CN113109212A - Method for establishing water migration control standard of gelatin hollow capsule - Google Patents
Method for establishing water migration control standard of gelatin hollow capsule Download PDFInfo
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- CN113109212A CN113109212A CN202110308526.6A CN202110308526A CN113109212A CN 113109212 A CN113109212 A CN 113109212A CN 202110308526 A CN202110308526 A CN 202110308526A CN 113109212 A CN113109212 A CN 113109212A
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- 239000002775 capsule Substances 0.000 title claims abstract description 137
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 title claims abstract description 127
- 108010010803 Gelatin Proteins 0.000 title claims abstract description 86
- 229920000159 gelatin Polymers 0.000 title claims abstract description 86
- 239000008273 gelatin Substances 0.000 title claims abstract description 86
- 235000019322 gelatine Nutrition 0.000 title claims abstract description 86
- 235000011852 gelatine desserts Nutrition 0.000 title claims abstract description 86
- 238000013508 migration Methods 0.000 title claims abstract description 75
- 230000005012 migration Effects 0.000 title claims abstract description 75
- 238000000034 method Methods 0.000 title claims abstract description 21
- 238000001035 drying Methods 0.000 claims abstract description 22
- 238000012360 testing method Methods 0.000 claims abstract description 17
- 238000001514 detection method Methods 0.000 claims abstract description 14
- 238000005485 electric heating Methods 0.000 claims abstract description 14
- 238000007689 inspection Methods 0.000 claims abstract description 6
- 239000011521 glass Substances 0.000 claims description 19
- 239000000843 powder Substances 0.000 claims description 12
- 239000008187 granular material Substances 0.000 claims description 11
- 238000012544 monitoring process Methods 0.000 claims description 7
- 239000002023 wood Substances 0.000 claims description 6
- 238000001816 cooling Methods 0.000 claims description 3
- -1 polytetrafluoroethylene Polymers 0.000 claims description 3
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 3
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 3
- 230000002194 synthesizing effect Effects 0.000 claims description 3
- 238000012546 transfer Methods 0.000 claims description 3
- YIXJRHPUWRPCBB-UHFFFAOYSA-N magnesium nitrate Chemical class [Mg+2].[O-][N+]([O-])=O.[O-][N+]([O-])=O YIXJRHPUWRPCBB-UHFFFAOYSA-N 0.000 description 3
- 230000007547 defect Effects 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 229940126680 traditional chinese medicines Drugs 0.000 description 2
- 229940126673 western medicines Drugs 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N13/00—Investigating surface or boundary effects, e.g. wetting power; Investigating diffusion effects; Analysing materials by determining surface, boundary, or diffusion effects
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/44—Sample treatment involving radiation, e.g. heat
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N3/00—Investigating strength properties of solid materials by application of mechanical stress
- G01N3/30—Investigating strength properties of solid materials by application of mechanical stress by applying a single impulsive force, e.g. by falling weight
- G01N3/303—Investigating strength properties of solid materials by application of mechanical stress by applying a single impulsive force, e.g. by falling weight generated only by free-falling weight
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N13/00—Investigating surface or boundary effects, e.g. wetting power; Investigating diffusion effects; Analysing materials by determining surface, boundary, or diffusion effects
- G01N2013/003—Diffusion; diffusivity between liquids
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2203/00—Investigating strength properties of solid materials by application of mechanical stress
- G01N2203/0001—Type of application of the stress
- G01N2203/001—Impulsive
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2203/00—Investigating strength properties of solid materials by application of mechanical stress
- G01N2203/003—Generation of the force
- G01N2203/0032—Generation of the force using mechanical means
- G01N2203/0033—Weight
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- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to the technical field of hollow capsule detection, provides a method for formulating a water migration control standard of a gelatin hollow capsule, finds a scientific friability detection method, accurately masters the friability condition of the current capsule on the basis, and formulates a friability control standard meeting requirements by combining the type of the capsule and the requirements of a user, thereby providing a capsule product meeting friability requirements for customers, and comprises the following steps: s1, performing capsule moisture migration test on the gelatin hollow capsules of different types; s2, preliminarily determining the control standards of the water content of the gelatin hollow capsules of various models before and after water migration; s3, preparing the gelatin hollow capsule after water migration by constant-temperature electric heating drying according to the control standard; and S4, performing friability inspection on the gelatin hollow capsules after water migration according to a method specified by pharmacopoeia, and determining the final water migration control standard of each type of gelatin hollow capsules.
