CN112516092A - Freeze-dried preparation manufacturing process with co-existing redissolution and freeze-dried spheres and freeze-dried preparation - Google Patents
Freeze-dried preparation manufacturing process with co-existing redissolution and freeze-dried spheres and freeze-dried preparation Download PDFInfo
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- CN112516092A CN112516092A CN202011472241.8A CN202011472241A CN112516092A CN 112516092 A CN112516092 A CN 112516092A CN 202011472241 A CN202011472241 A CN 202011472241A CN 112516092 A CN112516092 A CN 112516092A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
Abstract
The invention relates to the field of freeze-dried preparations in the field of biological medicines, in particular to a freeze-dried preparation manufacturing process and a freeze-dried preparation with coexisting redissolution and freeze-dried spheres. Paraffin is used for forming a partition in the container, so that the container is divided into a freeze-drying preparation cavity and a re-solution cavity, the freeze-drying preparation cavity is used for storing a freeze-drying preparation, the re-solution cavity is used for storing a re-solution, and the freeze-drying preparation cavity and the re-solution cavity are mutually isolated. By adopting the process, the deliquescence of freeze-dried finished products such as freeze-dried preparation balls and the like can be effectively prevented, and the beneficial effects of convenience in transportation, redissolution and storage can be achieved.
Description
Technical Field
The invention relates to the field of freeze-dried preparations in the field of biological medicines, in particular to a freeze-dried preparation manufacturing process and a freeze-dried preparation with coexisting redissolution and freeze-dried spheres.
Background
The biological activity of the biological preparation stored at normal temperature can be greatly reduced, so that the cold chain transportation and storage adopted in the prior art is a common mode, but the cost of the biological medicinal preparation is greatly increased by the mode. The freeze-dried biological preparation can be stored for a long time at normal temperature and still keeps good biological activity after being redissolved. However, the freeze-dried finished product of the biological preparation still has the defect that the freeze-dried preparation or the freeze-dried micro-core and the freeze-dried ball are easy to deliquesce, so that the freeze-dried preparation or the freeze-dried micro-core and the freeze-dried ball are preserved by adopting a sealing material in the prior art. However, the use of sealing materials such as bottles, plastic packages, etc. is very inconvenient, and therefore, it is an urgent requirement to design a lyophilized preparation which can effectively prevent the lyophilized preparation from deliquescing, is convenient to use, and can be transported as a reconstituted solution and a lyophilized pellet.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: the preparation process of the freeze-dried preparation and the freeze-dried preparation are provided, wherein the freeze-dried preparation is capable of effectively preventing the freeze-dried preparation from deliquescence, and is convenient to use, transport and redissolve, and the freeze-dried preparation coexists with the redissolution and the freeze-dried balls.
The technical scheme of the technical problem to be solved by the invention is as follows: a manufacturing process of a freeze-dried preparation with a re-solution and freeze-dried spheres coexisting comprises the following steps:
step A, placing the freeze-dried preparation ball coated with paraffin into a container;
step B, adding a complex solution into the container;
step C, sealing the container added with the compound solution and the freeze-drying preparation ball coated with the paraffin on the surface,
wherein the step A and the step B are not in sequence.
A manufacturing process of a freeze-dried preparation with a re-solution and freeze-dried spheres coexisting comprises the following steps:
step A, placing a freeze-dried preparation ball into a container;
step B, dripping the paraffin solution into the container in which the freeze-dried preparation balls are placed;
step C, embedding the freeze-dried preparation balls in paraffin after the paraffin solution is solidified, and then adding the compound solution;
and D, sealing the container added with the compound solution and the freeze-dried preparation ball.
A manufacturing process of a freeze-dried preparation with a re-solution and freeze-dried spheres coexisting comprises the following steps:
step A, adding a complex solution into a container and then dripping a paraffin solution into the container;
step B, forming a water-resisting layer on the compound solution after the paraffin is solidified, and then putting the freeze-dried preparation balls;
and step C, sealing the container added with the compound solution and the freeze-dried preparation ball.
