CN102579555A - Application of injection-used fat emulsion in medicine preparation for antagonizing general anesthesia medicine effect - Google Patents
Application of injection-used fat emulsion in medicine preparation for antagonizing general anesthesia medicine effect Download PDFInfo
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- CN102579555A CN102579555A CN2012100507318A CN201210050731A CN102579555A CN 102579555 A CN102579555 A CN 102579555A CN 2012100507318 A CN2012100507318 A CN 2012100507318A CN 201210050731 A CN201210050731 A CN 201210050731A CN 102579555 A CN102579555 A CN 102579555A
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Abstract
The invention relates to an application of injection-used fat emulsion in medicine preparation for antagonizing the general anesthesia medicine effect. The testing result shows that the fat emulsion can shorten the effective time of general anesthesia medicine, improves the awakening quality after the use of the medicine, promotes the recovery of cognitive ability, and is suitable for promoting the awakening after the maintenance period of various anaesthetics in clinic and for antagonizing the effects of sedation medicine, analgesic medicine and muscular relaxation medicine.
Description
Technical field
What the present invention relates to is the new purposes of injection fat milk, specifically is in the application aspect preparation antagonism anesthesia type, calm type, analgesia type and of flaccid muscles type of drugs with function.
Background technology
The injection fat milk; Be through the emulsifying of injection lecithin with the injection soybean oil; And add glycerol for injection and water for injection is the basic composition form, a kind of oil-in-water type sterilization emulsion liquid of processing, pH value 6.5 ~ 8.5; Commonly used clinically as the use of nutritional supplementation material, also be that unique approval can intravenous Emulsion.
Local anesthesia is existing being widely used in medical practice, and it acts on the part, is commonly referred to be through sodium-ion channel to play a role.Discover that local anesthetic uses the excessive nervous system toxicity that causes (as fainting from fear delirium; Go into a coma etc.) or cardiac toxicity (the not normal even asystole like heart rate); Cause that wherein the toxic case of maincenter is more rare, can play Detoxication, particularly to the rescue of cardiac toxicity through the intravenous injection fatty breast; In the case of asystole, can improve the success rate of cardiac resuccitation, its mechanism of action still is not very clear and definite at present.
General anesthesia in medical practice equally also in extensive use.Though the development of anaesthesia technology is very rapid, general anesthesia still exists much larger than the risk of local anesthesia even danger.The medication of general anesthesia is also more complicated, need comprise that generally the general anesthesia medicine is (like propofol, desflurane, isoflurane; Sevoflurane; Enflurane, halothane), the narcosis analgesic thing (like morphine, fentanyl; Soviet Union's fentanyl; Fentanyl, remifentanil), downern (benzene phenodiazine azole (as stable, Midazolam), right U.S. holder pyrimidine), medicine of flaccid muscles heterogeneitys such as (like SC and non depolarization muscle relaxant such as Rocuronium Bromide), different effects mechanism type medicine is used or drug combination.Because the physicochemical property of medicament that general anesthesia makes, site of action and metabolism etc. all has characteristics separately, is different from local anesthetic fully.The site of action of general anesthesia medication can include the multiple receptor and the ion channel thereof of brain and spinal cord; Act on neuromuscular junction more than the muscle relaxant wherein; Therefore its risk and danger are; Even under normal narcotism, the kinds of protect of human body also all disappears sexual reflex.Mostly anesthesia descendant's the recovery of reviving and realizing is to lean on medicine natural metabolism elimination in vivo usually, has also prolonged risk or dangerous persistent period undoubtedly; Therefore clinically, even in the normal use of general anesthesia, for the agonist drug that can resist the various effects of general anesthesia medication; Revive in advance with realization; Improve the quality of reviving, reduce the generation of anesthesia back nausea and vomiting etc., urgent demand is all arranged always.But the antagonist that up to the present, does not still have the definite general anesthesia medicine of effect.
Summary of the invention
To above-mentioned situation, the present invention finds that through big quantity research and experiment the injection fat milk is aspect the medicine of antagonism general anesthesia medication effect; Can have remarkable and beyond thought effect; Can be used as in the normal clinical use, effectively resist the effect of general anesthesia medication, realize reviving in advance; Improve the quality of reviving, reduce the generation of anesthesia back nausea and vomiting.Thereby, can greatly expand the range of application of injection fat milk in medical practice.
