CN102525962B - Power injection for injecting creatine phosphate sodium composition - Google Patents
Power injection for injecting creatine phosphate sodium composition Download PDFInfo
- Publication number
- CN102525962B CN102525962B CN 201210014132 CN201210014132A CN102525962B CN 102525962 B CN102525962 B CN 102525962B CN 201210014132 CN201210014132 CN 201210014132 CN 201210014132 A CN201210014132 A CN 201210014132A CN 102525962 B CN102525962 B CN 102525962B
- Authority
- CN
- China
- Prior art keywords
- phosphate sodium
- creatine phosphate
- injecting
- power injection
- injection
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to the field of medicament chemistry, in particular to a power injection for injecting a creatine phosphate sodium composition. The power injection for injecting the creatine phosphate sodium composition consists of creatine phosphate sodium and lignocaine hydrochloride, wherein the mass ratio of the creatine phosphate sodium to the lignocaine hydrochloride is 500:(7.92-9.9). Due to the adoption of the power injection for injecting the creatine phosphate sodium composition provided by the invention, keenly feel during injection is relieved; and compared with a positive medicinal control group, the power injection has the advantage that: the curative effect is enhanced remarkably.
Description
Technical field
The present invention relates to the pharmaceutical chemistry field, particularly power injection for injecting creatine phosphate sodium composition.
Background technology
Cardiovascular disease is one of main disease that threatens now human health, and M ﹠ M has surpassed malignant tumor, leaps to the first.According to World Health Organization (WHO) (WHO), the whole world approximately has more than 1,700 ten thousand people to die from cardiovascular and cerebrovascular disease every year, and wherein acute myocardial infarction, cerebral infarction have occupied 50%.Ministry of Health of China " national health service research " latest result shows: the ill total number of persons of China's blood circulation diseases is about 6,500 ten thousand people, and wherein the hypertension number of patients is about 3,400 ten thousand people, and cerebrovascular is about 8,500,000 people, and coronary heart disease is about 6,000,000 people.Nearly 2 years, under the impact of the natural growth of the population, the sustainable growth of blood circulation diseases prevalence became the disease that is day by day threatening human health.
The oxidative metabolism Power supply deficiency that causes that slows down is the key factor of myocardial cell injury formation and development.In myocardial damage, the quantity of high-energy phosphate compound in the cell, and have close relation between the survival of cell and the contractile function recovery capability.Phosphagen plays a significant role in the energy metabolism of muscle contraction, and it is the chemical energy deposit of cardiac muscle and skeletal muscle, and is used for the resynthesis of ATP, and the actomyosin contraction process that is hydrolyzed to of ATP provides energy.Therefore keeping the level of high-energy phosphate compound to become the basic principle of various restriction myocardial damage methods, also is the basis of heart metabolic defence simultaneously.The asystole test of animal experiment and human body has shown the effect of Creatine Phosphate Sodium and the probability of its protection cardiac muscle.