A manufacturing process of a freeze-dried preparation with a re-solution and freeze-dried spheres coexisting comprises the following steps:
step A, adding a reagent solution into a container;
step B, putting the container added with the reagent solution into freeze-drying equipment to freeze-dry the reagent solution;
c, dropping the paraffin solution on the upper part of the freeze-dried preparation in the freeze-dried container, and solidifying the paraffin to generate a water-resisting layer to prevent the freeze-dried preparation on the lower part from deliquescing;
d, adding the compound solution, and forming a water-resisting layer on the solidified paraffin wax compound solution;
and E, sealing the container added with the compound solution and the freeze-dried preparation ball.
Preferably, the paraffin wax is dissolved using xylene.
Preferably, after the paraffin solution is dropped into the vessel, the vessel is allowed to stand until the paraffin is solidified and the xylene is completely volatilized.
Preferably, the step A:
after the reconstituted solution is added into a container, the container is placed in a low-temperature environment to enable the temperature of the reconstituted solution to be below 20 ℃, and then the paraffin solution is dripped.
A freeze-dried preparation with the coexistence of a re-solution and freeze-dried spheres:
the method comprises the following steps:
sealing the container;
the water-resisting layer is generated by paraffin solidification, and divides the sealed container into a reagent cavity and a re-solution cavity;
a lyophilized formulation stored in a reagent cavity of the sealed container;
and the compound solution is stored in a compound solution cavity of the sealed container.
A method for reconstituting a lyophilized preparation in which a reconstitution solution and a lyophilized pellet coexist, comprising the steps of:
and heating the sealed container to melt the water-resisting layer formed by the paraffin.
Preferably, the sealed container is heated by a water bath method to melt the water-resisting layer formed by the paraffin. .
The invention has the beneficial effects that:
the process can effectively prevent the deliquescence of freeze-dried finished products such as freeze-dried preparation balls and the like, and can achieve the beneficial effects of convenient transportation, convenient redissolution and convenient storage.
Drawings
FIG. 1 is a schematic diagram of a process for coating paraffin with a lyophilized formulation according to the present invention;
FIG. 2 is a schematic diagram of a process for coating paraffin with a lyophilized formulation according to the present invention;
fig. 3 is a schematic view of a lyophilized formulation of the present invention solidified in a container;
fig. 4 is a schematic view of a lyophilized formulation of the present invention solidified in a container;
FIG. 5 is a schematic diagram of one embodiment of the present invention;
FIG. 6 is a schematic representation of the paraffin wax of the present invention sealing a reconstituted solution;
FIG. 7 is a schematic representation of the lyophilization of a reagent solution of the present invention directly in a container to produce a lyophilizate.
In the figure:
12. (ii) a 1. Freeze-drying the preparation balls; 2. paraffin wax; 3. compounding the solution; 4. a container; 5. a temperature-controlled pipetting head; 6. a perforated plate; 8. a motor; 7. rotating the container; 9. an external heating device of the container; 10. an in-container heating device; 12. and (4) freeze-drying the preparation.
Detailed Description
In order to make the technical solution and the advantages of the present invention clearer, the following explains embodiments of the present invention in further detail.
The freeze-dried preparation ball is protected in a manner that the surface of the freeze-dried preparation ball is coated with the paraffin because the paraffin has certain hydrophobicity and certain sealing property.
The invention relates to a technology for coating paraffin on a freeze-dried preparation ball, and discloses two technical schemes for realizing the coating of the paraffin on the freeze-dried preparation ball, and the related technology can be introduced in the subsequent process.
The technical scheme for preparing the freeze-dried preparation ball coated with paraffin comprises the following steps:
the method comprises the following steps:
step A, adding the freeze-dried preparation balls and paraffin particles into an inclined rotating container.
