CN104132899B - Penicillin antibiotic appearance evaluation method - Google Patents
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- CN104132899B CN104132899B CN201410307150.7A CN201410307150A CN104132899B CN 104132899 B CN104132899 B CN 104132899B CN 201410307150 A CN201410307150 A CN 201410307150A CN 104132899 B CN104132899 B CN 104132899B
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Abstract
The invention discloses a penicillin antibiotic appearance evaluation method which is as follows: determining appearance standards of a certain penicillin antibiotic by use of spectrophotometric method, and comparing the determined appearance standards with the absorbance of other batches of solutions of the penicillin antibiotic to evaluate wether the appearance of the penicillin antibiotic product of the to-be tested batch is qualified. A penicillin antibiotic appearance naked eye observation method is replaced by the penicillin antibiotic appearance evaluation method, the appearance standard is quantifiable, easy to control, objective and accurate, and does not change with time, place, personnel changes. The penicillin antibiotic appearance evaluation method has the advantages of low cost, high precision and high efficiency in the popularization and application in industrial production.
Description
Technical field
The present invention relates to Control of drug quality field, refer in particular to the outward appearance assessment method of PCs.
Background technology
The appearance color of medicine is an objective characterisation of medicine inherent quality, and it can be certain with the difference specifying color
The purity of medicine is reflected on degree.Pharmacopoeia of each country is all using the color of medicine color or drug solution as Drug's control
One important inspection project.
PCs is a kind of antibiotic containing beta-lactam nucleus, and structure is as shown in formula.It is 4 about in ph
Environment in, the intramolecular beta-lactam nucleus of PCs can occur molecular rearrangement, generates penicillenic acid
(penicillenic acid), its structure is as shown in formula.Penicillenic acid has oxazolone structure, the easy moisture absorption and lead to send out
Xanthochromia matter, is mixed with the change that penicillenic acid will cause PCs product appearance color in PCs.
Although penicillin parent nucleus 6-apa does not have α amino, find in research process to there is also such phenomenon.
At present, the appearance quality trait to above-mentioned PCs, typically all adopts artificial visual method, that is, pass through mesh
Directly visually observe depending on method and judge, color be white PCs be qualified products, and color be off-white color or
The PCs of yellow is then substandard product.But defining very difficult, different people for white and off-white color has
Different standards, Subjective Factors are too big.Judge the inadequate objective science of method of the quality of medicine by artificial visual method；
Workman, in the case of checking color for a long time, also easily produces visual fatigue, thus increasing the possibility of erroneous judgement.
Therefore, it is very necessary for finding a kind of objective, accurate PCs outward appearance assessment method.
The quantitative basis of UV-Vis Spectrophotometry are lamber-beer law.Lamber-beer law is applied to
Any uniform, the solid of non-scatter, liquid or gas medium.The degree of absorption to light for the solution, with solution concentration, liquid layer thickness and
The factors such as lambda1-wavelength are relevant.If keeping lambda1-wavelength constant, solution is to the degree of absorption of light only and solution concentration
Relevant with liquid layer thickness, and liquid layer thickness is changeless in UV-Vis scan chromatograph, therefore, solution is to light
Degree of absorption only relevant with solution concentration.Because the absorbance of penicillenic acid is higher than the absorbance of PCs,
So, to be detected from same lambda1-wavelength different solutions absorbance when, in solution, the content of penicillenic acid is higher, molten
The absorbance of liquid is bigger；The content of penicillenic acid is bigger, and the appearance color of this PCs is closer to yellow.Cause
This, the use principle of the present invention is as follows:
Absorbance at PCs color ∝ penicillenic acid concentration ∝ 318nm-342nm.
Content of the invention
The technical problem to be solved in the invention is to provide a kind of objective, accurate PCs outward appearance to comment
Determine method.
