CN112237949B

CN112237949B - Freeze-dried preparation production process, freeze-dried preparation and freeze-dried reagent preparation box

Info

Publication number: CN112237949B
Application number: CN202011465496.1A
Authority: CN
Inventors: 吴小峰; 乔燕春
Original assignee: Shanghai Janzy Biotechnology Co ltd
Current assignee: Shanghai Janzy Biotechnology Co ltd
Priority date: 2020-12-14
Filing date: 2020-12-14
Publication date: 2021-03-26
Anticipated expiration: 2040-12-14
Also published as: CN112237949A

Abstract

The invention relates to the technical field of biological reagent freeze-drying, in particular to a freeze-dried preparation production process. Pipette tips are used as carriers for lyophilized formulations. Directly freezing and storing the original liquid sucked by the pipette tip in the pipette tip to generate a freeze-dried reagent, and then packaging. When in use, the liquid transferring gun is directly connected. The invention also discloses a freeze-drying reagent preparation box based on the pipette tip as a carrier of the freeze-drying preparation, which comprises a shell, the pipette tip and a re-solution carrier. The shell is provided with a cavity with an open upper part; a freeze-dried reagent is placed at the bottom of the pipette tip; the carrier of the redissolution is provided with a liquid tank, the upper part of the liquid tank is provided with a liquid tank membrane, and the redissolution is stored in the carrier of the redissolution; the pipette tip is positioned at the upper part of the complex solution carrier, and the tip part faces to the liquid bath membrane; the upper opening of the cavity of the shell is provided with a sealing element. The freeze-dried reagent storage and transportation device is convenient for freeze-dried reagent storage and transportation, is convenient for freeze-dried reagent re-dissolution, and avoids pollution in the re-dissolution process.

Description

Freeze-dried preparation production process, freeze-dried preparation and freeze-dried reagent preparation box

Technical Field

The invention relates to the technical field of biological material freeze-drying, in particular to a freeze-drying preparation production process, a freeze-drying reagent and a freeze-drying reagent preparation box.

Background

Since the biological agent can well maintain the biological activity in a freeze-dried state, freeze-dried products of the reagent are widely applied. However, in the application process of the lyophilized reagent, the lyophilized reagent needs to be redissolved, that is, the lyophilized reagent is subpackaged into a container, then a redissolution is added, and then the redissolved lyophilized reagent is taken out and applied by a pipette gun. Therefore, the production process of the freeze-dried preparation which is convenient for redissolution operation, avoids pollution or cross pollution in the operation process and is easy to store, produce and transport is an urgent requirement.

Also, there is not a good product for storage based on the above lyophilized preparation, and therefore, it is an urgent requirement to design a lyophilized reagent preparation kit which is convenient for reconstitution operation, has a risk of contamination during operation, and is easy to store, produce and transport.

Disclosure of Invention

The technical problem to be solved by the invention is as follows: provides a freeze-dried preparation production process which is convenient for redissolution operation, avoids pollution or cross pollution in the operation process and is easy to store, produce and transport, a freeze-dried reagent prepared by the process, and a freeze-dried reagent preparation box.

The technical scheme of the technical problem to be solved by the invention is as follows:

firstly, the technical scheme of the production process of the freeze-dried preparation comprises the following steps:

step 1, operating a suction head of a pipettor to suck in stock solution;

step 2, putting the pipette suction head into freeze-drying equipment for freeze-drying;

and step 3, sealing the freeze-dried pipette tip.

Preferably, the step 2 further comprises a pre-freezing step:

prefreezing the pipette tip sucked with the stock solution to ensure that the stock solution is completely crystallized into a solid state; and then putting the prefrozen pipette tip into a freeze-drying device for freeze-drying.

Preferably, in the step 2, the pipette tip is inserted into the coolant to perform prefreezing.

Preferably, the refrigerant is one or a combination of liquid nitrogen, dry ice and low-temperature alcohol.

Preferably, the upper part of the freeze-drying reagent of the pipette tip is provided with a filter element with a drying function.

Preferably, in step 1: the suction head of the liquid transfer device is operated to suck quantitative stock solution, and after the suction head of the liquid transfer device leaves the liquid level, the suction head of the liquid transfer device is operated to suck trace air.

Preferably, the pipette tip which is freeze-dried in the last step is sealed at the wide-mouth end by an aluminum foil sealing film.

Preferably, the pipette tip which is freeze-dried in the last step is sealed by paraffin at the small opening end.

Preferably, the pipette tip which is freeze-dried in the last step is sealed by an aluminum foil sealing film at the wide-mouth end and is sealed by paraffin wax at the small-mouth end; or, placing the pipette tip finished by the last step of freeze-drying into a sealed container.

The technical scheme of the freeze-dried preparation prepared by the production process of the freeze-dried preparation is as follows:

the freeze-dried preparation comprises:

a pipette tip; the freeze-drying reagent is arranged at the lower part of the pipette tip; and the aluminum foil sealing film is hermetically arranged at the wide-mouth end of the pipette tip.

Preferably, a sealing cap is arranged at the small-mouth end of the pipette tip; or: and a paraffin sealing block is arranged at the small-opening end of the pipette tip.

The production process of the freeze-dried preparation and the freeze-dried preparation have the beneficial effects that:

1. the pipette tip is adopted as a carrier, so that the pipette tip is strong in universality, convenient to obtain materials and high in cost advantage.

2. The pipette tip is used as a carrier of a freeze-drying reagent, so that the pipette is convenient to use in quick fit.

3. The pipette tip is used as a carrier of the freeze-drying reagent, so that the freeze-drying reagent is convenient to store and redissolve.

4. Has the advantages of convenient transportation and long-term storage without fear of deliquescence.

The invention discloses a production process scheme for manufacturing a freeze-dried preparation based on a pipette tip, and also discloses a freeze-dried reagent preparation box for solving the problem that the freeze-dried preparation is stored due to the extension of a freeze-dried preparation production process, wherein the technical scheme comprises the following steps:

comprises a shell; the shell is at least provided with a cavity which is through up and down; a pipette tip is arranged in the cavity, and a freeze-dried reagent is stored at the bottom of the pipette tip; the upper opening of the cavity is provided with a sealing element, the lower opening of the cavity is hermetically connected with a re-solution carrier, and a re-solution is stored in the re-solution carrier; the opening of the complex solution carrier is sealed with a liquid tank film, the liquid tank film faces to a pipette tip, and the small-mouth end of the pipette tip is positioned at the upper part of the liquid tank film.

