CN106093217B - A method of evaluation Chinese and Western medicine injection sequential combination interval time - Google Patents
A method of evaluation Chinese and Western medicine injection sequential combination interval time Download PDFInfo
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- CN106093217B CN106093217B CN201610366206.5A CN201610366206A CN106093217B CN 106093217 B CN106093217 B CN 106093217B CN 201610366206 A CN201610366206 A CN 201610366206A CN 106093217 B CN106093217 B CN 106093217B
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- G—PHYSICS
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
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Abstract
The invention discloses the methods of evaluation Chinese and Western medicine injection sequential combination interval time a kind of, the described method comprises the following steps: (1) selecting test body to carry out traditional Chinese medicine administration, delay T1、T2......TNSampling, establishes serum HPLC fingerprint g1、g2......gN, N >=1；(2) test body is selected respectively, with Chinese medicine-Western medicine injection or with Western medicine-traditional Chinese medicine combination administration, is combined delivery time t1、t2.......tn, n > 1；(3) after the combination administration of different intervals, T is delayed respectively1、T2......TNSampling, establishes serum HPLC fingerprint, is indicated with matrix；(4) serum HPLC fingerprint of every a line in step (3) matrix is contrasted with the serum HPLC fingerprint of step (1) one-to-one correspondence respectively, so that it is determined that the Chinese and Western medicine injection sequential combination proportional spacing time.Method of the invention is the scientific definition reasonable delivery time of Chinese and Western medicine injection drug combination for the first time；Method of the invention is easy to operate, practical, can be applicable on a large scale.
Description
Technical field
The invention belongs to the technical fields of Chinese and Western medicine application, and in particular between a kind of sequential combination of evaluation Chinese and Western medicine injection
Every the method for time.
Background technique
Clinical Irrational Use of Drugs is one of an important factor for leading to traditional Chinese medicine adverse reaction.Clinically in order to avoid more
Kind drug mixing infusion causes adverse reaction rate to increase, and mostly uses the mode of sub-bottle intravenous drip to be administered, although can keep away
Exempting from two kinds of medical fluids, directly mixing reacts in vitro, but there are still the possibility that the two interacts in vivo, and in vivo
Drug interaction is increasingly complex, it will causes bigger harm to patient health.Therefore, " traditional Chinese medicine clinical use is basic
Principle " regulation traditional Chinese medicine should be used alone, when other drugs need to really be used in combination, should consider with caution and traditional Chinese medicine
The problems such as interval time and drug interaction, while providing that medicine injection combination in Chinese and Western is answered " using separated, sequential method
And washing pipe is wanted in centre ", avoid continuous sequential from using bring security risk with this.But clinic is only by rule of thumb in two kinds of drugs
Between input physiological saline, when the medicine injection continuous infusion of Chinese and Western, should be spaced how long? therefore, Chinese and Western medicine injection is sequential
When combination, it is the problem of can not be ignored that how science, which formulates the reasonable delivery time of Chinese and Western medicine injection,.
Summary of the invention
The middle problem is used in conjunction the purpose of the present invention is to solve Chinese and Western medicine injection in the prior art is sequential, provides
A method of evaluation Chinese and Western medicine injection sequential combination interval time.
To achieve the above object, the present invention provides the sides of evaluation Chinese and Western medicine injection sequential combination interval time a kind of
Method the described method comprises the following steps:
(1) selection test body carries out traditional Chinese medicine administration, delays T1, T2......TN sampling, establishes serum fingerprint image
Compose g1、g2......gN, wherein N >=1；
(2) select test body respectively, with Chinese medicine-Western medicine injection combination administration or with Western medicine-traditional Chinese medicine be combined to
Medicine is combined delivery time t1、t2.......tn, wherein n > 1；
(3) after the combination administration of step (2) different intervals, T is delayed respectively1、T2......TNSampling, establishes blood
Clear finger-printWherein, GijTo be combined delivery time tiAnd it completes combination and gives
Postpone T after medicinejThe serum HPLC fingerprint of foundation, here N >=1；
(4) by the serum HPLC fingerprint of every a line in step (3) matrix serum HPLC fingerprint g with step (1) respectively1、
g2......gNOne-to-one correspondence is contrasted, so that it is determined that the Chinese and Western medicine injection sequential combination proportional spacing time.