For solving above-mentioned technical problem, the technical solution used in the present invention is as follows:
The outward appearance assessment method of PCs, for any one PCs, comprises the following steps:
A. each portion of this kind of PCs taking Visual appearance to be white, off-white color and yellow, is configured to respectively
Three parts of standing wave solution are carried out full wavelength scanner with water for blank by the standing wave solution of same concentrations, determine this kind of green grass or young crops of detection
The lambda1-wavelength of mycin class antibiotic solution；
B. taking no less than the range estimation of three batches is this kind of PCs of white, is configured to same concentrations respectively
Calibration solution, with water as blank control group, with step a determine Detection wavelength, molten with every part of calibration of spectrophotometry
The absorbance of liquid；
C. calculate the mean value being measured mark solution absorbance, averaging of income value retains three after decimal point, by decimal point
3rd bit value takes zero afterwards, and institute's value is as the appearance standard of this kind of PCs；
D. take this kind of PCs of any batch, be configured to solution to be measured, with water as blank control group, with step
The Detection wavelength that rapid a determines, with the absorbance of spectrophotometry solution to be measured, if the absorbance of solution to be measured is more than step
Appearance standard determined by c, then this kind of PCs outward appearance of surveyed batch is unqualified；If the extinction of solution to be measured
Degree is less than or equal to appearance standard determined by step c, then this kind of PCs outward appearance of surveyed batch is qualified.
PCs of the present invention be 6-apa, ampicillin, Amoxicillin, aspoxicillin, apalcillin,
OXA, Cloxacillin, dicloxacillin, flucloxacillin, methicillin, NAF, azlocillin, mezlocillin, piperazine draw
XiLin, Furbucillin, Carbenicillin, carindacillin, Ticarcillin, ticarcillin disodium, temocillin, sulbenicillin, bar ammonia
XiLin, Pivampicillin, Talampicillin, Lenampicillin, hetacillin, Mecillinam, Pivmecillinam, bacmecillinam, Potassium Phenoxymethylpenicillin,
Pheneticillin, left general skin XiLin, propicillin, isopropicillin, Azidocillin, ciclacillin, fibracillin, quinacillin, according to
XiLin, metampicillin, sarpicillin, sarmocillin, Fuzlocillin, pirbenicillin, Benethamine Penicillin, Prazocillin, an ammonia
Any one in XiLin.
Standing wave solution of the present invention, the solvent calibrated used by solution and solution to be measured are identicals, and described solvent is alkali
One of liquid, alkaline buffer or water；The concentration of described standing wave solution, calibration solution and solution to be measured is identical, is
0.1g/ml～0.35g/ml, preferably 0.1g/ml～0.13g/ml..
Alkali lye of the present invention is organic base and/or inorganic alkali solution.
Organic base of the present invention be methylamine, urea, ethamine, monoethanolamine, ethylenediamine, dimethylamine, trimethylamine, triethylamine, third
Amine, isopropylamine, 1,3- propane diamine, 1,2- propane diamine, tripropyl amine (TPA), triethanolamine, butylamine, isobutyl amine, tert-butylamine, hexylamine, octylame,
Any one or a few in benzylamine, cyclohexylamine, pyridine, pregnancy urotropine, ortho-aminotoluene, meta-aminotoluene, para-totuidine, described
Inorganic alkali solution is ammoniacal liquor, sodium hydroxide solution, sodium carbonate liquor, any one or a few in sodium bicarbonate solution.
Alkaline buffer solution of the present invention is disodium hydrogen phosphate-citrate buffer solution, disodium hydrogen phosphate-sodium dihydrogen phosphate
Buffer solution, disodium hydrogen phosphate-potassium phosphate buffer, potassium dihydrogen phosphate-sodium hydrate buffer solution, barbital sodium-hydrochloric acid delay
Rush liquid, tris- hydrochloride buffer, boric acid-borate buffer solution, boric acid-borate buffer solution, Glycine-NaOH buffer solution,
Any one or a few in borax-sodium hydrate buffer solution, sodium carbonate-bicarbonate buffer solution.
Detection wavelength in step a of the present invention is 318nm～342nm, preferably 323nm～329nm.
The absorbance measurement of the calibration solution in step b of the present invention and step d and solution to be measured has been prepared in solution
Complete in after one-tenth 15 minutes；The temperature of the measurement of calibration solution and solution to be measured is 0 DEG C～30 DEG C.
Due to employing technique scheme, the technological progress that the present invention obtains is as follows:
The present invention estimates the extinction for any one white PCs solution by spectrophotometry
Degree, establishes the appearance standard of this kind of PCs；Pass through this kind of PCs solution of other batches again
Absorbance with determined by appearance standard be compared to evaluate surveyed batch this kind of PCs product appearance be
No qualified.The method instead of the observation method of naked eye of traditional PCs outward appearance, so that the standard of outward appearance can be quantified, easily
In control, objective, accurate, not in time, place, the change of personnel and change.The present invention should in industrial popularization
With in there is low cost, high precision, efficient feature.