Description
Technical Field
The invention relates to the technical field of hollow capsule detection, in particular to a method for establishing a water migration control standard of a gelatin hollow capsule.
Background
The gelatin hollow capsule and the enteric gelatin hollow capsule are used for capsules in pharmaceutical enterprises, the capsule filling materials comprise traditional Chinese medicines and western medicines, most of the traditional Chinese medicines and part of the western medicines have strong hygroscopicity, and the capsule occupies a small weight proportion in the whole capsule, so that the medicinal powder can migrate a lot of water in the capsule in the storage process very easily, and the capsule is brittle due to the reduction of the water content.
The capsule friability is an important index of capsule quality, the inspection of the friability of the enteric gelatin hollow capsules is increased in the 2020 edition pharmacopeia executed from 12 months to 30 days in 2020, and the detection method of the capsule friability in the pharmacopeia is as follows: soft saturated magnesium nitrate solution with relative humidity of about 55% is adopted, the capsule is subjected to water migration by placing for 24 hours at the constant temperature of 25 +/-1 ℃, and then the friability is checked, wherein the standard requirement is that the friability in 50 granules is not more than 5 granules; however, since the saturated magnesium nitrate solution has small water migration capacity, verification data show that only about 2% of water can be absorbed in 24 hours, so that the water content of the capsule is still about 13%, which is different from that of the capsule filled with the saturated magnesium nitrate solution by about 5% due to strong moisture absorption and low water content of the medicinal powder, so that the water content of the capsule after water loss is 8.5-9.5%, and the detection result is inaccurate. Therefore, a method for establishing a water migration control standard of the gelatin hollow capsule is provided.
Disclosure of Invention
Technical problem to be solved
Aiming at the defects of the prior art, the invention provides a method for establishing a water migration control standard of a gelatin hollow capsule, which overcomes the defects of the prior detection technology, finds a scientific friability detection method, accurately masters the friability condition of the prior capsule on the basis, improves the friability resistance of the capsule by measures such as formula adjustment or production process optimization and the like, and establishes a friability control standard meeting requirements by combining the type of the capsule and the requirements of users, thereby providing a capsule product meeting the friability requirements of the client.
(II) technical scheme
In order to achieve the purpose, the invention is realized by the following technical scheme:
a method for establishing a water migration control standard of a gelatin hollow capsule comprises the following steps:
s1, performing a capsule water migration test on each type of gelatin hollow capsule to obtain the water content of each type of gelatin hollow capsule after water migration;
s2, synthesizing the water content of the gelatin hollow capsules before water migration, and preliminarily determining the control standards of the water content of the gelatin hollow capsules of various models before water migration and after water migration;
s3, preparing the gelatin hollow capsule after water migration by constant-temperature electric heating drying according to the control standard;
and S4, performing friability inspection on the gelatin hollow capsules after water migration according to a method specified by pharmacopoeia, and determining the final water migration control standard of each type of gelatin hollow capsules.
Preferably, in step S1, the moisture migration test includes the following steps:
s1-a, producing gelatin hollow capsules of various types, respectively filling medicinal powder with the water content of 5-7%, and monitoring the water content of the hollow capsules and the medicinal powder for 1-2 years;
s1-b, obtaining the water content stability time limit of the water migration of the gelatin hollow capsule by integrating the water content monitoring data;
and S1-c, recording the water content and the water migration amount of the gelatin hollow capsule corresponding to the stability time limit for later use.
