CN112986499A - Homogeneous bone implant material residual water content uniformity determination method - Google Patents
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 title claims abstract description 151
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- 239000007943 implant Substances 0.000 title claims abstract description 86
- 210000000988 bone and bone Anatomy 0.000 title claims abstract description 84
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Abstract
The invention discloses a method for measuring the residual water quantity uniformity of an allograft implant material, which comprises the following steps: s1, taking 10 groups of test points from a freeze dryer bin; s2, taking the bone implant material near the test points of the 10 groups, detecting the residual water content of the bone implant material, and determining the residual water content uniformity of the bone implant material according to the formula 1; s3, after collecting the residual water quantity data of each group of test points of the freeze-drying batches for many times, determining the fluctuation degree of the residual water quantity of the bone implant material processed in the freeze-drying machine according to the formula 2; s4, taking 3 groups of bone implant materials in the same freeze-drying batch to detect residual water quantity, calculating average residual water quantity, replacing residual water quantity of all the bone implant materials in the freeze-drying batch with the average residual water quantity, and determining the fluctuation range of the residual water quantity of each bone implant material in the freeze-drying batch by adding the average residual water quantity and the fluctuation degree of the residual water quantity obtained in the step S3. The invention can reduce a large amount of detection time and save the subsequent production time.
Description
Technical Field
The invention relates to the technical field of biological materials and orthopedic materials, in particular to a method for measuring the uniformity of residual water content of an allograft implant material.
Background
In the clinical application of bone surgery, the appearance of the allograft bone implant material enables a patient to be free from secondary operation pain caused by the autologous bone, so that the allograft bone implant material has wide market application, but the success of bone implant is greatly dependent on the quality of the allograft bone, wherein the residual water quantity of the freeze-dried allograft bone is an important technical index which directly influences the product quality, and the detection of the residual water uniformity after freeze-drying is not reported at present.
When clinical operation is carried out, the residual water content of the allogeneic bone implant material is controlled to be below 6 percent, so that the autolytic activity causing tissue autolysis and degeneration and the reproduction of microorganisms possibly existing can be inhibited, and the product is easy to store and transport at room temperature.
The freeze drying principle of the freeze dryer is that water in bone materials is directly sublimated from a crystallization state to a gas state, and then vacuum is pumped to remove water vapor in the bone materials. The freeze dryer chamber also removes the moisture in the product by controlling the temperature and time in the chamber.
Since multiple product batches are contained within the same lyophilization batch, the volume is not sufficient (0.1 m)3) When the freeze dryer bin is used for detecting the residual water content, 3 samples are required to be taken from each batch for detecting about 1 hour to master the residual water content of all product batches in one freeze drying batch, and a large amount of time is required for detecting all the product batches.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide the method for measuring the uniformity of the residual water content of the allograft implant material, which is characterized in that only a small amount of samples are taken from the whole bin to detect the residual water content and calculate the average value, and the value and the fluctuation degree of the residual water content can represent the residual water content range of all product batches in the freeze-drying batch, thereby reducing a large amount of detection time and saving the subsequent production time.