Serum HPLC fingerprint g in step (1)1、g2......gNWith the serum HPLC fingerprint G in step (3)ij, it is respectively
Traditional Chinese medicine is administered alone serum HPLC fingerprint and Chinese medicine-Western medicine injection combination administration serum HPLC fingerprint.
The test body is SD rat, is administered through tail vein injection, and then orbital vein takes blood 0.5-1.0mL, centrifugation point
From rear, -80 DEG C of freezings are spare.
The revolving speed of centrifuge separation is 10000-14000r, time 10-15min.
Using LC-MS technology, serum HPLC fingerprint is established.
The invention has the benefit that
(1) method of the invention is when scientifically defining the reasonable dosing interval of Chinese and Western medicine injection drug combination for the first time
Between.
(2) method of the invention is easy to operate, practical, can be applicable on a large scale.
Detailed description of the invention
Fig. 1 is to evaluate models of Shuanghuanglian Injection-Ribavirin injection combination delivery time method in embodiment 1 to show
It is intended to；
Fig. 2 is to evaluate Ribavirin injection-models of Shuanghuanglian Injection combination delivery time method in embodiment 1 to show
It is intended to；
Fig. 3 is that 'Shuang Hualian ' injection injection is administered alone the serum HPLC fingerprint after 20min in embodiment 1；
Fig. 4 is that 'Shuang Hualian ' injection injection and Ribavirin injection are combined in embodiment 1, interval time 0min, connection
With the serum HPLC fingerprint after 20min；
Fig. 5 is that models of Shuanghuanglian Injection is administered alone the serum HPLC fingerprint after 170min in embodiment 1；
Fig. 6 is that models of Shuanghuanglian Injection and Ribavirin injection are combined in embodiment 1, interval time 150min, combination
Serum HPLC fingerprint after 20min；
Fig. 7 is that QINGKAILING ZHUSHEJI is administered alone the serum HPLC fingerprint after 20min in embodiment 2；
Fig. 8 is that QINGKAILING ZHUSHEJI and Ribavirin injection are combined in embodiment 2, interval time 0min, combination
Serum HPLC fingerprint after 20min；
Fig. 9 is that Qing kailing is administered alone the serum HPLC fingerprint after 170min in embodiment 2；
Figure 10 is that QINGKAILING ZHUSHEJI and Ribavirin injection are combined in embodiment 2, interval time 150min, combination
Serum HPLC fingerprint after 20min；
Figure 11 is that Safflower Yellow Injection is administered alone the serum HPLC fingerprint after 20min in embodiment 3；
Safflower Yellow Injection and naloxone hydrochloride injection are combined in Figure 12 embodiment 3, interval time 0min, connection
With the serum HPLC fingerprint after 20min；
Figure 13 is that Safflower Yellow Injection is administered alone the serum HPLC fingerprint after 170min in embodiment 3；
Figure 14 is that Safflower Yellow Injection and naloxone hydrochloride injection are combined in embodiment 3, and interval time is
150min, the serum HPLC fingerprint after being combined 20min.
Specific embodiment
The present invention is carried out with reference to the accompanying drawings and examples explanation is explained in detail.
Embodiment 1
A method of evaluation Chinese and Western medicine injection sequential combination interval time, comprising the following steps:
(1) four administration groups of SD rat are set
A) blank control group (non-administration test body group)
B) models of Shuanghuanglian Injection group
C) models of Shuanghuanglian Injection-Ribavirin injection different dosing interval time group
D) Ribavirin injection-models of Shuanghuanglian Injection different dosing interval time group
Every group of ten SD rats.
(2) for c group, models of Shuanghuanglian Injection-Ribavirin injection interval time is t1、t2...tn, settable
Every the time, models of Shuanghuanglian Injection can be administered simultaneously with Ribavirin injection.
For d group, Ribavirin injection-models of Shuanghuanglian Injection delivery time is t1、t2...tn, settable
Every the time, Ribavirin injection can be administered simultaneously with models of Shuanghuanglian Injection.