Further, the reconstitution fluid carrier comprises: the upper part of the liquid storage cup is provided with a liquid tank; the liquid tank membrane is arranged at the opening end of the liquid tank and is hermetically connected with the liquid storage cup, and the liquid tank membrane is an aluminum foil sealing membrane or a paraffin waterproof layer; the upper end of the liquid storage cup is hermetically connected with the lower opening of the cavity of the shell.

Furthermore, the liquid storage cup of the compound solution carrier is in a V shape, or the bottom of the liquid storage cup is provided with a groove matched with the shape of the small opening end of the pipette tip.

Another freeze-drying reagent preparation box adopts the technical scheme that:

the method comprises the following steps: a housing; the shell is at least provided with a cavity with an opening at the upper part, a pipette tip is arranged in the cavity, and freeze-drying reagents are stored at the bottom of the pipette tip; a sealing element is arranged at an upper opening of the cavity, a re-solution carrier is arranged at the bottom of the cavity, and a re-solution is stored in the re-solution carrier; the opening of the complex solution carrier is sealed with a liquid tank film, the liquid tank film faces to a pipette tip, and the small-mouth end of the pipette tip is positioned at the upper part of the liquid tank film.

Based on the two technical schemes:

preferably, a filter element is arranged at the upper part of the freeze-drying reagent at the bottom of the pipette tip.

Preferably, the compound solution carrier is a bubble cap, and the liquid tank film is an aluminum foil sealing film or a paraffin waterproof layer arranged at the opening end of the bubble cap.

Preferably, the sealing element is an aluminum foil sealing film covering the upper part of the cavity, or the sealing element is a cover body arranged on the upper part of the cavity.

Further, the cover body is of a hollow structure, a drying agent is arranged in the cover body, an opening is formed in the lower end of the cover body, and the opening faces the pipette tip.

Preferably, a stabilizing mechanism is arranged in the cavity,

the stabilizing mechanism comprises a pipettor suction head cup and a liquid suction spring; the pipette tip cup is arranged in the cavity of the shell in a sliding manner; the pipette tip cup is vertically communicated and is internally provided with a clamping bulge; the pipette tip is inserted into the pipette tip cup, and the clamping bulge is abutted against the upper part of the pipette tip; the lower end of the liquid suction spring is abutted against a boss arranged in the middle of the inner wall of the cavity of the shell, the upper end of the liquid suction spring is abutted against the bottom of a pipette tip cup, and the pipette tip cup is supported by the liquid suction spring and moves up and down in the cavity of the shell;

or the stabilizing mechanism is a positioning bracket which is arranged at the lower part of the inner wall of the cavity, one end of the positioning bracket is fixedly connected with the inner wall of the cavity, the other end of the positioning bracket is abutted against the pipette tip,

or the stabilizing mechanism is a conical spring matched with the pipette tip, and the pipette tip is inserted into the conical spring.

Preferably, a support sleeve with openings at two ends is arranged in the cavity, and the pipette tip is inserted into the support sleeve.

Furthermore, the support sleeve is made by pressing molecular sieve desiccant material,

or the support sleeve is made of flexible materials.

Preferably, the cross section of the cavity of the supporting sleeve is cylindrical; or the cross section of the supporting sleeve cavity is trapezoidal, or the shape of the supporting sleeve cavity is matched with that of the pipette tip.

Preferably, the number of the cavities on the shell is 4 or 8.

In addition to the above structural description of the lyophilized reagent preparation cartridge, the present invention also discloses a manufacturing method of the lyophilized reagent preparation cartridge, comprising the steps of:

the casing of the freeze-drying reagent preparation box is at least provided with a cavity with an opening at the upper part and a closed lower part,

step 1: adding a complex solution into the bottom of the cavity,

step 2: then dripping high-temperature molten liquid paraffin into the bottom of the cavity, cooling the paraffin to form a paraffin water-resisting layer,

and step 3: then installing a pipette tip on the paraffin waterproof layer, wherein freeze-dried reagents are stored at the bottom of the pipette tip;

and 4, step 4: and a sealing piece is arranged at the opening of the upper part of the cavity of the shell.

Preferably, the outer side of the pipette tip is sleeved with a support sleeve with openings at two ends.

Based on the structural description of the above lyophilized reagent preparation kit, the present invention discloses a method for reconstituting a lyophilized reagent for its application, using the lyophilized reagent preparation kit of any one of claims 17-24 or 28 or 30;

the method comprises the following steps:

step 1, removing a sealing element on the upper part of a cavity;

step 2, pressing and exhausting the liquid transfer gun to prepare for liquid absorption;

step 3, butting and inserting the pipette gun with the wide-mouth end of the pipette tip in the cavity;

step 4, pressing the pipette gun to drive the pipette tip to move downwards, and after the pipette tip moves to the bottom, piercing a liquid tank membrane on the upper part of the reconstituted solution carrier by the tip of the pipette tip so that the tip of the pipette tip is pierced into the reconstituted solution;

and 5, releasing a button of the pipette gun to suck liquid, and enabling liquid in the redissolved liquid carrier to enter the pipette tip to redissolve the freeze-dried reagent.

Preferably, in step 5, the reconstituted solution and the lyophilized reagent are thoroughly mixed and dissolved by pressing the pipette back and forth.

Preferably, the step 1 of removing the sealing member of the upper part of the chamber comprises opening a lid of the upper part of the chamber or puncturing an aluminum foil sealing film of the upper part of the chamber with a pipette.

The invention has the beneficial effects that:

1. for the extension of the production process of the freeze-dried preparation, the freeze-dried reagent preparation box which is convenient for storing and transporting freeze-dried reagents and can not be affected by deliquescence after long-term storage is designed and provided.

2. A pipette tip is used as a carrier and is matched with a pipette gun, so that the flow links are reduced, and efficient operation is realized.

3. The risk of leakage of the freeze-dried reagent is reduced, the re-dissolution of the freeze-dried reagent is facilitated, and pollution is avoided in the re-dissolution process.

Drawings

Fig. 1 is a schematic diagram of a pipette tip aspirating a stock solution;

fig. 2 is a schematic diagram of a pipette tip completing aspiration of a stock solution;

fig. 3 is a schematic view of a pipette tip after sealing;

FIG. 4 is an exploded view of multiple chambers in one embodiment of the invention;

FIG. 5 is a schematic view of multiple chambers in one embodiment of the invention;

FIG. 6 is a schematic view of multiple chambers in one embodiment of the invention;

FIG. 7 is a schematic diagram of one embodiment of the present invention;

FIG. 8 is a schematic diagram of one embodiment of the present invention;

FIG. 9 is an exploded schematic view of one embodiment of the present invention;

fig. 10 is a schematic view of a pipette tip puncturing a membrane of a pipette tip in accordance with one embodiment of the present invention;

FIG. 11 is an exploded view of one embodiment of the present invention;

FIG. 12 is a schematic view of an embodiment of the present invention;

fig. 13 is an exploded view of one embodiment of the present invention.

