regulation
Agent, surplus is water for injection；Wherein, the preparation method of pummelo peel extract comprises the following steps：
S101：Shaddock ped is soaked in water, then 60 DEG C of heating 35min, the mixture after heating is squeezed into shaddock ped slurry；
S102：The pH value of shaddock ped slurry is adjusted to 5.2, pectase, cellulase and naringinase is then added, mixing is equal
It is even, 4h is digested at 50 DEG C, then 60 DEG C of heating 90min；Wherein, pectase and the mass ratio that shaddock ped is starched are 0.29:100, it is fine
The plain enzyme of dimension and the mass ratio that shaddock ped is starched are 0.18:100, naringinase is 0.08 with the mass ratio that shaddock ped is starched:100；
S103：The product coarse filtration that S102 is obtained, collects filtrate, then filtrate is decolourized, concentrated, and obtains in 25 DEG C of measure
Relative density be 1.25 concentrate, by concentrate using 0.22 μm of membrane filtration, obtain pummelo peel extract.
By above-mentioned raw material, the preparation method of the parenteral solution containing naproxen sodium provided using the present invention is prepared and contains Nabumetone
The parenteral solution of raw sodium：
S1：Sodium chloride and water for injection are well mixed, sodium chloride solution is obtained；
S2：Reflux and filter after activated carbon is added in sodium chloride solution, it is clear and bright to sodium chloride solution；Wherein, activated carbon
The ratio of quality and the volume of sodium chloride solution is 0.03g:100mL；
S3：Other surplus stock components are added in the product that S2 is obtained, are well mixed, regulation pH value is adjusted to 7.0；
S4：The product that S3 is obtained obtains the parenteral solution containing naproxen sodium using 0.22 μm of filter element filtering；
S5：Parenteral solution containing naproxen sodium is filling in infusion bottle or infusion bag, after sealing, 115 DEG C of sterilizing 30min.
Embodiment five
The present embodiment provides a kind of parenteral solution containing naproxen sodium, raw material components by weight, including：
Per in 1000mL parenteral solutions, raw material components include：Naproxen sodium 1.0g, sodium chloride 6.0g, valine 0.5g, hydrochloric acid
Meptazinol 0.5g, bent 0.1g, sorbierite 0.5g, mannitol 0.5, pummelo peel extract 1.0g, pH value regulator,
Surplus is water for injection；Wherein, the preparation method of pummelo peel extract comprises the following steps：
S101：Shaddock ped is soaked in water, then 55 DEG C of heating 30min, the mixture after heating is squeezed into shaddock ped slurry；
S102：The pH value of shaddock ped slurry is adjusted to 5.0, pectase, cellulase and naringinase is then added, mixing is equal
It is even, 3h is digested at 45 DEG C, then 55 DEG C of heating 85min；Wherein, pectase and the mass ratio that shaddock ped is starched are 0.28:100, it is fine
The plain enzyme of dimension and the mass ratio that shaddock ped is starched are 0.2:100, naringinase is 0.05 with the mass ratio that shaddock ped is starched:100；
S103：The product coarse filtration that S102 is obtained, collects filtrate, then filtrate is decolourized, concentrated, and obtains in 25 DEG C of measure
Relative density be 1.2 concentrate, by concentrate using 0.22 μm of membrane filtration, obtain pummelo peel extract.
By above-mentioned raw material, the preparation method of the parenteral solution containing naproxen sodium provided using the present invention is prepared and contains Nabumetone
The parenteral solution of raw sodium：
S1：Sodium chloride and water for injection are well mixed, sodium chloride solution is obtained；
S2：Reflux and filter after activated carbon is added in sodium chloride solution, it is clear and bright to sodium chloride solution；Wherein, activated carbon
The ratio of quality and the volume of sodium chloride solution is 0.01g:100mL；
S3：Other surplus stock components are added in the product that S2 is obtained, are well mixed, regulation pH value is adjusted to 6.5；
S4：The product that S3 is obtained obtains the parenteral solution containing naproxen sodium using 0.22 μm of filter element filtering；
S5：Parenteral solution containing naproxen sodium is filling in infusion bottle or infusion bag, after sealing, 115 DEG C of sterilizing 45min.