Alleged general anesthesia medication among the application; Comprise above-mentioned direct general anesthetic, and narcosis analgesic, benzene phenodiazine azole drug, the right beautiful related drugs that holds in the palm heterogeneitys such as pyrimidine, muscle relaxant, different effects mechanism type that need be used or unite use usually; Said general anesthesia medication effect implication is meant the comprehensive function that behind these medicines of use human body is produced in the clinical anesthesia operation.
Further research and experiment show; On the basis that the injection fat milk is employed in above-mentioned medication preparation as the effect of antagonism general anesthetic, can also be respectively separately or unite as the calm type drug effect of antagonism, the effect of antagonism analgesic drug and of flaccid muscles type of pharmaceutically-active medicine of antagonism and be employed.
Below, foregoing of the present invention is remake further detailed description through embodiment and respective drawings.But should this be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following instance.Do not breaking away under the above-mentioned technological thought situation of the present invention, various replacements or change according to ordinary skill knowledge and customary means are made all should comprise within the scope of the invention.
Description of drawings
Fig. 1 is that the present invention gives behind the fat milk VAS contrast and experiment with matched group.
Fig. 2 is that the present invention gives behind the fat milk MMSE contrast and experiment with matched group.
The specific embodiment
The injection fat milk that following experiments is used is: (Huarui Pharmaceutical Co. Ltd. produces 30% fat emulsion injection, lot number 80EF090, the accurate word H19993200 of traditional Chinese medicines.Composition: the injection soybean oil, water for injection, glycerol, lecithin are emulsifying agent.
Case statistics in the clinical experiment, general anesthesia hold time and the dosage situation of general anesthetic as shown in table 1, show case zero difference between experimental group.MAC=MAC in the table, promptly inhalational anesthetic valid density.
Table 1 case statistics, the holding time and the dosage (
± SD or n) of general anesthetic of general anesthesia
? | Matched group (n=30) | Fat milk group (n=30) | P |
Age (year) | 40.3±10.6 | 37.1±12.2 | 0.28 |
Sex (man/woman) (n) | 5/25 | 9/21 | 0.22 |
Body Mass Index (kg/m 2) | 21.3±1.4 | 21.8±1.6 | 0.26 |
Smoking history (having/do not have) (n) | 6/24 | 3/27 | 0.47 |
Psychiatric history (having/do not have) (n) | 7/23 | 6/24 | 0.75 |
Postoperative nausea and vomiting (having/do not have) (n) | 2/28 | 2/28 | 1.00 |
Anaesthetize hold time (min) | 56.5±18.4 | 56.0±16.3 | 0.92 |
The anesthesia dosage: | ? | ? | ? |
Midazolam (Midazolam) (mg) | 2.1±0.6 | 2.3±0.3 | 0.11 |
Fentanyl (Fentanyl) (mg) | 0.18±0.04 | 0.18±0.04 | 1.00 |
Propofol (Propofol) (mg) | 110.5±12.4 | 114.2±14.6 | 0.29 |
Rocuronium Bromide (Rocuronium) (mg) | 33.2±3.7 | 34.3±4.4 | 0.29 |
Remifentanil (Remifentanil) (mg) | 0.3±0.1 | 0.3±0.2 | 0.72 |
Isoflurane concentration (Isoflurane (MAC-hr)) (%) | 1.2±0.5 | 1.2±0.4 | 0.98 |
Embodiment 1
In gallbladder removal operation, be main anesthesia with the isoflurane shown in the use table 1, keep general anesthesia after 1 hour, (dosage is: 2ml/kg) antagonism isoflurane to give 30% fat milk at the stage vein of reviving.
1. the anesthesia back recovery time of result of the test relatively is as shown in table 2.In the table: (MAS) Aldrete improvement scoring.Totally 5 of standards of grading, total points=10 are recovered in (Modified Aldrete score) standard anesthesia back; When total points >=9, think the anesthesia back recovery standard that reaches:
Energy: the activity of 2=extremity freely or accept instruction, two limbs of 1=are active, the 0=extremity are inactive;
Breathe: 2=can breathe deeply and effectively cough, and 1=dyspnea, table are shallow or limited;
Circulation: blood pressure ± 20mmgHg (millimetres of mercury) before the 2=anesthesia, blood pressure ± 20-50mmgHg before the 1=anesthesia,
Blood pressure ± 50mmgHg before the 0=anesthesia;
Consciousness: 2=is clear-headed fully, and 1=can wake up, and 0=is reactionless;
Oxygen saturation: during the 2=breathe air, Xue Yangbaohedu>92%; 1=inhales O
2The time, can keep Xue Yangbaohedu>92%;
0=inhales O
2The time, blood oxygen saturation<92%.