(3) preparation of Contained Serum sample: T is delayed in processing SD rat, tail vein injection administration respectively1、T2...TnThrough eye
Socket of the eye venous blood sampling 0.5mL, 12000r are centrifugated 10min administration group serum, and -80 DEG C of freezings are spare.
(4) certain several time point blood sampling upon administration are distinguished, using LC-MS after the administration of SD rat for b group
Technology establishes serum HPLC fingerprint.
For two groups of c, d, certain several time point takes blood after models of Shuanghuanglian Injection and the administration of Ribavirin injection respectively
Sample establishes serum HPLC fingerprint using LC-MS technology, in conjunction with principal component analysis (PCA) and partially minimum using pattern-recognition
Two multiply techniques of discriminant analysis (PLS-DA) analysis each group serum HPLC fingerprint difference.
(5) serum HPLC fingerprint at some time point is administered alone with b group after the administration of the different intervals of c group or d group
The serum HPLC fingerprint for corresponding to time point afterwards compares.
As shown in Figure 1, if models of Shuanghuanglian Injection-Ribavirin injection interval 150min administration, c group serum refer in c group
The serum HPLC fingerprint of 20min compares after line map and the administration of b group models of Shuanghuanglian Injection group, if two kinds of serum HPLC fingerprint class
Seemingly, models of Shuanghuanglian Injection in Ribavirin injection generating body a possibility that drug interaction it is smaller, illustrate interval time
150min is models of Shuanghuanglian Injection-Ribavirin injection proportional spacing time；If two kinds of serum HPLC fingerprint is variant,
Illustrate that interval time 150min is risky, is not models of Shuanghuanglian Injection-Ribavirin injection proportional spacing time.Similarly,
The serum HPLC fingerprint of c group Yu b group different time points can be compared.
As shown in Figure 2, if Ribavirin injection-models of Shuanghuanglian Injection interval 100min administration, d group serum refer in d group
Line map is compared with the serum HPLC fingerprint of 20min after the administration of b group models of Shuanghuanglian Injection group, if two kinds of serum HPLC fingerprint class
Seemingly, illustrate that interval time 100min is Ribavirin injection-models of Shuanghuanglian Injection proportional spacing time；If two kinds of serum
Finger-print is variant, illustrates that interval time 100min is risky, is not that Ribavirin injection-models of Shuanghuanglian Injection is reasonable
Interval time.Similarly, the serum HPLC fingerprint of d group and b group different time points can be contrasted.
By Fig. 3-6 it is found that models of Shuanghuanglian Injection serum after being administered alone the serum HPLC fingerprint after 20min and 170min
Finger-print indifference.'Shuang Hualian ' injection injection and Ribavirin injection are combined, and interval time 0min is combined 20min
Serum HPLC fingerprint and models of Shuanghuanglian Injection afterwards is variant in the serum HPLC fingerprint for being administered alone 20min, when illustrating interval
Between 0min be not 'Shuang Hualian ' injection injection Yu Ribavirin injection the reasonable combination time.'Shuang Hualian ' injection injection and benefit
The combination of Ba Weilin injection, interval time 150min, the serum HPLC fingerprint and models of Shuanghuanglian Injection for being combined 20min are independent
The serum HPLC fingerprint of administration 20min does not have difference, illustrates interval time 150min in models of Shuanghuanglian Injection and Ribavirin
Within the scope of time-wise separation.Determined through repetition test, the time-wise separation of models of Shuanghuanglian Injection and Ribavirin --- when
Between window be 140min.
Embodiment 2
A method of evaluation Chinese and Western medicine injection sequential combination interval time, comprising the following steps:
(1) four administration groups of SD rat are set
A) blank control group (non-administration test body group)
B) QINGKAILING ZHUSHEJI group
C) QINGKAILING ZHUSHEJI-Ribavirin injection different dosing interval time group
D) Ribavirin injection-QINGKAILING ZHUSHEJI different dosing interval time group
Every group of ten SD rats.
(2) for c group, QINGKAILING ZHUSHEJI-Ribavirin injection delivery time is t1、t2...tn, open clearly
Clever injection can be administered simultaneously with Ribavirin injection.
For d group, Ribavirin injection-QINGKAILING ZHUSHEJI delivery time is t1、t2...tn, Li Bawei
Woods injection can be administered simultaneously with QINGKAILING ZHUSHEJI.