The technical scheme adopted by the invention for realizing the purpose is as follows: a method for measuring the residual water quantity uniformity of an allogeneic bone implant material comprises the following steps:
s1: determining test points
Taking 4 groups of test points at the positions, close to four corners, of a carrying tray positioned on the upper layer in a freeze dryer bin, taking 4 groups of test points at the positions, close to four corners, of a carrying tray positioned on the lower layer, taking 1 group of test points at the center of the carrying tray positioned on the middle and lower layers, taking 1 group of test points at the center of the carrying tray positioned on the middle and upper layers, and taking 10 groups of test points in total;
s2: residual water volume uniformity calculation
After the bone implant materials are processed by the freeze dryer, taking the bone implant materials near the 10 groups of test points determined in the step S1, detecting the residual water content of the bone implant materials, taking a plurality of groups of bone implant materials near each group of test points, detecting the residual water content, and determining the residual water content uniformity of the bone implant materials according to the formula 1;
equation 1:
in equation 1: Δ Ru-residual water content uniformity,%;
Rimax-the maximum value,%, of the residual water content measured in the ith test run for each test run;
Rimin-minimum value of residual water,%, measured for the ith test point of each test point;
n is the number of the bone implant materials taken near each group of test points;
s3: residual water fluctuation calculation
After collecting the residual water quantity data of each group of test points of the freeze-drying batches for multiple times, determining the fluctuation degree of the residual water quantity of the bone implant material processed in the freeze-drying machine according to a formula 2;
equation 2:
ΔRf＝±(Rmax-Rmin)/2
in equation 2: deltaRf-degree of fluctuation of residual water,%;
Rmax-maximum residual water content,%;
Rmin-minimum residual water content,%;
s4: calculation of average residual water amount
Taking 3 groups of bone implant materials in the same freeze-drying batch to detect the residual water quantity, and calculating the average residual water quantity
Replacing the residual water content of all bone implant materials in the freeze-dried batch with the average residual water content
And Δ R obtained in step S3fAnd adding the residual water amount to determine the fluctuation range of the residual water amount of each bone implant material in the freeze-drying batch.
The freeze dryer is used for removing the moisture in the bone implant material, but remains partial residual moisture, the inner space of the freeze dryer bin is arranged into a cuboid, the loading trays placed in the freeze dryer bin are sequentially arranged from top to bottom, and the loading trays are integrally of a rectangular structure.
When the bone implant materials are taken near each group of test points and the residual water content is detected in the step S2, 3 groups of bone implant materials are taken near each group of test points, so that n is 3 in formula 1, and the formula 1 obtains the variant 1;
variation 1:
the residual water content uniformity Δ R obtained in step S2uWhether the residual water content in each bone implant material processed by the freeze dryer is uniform or not will be described, when Δ R isuThe smaller the value, the smaller the difference in the amount of residual water in each bone implant material.
The average residual water amount obtained in the step S4
The specific calculation method is obtained according to formula 3,
equation 3:
in equation 3: ri- -residual water content of the taken group i bone implant material,%.
The fluctuation range of the residual water content of the bone implant material in the same freeze-dried batch in the step S4 is represented as:
namely, the residual water amount of the bone implant material in the same freeze-dried batch fluctuates within the fluctuation range.
The invention has the beneficial effects that: measuring the residual water content uniformity of the bone implant materials according to the formula 1, wherein the residual water content uniformity can represent the difference of the residual water content of each bone implant material, and when the difference is delta RuThe smaller the value is, the smaller the difference of the residual water amount in each bone implant material is; the fluctuation degree of the residual water content of the bone implant material is measured according to a formula 2, sampling can be carried out according to freeze-drying batches, the average value of the residual water content is calculated by using a plurality of groups of residual water content data detected in the same freeze-drying batch, the residual water content average value replaces the residual water content values of all product batches, the sum of the residual water content average value and the fluctuation degree of the residual water content can be used for estimating the range values of the upper limit residual water content and the lower limit residual water content, the method greatly shortens the time of sampling and detecting the residual water content of different batches of products in the same freeze-dryer bin, the residual water content detection is used as a process detection item of the product quality, and the shortening of the time plays a key role in saving the product preparation process and.
Drawings
Fig. 1 is a schematic diagram of the distribution of test points on a carrier tray in a freeze dryer bin according to the present invention.