An important goal at present cardiac disorder treatment field is the New Policy of development myocardial preservation.Creatine Phosphate Sodium, chemical name are the Creatine PHospHate Sodium tetrahydrate, and molecular formula is C
4H
8N
3Na
2O
5P4H
2O, molecular weight: 327.14, structural formula is as follows:
Phosphagen plays a significant role in the energy metabolism of muscle contraction, and it is the chemical energy deposit of cardiac muscle and skeletal muscle, and is used for the resynthesis of ATP, and ATP can provide energy for the actomyosin contraction process through hydrolysis.Creatine Phosphate Sodium is as a kind of buffer agent and in-house energy carrier of energy, and it has following characteristics: the ischemic myocardium contractile function is had remarkable protective effect, make contractility well be recovered to descend rapidly with diastolic pressure; Keep the content of the interior ATP of cell and CP, keep myocardium energy reserves; Reduce the loss of CK, the infringement that alleviates cell membrane; The characteristic that anti-peroxidation is arranged.Fructose Diphosphate sodium is widely used in the myocarditic treatment for a long time as a kind of heart energy supply medicine.In the Children Myocarditis treatment, the curative effect of phosphagen all is higher than the effect of fructose, and statistics has the poor property of significance.Owing to having energy-rich phosphate bond in the phosphagen molecule, its energy-rich phosphate bond makes ADP be converted into ATP under the effect of phosphocreatinase, directly gives human body energy, and Fructose Diphosphate sodium is as a glucolytic intermediate product, need to indirectly play a role by anaerobic metabolism.Because phosphagen is direct effect, can at once have an effect, and therefore, is comparing aspect clinical symptoms and the heart failure two, statistics all has significant difference.Compare for arrhythmia, statistics has the reason of significant difference except above-mentioned molecular biology characteristics, and Creatine Phosphate Sodium also is improved the ischemic area conducting power, eliminates this zone electricity physiologic derangement.Owing in the myocarditic pathogenic process, having myocardial ischemia, virus attack, other also have immunoreation, multiple neuroendocrine variation, single or many factors effect in the factors, finally cause the structural damage of cardiac muscle fiber own, in addition hemodynamic change is so the chambers of the heart enlarges.This is a relatively slowly process, and after the treatment of protection cardiac muscle, recovering also can be slower.
Clinically, adopt the Creatine Phosphate Sodium powder ampoule agent for injection that the patient is treated more.But the Creatine Phosphate Sodium powder ampoule agent for injection is when injection, how with pain occurrence.Therefore, a kind of sense that can ease the pain is provided, does not affect the power injection for injecting creatine phosphate sodium composition of drug effect, significant.
Summary of the invention
In view of this, the invention provides a kind of power injection for injecting creatine phosphate sodium composition.This power injection for injecting creatine phosphate sodium composition has improved drug effect when alleviating pain.
In order to realize the foregoing invention purpose, the invention provides following technical scheme:
The invention provides a kind of power injection for injecting creatine phosphate sodium composition, formed by Creatine Phosphate Sodium and lidocaine hydrochloride; The mass ratio of described Creatine Phosphate Sodium and lidocaine hydrochloride is 500: 7.92～9.9.
Lidocaine hydrochloride, chemical name is N-(2,6 3,5-dimethylphenyls)-2-(lignocaine) acetamide hydrochloride-hydrate, belong to local anesthetics of amide derivatives, after the blood absorption or intravenously administrable, the central nervous system there is obvious excitement and suppresses biphasic effect, and can be without pioneer's excitement.Therefore, the present invention adds hydrochloric acid benefit card in Creatine Phosphate Sodium, the pain when reducing clinical practice.
When lidocaine hydrochloride blood drug level was low, analgesia and drowsiness, threshold of pain raising can appear; Along with dosage strengthens, the effect of lidocaine hydrochloride or toxicity strengthen, and anticonvulsant action is arranged during inferior poisoning blood drug level.Therefore, to select the mass ratio of Creatine Phosphate Sodium and lidocaine hydrochloride be 500: 7.92～9.9 in the present invention.
The present invention also provides a kind of preparation method of power injection for injecting creatine phosphate sodium composition, and raw material is comprised of Creatine Phosphate Sodium and lidocaine hydrochloride, and the mass ratio of described Creatine Phosphate Sodium and lidocaine hydrochloride is 500: 7.92～9.9; Take by weighing described raw material, cross 80～100 mesh sieves, obtain mixed liquor after the dissolving of adding water for injection, lyophilization makes described power injection for injecting creatine phosphate sodium composition.
In order to keep the drug effect of Creatine Phosphate Sodium, adopt Freeze Drying Technique that raw material is processed in the preparation method provided by the invention.Lyophilization is with after the thing quick freezing to be dried, the drying means of under high vacuum condition ice distillation wherein being removed for steam again.Because heat is taken away in the distillation of ice, make the whole process of lyophilizing keep the sharp freezing state, be not subjected to capillary effect, be conducive to the chemical composition and the physical property that keep original.