Preferably, in step S3, the constant-temperature electro-thermal drying includes the following steps:
s3-a, selecting a constant-temperature electric heating drying box with the temperature precision of +/-1 ℃, setting the drying temperature to be 50-55 ℃, and the drying time to be 0.5-3 hours;
s3-b, selecting 500-600 gelatin hollow capsules, placing the gelatin hollow capsules into a constant-temperature electric heating drying oven, and transferring the water of the gelatin hollow capsules to a water content control standard after water transfer;
s3-c, taking out the gelatin hollow capsule after water migration, and naturally cooling to room temperature to finish constant temperature electric heating drying.
Preferably, the brittle fracture checking in step S4 includes the following steps:
s4-a, taking 500 gelatin empty capsules after water migration, taking 50 gelatin empty capsules as a small group, and dividing the capsules into ten groups, namely A1, A2, A3, A4, A5, A6, A7, A8, A9 and A10;
s4-b, taking a small group A1 of the gelatin hollow capsules after water migration, placing the group A1 in a watch glass, putting the watch glass into a dryer, keeping the temperature at 25 +/-1 ℃ for 24 hours, and taking out the watch glass;
s4-c, putting the gelatin hollow capsules A1 into a glass tube standing on a wood board one by one, and freely dropping cylindrical weights from the mouth of the glass tube according to whether the capsules are broken or not and recording;
s4-d, repeating the steps 4-b and 4-c on the remaining nine groups of empty capsules to obtain comprehensive data for statistics, and comparing the friability standard, namely that 50 granules are not more than 5 granules for each detection, and simultaneously continuously detecting the same sample for 10 times, wherein the RSD of 50 granules which are not crushed for 10 times is not more than 10%.
Preferably, in step S4-c, the cylindrical weight is made of polytetrafluoroethylene, has a diameter of 22mm, and weighs 20 ± 0.1 g.
Preferably, in the step S4-c, the wood plate has a thickness of 2cm, the glass tube has an inner diameter of 24mm and a length of 200 mm.
(III) advantageous effects
The embodiment of the invention provides a method for establishing a water migration control standard of a gelatin hollow capsule, which has the following beneficial effects:
the embodiment of the invention provides a scientific friability detection method, accurately masters the friability condition of the current capsule on the basis, improves the friability resistance of the capsule by adjusting a formula or optimizing a production process and other measures, and formulates a friability control standard meeting the requirements by combining the type of the capsule and the requirements of a user, thereby providing a capsule product meeting the friability requirements of the client.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be understood that the embodiments described herein are merely illustrative of the present invention and are not intended to limit the present invention.
Example 1
A method for establishing a water migration control standard of a gelatin hollow capsule comprises the following steps:
s1, performing a capsule water migration test on each type of gelatin hollow capsule to obtain the water content of each type of gelatin hollow capsule after water migration;
the moisture migration test comprises the following steps:
s1-a, producing gelatin hollow capsules of various types, respectively filling medicinal powder with the water content of 5-7%, and monitoring the water content of the hollow capsules and the medicinal powder for 1-2 years;
s1-b, obtaining the water content stability time limit of the water migration of the gelatin hollow capsule by integrating the water content monitoring data;
and S1-c, recording the water content and the water migration amount of the gelatin hollow capsule corresponding to the stability time limit for later use.
S2, synthesizing the water content of the gelatin hollow capsules before water migration, and preliminarily determining the control standards of the water content of the gelatin hollow capsules of various models before water migration and after water migration;
taking fresh herba Leonuri powder as an example, after filling fresh herba Leonuri powder in gelatin hollow capsule, monitoring water content for 1-2 years, and the obtained data are shown in Table 1
TABLE 1
As can be seen from Table 1, the water content of the gelatin hollow capsule is stable after the water of the medicinal powder migrates for more than 1 year, and the above experimental data show that the water content of the gelatin hollow capsule is about 8.7 percent on average, 9.21 percent at the highest and 8.28 percent at the lowest;
the water mobility of the gelatin hollow capsule is 0.07-0.3;
therefore, on the premise that the moisture content of the medicinal powder is 2-6%, the water content of the capsule is transferred, and the standard definition of the water content of the capsule is 8.5-9.5%, which meets the water content test requirement of the friability detection capsule.