Embodiment six
The present embodiment provides a kind of parenteral solution containing naproxen sodium, raw material components by weight, including：
Per in 1000mL parenteral solutions, raw material components include：Naproxen sodium 5.0g, sodium chloride 10.0g, valine 0.8g, salt
Sour meptazinol 1.5g, bent 0.2g, sorbierite 1g, mannitol 1.5g, pummelo peel extract 2.0g, pH value regulation
Agent, surplus is water for injection；Wherein, the preparation method of pummelo peel extract comprises the following steps：
S101：Shaddock ped is soaked in water, then 65 DEG C of heating 40min, the mixture after heating is squeezed into shaddock ped slurry；
S102：The pH value of shaddock ped slurry is adjusted to 5.5, pectase, cellulase and naringinase is then added, mixing is equal
It is even, 5h is digested at 55 DEG C, then 65 DEG C of heating 95min；Wherein, pectase and the mass ratio that shaddock ped is starched are 0.3:100, fiber
Plain enzyme is 0.2 with the mass ratio that shaddock ped is starched:100, naringinase is 0.1 with the mass ratio that shaddock ped is starched:100；
S103：The product coarse filtration that S102 is obtained, collects filtrate, then filtrate is decolourized, concentrated, and obtains in 25 DEG C of measure
Relative density be 1.3 concentrate, by concentrate using 0.22 μm of membrane filtration, obtain pummelo peel extract.
By above-mentioned raw material, the preparation method of the parenteral solution containing naproxen sodium provided using the present invention is prepared and contains Nabumetone
The parenteral solution of raw sodium：
S1：Sodium chloride and water for injection are well mixed, sodium chloride solution is obtained；
S2：Reflux and filter after activated carbon is added in sodium chloride solution, it is clear and bright to sodium chloride solution；Wherein, activated carbon
The ratio of quality and the volume of sodium chloride solution is 0.05g:100mL；
S3：Other surplus stock components are added in the product that S2 is obtained, are well mixed, regulation pH value is adjusted to 7.5；
S4：The product that S3 is obtained obtains the parenteral solution containing naproxen sodium using 0.22 μm of filter element filtering；
S5：Parenteral solution containing naproxen sodium is filling in infusion bottle or infusion bag, after sealing, 121 DEG C of sterilizing 20min.
The parenteral solution usage and dosage for the sodium chloride containing naproxen sodium that the present invention is provided：Drip-feed, adult one time 250~
500mL, 1 times a day, slow to instil, the time of instiling must not be less than 30 minutes, 5~10mL of children's per kilogram of body weight or follow the doctor's advice.
The parenteral solution containing naproxen sodium that the embodiment of the present invention one to embodiment six is prepared, is tested by function assessment
Carry out system evaluation its effect.
1st, toxicity test
(1) test medicine and medication
Blank control：0.9% sodium chloride injection, it is commercially available, produced by Kelun Pharm Ind Co., Ltd., Sichuan.
Test specimen：The parenteral solution containing naproxen sodium that the embodiment of the present invention one and example IV are prepared, is colourless
Liquid, is condensed into required concentration through 100 DEG C before use.
Experimental animal：Rabbit, body weight 2kg or so, male and female half and half are purchased from Experimental Animal Center.
Administration time and dosage：Using intramuscular injection, administration phase is 12 weeks, and convalescence is 1 week, and intramuscular injection capacity is 2mL/
Kg/ times, once a day.