The comparison of recovery time after table 2 anesthesia
? | Matched group (n=30) | Fat milk group (n=30) | P |
Open eyes the time (minute) | 20.0 (10.0) | 15.5 (9.0) | 0.01 |
The tracheal intubation extubation time (minute) | 21.0(8.0) | 17.0 (6.0) | 0.08 |
MAS ≧ 9 minute | 33.1(13.5) | 28.5(12.7) | 0.18 |
Table 2 presentation of results, fat can breast shorten patient open eyes the time (
p<0.05).Extubation time (pulling out the time of tracheal intubation) as the index of recovery time does not have difference, but shortens 20% than matched group.Reach anesthesia back recovery standard (Aldrete score to 9), the fat milk group can shorten about 4min.Shown that the anesthesia that fat milk can shorten isoflurane holds time.
2. the result of the calmness of subjective assessment scoring (OAA/S) is as shown in table 3 after the administration.Result in the table is respectively number and the percentage ratio % that accounts for sum in the group.
The calmness of subjective assessment scoring (OAA/S, observer assessment of alertness and sedation) after table 3 administration
Wherein, the standards of grading of OAA/S are as shown in table 4, are divided into the 0-5 branch, and the clear-headed more greatly degree of mark is high more:
The standards of grading of table 4 OAA/S
Reaction | Language | Facial expression | Eyes | Score |
Reply freely calling name | Normally | Normally | Bright, no sagging | 5 (regaining consciousness) |
To calling name reaction asthenia | Slow slightly | Slightly loosen | Glossy or slightly sagging (half of eye) | 4 |
Only loud call name is replied | Unclear or obviously slack-off | Obviously loosen | Glossy and obviously sagging (> eye half the) | 3 |
Only to slight stimulation or shake reaction | Almost can not differentiate | — | — | 2 |
To slight stimulation or shake reactionless | — | — | — | 1 |
Severe is stimulated or shakes reactionless | — | — | — | 0 |
Table 3 shown in 60 minutes after giving fat milk, and the calmness of the case of each time point scoring, the high more explanation of the mark quality of reviving is good more.Its result can explain the identical time point behind the injection fat milk, and the scoring of fat milk group is higher, and the quality of reviving is obviously improved.
3. the comparing result of visual analogue scales (VAS, visual analog scales) is as shown in Figure 1.The mark of VAS is low more, and sleepiness is low more, explain revive thorough more.Abscissa among Fig. 1 is the time after the administration, and vertical coordinate is a score value.Dotted line is a matched group, and solid line is the group that gives fat milk.Fig. 1 result shows, according to the VAS point system, gives fat milk group and matched group relatively, and the fat milk group can obviously reduce sleepiness, and the quality of reviving significantly improves.
4. simple and easy mental status examination (MMSE, Mini-Mental State Examination) comparing result is as shown in Figure 2.
The full marks of MMSE are 30 minutes, and in order to estimate cognitive function, the high representative of mark is normal, and the low then explanation of mark maybe be dull-witted.Abscissa among Fig. 2 is the time after the administration, and vertical coordinate is a score value.Dotted line among the figure is a matched group, and solid line is the group that gives fat milk.Fig. 2 result shows, fat milk can improve the recovery of cognitive competence behind the general anesthesia fiber crops, shortens the time of recovering required, improves the recovery quality of reviving.
Above-mentioned each item clinical test results of embodiment 1 shows that postoperative uses the injection fat milk, can significantly shorten the time of opening eyes, and revives in advance.Standard anesthesia back is recovered scoring and is shown, fat milk can shorten about 4 minutes with reviving fully.In the 60 minute observing time that gives fat milk, fat milk group patient's OAA/s (the calmness scoring of subjective assessment), MMSE (simple and easy mental status examination) scoring all increases than matched group.Clear-headed quality improves than matched group.Do not observe serious adverse events.
The clinical experiment case of above-mentioned use combined anesthesia shows, the comprehensive function that fat milk can the medication of antagonism general anesthesia, and shortening with the isoflurane is main general anesthesia action time, has improved the quality of reviving behind the isoflurane anesthesia, promotes the recovery of cognitive competence.