S3, preparing the gelatin hollow capsule after water migration by constant-temperature electric heating drying according to the control standard;
the constant-temperature electric heating drying comprises the following steps:
s3-a, selecting a constant-temperature electric heating drying box with the temperature precision of +/-1 ℃, setting the drying temperature to be 50-55 ℃, and the drying time to be 0.5-3 hours;
s3-b, selecting 500-600 gelatin hollow capsules, placing the gelatin hollow capsules into a constant-temperature electric heating drying oven, and transferring the water of the gelatin hollow capsules to a water content control standard after water transfer;
s3-c, taking out the gelatin hollow capsule after water migration, and naturally cooling to room temperature to finish constant temperature electric heating drying.
The water migration test is respectively carried out on gelatin hollow capsules of five types, namely 0#, 1#, 2#, 3#, and 4# by the same instrument under the same parameters, and the water content test results of the capsules after the water migration are shown in tables 2, 3, 4, 5, and 6, wherein the tables 2-0#, 3-1#, 4-2#, 5-3#, and 6-4 #.
TABLE 2-0#
TABLE 3-1#
TABLE 4-2#
TABLE 5-3#
TABLE 6-4#
As shown in tables 2-6, the RSD of each batch of 6 test values and the RSD of two batches of 12 test values are both less than 5%, and the maximum RSD is only 3.31%, so that the requirement that the water content test value RSD of 6-part capsules of each person is less than or equal to 10% and the water content test value RSD of 12-part capsules of two persons is less than or equal to 15% is completely met, and therefore, the method for capsule water migration can ensure the accuracy of the test values.
S4, performing friability inspection on the gelatin hollow capsules after water migration according to a method specified by pharmacopoeia, and determining the final water migration control standard of each type of gelatin hollow capsules;
the brittle fracture inspection comprises the following steps:
s4-a, taking 500 gelatin empty capsules after water migration, taking 50 gelatin empty capsules as a small group, and dividing the gelatin empty capsules into ten groups, namely A1, A2, A3, A4, A5, A6, A7, A8, A9 and A10;
s4-b, taking a small group A1 of the gelatin hollow capsules after water migration, placing the group A1 in a watch glass, putting the watch glass into a dryer, keeping the temperature at 25 +/-1 ℃ for 24 hours, and taking out the watch glass;
s4-c, putting the gelatin hollow capsules A1 into a glass tube standing on a wood board one by one, and freely dropping cylindrical weights from the mouth of the glass tube according to whether the capsules are broken or not and recording;
the cylindrical weight is made of polytetrafluoroethylene, the diameter of the cylindrical weight is 22mm, the weight of the cylindrical weight is 20 +/-0.1 g, the thickness of a wood plate is 2cm, the inner diameter of a glass tube is 24mm, and the length of the glass tube is 200 mm;
s4-d, repeating the steps 4-b and 4-c on the remaining nine groups of empty capsules to obtain comprehensive data for statistics, and comparing the friability standard, namely that 50 granules are not more than 5 granules for each detection, and simultaneously continuously detecting the same sample for 10 times, wherein the RSD of 50 granules which are not crushed for 10 times is not more than 10%.
Through friability tests on four types of gelatin hollow capsules of 0#, 1#, 2#, and 3#, the water content of each type of gelatin hollow capsule in each batch is controlled to be 8.5-9.5%, and friability is tested for 10 times in parallel, wherein the test results are shown in tables 7, 8, 9, and 10:
TABLE 7
TABLE 8
TABLE 9
Watch 10
The water content of the capsules in the same batch of the four types of 0#, 1#, 2# and 3# can be 8.5-9.5% after 10 times of water migration, and the water content RSD is less than 10%, the maximum deviation of 50 friability grains is 4 grains after 10 times of detection, and the RSD of 50 uncrushed grains is less than 10%, so that the water migration of the capsules is effectively controlled, and the repeatability of the friability detection result meets the requirement on the premise of ensuring the consistent water content of the capsules;
the water migration of the obtained gelatin hollow capsules of various types is controlled to be between 8.5 and 9.5 percent.