The freeze-dried preparation balls and paraffin particles are put into an arc-shaped rotary container 7, as shown in fig. 1, and a thermal coating tool is applied, which comprises the rotary container 7, a motor 8 for driving the rotary container 7 to rotate, a heating device 10 in the container and a heating device 9 outside the container. The rotating shaft of the motor 8 is obliquely arranged, the rotating container 7 is also obliquely arranged, and the axial lead of the rotating container 7 is superposed with the axial lead of the rotating shaft of the motor 8 and fixedly connected with the rotating container. At this time, one side of the container body of the container 7 is rotated to place the paraffin 2 and the lyophilized preparation pellet 1. Since the lyophilized preparation pellets 1 are light in weight and easily deliquescent, the lyophilized preparation pellets 1 are easily scattered by blowing hot gas, the temperature and humidity of the blown gas are not well controlled, and foreign substances may be introduced, the heating is performed not by gas heating but by radiation heat. That is, the in-container heating apparatus 10 employs a radiant bar, and the out-container heating apparatus 9 employs a radiant panel, wherein both the radiant bar and the radiant panel employ an electric heating manner so as to control the temperature.
Further, a temperature sensor may be provided inside the body of the rotary container 7 to measure the temperature.
And step B, arranging a heat radiation rod on the upper part of a freeze-drying preparation ball and paraffin particle gathering area in the rotary container, and arranging a heat radiation plate on the lower part of the freeze-drying preparation ball and paraffin particle gathering area to heat the freeze-drying preparation ball 1 and paraffin particle 2. At this time, the heating device is started to heat the lyophilized preparation ball 1 and the paraffin 2.
And C, keeping the inclined rotating container to rotate, keeping the paraffin at a melting temperature, for example, the melting temperature of certain paraffin is 48-52 ℃, and keeping the temperature of the container within the temperature range until the freeze-dried preparation balls are uniformly embedded with the paraffin. After heating, the paraffin 2 melts, and due to the rolling action, the paraffin 2 is coated on the periphery of the lyophilized preparation pellet 1, and then the lyophilized preparation pellet coated with paraffin can be taken out.
Wherein step B may be performed first, in which case the container body is heated first, the temperature of the container body is maintained, and then paraffin and the lyophilized preparation pellets are put while maintaining paraffin at a specific temperature. The step A and the step B have no specific sequence.
Preparing a freeze-dried preparation ball coated with paraffin according to the second technical scheme:
as shown in fig. 2, the method comprises the following steps:
and step A, changing the solid paraffin 2 into liquid paraffin.
There are many ways to dissolve the paraffin wax 2 into a liquid state, and the paraffin wax 2 can be liquefied by heating, and meanwhile, the paraffin wax can be dissolved by using xylene. Wherein, in the mixed solution of the dimethylbenzene and the paraffin, the concentration of the paraffin is saturated.
In this embodiment, the liquid paraffin 2 is generated by heating the paraxylene paraffin solution. In the test procedure of this company, a solution of saturated paraffin at 30 ℃, a solution of saturated paraffin at 40 ℃ and a solution of saturated paraffin at 60 ℃ were used. Wherein the higher the temperature, the higher the paraffin saturation concentration, the better the coating effect.
And step B, placing the freeze-dried reagent ball on a multi-hole plate 6 or a hollow plate. The porous plate can be made of sponge sheets, sponge ceramics, porous ceramics and other materials with cellular gaps, or a hollow plate, wherein the hollow plate is provided with intensive suction holes, and the gap between the hole diameter and the hole is smaller than the diameter of the freeze-drying reagent ball.
And step C, dropping liquid paraffin on the upper part of the freeze-dried reagent ball on the multi-hole plate 6 by using the temperature control pipetting head 5.
The liquid paraffin 2 can be ensured to be in a liquid state by applying the temperature control pipetting head 5, so that the liquid paraffin can flow on the freeze-dried reagent ball 1 conveniently, and the redundant paraffin is adsorbed by the porous plate. In this embodiment, the porous plate 6 is a sponge.