Embodiment 2
In above-mentioned operation, use isoflurane or Sevoflurane to keep two hours after, waking up period give fat milk (dosage: 2ml/kg), result of the test is following:
1. fat milk is to the effect of isoflurane, and result of the test is as shown in table 5.
? | Matched group (n=35) | Fat milk group (n=39) | P |
Autonomous respiration recovery time (min) | 18.2±3.27 | 17.9±3.93 | 0.707 |
(min) opens eyes the time | 21.5±3.73 | 20.5±3.81 | 0.260 |
Tracheal intubation extubation time (min) | 23.6±4.20 | 21.6±3.62 | 0.031 |
Answer name required time (Orientation) (min) | 25.9±5.06 | 22.7±3.89 | 0.004 |
Response time and position time (Orientation) are (min) | 32.0±6.34 | 24.8±4.30 | 0.000 |
Modified Aldrete scores ≧9 (min) | 36.1±7.83 | 26.9±5.67 | 0.000 |
Table 5 is the result show; Fat milk can shorten general anesthesia recovery time; Wherein effect is apparent that the trachea extubation time most; Return to and can answer the name required time, returning to can response time and position time, and scoring is recovered greater than time of 9 minutes in Aldrete improvement scoring (Modified Aldrete score) standard anesthesia back.
2. fat milk is to the effect of Sevoflurane, and result of the test is as shown in table 6.
? | Matched group (n=38) | Fat milk group (n=38) | P |
Autonomous respiration recovery time (min) | 15.6±3.01 | 14.3±2.64 | 0.056 |
(min) opens eyes the time | 19.2±3.14 | 18.0±2.87 | 0.098 |
Tracheal intubation extubation time (min) | 20.2±3.00 | 19.0±2.60 | 0.054 |
Answer name required time (Orientation) (min) | 22.9±3.94 | 19.8±2.56 | 0.000 |
Response time and position time (Orientation) are (min) | 24.8±4.10 | 21.1±2.62 | 0.000 |
Modified Aldrete scores≧9(min) | 28.3±4.00 | 24.0±2.58 | 0.000 |
Table 6 is to keep the result anesthesia gives fat milk after two hours after with Sevoflurane, has shown that fat milk can shorten the needed time that regains one's consciousness after being anaesthetized significantly.Wherein be apparent that most return to can answer the name required time, return to can response time and position time and Aldrete improvement scoring (Modified Aldrete score) standard anesthesia back recover scoring greater than time of 9 minutes.
3. isoflurane anesthesia is anaesthetized the back incidence rate of adverse reaction, and result of the test is as shown in table 7.
Table 7 isoflurane anesthesia anesthesia back incidence rate of adverse reaction
? | Isoflurane fat milk group (n=39) | Isoflurane matched group (n=35) | Sevoflurane fat milk group (n=38) | Sevoflurane matched group ((n=35) |
Nausea and vomiting case (n) | 1 | 0 | 0 | 0 |
Shiver with cold case (n) | 0 | 0 | 0 | 0 |
Need analgesia case (n) | 0 | 0 | 0 | 0 |
Above-mentioned result of the test shows, after using Sevoflurane and isoflurane anesthesia to keep two hours, fat milk can be accelerated recovery time, and postoperative do not have the obvious adverse reaction generation, and explanation is safe, applicable to various anesthesia of holding time.
Embodiment 3
With the rat is laboratory animal, the effect of test fat milk antagonism whole body downern etomidate.Result of the test is as shown in table 8.
? | Righting response recovery time (second) | Normal activity recovery time (second) | Righting response is to the recovery time (second) of normal activity |
Matched group | 770.9±64.2 | 1003.1±48.9 | 232.2±36.9 |
The 2ml normal saline | 727.2±56.0 | 1040.4±103.7 | 313.2±61.4 |
1.5 normal saline+0.5ml fat milk | 759.9±49.7 | 920.7±57.3 | 160.8±30.7 |
1.0 normal saline+1.0ml fat milk | 658.7±41.4 | 768.0±33.0* | 109.3±22.5* |
0.5 normal saline+1.5ml fat milk | 554.8±22.1* | 697.1±30.9** | 142.3±19.7** |
2 ml fat milks | 475.7±25.8** | 610.5±37.2** | 134.9±16.9** |
Annotate: *: with matched group notable difference is arranged relatively, * *: fairly obvious difference is relatively arranged with matched group.