(2) experimental method and observation index
Experimental animal is grouped at random, is divided into one group of embodiment, example IV group and blank control group, except blank control group is given
Give outside 0.9% sodium chloride injection, remaining group drug dose is 2mL/kg/ times, every group of animal 10.Each group animal is per in the sky
Noon after the cropping of hind leg buttocks and routine disinfection, single-point intramuscular injection, left and right hind leg in turn, successive administration 12 weeks；Control group exists
0.9% sodium chloride injection is injected under the same terms.
Overview：Observe general behavior movable, fecal character, appetite and changes of weight etc., gait, mental act, the heart
Nausea and vomiting etc. are secreted and whether there is in rate, pupil size, nose and oral cavity.To 1 week after last dose from being administered first 7 days, daily
Observed and recorded 1 time；Wherein heart rate and pupil are measured 1 time for every 2 days, and body weight claims weekly 1 time.
Electrocardiographic examination：Rabbit is derived from right erect position, traces II lead, and administration is traced 2 times, traced within every 3 weeks after administration for first 7 days
1 time.
Blood blood examination is looked into：Extracting vein blood, red, leucocyte and quantitative blood red egg are counted with Couter blood counts (Britain's production)
In vain；With general microscopic counting blood platelet and leukocyte differential count.It is administered first 2 weeks, often weekly check 1 time；Every 3 weekly check 1 after administration
It is secondary.
Blood biochemistry checking：Venous blood sampling, anticoagulant heparin, separated plasma；Surveyed with automatic biochemical analyzer (Corona, Sweden's production)
Determine glutamic-pyruvic transaminase (GPT) and creatinine (CRTN), urea nitrogen (BUN) and sulfobromophthalein sodium (BSP) are determined with laboratory conventional method
Retention rate；The same hematological examination of sampling and measuring time.
Uroscopy：The urine test paper produced with Beijing Chemical Plant checks urine pH, albumen, glucose, ketoboidies, the urine of rabbit
Courage member, the red matter of courage and occult blood etc., microscopy cast, RBC and WBC etc., time of taking a sample to check same hematological examination.
System postmortem：3 are killed in every group of each work of animal in 24 hours after last dose, 1 week again after other rabbit last doses
Row system postmortem is entered in work.
Histological examination：Divide 2 batches, every batch every group each 5 are checked (time homologous ray postmortem).The scope of examination includes
Brain, the heart, lung, liver, kidney, adrenal gland, spleen, stomach, jejunum, pancreas and testis (hero).
Convalescence checks：Convalescence, its detection content was identical with administration phase in addition to by reagent is not given.
(3) result of the test
Overview：Each group animal does not occur obvious dry (mycteroxerosis and oral secretion after being administered 2~3 weeks
Less), Nausea and vomiting and anorexia (feed is reduced)；Activity and behavior and fecal character are had no significant effect；Body weight：Respectively
Body weight is without obvious change before and after group animal drugs；Pupil：Each group animal does not have obvious expansion pupil phenomenon；Heart rate：The each group animal heart
Rate changes equal no significant difference；Electrocardiogram：Electrocardiogram after the administration of each group animal, in addition to there is stopping up property increased heart rate early stage, without it
He substantially changes；Blood biochemical：GPT, BSP retention rate, blood urea nitrogen (BUN) (BUN) and creatinine after the administration of each group animal is without bright
It is aobvious to change, show to have no significant effect hepatic and renal function；Hematology：RBC and WBC sums, Hb, blood platelet after the administration of each group animal
Had no significant change with leukocyte differential count；Urine：Urine pH, albumen after the administration of each group animal, glucose, ketoboidies, the red matter of courage
With occult blood and microscopy finding, compare, change without obvious with preceding and blank control group is administered；System postmortem：Upon administration
12 weeks and the living blank control group killed and each embodiment group animal after being discontinued 1 week, system postmortem no significant difference, each group also have no
Abnormal change；Histological examination：Each group animal administration after 12 weeks and drug withdrawal 1 week after, do not found and medicine in 11 kinds of internal organs such as brain
The relevant pathological change of thing toxicity, and blank control group no significant difference.Conclusion：As a result show that all animals are administered 12 weeks and stopped
After medicine 1 week, urine, hematology and blood biochemical analysis inspection, system postmortem and histological examination have no significant change.Above-mentioned reality
Test result and show that the parenteral solution security containing naproxen sodium of the invention prepared is credible.