Solvent in the present invention selects alkali lye, alkaline buffer or water, has prevented PCs in acid condition
Under degraded, thus avoiding the impact to solution absorbance for the catabolite penicillenic acid so that testing result is more objective, accurate
Really.The present invention tests to determine Detection wavelength by PCs solution is carried out with full wavelength scanner, in Detection wavelength
The appearance of lower penicillenic acid maximizes, and increased the accuracy of detection.318nm～342nm is that detection PCs is molten
The generic wavelength of liquid absorbance.In the present invention, the absorbance measurement of PCs solution is controlled to prepare in solution and complete
Complete in 15 minutes afterwards, thus can be prevented effectively from PCs fall that is long due to solution standing time and occurring
Solution, the side reaction of generation penicillenic acid, it is to avoid make the absorbance of solution produce error in test process.The temperature of solution to be measured
Degree controls at 0 DEG C～30 DEG C, preferably 10 DEG C～25 DEG C, can be prevented effectively from solution temperature too high and lead to PCs
Degraded；And solution temperature is close to room temperature, simple to operation.
Specific embodiment
With reference to specific embodiment, the present invention is further described in detail, but the present invention be not limited in following
Embodiment.
INSTRUMENT MODEL used in the following example is Shimadzu ultraviolet-uisible spectrophotometer uv2550；The green grass or young crops being used
Mycin class antibiotic is produced by North China Pharmaceutical Group Company Ltd.
The outward appearance assessment method of PCs, for any one PCs, comprises the following steps:
A. each portion of a kind of PCs taking Visual appearance to be white, off-white color and yellow, is configured to respectively
Three parts of standing wave solution are carried out full wavelength scanner with water for blank by the standing wave solution of same concentrations, determine this kind of green grass or young crops of detection
The lambda1-wavelength of mycin class antibiotic solution；
B. taking no less than the range estimation of three batches is this kind of PCs of white, is configured to same concentrations respectively
Calibration solution, with water as blank control group, with step a determine Detection wavelength, molten with every part of calibration of spectrophotometry
The absorbance of liquid；
C. all mean values calibrating solution absorbances in calculation procedure b, averaging of income value retains three after decimal point, will
After decimal point, the 3rd bit value takes zero, and institute's value is as the appearance standard of this kind of PCs；
D. take this kind of PCs of any batch, be configured to solution to be measured, with water as blank control group, with step
The Detection wavelength that rapid a determines, with the absorbance of spectrophotometry solution to be measured, if the absorbance of solution to be measured is more than step
Appearance standard determined by c, then this kind of PCs outward appearance of surveyed batch is unqualified；If the extinction of solution to be measured
Degree is less than or equal to appearance standard determined by step c, then this kind of PCs outward appearance of surveyed batch is qualified.
PCs of the present invention includes 6-apa, ampicillin, Amoxicillin, aspoxicillin, A Paxi
Woods, OXA, Cloxacillin, dicloxacillin, flucloxacillin, methicillin, NAF, azlocillin, mezlocillin, piperazine
Draw XiLin, Furbucillin, Carbenicillin, carindacillin, Ticarcillin, ticarcillin disodium, temocillin, sulbenicillin, bar
Ammonia XiLin, Pivampicillin, Talampicillin, Lenampicillin, hetacillin, Mecillinam, Pivmecillinam, bacmecillinam, penicillin v
Potassium, pheneticillin, left general skin XiLin, propicillin, isopropicillin, Azidocillin, ciclacillin, fibracillin, quinacillin,
Epicillin, metampicillin, sarpicillin, sarmocillin, Fuzlocillin, pirbenicillin, Benethamine Penicillin, Prazocillin,
Ammonia XiLin.
Standing wave solution of the present invention, the solvent calibrated used by solution and solution to be measured are identicals, and described solvent is alkali
One of liquid, alkaline buffer or water；The concentration of described standing wave solution, calibration solution and solution to be measured is identical, all takes
Any value in any value in 0.1g/ml～0.35g/ml scope, and preferred 0.1g/ml～0.13g/ml scope.