(3) preparation of blank control group and administration blood serum sample: processing SD rat, tail vein injection administration are delayed respectively
T1、T2...Tn, take blood 0.5mL, 12000r to be centrifugated 10min administration group serum and blank control group serum through orbital vein ,-
80 DEG C of freezings are spare.
(4) certain several time point blood sampling upon administration are distinguished, using LC-MS after the administration of SD rat for b group
Technology establishes serum HPLC fingerprint.
For two groups of c, d, certain time point blood sampling after QINGKAILING ZHUSHEJI and the administration of Ribavirin injection, is adopted respectively
With LC-MS technology, serum HPLC fingerprint is established, using pattern-recognition, in conjunction with principal component analysis (PCA) and offset minimum binary
Techniques of discriminant analysis (PLS-DA) analyzes each group serum HPLC fingerprint difference.
(5) serum HPLC fingerprint at some time point is administered alone with b group after the administration of the different intervals of c group or d group
The serum HPLC fingerprint for corresponding to time point afterwards compares.
By Fig. 7-10 it is found that QINGKAILING ZHUSHEJI blood after being administered alone the serum HPLC fingerprint after 20min and 170min
Clear finger-print indifference.QINGKAILING ZHUSHEJI and Ribavirin injection are combined, interval time 0min, after being combined 20min
Serum HPLC fingerprint after being administered alone 20min of serum HPLC fingerprint and QINGKAILING ZHUSHEJI it is variant, when illustrating interval
Between 0min be not QINGKAILING ZHUSHEJI Yu Ribavirin injection the reasonable combination time.QINGKAILING ZHUSHEJI and Ribavirin are infused
Agent combination is penetrated, interval time 150min, the serum HPLC fingerprint and QINGKAILING ZHUSHEJI for being combined 20min is being administered alone
The serum HPLC fingerprint of 20min does not have difference, illustrates interval time 150min in QINGKAILING ZHUSHEJI and Ribavirin injection
Reasonable combination time range in.It is determined through repetition test, between QINGKAILING ZHUSHEJI and Ribavirin injection reasonable time
Every --- time window 110min.
Embodiment 3
A method of evaluation Chinese and Western medicine injection sequential combination interval time, comprising the following steps:
(1) four administration groups of SD rat are set
A) blank control group (non-administration test body group)
B) Safflower Yellow Injection group
C) Safflower Yellow Injection-naloxone hydrochloride injection different dosing interval time group
D) naloxone hydrochloride injection-Safflower Yellow Injection different dosing interval time group
Every group of ten SD rats.
(2) for c group, Safflower Yellow Injection-naloxone hydrochloride injection delivery time is t1、
t2...tn, Safflower Yellow Injection can be administered simultaneously with naloxone hydrochloride injection.
For d group, naloxone hydrochloride injection-Safflower Yellow Injection delivery time is t1、t2...tn, salt
Sour Naloxone injection can be administered simultaneously with Safflower Yellow Injection.
(3) preparation of blank control group and administration blood serum sample: processing SD rat, tail vein injection administration are delayed respectively
T1、T2...Tn, take blood 0.5mL, 12000r to be centrifugated 10min administration group serum through orbital vein, -80 DEG C of freezings are spare.
(4) certain several time point blood sampling upon administration are distinguished, using LC-MS after the administration of SD rat for b group
Technology establishes serum HPLC fingerprint.
For two groups of c, d, respectively in Safflower Yellow Injection and certain several time after naloxone hydrochloride injection administration
Point blood sampling using LC-MS technology establishes serum HPLC fingerprint, using pattern-recognition, in conjunction with principal component analysis (PCA) and
Partial least squares discriminant analysis method (PLS-DA) analyzes each group serum HPLC fingerprint difference.
(5) serum HPLC fingerprint at some time point is administered alone with b group after the administration of the different intervals of c group or d group
The serum HPLC fingerprint for corresponding to time point afterwards compares.