In the figure:

100. a pipette tip; 110. compounding the solution; 120. a filter element; 130. lyophilizing the reagent;

200. a housing; 290. a support sleeve;

300. a seal member; 310. an aluminum foil sealing film; 320. a cover body; 321. opening a hole;

400. a desiccant; 401. paraffin wax;

500. covering a film;

600. a pipette tip cup;

700. a liquid suction spring;

800. a reconstituted solution carrier; 810. a liquid storage cup; 820. and (4) liquid tank membranes.

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.

For the sake of clarity and understanding of the present invention, the present invention is described in detail in the related parts of the production process of lyophilized preparation and the kit of lyophilized preparation.

A first part: a freeze-dried preparation and a production process thereof are provided.

The basic principle of freeze-drying is based on the tristate change of water. Water (H)₂O) has three phases, solid, liquid and gaseous, which can be either interconverted or co-exist.

In freeze drying, the temperature of the air containing water vapor is indirectly reduced by a refrigerant, and the water in the air is removed by condensation and precipitation of the water vapor. Is a common air drying method. Can also be used for low-temperature dehydration of fruits and vegetables.

Vacuum freeze-drying has become increasingly popular due to its incomparable advantages over other drying methods, and has become widely used in medicine, biological products and food. Most of biological products such as serum, strains, Chinese and western medicines and the like are bioactive substances, and the vacuum freeze drying technology provides a good solution for preserving the bioactivity. The vacuum freeze-dried product can well preserve the nutritional health-care components, color, fragrance, taste and shape of the processing raw materials. The excellent performance is particularly excellent in the instant fast food, and shows strong development momentum.

Pipette tip — pipette tip (disposable tip) is a consumable product for laboratory pipettors, and a certain amount of sample is aspirated from a sample container through the pipette tip (disposable tip) and injected into a test container, and the pipette tip is discarded after sampling is completed.

The suction head series products comprise 10ul white suction heads, 10ul filter core white suction heads, 200ul yellow suction heads, 200ul filter core yellow suction heads, 1000ul blue suction heads, 1000ul filter core blue suction heads, 10ul box-packed white suction heads, 200ul box-packed yellow suction heads, 1000ul box-packed blue suction heads, 10ul sterilized white suction heads, 200ul sterilized yellow suction heads and 1000ul sterilized blue suction heads.

Pipette tips, also known as pipette tips, tip tips are one of these.

The invention is carried out by means of a freeze drying technology and a common pipette tip, in particular based on a pipette tip.

The method specifically comprises the following steps: a freeze-drying preparation production process uses a pipette tip 100 as a carrier of the freeze-drying preparation. The lyophilized formulation is directly encapsulated inside pipette tip 100. Freeze-dried powder may be loaded into the interior of the pipette tip 100, or the freeze-dried reagent 130 may be directly generated in the interior of the pipette tip 100 by directly freeze-drying the pipette tip 100 containing the stock solution using the pipette tip 100 as a carrier of the reagent solution.

In this example, lyophilization is described using pipette tip 100 as a reagent carrier.

See fig. 1.

Step 1, sucking a stock solution into a pipette tip 100; at this time, the raw liquid enters the interior of the pipette tip 100 and is in a liquid state.

And 2, putting the pipette tip 100 into a freeze-drying device for freeze-drying. Preferably, the step 2 further comprises a pre-freezing step: prefreezing the pipette tip 100 sucked with the stock solution to crystallize the stock solution into a solid state; the prefrozen pipette tip 100 is then placed into a lyophilization apparatus for lyophilization. Specifically, according to the well-established lyophilization technique for stock solutions, the lyophilized formulation is generated inside pipette tip 100 by lyophilization in a lyophilization apparatus.

In this step, the pipette tip 100 that sucks the stock solution is inserted into the refrigerant to achieve prefreezing. The refrigerant can be one or a combination of liquid nitrogen, dry ice, low-temperature alcohol or low-temperature metal. Wherein the temperature of the low-temperature alcohol and the low-temperature metal is below-5 ℃. The prefreezing effect is achieved until the stock solution in pipette tip 100 is completely crystallized to a solid state.

Under the high vacuum state, the sublimation principle is utilized, so that the moisture in the pre-frozen material is directly sublimated into water vapor in the ice state without melting the ice, and the water vapor is removed, thereby achieving the aim of freeze drying. The vacuum freeze-dried product can ensure various nutritional ingredients such as protein, vitamins and the like in the food, especially volatile and heat-sensitive ingredients. Therefore, the original nutrient components can be kept to the maximum extent, the oxidation in the drying process can be effectively prevented, and the transformation and state change of the nutrient components can be prevented. The freeze-dried product is spongy, has no drying shrinkage, has excellent rehydration, is convenient to eat, has very little moisture, and can be preserved and transported for a long time at normal temperature after being correspondingly packaged.

Preferably, as shown in fig. 2, in order to prevent the pre-freezing refrigerant from contaminating the stock solution, the pipette tip 100 sucks a certain amount of the stock solution, and after the pipette tip 100 leaves the liquid surface, the pipette tip 100 sucks a small amount of air, so that the stock solution leaves a distance from the small-opening end of the pipette tip 100. The air gap at the tip of pipette tip 100 is used to relatively block the refrigerant.

Preferably, to ensure the internal environment of pipette tip 100 is dry and clean, filter element 120 is disposed on top of pipette tip 100, and is located near the wide-mouth end of pipette tip 100 and above the lyophilized formulation formed by lyophilization.

And step 3, sealing the freeze-dried pipette tip 100.

To prevent deliquescence of the lyophilized formulation, the above is preferably conducted in a dry environment.

To seal a freeze-dried pipette tip 100, it is simpler to place the last freeze-dried pipette tip 100 into a sealed container. Such as in a sealed vial, in a vacuum blister pack, in a sealed blister, etc.

Also, in order to ensure the sealing properties of the lyophilized preparation, which is lyophilized, and prevent contamination and deliquescence, the pipette tip 100, which is lyophilized in the last step, may be individually sealed at its wide-mouth end with an aluminum foil sealing film 310. In short term and drier environments, the sealing means may not be considered, as the small-mouth end itself has capillary properties that prevent air flow, although it is preferred that the pipette tip 100 that has been freeze dried in the last step is also paraffin sealed at its small-mouth end.