Described alkali lye is organic base and/or inorganic alkali solution, organic base be methylamine, urea, ethamine, monoethanolamine, ethylenediamine, two
Methylamine, trimethylamine, triethylamine, propylamine, isopropylamine, 1,3- propane diamine, 1,2- propane diamine, tripropyl amine (TPA), triethanolamine, butylamine, different
Butylamine, tert-butylamine, hexylamine, octylame, benzylamine, cyclohexylamine, pyridine, pregnancy urotropine, ortho-aminotoluene, meta-aminotoluene, para-totuidine
In any one or a few, described inorganic alkali solution is ammoniacal liquor, sodium hydroxide solution, sodium carbonate liquor, sodium bicarbonate solution
In any one or a few mixing.
Described alkaline buffer solution is disodium hydrogen phosphate-citrate buffer solution, disodium hydrogen phosphate-sodium dihydrogen phosphate buffering
Liquid, disodium hydrogen phosphate-potassium phosphate buffer, potassium dihydrogen phosphate-sodium hydrate buffer solution, barbital sodium-hydrochloride buffer,
Tris- hydrochloride buffer, boric acid-borate buffer solution, boric acid-borate buffer solution, Glycine-NaOH buffer solution, borax-hydrogen
Any one or a few mixing in sodium oxide molybdena buffer solution, sodium carbonate-bicarbonate buffer solution.
Detection wavelength in step a of the present invention is 318nm～342nm, preferably 323nm～329nm.
The absorbance measurement of the calibration solution in step b of the present invention and step d and solution to be measured has been prepared in solution
Complete in after one-tenth 15 minutes, preferably complete in 10 minutes after the completion of solution preparation；Calibration solution and the mensure of solution to be measured
Temperature is 0 DEG C～30 DEG C, preferably 10 DEG C～25 DEG C.
Embodiment 1
The outward appearance assessment method of ampicillin, comprises the following steps:
A. take each 1 part of the ampicillin that Visual appearance is white, off-white color and yellow, every part of medicine takes 1.7g, constantly stirs
Mix in lower input 3ml purified water, stirring is lower to drip 3ml10% ammoniacal liquor, is settled to 10ml, is configured to three parts of standing waves of same concentrations
Solution, standing wave solution concentration is 0.17g/ml, for blank, three parts of standing wave solution is carried out with full wavelength scanner with water, contrasts three
The full wavelength scanner result of part standing wave solution, finds that three parts of standing wave solution absorbance difference at 325nm are very big, it is thus determined that inspection
The wavelength surveying ampicillin solution is 325nm；
B. the Visual appearance taking 3 batches is white ampicillin sample, is configured to respectively by method described in step a
Three parts of calibration solution of same concentrations, calibration solution concentration is 0.3g/ml；With water as blank control group, with 325nm for detecting ripple
Long, measure the absorbance of three parts of calibration solution；The temperature of calibration solution is 15 DEG C, and continuous mode is after the completion of calibration solution is prepared
5min within terminate；Measurement result is shown in Table 1；
Absorbance at 325nm for the table 1 white ampicillin solution
The mean value of three parts of c. obtained in calculation procedure b calibration solution absorbances is 0.501, by 0.501 decimal
Point after the 3rd bit value take zero, obtain 0.500, will ampicillin solution at 325nm absorbance 0.500 as ampicillin
Appearance standard；
D. take Visual appearance to be white, each three batches in the ampicillin of off-white color, yellow, by method described in step a
It is configured to solution to be measured respectively, the concentration of solution to be measured is 0.12g/ml, with water as blank, with 325nm as Detection wavelength,
Measure the absorbance of every part of solution to be measured, the temperature of solution to be measured is 15 DEG C, and continuous mode is after the completion of solution to be measured is prepared
Complete in 5min, measurement result is shown in Table 2.