As preferably, described cryodesiccated condition is: the pre-freeze temperature is-55～-30 ℃, and the pre-freeze time is 1～8h; Sublimation temperature is-35～-10 ℃, and the distillation time is 5～20h; Baking temperature is 15～50 ℃, and be 3～15h drying time.
As preferably, before described lyophilization, also comprise the step of fine straining, fill.
The invention provides a kind of power injection for injecting creatine phosphate sodium composition, formed by Creatine Phosphate Sodium and lidocaine hydrochloride; The mass ratio of described Creatine Phosphate Sodium and lidocaine hydrochloride is 500: 7.92～9.9.
Shown by survey result, from national northwest, southwest, northeast, North China, the southeast, Central China's each age group, every profession and trade personage altogether 1080 among the examination person, the pain satisfaction rate is 86.63% during the injection of the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 is provided, and the pain satisfaction rate is 91.73% after the injection.
The test of pesticide effectiveness shows, the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides is compared with the positive drug matched group, and the total effective rate of chronic heart failure is increased to 95.7% by 92.3%, and difference has significance (P＜0.05); The total effective rate of congenital heart disease is increased to 86.2% by 80.8%, significant difference (P＜0.05); The cure rate of myocardial ischemia is increased to 87.1% by 83.2%, and difference is (P＜0.01) extremely significantly; Comprehensive the above results, the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides is compared with the positive drug matched group, has significantly improved drug effect.
Comprehensive the above results, the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides is compared with the positive drug matched group, has significantly improved the drug effect to dacryocystisis, palpebral abscess, corneal ulcer, panophthalmitis, orbital cellulitis, purulent meningitis, acute suppurative tonsillitis, acute pneumonia, urinary tract infection, cervical region purulent lymphadenitis, facial cellulitis.
The specific embodiment
The invention discloses a kind of power injection for injecting creatine phosphate sodium composition, those skilled in the art can use for reference this paper content, suitably improve technological parameter and realize.Special needs to be pointed out is, all similarly replace and change apparent to those skilled in the art, and they all are deemed to be included in the present invention.Method of the present invention and application are described by preferred embodiment, the related personnel obviously can change or suitably change and combination methods and applications as herein described within not breaking away from content of the present invention, spirit and scope, realizes and use the technology of the present invention.
Used medicine, reagent all can be buied by market in the power injection for injecting creatine phosphate sodium composition provided by the invention.
Below in conjunction with embodiment, further set forth the present invention:
Embodiment 1 power injection for injecting creatine phosphate sodium composition provided by the invention
Accurately take by weighing Creatine Phosphate Sodium 500g, lidocaine hydrochloride 7.92g crosses 80 mesh sieves, and after the mixing, then fine straining, fill, sealing are-55 ℃ in the pre-freeze temperature, and the pre-freeze time is 1h; Sublimation temperature is-35 ℃, and the distillation time is 5h; Baking temperature is 15 ℃, and be to carry out lyophilization under the condition of 15h drying time, makes power injection for injecting creatine phosphate sodium composition.
Embodiment 2 power injection for injecting creatine phosphate sodium compositions provided by the invention
Accurately take by weighing Creatine Phosphate Sodium 500g, lidocaine hydrochloride 9.9g crosses 80 mesh sieves, and after the mixing, then fine straining, fill, sealing are-55～-30 ℃ in the pre-freeze temperature, and the pre-freeze time is 1～8h; Sublimation temperature is-35～-10 ℃, and the distillation time is 5～20h; Baking temperature is 15～50 ℃, and be to carry out lyophilization under the condition of 3～15h drying time, makes power injection for injecting creatine phosphate sodium composition.
Embodiment 3 power injection for injecting creatine phosphate sodium compositions provided by the invention
Accurately take by weighing Creatine Phosphate Sodium 1000g, lidocaine hydrochloride 16.8g crosses 100 mesh sieves, and after the mixing, then fine straining, fill, sealing are-30 ℃ in the pre-freeze temperature, and the pre-freeze time is 8h; Sublimation temperature is-10 ℃, and the distillation time is 20h; Baking temperature is 50 ℃, and be to carry out lyophilization under the condition of 3h drying time, makes power injection for injecting creatine phosphate sodium composition.