Although xylene is toxic, it is also volatile, and thus the coated lyophilized reagent beads 1 need to be left to evaporate after being manufactured. The paraffin adsorbed on the perforated plate can be recovered and utilized by heating. The porous plates and the hollow plates such as sponge can be placed in hot water higher than 70 ℃, paraffin floats after being dissolved, and the paraffin is fished out after being cooled by water.
The invention also discloses a process for coexistence of the freeze-dried preparation and the redissolution, namely a process for manufacturing the freeze-dried preparation containing the redissolution convenient for redissolution, which applies paraffin to separate the freeze-dried preparation ball and the redissolution in a container.
Manufacturing process of the lyophilized preparation in which the reconstituted solution and the lyophilized pellet coexist includes:
as shown in fig. 5, according to the first technical scheme of coating paraffin with the freeze-dried preparation ball, the freeze-dried preparation ball 1 is coated with paraffin 2 to form a freeze-dried preparation ball coated with paraffin, the freeze-dried preparation ball 1 coated with paraffin and a re-solution 3 are added into a container, and then the container is sealed.
If the container is a penicillin bottle, a rubber plug can be used for sealing. If the tube is an eight-connected tube, a special cover for the eight-connected tube is used for sealing, and meanwhile, the sealing treatment can be carried out in a wax sealing mode.
Manufacturing process example two of the lyophilized preparation in which the reconstituted solution and the lyophilized pellet coexist:
as shown in fig. 3, the method comprises the following steps:
step A, placing the freeze-dried preparation ball into a container. In this step, the lyophilized preparation pellet is the lyophilized preparation pellet 1 which is not coated with paraffin.
As shown in fig. 4, step B, the paraffin solution is dropped into the interior of the container in which the lyophilized preparation pellet is placed.
And step C, after the paraffin solution is solidified, adding the compound solution 3, and embedding the freeze-dried preparation ball into the solidified paraffin. If xylene is used for dissolving the paraffin, the step also needs to set the standing volatilization time. After the paraffin is added, the paraffin fixes the lyophilized preparation ball inside the container and performs a function of coating the lyophilized preparation ball 1.
Furthermore, the paraffin is dissolved by using xylene, and in the step C, the container is placed in a freeze-drying device for standing, wherein the freeze-drying device is provided with an air treatment device so as to collect xylene gas, and the pollution to the environment is reduced.
And D, sealing the container added with the compound solution and the freeze-dried preparation ball.
If the container is a penicillin bottle, a rubber plug can be used for sealing. If the tube is an eight-connected tube, a special cover for the eight-connected tube is used for sealing, and meanwhile, the sealing treatment can be carried out in a wax sealing mode.
Preparation process example three of the lyophilized preparation in which the reconstituted solution and the lyophilized pellet coexist:
as shown in fig. 6, the method comprises the following steps:
step A, adding the complex solution 3 into a container, and then dripping the paraffin solution.
Preferably, the reconstituted solution is added to the vessel, and then the vessel is placed in a low temperature environment so that the temperature of the reconstituted solution becomes 20 ℃ or lower, and then the paraffin solution is dropped. At this time, the paraffin can be rapidly solidified, and the time cost is saved. In this embodiment, paraffin wax with a melting temperature greater than 30 ℃ may be selected to provide a temperature differential to allow the paraffin wax to solidify rapidly.
And step B, after paraffin is solidified, putting the freeze-dried preparation balls.
And step C, sealing the container 4 added with the compound solution and the freeze-dried preparation balls.
If the container is a penicillin bottle, a rubber plug can be used for sealing. If the tube is an eight-connected tube, a special cover for the eight-connected tube is used for sealing, and meanwhile, the sealing treatment can be carried out in a wax sealing mode.
Manufacturing process example four of the lyophilized preparation in which the reconstituted solution and the lyophilized pellet coexist:
as shown in fig. 7, the method comprises the following steps:
step A, adding a reagent solution into a container.