2nd, to the influence of hot plate induced pain mouse
Test method：KM mouse are chosen, female, body weight (20 ± 2) g is provided, laboratory temperature 20 by animal experimental center
~25 DEG C, humidity 40%~70%.KM female mices are placed on (55.0 ± 0.5) DEG C hot plate, start to clock, until mouse licks
Metapedes, stops clocking, and this period is the Basic Pain Threshold of this mouse.The requirement of Basic Pain Threshold value does not conform between 10s~30s
Lattice are screened out.Qualified mouse is taken to be randomly divided into blank control group, naproxen capsules agent (times profit) group, naproxen sodium tablet
(wind is safe) six groups of group, one group of embodiment, two groups of embodiment, three groups of embodiment, example IV group, five groups of embodiment and embodiment.
Every group 10, successive administration 3d, wherein, naproxen capsules agent (times profit) 0.05g/ pcs/day of gavage of group, naproxen sodium tablet
(wind is safe) 0.05g/ pcs/day of gavage of group, one group of embodiment, two groups of embodiment, three groups of embodiment, example IV group, embodiment five
The group parenteral solution containing naproxen sodium corresponding with six groups of difference single-point intramuscular injection of embodiment 1mL//times.1h was administered in the 3rd day
After determine the threshold of pain.In an experiment in order to avoid mouse metapedes is burned, it is the break period to determine 60s, more than 60s person based on 60s
Calculate.Each mouse threshold of pain average value determined, calculates the threshold of pain after medication and improves percentage.
Result of the test：Data processing, one-way analysis of variance between being organized, data are carried out using SPSS17.0 statistical softwares
As a result show：Naproxen capsules agent (times profit) group, naproxen sodium tablet (wind is safe) group, one group of embodiment, two groups of embodiment, reality
The hot plate induced pain mouse threshold of pain can be extended by applying six groups of three groups of example, example IV group, five groups of embodiment and embodiment.Before administration, with
Blank control group compares, each group there are no significant difference (p ＞ 0.05)；After administration, naproxen capsules agent (times profit) group, Nabumetone
Raw sodium tablet (wind is safe) group, one group of embodiment, two groups of embodiment, three groups of embodiment, example IV group, five groups of embodiment and implementation
There is different degrees of increase rate the threshold of pain that six groups of example, is specifically shown in shown in table 1 below.
Influence of the table 1 to hot plate induced pain mouse
3rd, to the influence of mouse agar granuloma hyperplasia
Test method：Kunming mouse, male, body weight (20 ± 2) g is provided, laboratory temperature 20 by animal experimental center
~25 DEG C, humidity 40%~70%.Kunming mouse 90 is taken, 9 groups is randomly divided into, every group 10, is respectively：Blank control
Group, naproxen capsules agent (times profit) group, naproxen sodium tablet (wind is safe) group, one group of embodiment, two groups of embodiment, embodiment three
Six groups of group, example IV group, five groups of embodiment and embodiment.Successive administration 5d, wherein, naproxen capsules agent (times profit) group is filled
0.05g/ pcs/day of stomach, naproxen sodium tablet (wind is safe) 0.05g/ pcs/day of gavage of group, one group of embodiment, two groups of embodiment, implementation
Three groups of example, example IV group, five groups of the embodiment note containing naproxen sodium corresponding with six groups of difference single-point intramuscular injection of embodiment
Penetrate liquid 1mL//times.In each group mouse sterile working in the case where ether is gently anaesthetized in the 3rd day is administered, subcutaneously noted in each mouse dorsal line
Penetrate 2% agar 0.5ml.Each group animal is taken off into cervical vertebra and put to death within second day after last dose, complete granulation tissue is won in operation, is claimed
Weight, and calculate swelling inhibiting rate.