Embodiment 4 power injection for injecting creatine phosphate sodium compositions provided by the invention
Accurately take by weighing Creatine Phosphate Sodium 500g, lidocaine hydrochloride 8.85g crosses 90 mesh sieves, and after the mixing, then fine straining, fill, sealing are-45 ℃ in the pre-freeze temperature, and the pre-freeze time is 5h; Sublimation temperature is-25 ℃, and the distillation time is 12h; Baking temperature is 35 ℃, and be to carry out lyophilization under the condition of 7h drying time, makes power injection for injecting creatine phosphate sodium composition.
Embodiment 5 power injection for injecting creatine phosphate sodium compositions provided by the invention
Accurately take by weighing Creatine Phosphate Sodium 1000g, lidocaine hydrochloride 18.4g crosses 90 mesh sieves, and after the mixing, then fine straining, fill, sealing are-40 ℃ in the pre-freeze temperature, and the pre-freeze time is 3h; Sublimation temperature is-15 ℃, and the distillation time is 16h; Baking temperature is 40 ℃, and be to carry out lyophilization under the condition of 5h drying time, makes power injection for injecting creatine phosphate sodium composition.
Embodiment 6 power injection for injecting creatine phosphate sodium compositions provided by the invention
Accurately take by weighing Creatine Phosphate Sodium 500g, lidocaine hydrochloride 8.21g crosses 80 mesh sieves, and after the mixing, then fine straining, fill, sealing are-35 ℃ in the pre-freeze temperature, and the pre-freeze time is 6h; Sublimation temperature is-28 ℃, and the distillation time is 8h; Baking temperature is 20 ℃, and be to carry out lyophilization under the condition of 12h drying time, makes power injection for injecting creatine phosphate sodium composition.
Pain detects during embodiment 7 power injection for injecting creatine phosphate sodium composition clinical practice provided by the invention
Choose at random respectively 1080 altogether of each age group, every profession and trade personages in national northwest, southwest, northeast, North China, the southeast, Central China, be divided into 36 groups according to age, engaged in trade, every group 30 for examination person, when the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 is provided is injected after pain and the injection pain estimate, the pain evaluation criterion sees Table 1, and evaluation result sees Table 2, table 3.
Table 1 pain evaluation criterion
Pain evaluation result during table 2 injection
Pain evaluation result after table 3 injection
Shown by survey result, from national northwest, southwest, northeast, North China, the southeast, Central China's each age group, every profession and trade personage altogether 1080 among the examination person, the pain satisfaction rate is 87.73% during the injection of the Creatine Phosphate Sodium powder ampoule agent for injection that the embodiment of the invention 1 to 6 is provided, and the pain satisfaction rate is 92.27% after the injection.
Embodiment 8 power injection for injecting creatine phosphate sodium composition influence factor tests provided by the invention
Influence factor's test is carried out under the condition fiercer than accelerated test, and its influence factor comprises: high humility, high temperature and strong illumination.According to Chinese Pharmacopoeia version in 2010 two appendix XI X C and " chemical drugs and treatment are studied guideline with biological product ", select following investigation project with quality standard in conjunction with the clinical research of this product: character, moisture, related substance, content.
Get the Creatine Phosphate Sodium powder ampoule agent for injection that the embodiment of the invention 1 to 6 provides an amount of, put suitable weighing botle, spread out into≤thin layer that 5mm is thick, carry out influence factor's test.
Hot test:
Creatine Phosphate Sodium is at high temperature unstable according to the literature, and its preparation description holding conditions is: preserve below 30 ℃.So in the hot test of the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides, be positioned over simultaneously under 60 ℃, 40 ℃ two conditions, in the 5th day and sampling detection in the 10th day.With result of the test and compared in 0 day.