Table 2 white, off-white color, absorbance at 325nm for the yellow ampicillin solution
| Numbering | Lot number | Appearance color | Absorbance |
| 1 | 201103010 | White | 0.525 |
| 2 | 201103011 | White | 0.478 |
| 3 | 201103012 | White | 0.485 |
| 4 | 201103004 | Off-white color | 0.758 |
| 5 | 201103005 | Off-white color | 0.805 |
| 6 | 201103006 | Off-white color | 0.912 |
| 7 | 201103007 | Yellow | 1.422 |
| 8 | 201103008 | Yellow | 1.377 |
| 9 | 201103009 | Yellow | 1.352 |
As can be seen from Table 2, lot number be 201103010 white ampicillin absorbance at 325nm for the solution big
In determined by appearance standard 0.500 although Visual appearance is white, but determine this batch ammonia through spectrophotometry
The outward appearance in benzyl XiLin is unqualified；Absorbance at 325nm for the solution of the ampicillin for white for the range estimation of two other batch
It is respectively less than 0.500, outward appearance is qualified.And estimate the solution of the ampicillin for off-white color and yellow absorbance at 325nm
All it is significantly greater than 0.500, outward appearance is unqualified, and ocular estimate is consistent with the testing result of the inventive method.
Embodiment 2
The outward appearance assessment method of Amoxicillin, comprises the following steps:
A. Visual appearance is taken to be that white, off-white color and yellow Amoxicillin respectively take 1 part, every part of medicine takes 2.5g, constantly stirs
Mix in lower addition 10ml purified water, stirring is lower to drip triethylamine dissolving, constant volume to 20ml, is configured to three parts of same concentrations
Standing wave solution, standing wave solution concentration is 0.125g/ml, carries out full wavelength scanner for blank to three parts of standing wave solution with water,
The full wavelength scanner result of three parts of standing wave solution of contrast, finds that three parts of standing wave solution absorbance difference at 328nm are very big, therefore
Determine that the wavelength detecting Amoxicillin solution is 328nm；
B. the Amoxicillin sample taking 3 batch Visual appearance to be white, is configured to same concentrations by step a methods described
Three parts calibration solution, calibration solution concentration be 0.125g/ml；With water as blank control group, with 328nm as Detection wavelength,
Measure the absorbance of three parts of calibration solution；The temperature of calibration solution is 25 DEG C, and continuous mode is after the completion of calibration solution is prepared
Complete in 8min；Measurement result is shown in Table 3；
Absorbance at 338nm for the solution of the white Amoxicillin of table 3
The mean value of three parts of c. obtained in calculation procedure b calibration solution absorbances is 0.503, by 0.503 decimal
Point after the 3rd bit value take zero, obtain 0.500, will Amoxicillin solution at 328nm absorbance 0.500 as Amoxicillin
Appearance standard；
D. take Visual appearance to be white, each three batches in the Amoxicillin of off-white color, yellow, by method described in step a
Prepare solution to be measured respectively, the concentration of solution to be measured is 0.125g/ml, with water as blank, with 328nm as Detection wavelength,
Measure the absorbance of every part of solution to be measured, the temperature of solution to be measured is 25 DEG C, and continuous mode is after the completion of solution to be measured is prepared
Complete in 8min, the results are shown in Table 4.
Table 4 white, off-white color, the absorbance at 328nm for the solution of yellow Amoxicillin
| Numbering | Lot number | Appearance color | Absorbance |
| 1 | 2011030053 | White | 0.485 |
| 2 | 2011030054 | White | 0.540 |
| 3 | 2011030055 | White | 0.481 |
| 4 | 2011030013 | Off-white color | 0.733 |
| 5 | 2011030014 | Off-white color | 0.987 |
| 6 | 2011030015 | Off-white color | 0.899 |
| 7 | 2011030016 | Yellow | 1.529 |
| 8 | 2011030017 | Yellow | 1.458 |
| 9 | 2011030018 | Yellow | 1.682 |
As can be seen from Table 4, lot number be 201103054 white Amoxicillin absorbance at 328nm for the solution big
In determined by appearance standard 0.500 although Visual appearance be white, but through spectrophotometry determine this batch Ah
Amdinocillin appearance color is unqualified, the extinction at 328nm for the solution of the range estimation of two other batch Amoxicillin for white
Degree is respectively less than 0.500, and outward appearance is qualified；And it is equal to estimate the solution of the Amoxicillin for off-white color and yellow absorbance at 328nm
More than 0.500, outward appearance is unqualified, and ocular estimate is consistent with the testing result of the inventive method.