And step B, putting the container added with the reagent solution into a freeze-drying device to freeze-dry the reagent solution. After lyophilization is complete, a lyophilized formulation forms at the bottom of the container.
C, dripping the paraffin solution on the upper part of the freeze-dried preparation 12 in the freeze-dried container, and solidifying the paraffin to generate a water-resisting layer to prevent the freeze-dried preparation 12 on the lower part from deliquescing;
and D, adding the compound solution. The container may then be sealed.
If the container is a penicillin bottle, a rubber plug can be used for sealing. If the tube is an eight-connected tube, a special cover for the eight-connected tube is used for sealing, and meanwhile, the sealing treatment can be carried out in a wax sealing mode.
Based on the disclosed technical scheme, the invention also discloses a freeze-dried preparation which can be prepared by the process and is convenient to store.
A lyophilized formulation of a reconstituted solution and lyospheres in coexistence comprising: sealing container, water-resisting layer, freeze-drying preparation and compound solution.
The sealed container can adopt a glass bottle, a test tube-shaped glass bottle, a plastic bottle, an eight-connecting pipe and the like.
And the water-resisting layer is generated by paraffin solidification, and divides the sealed container into a reagent cavity and a complex solution cavity. The freeze-dried preparation is stored in a reagent cavity of the sealed container; the re-dissolving solution is stored in the re-dissolving cavity of the sealed container.
In order to facilitate the application of the freeze-dried preparation, the invention also discloses a re-dissolving method of the freeze-dried preparation with the co-existing re-solution and freeze-dried spheres, which comprises the following steps: and heating the sealed container to melt the water-resisting layer formed by the paraffin.
Preferably, the sealed container is heated by means of a water bath.
In summary, the present invention is only a preferred embodiment, and is not intended to limit the scope of the present invention, and various changes and modifications can be made by workers in the light of the above description without departing from the technical spirit of the present invention. The technical scope of the present invention is not limited to the content of the specification, and all equivalent changes and modifications in the shape, structure, characteristics and spirit described in the scope of the claims of the present invention are included in the scope of the claims of the present invention.
Claims (10)
1. A manufacturing process of a freeze-dried preparation with a redissolution and freeze-dried spheres, which is characterized by comprising the following steps:
step A, placing the freeze-dried preparation ball coated with paraffin into a container;
step B, adding a complex solution into the container;
step C, sealing the container added with the compound solution and the freeze-drying preparation ball coated with the paraffin on the surface,
wherein the step A and the step B are not in sequence.
2. A manufacturing process of a freeze-dried preparation with a redissolution and freeze-dried spheres coexisting is characterized by comprising the following steps of:
step A, placing a freeze-dried preparation ball into a container;
step B, dripping the paraffin solution into the container in which the freeze-dried preparation balls are placed;
step C, embedding the freeze-dried preparation balls in paraffin after the paraffin solution is solidified, and then adding the compound solution;
and D, sealing the container added with the compound solution and the freeze-dried preparation ball.
3. A manufacturing process of a freeze-dried preparation with a redissolution and freeze-dried spheres coexisting is characterized by comprising the following steps of:
step A, adding a complex solution into a container and then dripping a paraffin solution into the container;
step B, forming a water-resisting layer on the compound solution after the paraffin is solidified, and then putting the freeze-dried preparation balls;
and step C, sealing the container added with the compound solution and the freeze-dried preparation ball.
4. A manufacturing process of a freeze-dried preparation with a redissolution and freeze-dried spheres coexisting is characterized by comprising the following steps of:
step A, adding a reagent solution into a container;
step B, putting the container added with the reagent solution into freeze-drying equipment to freeze-dry the reagent solution;
c, dropping the paraffin solution on the upper part of the freeze-dried preparation in the freeze-dried container, and solidifying the paraffin to generate a water-resisting layer to prevent the freeze-dried preparation on the lower part from deliquescing;
d, adding the compound solution, and forming a water-resisting layer on the solidified paraffin wax compound solution;
and E, sealing the container added with the compound solution and the freeze-dried preparation ball.