Table 8 explanation, the intravenous injection fatty breast can rely on the time that ground shortening rat revives by dosage from the etomidate sedation.The big more effect of dosage is obvious more.Disappearance/the recovery of righting response is the generation/the most general evaluation of recovery that is used for or anesthesia calm to rat.Righting response returns to the length of normal activity time, can reflect that rat is in calm or the postanesthetic quality of reviving.
Embodiment 4
The test of fat milk antagonism medicine SCH of flaccid muscles.
The basic condition of each test group case is as shown in table 9, shows that the situation of respectively organizing case does not have significant difference.Body Mass Index shows that patient is whether fat or becomes thin that the meansigma methods of each case belongs to normally, is of universal significance.
Table 9 is respectively organized the basic data (
± SD) of case
? | Matched group (n=21) | Fat milk group (n=21) | P |
Sex (man/woman) | 11/10 | 10/11 | 0.758 |
Age (year) | 48.4±12.4 | 48.0±11.4 | 0.908 |
Body Mass Index (kg/ ㎡) | 21.8±2.0 | 22.3±2.1 | 0.410 |
It is as shown in table 10 that each organizes the pharmacology result of medicine of flaccid muscles of case.
Table 10 is respectively organized the pharmacology result (
± SD) of the medicine of flaccid muscles of case
? | Matched group (n=21) | Fat milk group (n=21) | P |
Onset time (second) | 43.0±8.0 | 42.4±7.7 | 0.829 |
The reactionless time (second) | 419.5±64.9 | 403.0±74.1 | 0.448 |
Persistent period (second) | 477.5±58.0 | 456.9±76.2 | 0.330 |
50% recovery time (second) | 533.4±64.0 | 482.4±81.8 | 0.030 |
75% recovery time (second) | 560.6±74.6 | 504.9±88.9 | 0.034 |
95% recovery time (second) | 612.4±98.1 | 514.4±89.4 | 0.002 |
The pharmacological effect of medicine of flaccid muscles; Comprised holding time of onset time, patient complete unresponsive time, myorelaxant effects; And the flesh pine acts on the time aspects of recovering such as (comprising the recovery of 50%, 75%, 95% different proportion) after giving fat milk.The result of table 10 shows that fat milk can be accelerated the recovery behind the medicine of flaccid muscles.
Above-mentioned result of the test shows that fat milk can shorten the effect of medicine of flaccid muscles and hold time.
Claims (5)
1. the injection fat milk is as the application in the medication preparation of antagonism general anesthesia medication effect.
2. the injection fat milk is as the application in the medication preparation of antagonism general anesthetic effect.
3. the injection fat milk is as the application in the calm type pharmaceutically-active medication preparation of antagonism.
4. the injection fat milk is as the application in the medication preparation of antagonism analgesic drug effect.
5. the injection fat milk is as the application in of flaccid muscles type of pharmaceutically-active medication preparation of antagonism.
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Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
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US5714520A (en) * | 1994-03-22 | 1998-02-03 | Zeneca Limited | Propofol compostion containing edetate |
CN101199480A (en) * | 2007-12-11 | 2008-06-18 | 西安力邦医药科技有限责任公司 | Compounded propofol fat emulsion injection containing analgesics and process for preparing same |
-
2012
- 2012-03-01 CN CN2012100507318A patent/CN102579555A/en active Pending
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5714520A (en) * | 1994-03-22 | 1998-02-03 | Zeneca Limited | Propofol compostion containing edetate |
CN101199480A (en) * | 2007-12-11 | 2008-06-18 | 西安力邦医药科技有限责任公司 | Compounded propofol fat emulsion injection containing analgesics and process for preparing same |
Non-Patent Citations (3)
Title |
---|
DANIELLE E. TURNER-LAWRENCE: "《Intravenous Fat Emulsion: A Potential Novel Antidote》", 《JOURNAL OF MEDICAL TOXICOLOGY》 * |
刘沙等: "《静脉注射用载药脂肪乳的研究近况》", 《药学进展》 * |
张鸿飞等: "《脂肪乳用于脂溶性药物急性毒性的救治》", 《2009年西部麻醉学术论坛论文汇编》 * |
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Application publication date: 20120718 |