Embodiment 3:
The outward appearance assessment method of 6-apa, comprises the following steps:
A. extracting waste, off-white color and yellow 6-apa respectively take 1 part, and every part of medicine takes 1.2g, are stirred continuously lower addition 8.5ml
In purified water, it is stirred continuously lower dropping 30% ammonia spirit to molten clear, constant volume to 10ml, is configured to three parts of same concentrations
Standing wave solution, standing wave solution concentration is 0.12g/ml, carries out full wavelength scanner for blank to three parts of standing wave solution with water, right
The ratio full wavelength scanner result of three parts of standing wave solution, finds that three parts of standing wave solution absorbance difference at 325nm are very big, therefore really
Determining 6-apa solution Detection wavelength is 325nm；
B. the 6-apa sample that 3 batch Visual appearance are white is taken to be configured to the three of same concentrations by step a methods described
Part calibration solution, the concentration of calibration solution is 0.12g/ml；With water as blank, with 325nm as Detection wavelength, measure three parts
The absorbance of calibration solution；The temperature of calibration solution is 25 DEG C, and continuous mode is complete in 10min after the completion of calibration solution is prepared
Become, measurement result is shown in Table 5；
Absorbance at 325nm for the solution of the white 6-apa of table 5
C. the mean value of three parts of calibration solution absorbances obtained by calculation procedure step is 0.504, by 0.504 decimal
After point, the 3rd bit digital obtains 0.500 after taking zero, that is, take 6-apa solution absorbance 0.500 at 325nm outer as 6-apa
Sight standard；
D. take Visual appearance to be white, each three batches of the 6-apa of off-white color, yellow, be configured to by step a methods described
Concentration is the solution to be measured of 0.12g/ml；With water as blank, with 325nm as Detection wavelength, measure every part of solution to be measured
Absorbance；The temperature of solution to be measured is 25 DEG C, and continuous mode completes in 10min after the completion of solution to be measured is prepared, and the results are shown in Table
6.
Table 6 white, off-white color, the absorbance at 328nm for the solution of yellow 6-apa
| Numbering | Lot number | Appearance color | Absorbance |
| 1 | 2011030059 | White | 0.512 |
| 2 | 2011030060 | White | 0.490 |
| 3 | 2011030061 | White | 0.492 |
| 4 | 2011030031 | Off-white color | 1.415 |
| 5 | 2011030032 | Off-white color | 1.381 |
| 6 | 2011030033 | Off-white color | 1.849 |
| 7 | 2011030034 | Yellow | 2.737 |
| 8 | 2011030035 | Yellow | 2.937 |
| 9 | 2011030036 | Yellow | 2.954 |
As can be seen from Table 6, lot number is that the absorbance at 325nm for the solution of 201103059 white 6-apa is more than institute
The appearance standard 0.500 determining is although estimate as white, but determines that through spectrophotometry the 6-apa's of this batch is outer
See unqualified, the absorbance at 325nm for the solution of the range estimation of two other batch 6-apa for white is respectively less than 0.500, outward
Sight is qualified；And estimate the solution of the 6-apa for off-white color and yellow absorbance at 325nm and be all higher than 0.500, outward appearance is not
Qualified, ocular estimate is consistent with the testing result of the inventive method.
The present invention can not exhaustive all kinds PCs presentation quality assessment method, but pass through above-mentioned 3
Individual embodiment, the method for the present invention is extended to all kinds PCs, thus to various, each in actual production
The PCs of batch carries out presentation quality evaluation, with outside the produced PCs of digital form reaction
Appearance quality, and no longer adopt estimation mode, it is to avoid the error that human factor causes.