5. The process for preparing a lyophilized preparation of any one of claims 2 to 4, wherein the reconstitution liquid and the lyophilized pellet are present, comprising the steps of:
the paraffin wax is dissolved using xylene.
6. The process for preparing a lyophilized formulation of claim 5, wherein the reconstituted solution and the lyophilized pellet are present, comprising the steps of:
after the paraffin solution was dropped into the vessel, it was allowed to stand until the paraffin was solidified and the xylene was completely volatilized.
7. The manufacturing process of the lyophilized preparation of claim 3, wherein the manufacturing process comprises the following steps:
the step A:
after the reconstituted solution is added into a container, the container is placed in a low-temperature environment to enable the temperature of the reconstituted solution to be below 20 ℃, and then the paraffin solution is dripped.
8. A freeze-dried preparation with a re-solution and freeze-dried spheres coexisting, which is characterized in that:
the method comprises the following steps:
sealing the container;
the water-resisting layer is generated by paraffin solidification, and divides the sealed container into a reagent cavity and a re-solution cavity;
a lyophilized formulation stored in a reagent cavity of the sealed container;
and the compound solution is stored in a compound solution cavity of the sealed container.
9. The method for reconstituting a lyophilized formulation in which a reconstitution liquid and lyophilized pellet coexist according to claim 8, comprising the steps of:
and heating the sealed container to melt the water-resisting layer formed by the paraffin.
10. The method for reconstituting a lyophilized formulation in which a reconstituted solution and lyophilized spheres coexist according to claim 9, comprising the steps of:
and heating the sealed container in a water bath mode to melt the water-resisting layer formed by the paraffin.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011472241.8A CN112516092A (en) | 2020-12-14 | 2020-12-14 | Freeze-dried preparation manufacturing process with co-existing redissolution and freeze-dried spheres and freeze-dried preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011472241.8A CN112516092A (en) | 2020-12-14 | 2020-12-14 | Freeze-dried preparation manufacturing process with co-existing redissolution and freeze-dried spheres and freeze-dried preparation |
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| CN112516092A true CN112516092A (en) | 2021-03-19 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202011472241.8A Pending CN112516092A (en) | 2020-12-14 | 2020-12-14 | Freeze-dried preparation manufacturing process with co-existing redissolution and freeze-dried spheres and freeze-dried preparation |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1059750A (en) * | 1990-09-10 | 1992-03-25 | 郑亢三 | Water-proofing powder and manufacture method thereof |
| CN105886387A (en) * | 2016-05-30 | 2016-08-24 | 北京安洁优科技有限公司 | Integral-tubing packaging method for diagnostic reagent and diagnostic reagent bottle subjected to integral-tubing packaging |
| CN206970629U (en) * | 2017-07-20 | 2018-02-06 | 温和心 | A kind of paraffin cellular-type ring mediated responses pipe device |
| CN207567206U (en) * | 2017-11-15 | 2018-07-03 | 郑州安图生物工程股份有限公司 | Prestore the reaction tube of freeze-dried reagent |
-
2020
- 2020-12-14 CN CN202011472241.8A patent/CN112516092A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1059750A (en) * | 1990-09-10 | 1992-03-25 | 郑亢三 | Water-proofing powder and manufacture method thereof |
| CN105886387A (en) * | 2016-05-30 | 2016-08-24 | 北京安洁优科技有限公司 | Integral-tubing packaging method for diagnostic reagent and diagnostic reagent bottle subjected to integral-tubing packaging |
| CN206970629U (en) * | 2017-07-20 | 2018-02-06 | 温和心 | A kind of paraffin cellular-type ring mediated responses pipe device |
| CN207567206U (en) * | 2017-11-15 | 2018-07-03 | 郑州安图生物工程股份有限公司 | Prestore the reaction tube of freeze-dried reagent |
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Application publication date: 20210319 |