Exposure experiments to light:
Getting the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides, put in the lighting box that daylight lamp is housed, is to place 10 days under the condition of 4500lx in illumination, in the 5th day and sampling detection in the 10th day, and with result of the test and compared in 0 day.
High wet test:
Draw moist test as can be known by medicine, Creatine Phosphate Sodium draws moist medicine for having.Therefore selecting the relative humidity condition when high wet test is 75%; get the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides; opening is put in the constant humidity hermetic container; placed 10 days under respectively at relative humidity 75% condition at 25 ℃; in the 5th day and sampling detection in the 10th day, and with result of the test and compared in 0 day.Result of the test sees Table 4 to table 7.
The power injection for injecting creatine phosphate sodium composition influence factor part check item result of the test that table 4 embodiment 1 to 3 makes
The power injection for injecting creatine phosphate sodium composition influence factor result of the test that table 5 embodiment 1 to 3 makes
The power injection for injecting creatine phosphate sodium composition influence factor part check item result of the test that table 6 embodiment 4 to 6 makes
The power injection for injecting creatine phosphate sodium composition influence factor result of the test that table 7 embodiment 4 to 6 makes
Result of the test shows, when the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides was placed 5 days under 60 ℃ of conditions of high temperature, related substance obviously increased, and exceeds standard.When placing 5 days under super-humid conditions, two sample moisture absorption weightening finishes of parallel placement are all above 15%.Placed 10 days under 40 ℃ of conditions, related substance also exceeds standard, and content obviously descends; Placed 10 days under the 4500lx illumination condition, except content slightly reduces, outside related substance slightly raise, other indices had no significant change.As seen except high temperature, high humidity were large to the quality influence of this product, illumination also had certain impact to this product, therefore this product is answered lucifuge, sealing in put procedure, preserves at dry place below 30 ℃.
Embodiment 9 power injection for injecting creatine phosphate sodium composition stability tests provided by the invention
Accelerated test:
Because the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides is after placing 10 days under 40 ℃ of conditions, related substance exceeds standard, therefore, adopt 30 ± 2 ℃ of temperature, the condition of relative humidity 75 ± 5% is as the accelerated test condition of this product.Get this product three batch samples and listing product by commercially available back, 30 ℃ ± 2 ℃ of temperature, placed 6 months under the condition of relative humidity 75% ± 5%, in duration of test the 0th, 1,2,3,6 sampling at the end of month once, detect by stable emphasis inspection item.With result of the test and comparison in 0 month, testing result sees Table 8 to table 10.
Table 8 Creatine Phosphate Sodium accelerated test some projects check result
Table 9 Creatine Phosphate Sodium accelerated test some projects check result
Table 10 Creatine Phosphate Sodium accelerated test sundry item check result
Result of the test shows, the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides is by under the commercially available back condition, 30 ± 2 ℃ of temperature, place after 6 months under relative humidity 75 ± 5% conditions, except content slightly reduces, outside related substance slightly raise, other every investigation indexs were compared with 0 month, all without significant change, all up to specification.
Long term test:
Get power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides by commercially available back, 25 ℃ ± 2 ℃ of temperature, placed 36 months under the condition of relative humidity 60% ± 10%, in duration of test the 0th, 3,6,9,12,18,24 and 36 samplings at the end of month once, detect by stable emphasis inspection item.Result of the test was compared to determine the effect duration of medicine with 0 month, result of the test sees Table 11 to table 13.
Table 11 Creatine Phosphate Sodium long term test some projects check result
Table 12 Creatine Phosphate Sodium long term test some projects check result
Table 13 Creatine Phosphate Sodium long term test sundry item check result
Result of the test shows, the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides is by under the commercially available back condition, 25 ℃ ± 2 ℃ of temperature, place after 18 months under relative humidity 60% ± 10% condition, except content slightly reduces, related substance slightly raises, other every investigation indexs were compared with 0 month, and are without significant change, all up to specification.