If the pipette tip finished by the last step of freeze drying is sealed by an aluminum foil sealing film 310 at the wide-mouth end, paraffin wax sealing is selected as the upper choice. If paraffin is used to seal the small end, paraffin is melted in a high temperature environment and the outlet at the lower end of the pipette tip 100 is opened. Wherein the high temperature environment floats at 3 ℃ above and below the melting temperature of the paraffin. Even if the temperature is 3 ℃ lower than the melting temperature, the paraffin in this state is softened, and the outlet at the lower part can be opened by squeezing or the like.

To achieve longer storage, pipette tips 100 made according to the lyophilized formulation manufacturing process may be placed in a sealed container, or enclosed in a vacuum bag, or a nitrogen bag.

Based on the idea of the invention, the invention also discloses a freeze-dried preparation, which comprises the following components:

pipette tip 100 and lyophilized reagents. The lyophilized reagent is disposed at the lower portion of the pipette tip 100; the aluminum foil sealing film 310 is hermetically disposed at the wide-mouth end of the pipette tip 100, the aluminum foil sealing film 310 is hermetically connected with the wide-mouth end of the pipette tip 100, and the aluminum foil sealing film 310 seals the upper port of the pipette tip 100.

The lower end of pipette tip 100 may or may not be sealed. The principle of the unsealing is that the lower end of the pipette tip 100 corresponds to a capillary tube, and the steps and structure of the lower end sealing can be simplified in the production process of a reagent that is not stored for a long time.

Preferably, a sealing cap may be provided at the lower end of the pipette tip 100. The sealing cap can adopt a rubber plug or a rubber cap. Alternatively, a paraffin sealing block is disposed at the lower end of the pipette tip 100. As shown in fig. 3, the upper portion of the pipette tip 100 is sealed with an aluminum foil sealing film 310, and the lower end is sealed with paraffin wax.

Preferably, in order to ensure the sealing performance of the lyophilized preparation after lyophilization and prevent contamination and deliquescence, a filter element with a drying function is arranged at the upper part of the pipette tip 100, specifically, the filter element with the drying function is placed above the lyophilized reagent in the pipette tip after lyophilization. The particular filter element is positioned proximate the wide-mouth end of pipette tip 100 and above the lyophilized formulation formed by lyophilization.

Further, to achieve longer storage, pipette tip 100 may be placed in a sealed container, or enclosed in a vacuum bag, or a nitrogen bag.

A second part: relates to a freeze-drying preparation box and the re-dissolving of the freeze-drying preparation.

The invention discloses a production process scheme for manufacturing a freeze-dried preparation based on a pipette tip, and the problem that the storage of the freeze-dried preparation is naturally involved in the extended application of a freeze-dried preparation production process. Meanwhile, the invention aims to facilitate the application of the freeze-dried preparation and reduce pollution, and also discloses a redissolution method.

The invention also discloses a freeze-drying reagent preparation box which comprises a first mode and a second mode.

Reagent preparation kit mode of freeze-drying:

referring to fig. 4 and 5, the technical scheme includes:

the shell 200, the said shell 200 has a cavity through from top to bottom at least; a pipette tip 100 is arranged in the cavity, and freeze-dried reagents are stored at the bottom of the pipette tip 100; the upper opening of the cavity is provided with a sealing element 300, the lower opening of the cavity is hermetically connected with a re-solution carrier 800, and a re-solution is stored in the re-solution carrier 800; a liquid bath film 820 is sealed at the opening of the reconstituted solution carrier 800, the liquid bath film 820 faces the pipette tip 100, and the small-mouth end of the pipette tip 100 is located at the upper part of the liquid bath film 820.

Reagent kit mode two of freeze-drying:

the technical scheme comprises the following steps:

the kit comprises a shell 200, wherein the shell 200 is at least provided with a cavity with an opening at the upper part, a pipette tip 100 is arranged in the cavity, and freeze-drying reagents are stored at the bottom of the pipette tip 100; a sealing element 300 is arranged at the upper opening of the cavity, a re-solution carrier 800 is arranged below the cavity, and a re-solution is stored in the re-solution carrier 800; a liquid bath film 820 is sealed at the opening of the reconstituted solution carrier 800, the liquid bath film 820 faces the pipette tip 100, and the small-mouth end of the pipette tip 100 is located at the upper part of the liquid bath film 820.

Fig. 7 and 8 are schematic views of an embodiment of the second lyophilized reagent kit, and fig. 9 is an exploded view of the lyophilized reagent kit, which is a preferred embodiment with simple structure, low production cost and few steps.

Based on the two modes, the number of the cavities can be 1 or more. Preferably, 4 or 8 cavities are provided for use with the eight-connecting pipe in the prior art. Figures 4, 5, 6 illustrate embodiments of a lyophilized reagent preparation cartridge having a plurality of cavities.

Since the lyophilized reagent needs to be stored in a highly dry environment to prevent deliquescence of the lyophilized reagent, which affects the quality and testing effect of the lyophilized reagent, the chamber needs to be sealed.

Preferably, the sealing member 300 is an aluminum foil sealing film 310 covering the upper portion of the chamber in order to reduce the cost and material cost of the reagent carrier. As shown in fig. 3, an aluminum foil sealing film 310 is coated on the upper portion of the chamber to seal the chamber. The sealing process of the aluminum foil sealing film is a well-established technology and is not described in detail.

Preferably, in order to improve the recycling rate of the reagent kit, the upper part of the cavity of the sealing member 300 is provided with a cover 320. The cover body 320 may be coupled to the upper portion of the cavity by means of a screw coupling. As shown in fig. 10, the inner wall of the upper portion of the cavity is provided with threads, and the outer portion of the cover 320 is provided with external threads, which are screwed together. Further, a sealing ring may be provided between the two to increase the sealing effect.

Further, in order to better maintain the drying effect, the cover body 320 has a hollow structure and is provided with a drying agent 400 inside, and the lower end of the cover body 320 is provided with an opening 321, and the opening 321 faces the pipette tip 100. By placing a desiccant inside the cover 320, the interior of the cavity is kept dry, and thus the interior of the pipette tip 100 can be kept dry.

The drying agent adopts a drying ball, and in order to realize the placement of the drying agent, the hollow cavity is a cavity with an opening at the upper part, and the film coating treatment is carried out after the drying agent is placed. That is, the upper portion of the hollow portion of the cap body 320 is sealed by the cap film 500 provided on the upper portion of the cap body 320. At this time, the aperture of the opening 321 at the lower portion is smaller than the diameter of the drying ball, and the drying ball is prevented from falling into the cavity. Alternatively, the aperture 321 is larger than the diameter of the drying ball, the drying ball is put into the cover 320 from the aperture 321, and then the drying ball is prevented from falling into the cavity by providing a grid at the aperture of the aperture 321.