Result of the test：Data processing, one-way analysis of variance between being organized, data are carried out using SPSS17.0 statistical softwares
As a result show：Naproxen capsules agent (times profit) group gavage, naproxen sodium tablet (wind is safe) group, one group of embodiment, embodiment two
Six groups of group, three groups of embodiment, example IV group, five groups of embodiment and embodiment can suppress agar granuloma hyperplasia, specific knot
Fruit is shown in Table 2.
Influence of the table 2 to mouse agar granuloma hyperplasia
| Group | Granulation weight (mg) | Swelling inhibiting rate (%) |
| Blank control group | 235.4 | - |
| Naproxen capsules agent (times profit) group | 136.7 | 41.93% |
| Naproxen sodium tablet (wind is safe) group | 137.6 | 41.54% |
| One group of embodiment | 85.6 | 63.64% |
| Two groups of embodiment | 83.7 | 64.44% |
| Three groups of embodiment | 84.9 | 63.93% |
| Example IV group | 51.7 | 78.04% |
| Five groups of embodiment | 52.3 | 77.78% |
| Six groups of embodiment | 52.0 | 77.91% |
4th, antipyretic response
Test method：The small white mouse 80 (each 40 of male and female) for selecting body weight to be 18~22g, is divided into 8 groups, every group of male and female each 5
Only, it is respectively：Blank control group, naproxen sodium tablet (wind is safe) group, one group of embodiment, two groups of embodiment, three groups of embodiment, reality
Apply six groups of four groups of example, five groups of embodiment and embodiment.Measurement of bldy temperature is carried out to every mouse, 2,4- dinitros are subcutaneously injected respectively
Phenol 30mg/kg, manufactures the model of heating, after 1 hour, measures the body temperature of every mouse.Then it is administered, wherein, naproxen sodium tablets
Agent (wind is safe) group gavage 0.05g/, one group of embodiment, two groups of embodiment, three groups of embodiment, example IV group, five groups of embodiment
Injecting the corresponding parenteral solution 1mL/ containing naproxen sodium respectively with six groups of embodiment, only (control group gives the physiology salt of equivalent weight
Water), 10min, 2h, 12h detect body temperature after 24h and 48h respectively.
Test effect：The specific body temperature numerical value of different time points see the table below shown in 3.
The body temperature situation of the different time points of table 3
5th, for the curative effect of cold, fever patient
Recruit each 200 of the cold patients that the age is 1 years old~10 years old and 60~70 years old, totally 400, the clinical symptoms of patient
Mainly include：Because catching cold, the cold symptoms such as nasal obstruction, runny nose, cough, heating for then occurring, body temperature 38.5 DEG C~40.3
DEG C, patient flushes red, lassitude, and headache is more than, has no appetite.Two class patients are divided into 4 groups, i.e., every group include 1~
10 years old patients 50 and 60~70 years old patient 50；The drip-feed embodiment of the present invention one, example IV group is tried out respectively to prepare
The obtained parenteral solution (being 250mL/ days, injection in morning is slow to instil, and instils 40 minutes time) containing naproxen sodium, orally
Naproxen capsules agent (times profit) (4/day, sooner or later each 2), naproxen sodium tablet (wind is safe) (4 tablet per days, sooner or later each 2).
Inject or take 2 days, observe result.Wherein, curative effect situation criterion is to cure：Patient's heating paresthesia is wholly absent, and is recovered
Normally, within two weeks without body temperature repeatedly and without other cold symptoms recurrence；It is effective：Patient's heating paresthesia disappears substantially, has a stuffy nose, flows
The cold symptoms such as tears, cough do not take a turn for the better completely, and Relapse rate phenomenon is not present in two weeks；Effectively：Patient's heating paresthesia has disappeared
Lose, the cold symptoms such as nasal obstruction, runny nose, cough have taken a turn for the better, and there is Relapse rate phenomenon in two weeks；It is invalid：Patient symptom without appoint
What takes a turn for the better.Efficacy result statistics is as shown in table 4 below.