In the figure, points A, B, C, D, E, F, G, H, O, P represent respective sets of test points.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1
Referring to fig. 1, a method for measuring the residual water uniformity of an allograft implant material comprises the following steps:
s1: determining test points
Taking 4 groups of test points at the positions, close to four corners, of a carrying tray positioned on the upper layer in a freeze dryer bin, taking 4 groups of test points at the positions, close to four corners, of a carrying tray positioned on the lower layer, taking 1 group of test points at the center of the carrying tray positioned on the middle and lower layers, taking 1 group of test points at the center of the carrying tray positioned on the middle and upper layers, and taking 10 groups of test points in total;
s2: residual water volume uniformity calculation
After the bone implant materials are processed by the freeze dryer, taking the bone implant materials near the 10 groups of test points determined in the step S1, detecting the residual water content of the bone implant materials, taking a plurality of groups of bone implant materials near each group of test points, detecting the residual water content, and determining the residual water content uniformity of the bone implant materials according to the formula 1;
equation 1:
in equation 1: Δ Ru-residual water content uniformity,%;
Rimax-the maximum value,%, of the residual water content measured in the ith test run for each test run;
Rimin-minimum value of residual water,%, measured for the ith test point of each test point;
n is the number of the bone implant materials taken near each group of test points;
s3: residual water fluctuation calculation
After collecting the residual water quantity data of each group of test points of the freeze-drying batches for multiple times, determining the fluctuation degree of the residual water quantity of the bone implant material processed in the freeze-drying machine according to a formula 2;
equation 2:
ΔRf＝±(Rmax-Rmin)/2
in equation 2: Δ Rf-degree of fluctuation of residual water,%;
Rmax-maximum residual water content,%;
Rmin-minimum residual water content,%;
s4: calculation of average residual water amount
Taking 3 groups of bone implant materials in the same freeze-drying batch to detect the residual water quantity, and calculating the average residual water quantity
Replacing the residual water content of all bone implant materials in the freeze-dried batch with the average residual water content
And Δ R obtained in step S3fAnd adding the residual water amount to determine the fluctuation range of the residual water amount of each bone implant material in the freeze-drying batch.
Example 2
To further explain and supplement embodiment 1, the freeze dryer is used for removing the water in the bone implant material, but retaining part of the residual water, the inner space of the freeze dryer bin is arranged to be a cuboid, and the carrying trays arranged in the freeze dryer bin are arranged in sequence from top to bottom, and the carrying trays are integrally rectangular.
When the bone implant materials are taken near each group of test points and the residual water content is detected in the step 2, 3 groups of bone implant materials are taken near each group of test points, n is 3 in the formula 1, and the formula 1 obtains the variant 1;
variation 1:
the residual water content uniformity Δ R obtained in step S2uWhether the residual water content in each bone implant material processed by the freeze dryer is uniform or not will be described, when Δ R isuThe smaller the value, the smaller the difference in the amount of residual water in each bone implant material.
Average residual Water amount obtained in step S4
The specific calculation method is obtained according to formula 3,
equation 3:
in equation 3: ri- -residual water content of the taken group i bone implant material,%.
The fluctuation range of the residual water content of the bone implant material in the same lyophilized batch in step S4 is represented as:
namely, the residual water amount of the bone implant material in the same freeze-dried batch fluctuates within the fluctuation range.
Example 3
Measuring the residual water content uniformity of the bone implant materials according to the formula 1, wherein the residual water content uniformity can represent the difference of the residual water content of each bone implant material, and when the difference is delta RuThe smaller the value is, the smaller the difference of the residual water amount in each bone implant material is; the fluctuation degree of the residual water content of the bone implant material is determined according to the formula 2, sampling can be carried out according to freeze-drying batches, the average value of the residual water content is calculated by using a plurality of groups of residual water content data detected in the same freeze-drying batch, and the average value of the residual water content replaces the residual water content of all product batchesThe water content value, the average value of the residual water content and the fluctuation degree of the residual water content are added to be used for estimating the range value of the upper limit residual water content and the lower limit residual water content, the method greatly shortens the time of sampling and detecting the residual water content of different batches of products in the same freeze dryer bin, the residual water content detection is used as a process detection item of product quality, and the shortening of the time plays a key role in saving the product preparation process and the product production cost.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.