Preferably, for convenience of operation, as shown in fig. 8 and 11, the sealing member 300 is a cap provided with a through hole, a sealing pad is provided between the sealing member 300 and the housing 200, and the sealing of the cavity is achieved by crimping the sealing member 300 and the housing 200. When in use, the liquid transfer gun can be used for puncturing directly. In this way, the sealing element 300 does not need to be removed, the use steps are simplified, and the test, production and detection efficiency of the biological agent can be greatly improved.

In the first reagent cartridge system of the lyophilized reagent 130, the upper part of the chamber is sealed with the sealing member 300, and the lower part of the chamber is sealed with the reconstitution fluid carrier 800. The composite solution carrier 800 serves as both a container for the composite solution 110 and a sealing member for the lower opening of the chamber.

In the second freeze-drying reagent preparation box mode, the lower end of the cavity is closed, and the re-solution carrier 800 is directly placed in the cavity. For the freeze-dried reagent kit, the above-mentioned sealing method of the reconstituted solution carrier 800 can be adopted.

Preferably, the reconstituted liquid carrier 800 is in a bubble cap configuration for cost savings. The interior of the bubble cap is provided with the compound solution, the film covering surface of the bubble cap is connected with the lower end of the shell 200 in a sealing manner, and the positions of the bubble cap and the cavity are overlapped up and down. And the number of blisters is the same as the number of cavities. The bubble cap technology is adopted, namely, the bubble cap for holding tablets in the prior art is used for holding the compound solution. When needed, the small end of pipette tip 100 is used to pierce the aluminum foil into the interior of the blister to aspirate the solution. The aluminum foil sealing film arranged at the opening end of the bubble cap is the liquid tank film 820 of the compound solution carrier 800. The reconstituted solution carrier 800 is in the form of a bubble cap, and the bubble cap can be hermetically connected with the lower opening of the cavity in a bonding mode and the like.

Further, in order to simplify the process and reduce the cost, when the re-solution carrier 800 adopts a bubble cap structure, a paraffin water-proof layer is used as the liquid tank film 820 of the bubble cap. The upper portion of the blister is secured and sealingly connected directly to the outer edge of the lower end of the cavity. The following method of making a lyophilized reagent preparation kit will be described in detail.

It should be noted that, no matter the cavity of the freeze-drying preparation box is through from top to bottom or one end is open, the cavity is sealed, so that the freeze-drying reagent stored in the pipette tip 100 in the freeze-drying preparation box does not need to be sealed separately, and further, it is not necessary that the pipette tip adopts the aluminum foil sealing film 310 at the wide-mouth end and paraffin wax sealing at the small-mouth end. However, the provision of a filter element 120 at the top of the lyophilized reagent at the bottom of the pipette tip 100 is an optional consideration.

Preferably, in order to improve recycling rate and reduce the influence on the environment, the re-solution carrier 800 comprises a liquid storage cup 810 and a liquid tank membrane 820. The upper part of the liquid storage cup 810 is provided with a liquid tank for containing the compound solution. A liquid tank membrane 820 is provided on the upper part of the liquid tank to prevent the compound solution 110 from scattering and contaminating. The liquid storage cups 810 can be coated with films by adopting a bubble cap coating process, so that the liquid storage cups 810 can be hermetically connected. The fluid reservoir membrane 820 may be a plastic membrane or any other membrane that is pierced by a particular force. The liquid bath film 820 adopts a composite pressure-sensitive film or a pe film. Choose for use pe complex film when sealing, need adopt electromagnetic induction to seal the technique to the high temperature that produces when reducing the heat-seal influences the goods. Also, the liquid bath film 820 may be provided as a water barrier layer for the paraffin 401. The reservoir 810 of the reconstituted liquid carrier 800 may also be sealed with paraffin. When the paraffin water-proof layer is used as the liquid tank film 820, in the process of processing and production, the complex solution is injected into the liquid storage cup 810, then the liquid paraffin with high melting point is dropped, and the liquid tank film is formed after the paraffin is cooled.

Preferably, the liquid tank film 820 can be connected with the liquid storage cup 810 in a pressing mode, the liquid tank film 820 is placed between the lower end of the cavity of the shell and the liquid storage cup 810, and the liquid storage cup 810 and the cavity are connected to realize pressing fit of the liquid storage cup 810 and the cavity so as to seal the liquid storage cup 810 and the cavity.

Preferably, in the first and second modes, in order to make the pipette tip 100 more completely absorb the reconstitution fluid in the reconstitution fluid carrier 800, the liquid storage cup 810 of the reconstitution fluid carrier 800 is V-shaped, or the bottom of the liquid storage cup 810 is provided with a groove for matching with the tip of the pipette tip 100. At this time, since the area of the tip of the pipette tip 100 in contact with the lowest end of the reconstituted solution carrier 800 is minimized, the solution inside the blister can be completely absorbed by the pipette tip 100.

In the first and second modes, in order to keep the stability of pipette tip 100 in the cavity of housing 200 and reduce the breakage of liquid bath film 820 caused by impact due to unstable factors during transportation, a stabilizing mechanism is provided in the cavity to stabilize pipette tip 100, and the following schemes may be adopted for the stabilizing mechanism:

the first scheme of the stabilizing mechanism is as follows:

as shown in fig. 6, the securing mechanism is a positioning bracket. The positioning bracket is arranged at the bottom of the cavity. One end of the positioning support is fixedly connected with the inner wall of the cavity, and the other end of the positioning support is abutted to the pipette tip 100. The locating support is the quarter butt, is provided with a plurality ofly and along same circumference evenly distributed, and a jack is formed at the middle part of all locating supports for pegging graft pipettor suction head 100. The positioning support is made of flexible materials. At this time, the inner diameter of the cavity is slightly larger than the outer diameter of the upper end of the pipette tip 100, so that the pipette tip 100 does not shake in the cavity to a large extent, and the pipette tip 100 can be ensured to be more stable under the fixed support of the positioning bracket.

During reconstitution, pipette tip 100 may be inserted into the interior of the liquid reservoir of liquid cup 810 due to the flexibility of the positioning bracket. Or the positioning bracket is made of rigid materials, such as hard plastics, the supporting parts at the two ends of the positioning bracket are used for being fixedly connected with the inner wall of the cavity, and the weakening groove is arranged in the middle of one or two supporting parts and is broken after being pressed forcibly. Thereby ensuring that pipette tip 100 enters the interior of reconstituted liquid carrier 800.