Table 4 is directed to the curative effect situation that cat fever is coughed
6th, stability
The naproxen sodium sodium chloride injection that the embodiment of the present invention one to embodiment six is prepared is stood, and is seen whether
There is a material suspension, whether solution clear and bright etc., it is as a result as shown in table 5 below.
The stability test result of table 5
| Storage time | 30 days | Half a year | 1 year | 3 years |
| Embodiment one | Clear and bright/no suspended substance | Clear and bright/no suspended substance | Clear and bright/no suspended substance | Clear and bright/no suspended substance |
| Embodiment two | Clear and bright/no suspended substance | Clear and bright/no suspended substance | Clear and bright/no suspended substance | Clear and bright/no suspended substance |
| Embodiment three | Clear and bright/no suspended substance | Clear and bright/no suspended substance | Clear and bright/no suspended substance | Clear and bright/no suspended substance |
| Example IV | Clear and bright/no suspended substance | Clear and bright/no suspended substance | Clear and bright/no suspended substance | Clear and bright/no suspended substance |
| Embodiment five | Clear and bright/no suspended substance | Clear and bright/no suspended substance | Clear and bright/no suspended substance | Clear and bright/no suspended substance |
| Embodiment six | Clear and bright/no suspended substance | Clear and bright/no suspended substance | Clear and bright/no suspended substance | Clear and bright/no suspended substance |
It should be noted that situation about being enumerated to embodiment six except above-described embodiment one, from other raw material components
Proportioning and preparation method thereof parameter is also feasible.
The technical scheme that the present invention is provided, with following beneficial effect：(1) note containing naproxen sodium that the present invention is provided
Penetrate liquid and can be directly used for venoclysis, reduce medical personnel the step of Clinical practice process dilutes compatibility, it is to avoid medicine
Secondary pollution and the uneven operating efficiency for causing the situation of unsatisfactory curative effect, improving clinical staff of dilution, are added containing naphthalene
The parenteral solution of general raw sodium sodium chloride is applied in clinic, meets need of the different patients to the parenteral solution of the sodium chloride containing naproxen sodium
Ask；(2) the parenteral solution stability containing naproxen sodium that provides of the present invention is good, long shelf-life, instant effect and evident in efficacy；(3)
The preparation method for the parenteral solution containing naproxen sodium that the present invention is provided is simple, and production cost is low.
It should be noted that unless otherwise indicated, technical term or scientific terminology used in this application should be this hair
The ordinary meaning that bright one of ordinary skill in the art are understood.Unless specifically stated otherwise, otherwise illustrate in these embodiments
Part and relative step, numerical expression and the numerical value of step are not limit the scope of the invention.It is illustrated and described herein
In all examples, unless otherwise prescribed, any occurrence should be construed as merely exemplary, not as limitation, because
This, other examples of exemplary embodiment can have different values.
Finally it should be noted that：Various embodiments above is merely illustrative of the technical solution of the present invention, rather than its limitations；To the greatest extent
The present invention is described in detail with reference to foregoing embodiments for pipe, it will be understood by those within the art that：Its according to
The technical scheme described in foregoing embodiments can so be modified, or which part or all technical characteristic are entered
Row equivalent substitution；And these modifications or replacement, the essence of appropriate technical solution is departed from various embodiments of the present invention technology
The scope of scheme, it all should cover among protection scope of the present invention.
Claims (10)
1. a kind of parenteral solution containing naproxen sodium, it is characterised in that per in 1000mL parenteral solutions, raw material components include：
1.0~5.0g of naproxen sodium, 6.0~10.0g of sodium chloride, 0.5~0.8g of valine, 0.5~1.5g of meptazinol hydrochloride,
Surplus is water for injection.