Furthermore, it should be understood that although the present description refers to embodiments, not every embodiment may contain only a single embodiment, and such description is for clarity only, and those skilled in the art should integrate the description, and the embodiments may be combined as appropriate to form other embodiments understood by those skilled in the art.
Claims (6)
1. A method for measuring the uniformity of residual water content of an allogenic bone implant material is characterized by comprising the following steps of:
s1: determining test points
Taking 4 groups of test points at the positions, close to four corners, of a carrying tray positioned on the upper layer in a freeze dryer bin, taking 4 groups of test points at the positions, close to four corners, of a carrying tray positioned on the lower layer, taking 1 group of test points at the center of the carrying tray positioned on the middle and lower layers, taking 1 group of test points at the center of the carrying tray positioned on the middle and upper layers, and taking 10 groups of test points in total;
s2: residual water volume uniformity calculation
After the bone implant materials are processed by the freeze dryer, taking the bone implant materials near the 10 groups of test points determined in the step S1, detecting the residual water content of the bone implant materials, taking a plurality of groups of bone implant materials near each group of test points, detecting the residual water content, and determining the residual water content uniformity of the bone implant materials according to the formula 1;
equation 1:
in equation 1: Δ Ru-residual water content uniformity,%;
Rimax-the maximum value,%, of the residual water content measured in the ith test run for each test run;
Rimin-minimum value of residual water,%, measured for the ith test point of each test point;
n is the number of the bone implant materials taken near each group of test points;
s3: residual water fluctuation calculation
After collecting the residual water quantity data of each group of test points of the freeze-drying batches for multiple times, determining the fluctuation degree of the residual water quantity of the bone implant material processed in the freeze-drying machine according to a formula 2;
equation 2:
ΔRf＝±(Rmax-Rmin)/2
in equation 2: Δ Rf-degree of fluctuation of residual water,%;
Rmax-maximum residual water content,%;
Rmin-minimum residual water content,%;
s4: calculation of average residual water amount
Taking 3 groups of bone implant materials in the same freeze-drying batch to detect the residual water quantity, and calculating the average residual water quantity
Replacing the residual water content of all bone implant materials in the freeze-dried batch with the average residual water content
And Δ R obtained in step S3fAnd adding the residual water amount to determine the fluctuation range of the residual water amount of each bone implant material in the freeze-drying batch.
2. The method for measuring the uniformity of the residual water content of the allograft implant material as claimed in claim 1, wherein: the freeze dryer is used for removing the moisture in the bone implant material, but remains partial residual moisture, the inner space of the freeze dryer bin is arranged into a cuboid, the loading trays placed in the freeze dryer bin are sequentially arranged from top to bottom, and the loading trays are integrally of a rectangular structure.
3. The method for measuring the uniformity of the residual water content of the allograft implant material as claimed in claim 1, wherein: when the bone implant materials are taken near each group of test points and the residual water content is detected in the step S2, 3 groups of bone implant materials are taken near each group of test points, so that n is 3 in formula 1, and the formula 1 obtains the variant 1;
variation 1:
4. the method for measuring the uniformity of the residual water content of the allograft implant material as claimed in claim 1, wherein: the residual water content uniformity Δ R obtained in step S2uWhether the residual water content in each bone implant material processed by the freeze dryer is uniform or not will be described, when Δ R isuThe smaller the value, the smaller the difference in the amount of residual water in each bone implant material.
5. The method for measuring the uniformity of the residual water content of the allograft implant material as claimed in claim 1, wherein: the average residual water amount obtained in the step S4
The specific calculation method is obtained according to formula 3,
equation 3:
in equation 3: ri- -residual water content of the taken group i bone implant material,%.
6. The method for measuring the residual water quantity and average degree of the allograft bone implant material according to claim 5, wherein the method comprises the following steps: the fluctuation range of the residual water content of the bone implant material in the same freeze-dried batch in the step S4 is represented as:
namely, the residual water amount of the bone implant material in the same freeze-dried batch fluctuates within the fluctuation range.
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