The embodiments of the present invention are disclosed as the preferred embodiments, but not limited thereto, and those skilled in the art can easily understand the spirit of the present invention and make various extensions and changes without departing from the spirit of the present invention.
Claims (6)
1. A method for establishing a water migration control standard of a gelatin hollow capsule is characterized by comprising the following steps:
s1, performing a capsule water migration test on each type of gelatin hollow capsule to obtain the water content of each type of gelatin hollow capsule after water migration;
s2, synthesizing the water content of the gelatin hollow capsules before water migration, and preliminarily determining the control standards of the water content of the gelatin hollow capsules of various models before water migration and after water migration;
s3, preparing the gelatin hollow capsule after water migration by constant-temperature electric heating drying according to the control standard;
and S4, performing friability inspection on the gelatin hollow capsules after water migration according to a method specified by pharmacopoeia, and determining the final water migration control standard of each type of gelatin hollow capsules.
2. The method for establishing the water migration control standard of the gelatin hollow capsule as claimed in claim 1, wherein the water migration control standard comprises the following steps: in step S1, the moisture migration test includes the following steps:
s1-a, producing gelatin hollow capsules of various types, respectively filling medicinal powder with the water content of 5-7%, and monitoring the water content of the hollow capsules and the medicinal powder for 1-2 years;
s1-b, obtaining the water content stability time limit of the water migration of the gelatin hollow capsule by integrating the water content monitoring data;
and S1-c, recording the water content and the water migration amount of the gelatin hollow capsule corresponding to the stability time limit for later use.
3. The method for establishing the water migration control standard of the gelatin hollow capsule as claimed in claim 1, wherein the water migration control standard comprises the following steps: in the step S3, the constant-temperature electro-thermal drying includes the following steps:
s3-a, selecting a constant-temperature electric heating drying box with the temperature precision of +/-1 ℃, setting the drying temperature to be 50-55 ℃, and the drying time to be 0.5-3 hours;
s3-b, selecting 500-600 gelatin hollow capsules, placing the gelatin hollow capsules into a constant-temperature electric heating drying oven, and transferring the water of the gelatin hollow capsules to a water content control standard after water transfer;
s3-c, taking out the gelatin hollow capsule after water migration, and naturally cooling to room temperature to finish constant temperature electric heating drying.
4. The method for establishing the water migration control standard of the gelatin hollow capsule as claimed in claim 1, wherein the water migration control standard comprises the following steps: the crispness check in step S4 includes the following steps:
s4-a, taking 500 gelatin empty capsules after water migration, taking 50 gelatin empty capsules as a small group, and dividing the capsules into ten groups, namely A1, A2, A3, A4, A5, A6, A7, A8, A9 and A10;
s4-b, taking a small group A1 of the gelatin hollow capsules after water migration, placing the group A1 in a watch glass, putting the watch glass into a dryer, keeping the temperature at 25 +/-1 ℃ for 24 hours, and taking out the watch glass;
s4-c, putting the gelatin hollow capsules A1 into a glass tube standing on a wood board one by one, and freely dropping cylindrical weights from the mouth of the glass tube according to whether the capsules are broken or not and recording;
s4-d, repeating the steps 4-b and 4-c on the remaining nine groups of empty capsules to obtain comprehensive data for statistics, and comparing the friability standard, namely that 50 granules are not more than 5 granules for each detection, and simultaneously continuously detecting the same sample for 10 times, wherein the RSD of 50 granules which are not crushed for 10 times is not more than 10%.
5. The method for establishing the water migration control standard of the gelatin hollow capsule as claimed in claim 4, wherein the water migration control standard comprises the following steps: in the step S4-c, the cylindrical weight is made of polytetrafluoroethylene, the diameter of the cylindrical weight is 22mm, and the weight of the cylindrical weight is 20 +/-0.1 g.
6. The method for establishing the water migration control standard of the gelatin hollow capsule as claimed in claim 4, wherein the water migration control standard comprises the following steps: in the step S4-c, the wood plate is 2cm thick, and the glass tube has an inner diameter of 24mm and a length of 200 mm.
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