Compatibility stability is investigated: get the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides, add the water for injection dissolving, add respectively among 5% glucose injection 100mL, the 0.9% sodium chloride injection 100mL, investigate, the results are shown in Table 14, table 15.
Table 14 and the test of 5% glucose injection compatibility
Table 15 and the test of 0.9% sodium chloride injection compatibility
Known by above result, stable in 4 hours behind the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides and 5% glucose injection, the 0.9% sodium chloride injection compatibility, can use with its compatibility.
Embodiment 9 power injection for injecting creatine phosphate sodium composition pharmacology provided by the invention, toxicity, the test of pesticide effectiveness
The power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides is the auxiliary therapeutic agent of heart disease; has the vigor that strengthens cardiac muscle (striped muscle); improve the metabolism of cardiac conduction and cardiac muscle, cardiac muscle is had protective effect, blood vessel is had certain dilating effect.
(age in days 70～95d, body weight 350～400g) is divided into recovery group (A group) at random, low dose of CP group (B group), heavy dose of CP group (C group), matched group (D group), 8 every group with 32 bull rats in the animal pharmacodynamic experiment.A group is only gone anesthesia and tracheal intubation, vascular puncture, and not all right clamp suffocates and cardio-pulmonary resuscitation (CPR).B, C, D group rat are pressed from both sides the cannula of holding one's breath in end-tidal, begin to carry out CPR behind the 7min that suffocates.B, C group is injected CP at conventional CPR basis upper vein: first administration when CPR begins, and B organizes 0.5g/kg, and C organizes 1.0g/kg; Rechallenge behind the 2h, B organizes 1.0g/kg, and C organizes 2.0g/kg.The result shows: compare with the A group, B, C group Serum CK-MB and cTn I content from 6h behind the ROSC all significantly reduce, and cardiac muscular tissue's pathological change all obviously alleviates, and show that myocardial damage has obvious protective effect after CP is to rat CPR; Compare with the A group; C group Serum CK-MB and cTn I level each time point after recovery reduces all more obvious; point out heavy dose of CP stronger to the protective effect of myocardial damage; show that CP has certain dose-effect relationship to the protective effect of myocardial damage, larger dose or repeatedly use CP may be more favourable to myocardial damage after alleviating CPR.
Anaphylaxis, hemolytic and vascular stimulation tests data show, the clinical plan of power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides is carried out each test with Cmax, has no the reactions such as haemolysis and red cell agglutination under this experimental condition, has no blood vessel irritation and react, have no Cavia porcellus and anaphylaxis occurs.
The toxicology test demonstration, the power injection for injecting creatine phosphate sodium composition that short-term and the life-time service embodiment of the invention 1 to 6 provide is treated all without genotoxic potential, without teratogenesis.
Intramuscular injection Creatine Phosphate Sodium various cardiomyopathys that the reasons such as isoproterenol (rat and pigeon), thyroxine (rat), ipecine (Cavia porcellus), p-NP (rat), labour (rat) are caused have the protective effect of dose dependent in advance.
Creatine Phosphate Sodium is to the heart of stripped Rana nigromaculata, rat and Cavia porcellus and the auricle performance positive inotropic action of Cavia porcellus.But Creatine Phosphate Sodium antagonism anoxia is to the negative inotropic action in guinea-pig heart room.In to body and in the test of the multiple test model that exsomatizes, add Creatine Phosphate Sodium in the cardioplegic solution and all can strengthen protection to cardiac muscle.Creatine Phosphate Sodium provides protection to Myocardial Infarction and the arrhythmia that coronary occlusion causes.The myocardial preservation function of Creatine Phosphate Sodium is relevant with following effect: the stable muscles fibrous membrane; Keep adenylic acid level in the cell by suppressing the nucleotide catabolic enzyme, suppress the phospholipids degradation at ischemic myocardium position; Improve the microcirculation of ishemic part by suppressing platelet aggregation that ADP-induces.Show power injection for injecting creatine phosphate sodium composition safety that the embodiment of the invention 1 to 6 provides, effectively by above-mentioned pharmacological toxicology research data.