Claims (7)
1. a kind of outward appearance assessment method of PCs is it is characterised in that comprise the following steps:
A. each portion of a kind of PCs taking Visual appearance to be white, off-white color and yellow, is configured to identical respectively
Three parts of standing wave solution are carried out full wavelength scanner with water for blank by the standing wave solution of concentration, determine this kind of penicillin of detection
The lambda1-wavelength of class antibiotic solution；
B. taking no less than the range estimation of three batches is this kind of PCs of white, is configured to determining of same concentrations respectively
Mark solution, with water as blank control group, with the Detection wavelength of step a determination, with every part of calibration solution of spectrophotometry
Absorbance；
C. the mean value of all calibration solution absorbances of calculation procedure b, averaging of income value retains three after decimal point, and will be little
The 3rd bit value after several points takes zero, and institute's value is as the appearance standard of this kind of PCs；
D. take this kind of PCs of any batch, be configured to solution to be measured, with water as blank control group, with step a
The Detection wavelength determining, with the absorbance of spectrophotometry solution to be measured；If the absorbance of solution to be measured is more than in step c
Determined by appearance standard, then this kind of PCs outward appearance of surveyed batch is unqualified；If the absorbance of solution to be measured
Less than or equal to appearance standard determined by step c, then this kind of PCs outward appearance of surveyed batch is qualified；
Described standing wave solution, calibration solution are identical with solvent used in solution to be measured, and described solvent is alkali lye, alkaline buffer
Or any one in water；Described standing wave solution, calibration solution and the concentration of solution to be measured are identicals, all take 0.1g/ml～
Any value in 0.35g/ml scope；
Detection wavelength in described step a is 318nm～342nm；
In described step b and step d, calibration solution and solution to be measured absorbance measurement solution preparation after the completion of 15 minutes
Inside complete；The temperature of the measurement of calibration solution and solution to be measured is 0 DEG C～30 DEG C.
2. PCs according to claim 1 outward appearance assessment method it is characterised in that: described PCs
Antibiotic includes 6-apa, ampicillin, Amoxicillin, aspoxicillin, apalcillin, OXA, Cloxacillin, double chlorine west
Woods, flucloxacillin, methicillin, NAF, azlocillin, mezlocillin, Piperacillin, Furbucillin, Carbenicillin, card
Indenes XiLin, Ticarcillin, ticarcillin disodium, temocillin, sulbenicillin, Bacampicillin, Pivampicillin, Talampicillin, logical sequence
Ammonia XiLin, hetacillin, Mecillinam, Pivmecillinam, bacmecillinam, Potassium Phenoxymethylpenicillin, pheneticillin, left general skin XiLin, third west
Woods, isopropicillin, Azidocillin, ciclacillin, fibracillin, quinacillin, Epicillin, metampicillin, sarpicillin, sand
Amdinocillin, Fuzlocillin, pirbenicillin, Benethamine Penicillin, Prazocillin, Pivampicillin.
3. PCs according to claim 1 outward appearance assessment method it is characterised in that: described alkali lye is that have
Machine alkali and/or inorganic alkali solution.
4. a kind of PCs according to claim 3 outward appearance assessment method it is characterised in that: described organic
Alkali be methylamine, urea, ethamine, monoethanolamine, ethylenediamine, dimethylamine, trimethylamine, triethylamine, propylamine, isopropylamine, 1,3- propane diamine, 1,
2- propane diamine, tripropyl amine (TPA), triethanolamine, butylamine, isobutyl amine, tert-butylamine, hexylamine, octylame, benzylamine, cyclohexylamine, pyridine, hexamethyl
Any one or a few in tetramine, ortho-aminotoluene, meta-aminotoluene, para-totuidine；Described inorganic alkali solution is ammoniacal liquor, hydroxide
Any one or a few mixing in sodium solution, sodium carbonate liquor, sodium bicarbonate solution.
5. PCs according to claim 1 outward appearance assessment method it is characterised in that: described alkaline buffer
Solution is disodium hydrogen phosphate-citrate buffer solution, disodium hydrogen phosphate-phosphate sodium dihydrogen buffer solution, disodium hydrogen phosphate-biphosphate
Potassium buffer solution, potassium dihydrogen phosphate-sodium hydrate buffer solution, barbital sodium-hydrochloride buffer, tris- hydrochloride buffer, boric acid-
Borate buffer solution, boric acid-borate buffer solution, Glycine-NaOH buffer solution, borax-sodium hydrate buffer solution, sodium carbonate-
Any one or a few mixing in sodium bicarbonate buffer liquid.
6. PCs according to claim 1 outward appearance assessment method it is characterised in that: described standing wave is molten
The concentration of liquid, calibration solution and solution to be measured all takes any value in 0.1g/ml～0.13g/ml.
7. PCs according to claim 1 outward appearance assessment method it is characterised in that: in described step a
Detection wavelength be 323nm～329nm.
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| CN201410307150.7A CN104132899B (en) | 2014-06-30 | 2014-06-30 | Penicillin antibiotic appearance evaluation method |
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