2. the parenteral solution according to claim 1 containing naproxen sodium, it is characterised in that the parenteral solution also includes：
PH value regulator, the consumption of the pH value regulator is that the pH value of the parenteral solution is adjusted into 6.5~7.5.
3. the parenteral solution according to claim 2 containing naproxen sodium, it is characterised in that：
The pH value regulator is hydrochloric acid, sulfuric acid, phosphoric acid, acetic acid, lactic acid, citric acid, tartaric acid, malic acid, sodium hydroxide, carbon
Sour sodium, sodium acid carbonate, sodium phosphate, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium acetate, sodium lactate, sodium citrate, sodium tartrate and
One or more in natrium malicum.
4. the parenteral solution containing naproxen sodium according to claim any one of 1-3, it is characterised in that per 1000mL parenteral solutions
In, raw material components also include：
0.1~0.2g of bent, 0.5~1g of sorbierite, 1.0~2.0g of 0.5~1.5g of mannitol and pummelo peel extract.
5. the parenteral solution according to claim 4 containing naproxen sodium, it is characterised in that the preparation side of the pummelo peel extract
Method comprises the following steps：
S101：Shaddock ped is soaked in water, then heated, the mixture after the heating is squeezed into shaddock ped slurry；
S102：The pH value of the shaddock ped slurry is adjusted to 5.0~5.5, pectase, cellulase and naringinase is then added, mixes
Close uniform, then 45~55 DEG C of 3~5h of enzymolysis heat；
S103：The product coarse filtration that the S102 is obtained, collects filtrate, and then the filtrate is decolourized, concentrated, dense by what is obtained
Contracting liquid obtains the pummelo peel extract using 0.22 μm of membrane filtration.
6. the parenteral solution according to claim 5 containing naproxen sodium, it is characterised in that：
In the S101, the temperature of the heating is 55~65 DEG C, and time of the heating is 30~40min, the shaddock ped and
The mass ratio of the water is 1:(1~3).
7. the parenteral solution according to claim 5 containing naproxen sodium, it is characterised in that：
In the S102, the pectase is (0.28~0.3) with the mass ratio that the shaddock ped is starched:100, the cellulase with
The mass ratio of the shaddock ped slurry is (0.15~0.2):100, the mass ratio that the naringinase and the shaddock ped are starched for (0.05~
0.1):100, the temperature of the heating is 55~65 DEG C, and the time of the heating is 85~95min；
In the S103, the concentrate is 1.2~1.3 in the relative density of 25 DEG C of measure.
8. the preparation method of the parenteral solution containing naproxen sodium described in claim any one of 1-7, it is characterised in that including as follows
Step：
S1：Sodium chloride and water for injection are well mixed, sodium chloride solution is obtained；
S2：Reflux and filter after activated carbon is added in the sodium chloride solution, it is clear and bright to the sodium chloride solution；
S3：Other surplus stock components are added in the product that the S2 is obtained, are well mixed, regulation pH value is adjusted to 6.5~
7.5；
S4：The product that the S3 is obtained obtains the parenteral solution containing naproxen sodium using 0.22 μm of filter element filtering.
9. the preparation method of the parenteral solution according to claim 8 containing naproxen sodium, it is characterised in that：
In the S2, the ratio of the volume of the quality of the activated carbon and the sodium chloride solution is (0.01~0.05) g:
100mL。
10. the preparation method of the parenteral solution according to claim 8 containing naproxen sodium, it is characterised in that：
Also include step S5 after the S4：The parenteral solution containing naproxen sodium is filling in infusion bottle or infusion bag, it is close
It is honored as a queen, sterilize 20~45min at 115 DEG C~121 DEG C.
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| CN113730344A (en) * | 2021-09-13 | 2021-12-03 | 艾迈华创(武汉)科技有限公司 | Injectable naproxen preparation and application thereof |
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