The power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides carries out the test of pesticide effectiveness to chronic heart failure, congenital heart disease, Patients with Myocardial Ischemia: the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 is provided is as test group, respectively chronic heart failure, congenital heart disease, each 300 patient of myocardial ischemia are executed and control with the positive drug matched group, the results are shown in Table 16.
The table 16 Creatine Phosphate Sodium powder ampoule agent for injection test of pesticide effectiveness
As shown in Table 16, the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides is compared with the positive drug matched group, and the total effective rate of chronic heart failure is increased to 95.7% by 92.3%, and difference has significance (P＜0.05); The total effective rate of congenital heart disease is increased to 86.2% by 80.8%, significant difference (P＜0.05); The cure rate of myocardial ischemia is increased to 87.1% by 83.2%, and difference is (P＜0.01) extremely significantly; Comprehensive the above results, the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides is compared with the positive drug matched group, has significantly improved drug effect.
Comprehensive the above results, the power injection for injecting creatine phosphate sodium composition that the embodiment of the invention 1 to 6 provides is compared with the positive drug matched group, has significantly improved the drug effect to chronic heart failure, congenital heart disease, myocardial ischemia.
The above only is preferred implementation of the present invention; should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the principle of the invention; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.
Claims (2)
1. a power injection for injecting creatine phosphate sodium composition is characterized in that, is comprised of Creatine Phosphate Sodium, lidocaine hydrochloride; The mass ratio of described Creatine Phosphate Sodium and lidocaine hydrochloride is 500:7.92～9.9;
The preparation method of described power injection for injecting creatine phosphate sodium composition is: raw material is comprised of Creatine Phosphate Sodium and lidocaine hydrochloride, and the mass ratio of described Creatine Phosphate Sodium and lidocaine hydrochloride is 500:7.92～9.9; Take by weighing described raw material, cross 80～100 mesh sieves, obtain mixed liquor after the dissolving of adding water for injection, lyophilization makes described power injection for injecting creatine phosphate sodium composition;
Described cryodesiccated condition is: the pre-freeze temperature is-55～-30 ℃, and the pre-freeze time is 1～8h; Sublimation temperature is-35～-10 ℃, and the distillation time is 5～20h; Baking temperature is 15～50 ℃, and be 3～15h drying time.
2. preparation method as claimed in claim 1 is characterized in that, before the described lyophilization, also comprises the step of fine straining, fill.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201210014132 CN102525962B (en) | 2012-01-17 | 2012-01-17 | Power injection for injecting creatine phosphate sodium composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201210014132 CN102525962B (en) | 2012-01-17 | 2012-01-17 | Power injection for injecting creatine phosphate sodium composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102525962A CN102525962A (en) | 2012-07-04 |
| CN102525962B true CN102525962B (en) | 2013-03-27 |
Family
ID=46334796
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 201210014132 Active CN102525962B (en) | 2012-01-17 | 2012-01-17 | Power injection for injecting creatine phosphate sodium composition |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102525962B (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102772375B (en) * | 2012-08-23 | 2013-07-17 | 孙威 | Creatine phosphate sodium for injection and preparation method for creatine phosphate sodium for injection |
| CN114557969B (en) * | 2022-02-18 | 2023-04-18 | 海南久常制药有限公司 | Creatine phosphate sodium powder injection for injection and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101288649A (en) * | 2007-04-19 | 2008-10-22 | 上海慈瑞医药科技有限公司 | Preparation technique of sodium phosphocreatine powder and injection preparation |