The second stabilizing mechanism scheme:

the stabilizing mechanism is a conical spring arranged in the cavity, and the tip end of the conical spring faces downwards and is abutted against the bottom of the cavity. Correspondingly, a convex ring is arranged on the inner wall of the bottom of the cavity, and the bottom end of the conical spring is clamped at the upper part of the conical spring. The inner diameter of the upper portion of the conical spring is smaller than the outer diameter of the upper portion of pipette tip 100 to ensure that the conical spring can activate the supporting action after pipette tip 100 is inserted into the conical spring.

The third scheme of the stabilizing mechanism is as follows:

the stabilizing mechanism is provided with a pipette tip cup 600 and a pipette spring 700. The pipette tip cup 600 is slidably disposed inside the cavity of the housing 200; the pipette tip cup 600 is tubular and has a snap-fit protrusion inside. The snap protrusions are used to support pipette tip 100. The pipette tip 100 is inserted into the pipette tip cup 600, and is automatically inserted into the pipette tip cup 600 after the pipette tip 100 is inserted into the pipette tip cup 600. The lower end of the imbibition spring 700 is connected with a boss arranged in the middle of the inner wall of the cavity of the shell 200, and the upper end of the imbibition spring 700 is abutted against the bottom of the pipette tip cup 600, is supported by the imbibition spring 700 and moves up and down in the cavity of the shell 200. When the pipette tip 100 is pressed by the pipette gun, the pipette tip 100 may be pressed into the double solution carrier 800, and when it is necessary to take out the pipette tip, the pipette tip cup 600 may be outwardly sprung by the liquid suction spring 700 so as to take out the pipette tip 100.

The scheme of the stabilizing mechanism is four:

the stabilizing mechanism is a supporting sleeve 290 arranged in the cavity, and the supporting sleeve 290 is provided with a through hole which is open at two ends and is through up and down for inserting the pipette tip 100.

Preferably, the support sleeve 290 is made of a flexible material, such as sponge, pearl wool, etc. Due to the compressibility of the sponge, it may be supported within the cavity, while the interior of support sleeve 290 may protect pipette tip 100.

The support sleeve 290 may be shaped like a tube with a pipe in the middle based on the support sleeve made of the flexible material. The tubular structure is cylindrical and the shape of the lumen of the support sleeve 290 may also be designed to match the shape of the pipette tip 100.

Preferably, the support sleeve 290 may be a tube sleeve, the tube cavity of which has a trapezoidal cross-sectional shape in the vertical direction, and the small end of the trapezoid faces downward.

Further, the shape of the lumen of support sleeve 290 matches the shape of pipette tip 100, and likewise, a granular flexible material may be packed into the space between the lumen and pipette tip 100.

Preferably, in order to prevent the sealing from being damaged and leakage caused by aging of the sealing, the air inside the cavity is humid, and meanwhile, in order to reduce the water resistance requirement of the material, a drier environment is formed inside the cavity, and the shelf life is prolonged, the support sleeve is made of a molecular sieve desiccant material in a pressing mode. Further, in order to realize buffering and prevent impact, a buffer layer is arranged on the inner wall or the outer wall of the support sleeve formed by pressing the molecular sieve desiccant material, and the buffer layer can be a coating made of materials such as sponge and rubber.

Pipette tip 100 is inserted into the middle of support sleeve 290, and the outside of the support sleeve abuts against the inner wall of the cavity. During manufacturing, reagents are lyophilized inside pipette tip 100, and then pipette tip 100 is inserted into the inner wall of support sleeve 290. Support sleeve 290, i.e., pipette tip 100, is then inserted into the interior of the cavity. The outer wall of the support sleeve is abutted against the inner wall of the cavity, the outer wall of the support sleeve and the inner wall of the cavity keep the relative positions unchanged under the condition of no stress, and the support sleeve can slide in the cavity by pressing when in use.

Fig. 5 is a schematic diagram illustrating the assembly of the lyophilized reagent kit disclosed in the present invention, wherein the position where the pipette tip 100 is not assembled is the cavity disposed on the housing 200. In the drawing, in order to ensure purity of the solution in pipette tip 100, a filter element 120 is provided in the upper portion of pipette tip 100. At the bottom end of pipette tip 100 is provided lyophilized reagent 130. The reconstituted solution 110 is stored inside the reconstituted solution carrier 800, which is shown as the interior of the liquid tank of the liquid storage cup 810. After assembly, pipette tip 100 is placed inside the cavity of housing 200. At the time of use, the pipette tip 100 is attached with a pipette gun and then the reconstituted solution inside the reconstituted solution carrier 800 is sucked up.

the following is a general description of the method of making the above-described lyophilized reagent kit set:

firstly, sealing the compound solution in a bubble cap or a liquid storage cup 810 and sealing; then, the bubble cap is placed in the cavity of the shell 200, or the liquid storage cup 810 is placed in the shell 200, or the re-solution carrier 800 is hermetically connected with the lower opening of the cavity; then placing pipette tip 100 containing lyophilized reagents into the cavity of housing 200; finally, the upper opening of the cavity of the housing 200 is sealed in a dry environment.

As shown in fig. 10 and 11, for a chamber having upper and lower openings, the re-solution carrier 800 is provided with an external thread, or the exterior of the liquid storage cup 810 is provided with an external thread, and the lower portion of the chamber of the housing 200 is provided with an internal thread and is screw-coupled with the external thread of the liquid storage cup 810. The two are connected by screw connection. As shown in fig. 12 and 13, the sealing connection may be performed by direct bonding.

In addition to the two configurations described above, the following simplified configurations may be provided:

in the mode, the shell is at least provided with a cavity with an upper opening. The redissolved solution carrier 800 is disposed at the bottom of the cavity, and the redissolved solution carrier 800 and the cavity of the housing 200 may be integrally formed, that is, the redissolved solution carrier 800 is a space surrounded by the bottom of the cavity. The cavity is internally provided with a liquid bath film 820. The liquid tank film is positioned at the lower position of the cavity. The liquid tank film 820 is a paraffin waterproof layer. The lower part of the liquid bath film 820 is provided with a compound solution, namely, the liquid bath film 820 composed of a paraffin layer and the lower part of the cavity form a compound solution carrier 800. The liquid tank film 820 is a paraffin water-proof layer, and a pipette tip 100 is arranged on the upper part of the liquid tank film. When in use, the paraffin waterproof layer is directly punctured. Namely, the liquid bath film 820 is arranged inside the cavity. The liquid tank film is positioned at the lower position of the cavity. The liquid tank film 820 is a paraffin waterproof layer. A complex solution is arranged at the lower part of the liquid tank membrane 820; and a pipette tip 100 containing a freeze-dried reagent is arranged at the upper part of the paraffin waterproof layer. The paraffin water-proof layer divides the cavity into two parts, the upper part is used for placing the pipette tip 100 containing the freeze-dried reagent, and the lower part is used for placing the re-solution.