By Figure 11-14 it is found that serum HPLC fingerprint and 170min of the Safflower Yellow Injection after being administered alone 20min
Serum HPLC fingerprint indifference afterwards.Carthamin yellow and naloxone hydrochloride injection are combined, interval time 0min, combination
The serum HPLC fingerprint of serum HPLC fingerprint and Safflower Yellow Injection after being administered alone 20min after 20min is variant,
Illustrating interval time 0min not is the reasonable combination interval time of carthamin yellow Yu naloxone hydrochloride injection.Carthamin yellow
It is combined with naloxone hydrochloride injection, interval time 150min, serum HPLC fingerprint and injection safflower after being combined 20min
Serum HPLC fingerprint of the uranidin after being administered alone 20min does not have difference, illustrates that interval time 150min is carthamin yellow
Interval time is rationally combined with naloxone hydrochloride injection.It is determined through repetition test, carthamin yellow and naloxone hydrochloride are injected
Agent time-wise separation --- time window 120min.
Presently preferred embodiments of the present invention is not intended to limit the invention, all made in substantive content of the present invention
Any modification, equivalent replacement and simple modifications etc., should all be included in the protection scope of the present invention.
Claims (3)
1. a kind of method of evaluation Chinese and Western medicine injection sequential combination interval time, which is characterized in that the method includes following
Step:
(1) selection test body carries out traditional Chinese medicine administration, delays T1、T2......TNSampling, establishes serum HPLC fingerprint g1、
g2......gN, wherein N >=1；
(2) test body is selected respectively, with Chinese medicine-Western medicine injection combination administration or with Western medicine-traditional Chinese medicine combination administration, connection
With delivery time t1、t2.......tn, wherein n > 1；
(3) after the combination administration of step (2) different intervals, T is delayed respectively1、T2......TNSampling, establishes serum and refers to
Line mapWherein, GijTo be combined delivery time tiAnd prolong after completing combination administration
Slow TjThe serum HPLC fingerprint of foundation, here N >=1；
(4) by the serum HPLC fingerprint of every a line in step (3) matrix serum HPLC fingerprint g with step (1) respectively1、
g2......gNOne-to-one correspondence is contrasted, using pattern-recognition, in conjunction with principal component analysis (PCA) and partial least squares discriminant analysis method
(PLS-DA) each group serum HPLC fingerprint difference is analyzed, so that it is determined that the Chinese and Western medicine injection sequential combination proportional spacing time；
Wherein, the test body is SD rat, is administered through tail vein injection, and then orbital vein takes blood 0.5-1.0mL, centrifugation point
From rear, -80 DEG C of freezings are spare；Using LC-MS technology, serum HPLC fingerprint is established.
2. the method for evaluation Chinese and Western medicine injection sequential combination interval time according to claim 1, which is characterized in that step
Suddenly the serum HPLC fingerprint g in (1)1、g2......gNWith the serum HPLC fingerprint G in step (3)ij, it is that Chinese medicine is applied alone to infuse respectively
Penetrate agent serum HPLC fingerprint and Chinese medicine-Western medicine injection combination administration serum HPLC fingerprint.
3. the method for evaluation Chinese and Western medicine injection sequential combination interval time according to claim 1, which is characterized in that from
The revolving speed of heart separation is 10000-14000r/min, time 10-15min.
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Citations (2)
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| CN102375004A (en) * | 2010-08-27 | 2012-03-14 | 中国人民解放军第三○二医院 | Method for evaluating clinical compatibility of injections |
| CN102893155A (en) * | 2010-05-19 | 2013-01-23 | 霍夫曼-拉罗奇有限公司 | Combination therapy and method for assessing resistance to treatment |
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2016
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102893155A (en) * | 2010-05-19 | 2013-01-23 | 霍夫曼-拉罗奇有限公司 | Combination therapy and method for assessing resistance to treatment |
| CN102375004A (en) * | 2010-08-27 | 2012-03-14 | 中国人民解放军第三○二医院 | Method for evaluating clinical compatibility of injections |
Non-Patent Citations (2)
| Title |
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| 中西药注射剂联合用药安全性评价序贯检测Δ;冯雪 等;《中国药房》;20101231;第21卷(第47期);第4465-4467页 |
| 大鼠体内川芎多成分序贯代谢研究;吕贝然 等;《中国中医药信息杂志》;20150430;第22卷(第4期);第77-82页 |
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