| CN101732263A (en) * | 2008-11-14 | 2010-06-16 | 杨军 | Creatine phosphate sodium freeze-dried preparation and method for preparing same |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030212034A1 (en) * | 2001-06-11 | 2003-11-13 | Winder William W | Method of treatment of obesity and paralyzed muscle and ergogenic aids |
-
2012
- 2012-01-17 CN CN 201210014132 patent/CN102525962B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101288649A (en) * | 2007-04-19 | 2008-10-22 | 上海慈瑞医药科技有限公司 | Preparation technique of sodium phosphocreatine powder and injection preparation |
| CN101732263A (en) * | 2008-11-14 | 2010-06-16 | 杨军 | Creatine phosphate sodium freeze-dried preparation and method for preparing same |
Also Published As
| Publication number | Publication date |
|---|---|
| CN102525962A (en) | 2012-07-04 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Reed et al. | Acute barbiturate intoxication: a study of 300 cases based on a physiologic system of classification of the severity of the intoxication | |
| O'Connell et al. | Cardiac and pulmonary effects of high doses of cyclophosphamide and isophosphamide | |
| Huang et al. | The neuroprotective effects of intraperitoneal injection of hydrogen in rabbits with cardiac arrest | |
| CN109748881A (en) | Cystathionie-γ-lyase (CSE) inhibitor | |
| CN105722516A (en) | A method for treating infection, sepsis and injury | |
| Wang et al. | QT interval prolongation and pleomorphic ventricular tachyarrhythmia (Torsade de pointes') in organophosphate poisoning: report of a case | |
| CN101032504B (en) | Application of liquiritin in medicines | |
| CN102525962B (en) | Power injection for injecting creatine phosphate sodium composition | |
| CN102935222B (en) | Application of ferric iron ferriporphyrin compound in preparation of anti-type-2 diabetes drug | |
| CN107488162A (en) | A kind of bicyclic alcohol derivatives and its preparation and application | |
| Fowler et al. | Accidental digitalis intoxication in children | |
| Schneider et al. | Cardiopulmonary resuscitation | |
| Chen et al. | Successful rescue of a patient with acute aconitine poisoning complicated by polycystic renal hemorrhage | |
| CN104546809B (en) | Application of 3,3 ', 5,5 '-tetra isopropyls-the 4,4 '-bigeminy phenol in preventing and treating cerebral arterial thrombosis | |
| Zhang et al. | Mild therapeutic hypothermia improves neurological outcomes in a rat model of cardiac arrest | |
| CN101085295B (en) | Freeze dried injection containing muskone and preparation method thereof | |
| CN107198693A (en) | Application of the rutin class medicine in the medicine of prevention or curative physical property cardiac toxic is prepared | |
| Hagemann | Effect of dimethyl sulfoxide on RNA synthesis in S-180 tumor cells | |
| CN102697757B (en) | Application of p-hydroxy benzylidene acetone in preparation of drugs for preventing and/or treating encephalopathy | |
| CN104940181A (en) | Application of beta-hydroxybutyric acid or pharmaceutically acceptable salt thereof | |
| Li et al. | Electrophysiological effects of Chinese medicine Shen song Yang xin (SSYX) on Chinese miniature swine heart and isolated guinea pig ventricular myocytes | |
| CN104510752B (en) | The medical usage of red sandalwood alkane glycosides | |
| CN103385877A (en) | Taxol and cimetidine pharmaceutical composition | |
| Pace et al. | The effect of the vagus nerves on the bradycardia and ventricular arrhythmias induced by digitoxin and digoxin | |
| KR930009197B1 (en) | Antipyretic analgesics and process for preparing thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C56 | Change in the name or address of the patentee |
Owner name: SHANDONG LUOXIN PHARMACY GROUP CO., LTD. Free format text: FORMER NAME: SHANDONG LUOXIN PHARMACY STOCK CO., LTD. |
|
| CP01 | Change in the name or title of a patent holder |
Address after: Seven of 276017 Shandong province Linyi city Luozhuang District Patentee after: Shandong Luo Xin Pharmaceutical Group Plc Address before: Seven of 276017 Shandong province Linyi city Luozhuang District Patentee before: SHANDONG LUOXIN PHARMACY STOCK Co., LTD. |