The invention discloses a practical manufacturing method of a freeze-drying reagent preparation box based on the freeze-drying reagent preparation box with a cavity structure with an upper opening and a lower closed structure in a simplified mode, which specifically comprises the following steps:

wherein, the housing 200 of the freeze-drying reagent preparation box is at least provided with a cavity with an upper opening and a lower closed part,

step 1: during assembly, firstly adding a complex solution 110 at the bottom of the cavity;

step 2: then dripping high-temperature molten liquid paraffin into the bottom of the cavity, and cooling the paraffin to form a paraffin water-resisting layer;

and step 3: then, installing a pipette tip 100 on the paraffin 401 water-resisting layer, wherein freeze-dried reagents are stored at the bottom of the pipette tip 100;

and 4, step 4: a sealing member is installed at an upper opening of the housing 200.

At this moment, during assembly, the complex solution 110 is added into the cavity, then the liquid paraffin melted at high temperature is dripped, the paraffin 401 waterproof layer is formed after the paraffin is cooled, and then the pipette tip 100 and the sealing element on the upper part are installed in a dry environment, so that the production process can be greatly simplified and the efficiency can be improved.

Preferably, the upper part of the bottom freeze-dried reagent of the pipette tip 100 is provided with a filter element 120.

Preferably, the outside of the pipette tip 100 is sleeved with a support sleeve 290 with two open ends.

Preferably, the cross section of the lumen of the support sleeve 290 is cylindrical; alternatively, the cross-sectional shape of the lumen of the support sleeve 290 is trapezoidal, or the shape of the lumen of the support sleeve 290 matches the shape of the pipette tip 100.

Based on the structural description of the freeze-dried reagent preparation box, the invention discloses a re-dissolving method of a freeze-dried reagent aiming at the application of the freeze-dried reagent preparation box, which comprises the following steps:

step 1, removing a sealing member 300 at the upper part of the cavity; including rotating the cover 320 to open the upper portion of the cavity, care is taken to prevent the desiccant 400 from shattering in the case where the desiccant 400 is disposed in the cover 320. As shown in fig. 10, for a seal using the aluminum foil sealing film 310, the aluminum foil sealing film 310 at the upper part of the chamber may be punctured by a pipette.

Step 2, pressing and exhausting the liquid transfer gun to prepare for liquid absorption; since the reconstitution liquid needs to be sucked into the pipette tip 100 during reconstitution, the pipette gun needs to be pressed and evacuated to prevent the freeze-dried reagent 130 in the pipette tip 100 from being ejected.

And 3, butting and inserting the pipette gun with the wide-mouth end of the pipette tip 100 in the cavity. The tip of the pipette gun is plugged directly into the upper wide end of pipette tip 100. At this point, the two may not be firmly connected, but subsequent steps may take some measures to make the two firmly connected.

And 4, pressing the pipette gun to drive the pipette tip 100 to move downwards, and after the pipette tip 100 moves to the bottom, piercing a liquid tank film 820 on the upper part of the reconstituted liquid carrier 800 by the tip of the pipette tip 100, and piercing the tip of the pipette tip 100 into the reconstituted liquid 110 as shown in fig. 8. In this process, pipette tip 100 is firmly attached to the pipette gun by the resistance of the securing mechanism provided inside the cavity, the membrane 820 of the cuvette or the bottom of the blister.

And 5, after the re-solution is inserted, releasing a button of the pipette gun to suck the liquid, and enabling the liquid in the re-solution carrier 800 to enter the pipette tip 100 to re-dissolve the freeze-dried reagent 130.

Preferably, in step 5, the reconstituted solution 110 and the lyophilized reagent 130 are thoroughly mixed and dissolved by pressing the pipette back and forth.

The pipette tip 100 is then removed from the pipette gun, which carries the pipette tip 100 with it, allowing for subsequent testing or testing.

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

1. A production process of a freeze-dried preparation is characterized by comprising the following steps:

step 1, operating a pipette tip (100) to suck quantitative stock solution, and operating the pipette tip (100) to suck trace air after the pipette tip (100) leaves a liquid level; a filter element (120) with a drying function is arranged at the upper part of the freeze-drying reagent (130) of the pipette tip (100);

step 2, putting the pipette tip (100) into freeze-drying equipment for freeze-drying;

and 3, sealing the freeze-dried pipette tip (100) at the wide-mouth end by using an aluminum foil sealing film (310), and sealing the freeze-dried pipette tip (100) at the small-mouth end by using paraffin (401).

2. The process for producing a lyophilized formulation according to claim 1, wherein:

the step 2 also comprises a pre-freezing step:

prefreezing a pipette tip (100) sucked with stock solution to crystallize all the stock solution into a solid state; the prefrozen pipette tip (100) is then placed into a lyophilization apparatus for lyophilization.

3. The process for producing a lyophilized formulation according to claim 2, wherein:

in the step 2, the pipette tip (100) is inserted into a refrigerant for prefreezing.

4. A process for the production of a lyophilized formulation according to claim 3, wherein:

the refrigerant is one or a combination of liquid nitrogen, dry ice and low-temperature alcohol.

5. A lyophilized preparation produced by the process according to claim 1.

6. A lyophilized reagent formulation cartridge, comprising:

comprises a housing (200);

the shell (200) is at least provided with a cavity which is through up and down;

a pipette tip (100) is arranged in the cavity, and a freeze-drying reagent (130) is stored at the bottom of the pipette tip (100);

a sealing piece (300) is arranged at the upper opening of the cavity,

a complex solution carrier (800) is hermetically connected to the lower opening of the cavity, and a complex solution (110) is stored in the complex solution carrier (800); a liquid bath film (820) is sealed at the opening of the compound solution carrier (800), the liquid bath film (820) faces to the pipette tip (100), and the small-mouth end of the pipette tip (100) is positioned at the upper part of the liquid bath film (820).

7. The lyophilized reagent formulation cartridge of claim 6, wherein:

the upper part of the freeze-drying reagent at the bottom of the pipette tip (100) is provided with a filter element (120).

8. The lyophilized reagent formulation cartridge of claim 6, wherein:

the compound solution carrier (800) is a bubble cap, and the liquid groove film (820) is an aluminum foil sealing film (310) or a paraffin waterproof layer arranged at the opening end of the bubble cap.

9. The lyophilized reagent formulation cartridge of claim 6, wherein:

the complex solution carrier (800) comprises:

a liquid storage cup (810) with a liquid tank on the upper part;

the liquid tank film (820) is arranged at the opening end of the liquid tank and is in sealing connection with the liquid storage cup (810), and the liquid tank film (820) is an aluminum foil sealing film (310) or a paraffin waterproof layer;

the upper end of the liquid storage cup (810) is hermetically connected with the lower opening of the cavity of the shell (200).

10. The lyophilized reagent formulation cartridge of claim 9, wherein:

the liquid storage cup (810) of the complex solution carrier (800) is in a V shape,

or, the bottom of the liquid storage cup (810) is provided with a groove matched with the shape of the small end of the pipette tip (100).

11. A lyophilized reagent formulation cartridge, comprising:

the method comprises the following steps: a housing (200);

the shell (200) is at least provided with a cavity with an upper opening,

a sealing piece (300) is arranged at the upper opening of the cavity,

a compound solution carrier (800) is arranged at the bottom of the cavity, and a compound solution (110) is stored in the compound solution carrier (800); a liquid bath film (820) is sealed at the opening of the compound solution carrier (800), the liquid bath film (820) faces to the pipette tip (100), and the small-mouth end of the pipette tip (100) is positioned at the upper part of the liquid bath film (820).

12. The lyophilized reagent formulation cartridge of claim 11, wherein:

13. The lyophilized reagent formulation cartridge of claim 11, wherein:

14. A lyophilized reagent preparation cartridge according to any one of claims 6-13, wherein:

the sealing member (300) is an aluminum foil sealing film (310) covering the upper part of the cavity,

or the sealing element (300) is a cover body (320) arranged at the upper part of the cavity body.

15. The lyophilized reagent formulation cartridge of claim 14, wherein:

the cover body (320) is of a hollow structure, a drying agent (400) is arranged in the cover body, an opening hole (321) is formed in the lower end of the cover body (320), and the opening hole (321) faces the pipette tip (100).

16. A lyophilized reagent preparation cartridge according to any one of claims 6-13, wherein:

a stabilizing mechanism is arranged in the cavity body,

the stabilizing mechanism comprises a pipette tip cup (600) and a liquid suction spring (700); the pipette tip cup (600) is arranged in the cavity of the shell (200) in a sliding manner; the pipette tip cup (600) is communicated up and down and is internally provided with a clamping bulge; the pipette tip (100) is inserted into the pipette tip cup (600), and the clamping bulge is abutted to the upper part of the pipette tip (100); the lower end of the liquid suction spring (700) is abutted against a boss arranged in the middle of the inner wall of the cavity of the shell (200), the upper end of the liquid suction spring is abutted against the bottom of the liquid suction head cup (600), and the liquid suction head cup (600) is supported by the liquid suction spring (700) and moves up and down in the cavity of the shell (200);

or the stabilizing mechanism is a positioning bracket which is arranged at the lower part of the inner wall of the cavity, one end of the positioning bracket is fixedly connected with the inner wall of the cavity, the other end of the positioning bracket is abutted against the pipette tip (100),

or the stabilizing mechanism is a conical spring matched with the pipette tip (100), and the pipette tip (100) is inserted into the conical spring.

17. The lyophilized reagent preparation cartridge of claim 15, wherein:

a stabilizing mechanism is arranged in the cavity body,

18. A lyophilized reagent preparation cartridge according to any one of claims 6-13, wherein:

support sleeves (290) with openings at two ends are arranged in the cavity, and the pipette tip (100) is inserted into the support sleeves (290).

19. The lyophilized reagent formulation cartridge of claim 18, wherein:

the support sleeve (290) is made of a molecular sieve desiccant material by pressing,

alternatively, the first and second electrodes may be,

the support sleeve (290) is made of flexible material.

20. The lyophilized reagent formulation cartridge of claim 18, wherein:

21. The lyophilized reagent formulation cartridge of claim 20, wherein:

22. The lyophilized reagent formulation cartridge of claim 18, wherein:

the section of the tube cavity of the support sleeve (290) is cylindrical;

or the like, or, alternatively,

the cross section of the tube cavity of the support sleeve (290) is trapezoidal,

or the like, or, alternatively,

the shape of the support sleeve (290) lumen matches the shape of the pipette tip (100).

23. A lyophilized reagent preparation cartridge according to any one of claims 6-13 or 17 or 19, wherein:

the number of the cavities on the shell (200) is 4 or 8.

24. A manufacturing method of a freeze-dried reagent preparation box is characterized by comprising the following steps: comprises the following steps

The housing (200) of the freeze-drying reagent preparation box is at least provided with a cavity with an upper opening and a lower closed part,

step 1: adding a complex solution (110) at the bottom of the cavity,

and step 3: then installing a pipette tip (100) above the paraffin water-resisting layer, wherein freeze-dried reagents are stored at the bottom of the pipette tip (100);

and 4, step 4: and a sealing piece is arranged at the upper opening of the cavity of the shell (200).

25. The method of making a lyophilized reagent formulation cartridge of claim 24, wherein:

26. The method of making a lyophilized reagent formulation cartridge of claim 24, wherein:

the outer side of the pipette tip (100) is sleeved with a support sleeve (290) with two open ends.

27. The method of making a lyophilized reagent formulation cartridge of claim 26, wherein:

the section of the tube cavity of the support sleeve (290) is cylindrical;

or the like, or, alternatively,

28. A method for reconstituting a lyophilized reagent, comprising:

use of a lyophilized reagent preparation kit according to any one of claims 6-13 or 17 or 19;

the method comprises the following steps:

step 1, removing a sealing member (300) at the upper part of the cavity;

step 3, butting and inserting the pipette gun with the wide-mouth end of a pipette tip (100) in the cavity;

step 4, pressing the pipette gun to drive the pipette tip (100) to move downwards, and after the pipette tip (100) moves to the bottom, piercing a liquid tank film (820) on the upper part of the redissolution carrier (800) by the tip of the pipette tip (100) to prick the tip of the pipette tip (100) into the redissolution (110);

and 5, releasing a button of the pipette gun to suck liquid, and enabling liquid in the redissolved liquid carrier (800) to enter the pipette tip (100) to redissolve the freeze-dried reagent (130).

29. A method of reconstituting a lyophilized reagent according to claim 28, wherein:

in step 5, the reconstituted solution (110) and the lyophilized reagent (130) are thoroughly mixed and dissolved by pressing the pipette back and forth.

30. A method of reconstituting a lyophilized reagent according to claim 28, wherein:

removing the seal (300) of the upper portion of the chamber in step 1 may include opening a lid (320) of the upper portion of the chamber or puncturing an aluminum foil sealing film (310) of the upper portion of the chamber with a pipette.