Tuberculin micro-needle patch as well as preparation method and application thereof

A tuberculin and microneedle sticking technology, applied in the medical field, can solve the problems of large side effects, waste, and difficulty in distinguishing active tuberculosis patients, and achieve the effects of simple result judgment, elimination of input doses, and avoidance of adverse reactions

Active Publication Date: 2018-03-23
HUBEI UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the routine clinical immunological diagnosis method is the tuberculin skin test (TST). The tuberculin pure protein derivative (PPD) is injected into the skin of the forearm with a syringe, and the results are observed for 24-72 hours by measuring the size of the redness and swelling of the skin. Judgment, although this method is simple, it has serious side effects after the skin test, and it is difficult to distinguish active tuberculosis patients, latent infection patients and BCG-immunized patients
In addition, the existing TST uses intradermal injection, and the PPD preparation needs to be stored at 4°C. Each PPD preparation is 1ml, and the amount of each inoculation is 100ul / person, which requires professional operators to accurately measure, and often There is waste due to insufficient number of vaccinators

Method used

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  • Tuberculin micro-needle patch as well as preparation method and application thereof
  • Tuberculin micro-needle patch as well as preparation method and application thereof
  • Tuberculin micro-needle patch as well as preparation method and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0043] Embodiment 1: A kind of preparation method of tuberculin microneedle patch, concrete steps are as follows:

[0044] (1) On the aseptic operation table, transfer 5 commercial tuberculin pure protein derivative (PPD) injections (20IU / 1ml / ampule) into the sterilized EP (7ml), place Freeze overnight in a -80°C refrigerator; open the frozen EP tube cap and seal it with a parafilm, prick a small hole in the parafilm with a needle, then place it in a vacuum freeze dryer at -40°C, and drain until it becomes Powder;

[0045] (2) Dissolve the powdery PPD in step (1) with 1ml sterile water, then the PPD specification after concentration is 100IU / ml;

[0046] (3) Weigh 150 mg powdered hyaluronic acid (HA), add it to the concentrated PPD to make a PPD-HA mixed solution with a concentration of 15%, and shake it at 4°C for 3 days;

[0047] (4) Take another 100mg HA and mix it in 1ml sterile water to prepare a 10% pedestal raw material solution for later use;

[0048] (5) Take out 5...

Embodiment 2

[0054] Embodiment 2: Using PPD microneedle patch to carry out transdermal test, the specific steps are as follows:

[0055] 1. Make the dyed microneedle that can be used for observing the result earlier by the method of embodiment 1, in its specific preparation process, in step (3), join 2mg rhodamine B dyestuff (SRB) to the PPD-HA that concentration is 15% in the mixed solution, placed at 4°C and mixed evenly, and then prepared into a dyed microneedle patch (such as Figure 3-1 );

[0056] 2. Take a Kunming mouse and inject 100l of lidocaine hydrochloride injection intraperitoneally. After anesthesia, cut off the hair on the lower back and depilate with depilatory cream to expose the skin. Wipe the depilated skin surface of the mouse with warm water; The prepared dyed microneedle patch was vertically and quickly pressed into the bare skin of the mouse, and pressed for 30 seconds. After the microneedle patch continued to stick on the mouse skin for 15 minutes, the microneedle...

Embodiment 3

[0058] Embodiment 3, for the mensuration of the PPD microneedle patch action time prepared in embodiment 1, specifically as follows:

[0059] Take 5 PPD microneedle patches prepared according to the preparation method in Example 1, and press them into the front skin of the volunteer's arm at the same time, and take off one patch at 15min, 30min, 1h, 2h, and 4h respectively, and put them at different times The microneedles on the patches that were removed were placed under a microscope for observation and photographed for comparison, and the best action time after the patches were pierced into the skin has been determined.

[0060] Before the PPD microneedle patch is pressed into the skin, the state schematic diagram of the microneedle observed by the microscope is as follows Pic 4-1 As shown, it is conical; the schematic diagram of the microneedle state after being pressed into the skin of the volunteer's forearm for 15 minutes is as follows Figure 4-2 As shown, the tip of ...

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Abstract

The invention discloses a tuberculin micro-needle patch as well as a preparation method and application thereof. The tuberculin micro-needle patch is prepared by the following steps: adding a micro-needle raw material solution, which is prepared by mixing tuberculin, a degradable material and sterile water, into a micro-needle template, wherein the concentration of the tuberculin is 20IU/ml to 200IU/ml and the mass percentage of the degradable material is 10 percent to 20 percent; after carrying out centrifuging treatment, removing part of the raw material on a needle hole of a micro-needle; adding a degradable material solution with the concentration of 5 percent to 10 percent; carrying out the centrifuging treatment again; putting the mixture into a drying oven and drying; then de-molding. The tuberculin micro-needle patch disclosed by the invention can be adhered to an adhesive tape and is directly stuck to skin through the adhesive tape so as to replace traditional injector intradermal vaccination; the total content of the tuberculin in the micro-needle patch is 0.05IU. The inoculation operation is simple and convenient and professional persons are not needed; the dosage of medicines is few and a phenomenon that bad skin response is easily generated by an injection skin test is avoided.

Description

technical field [0001] The invention belongs to the medical field, and in particular relates to a tuberculin microneedle patch and its preparation method and application. The microneedle patch can replace the traditional syringe intradermal inoculation method, and has no skin adverse reaction, and the interpretation of the result is simple and convenient. BCG immunizations can be distinguished. Background technique [0002] Tuberculosis is currently the most harmful bacterial infectious disease. One-third of the world's people are infected, and 5% to 10% of them will develop clinical diseases in their lifetime. According to the World Tuberculosis Report in 2016, there were about 10.4 million new cases and about 1.5 million deaths. At present, the "gold standard" for diagnosing tuberculosis sputum disease is still the method of smear microscopy and tuberculosis culture. The limitation is that the detection rate of sputum smear microscopy is low and the time of culture is too...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K47/34A61K47/36A61K47/42A61K49/00A61B10/00A61M37/00
CPCA61B10/00A61K9/0021A61K47/34A61K47/36A61K47/42A61K49/0006A61M37/0015A61M2037/0053A61M2037/0061
Inventor 陈凡周菁吴雨薇朱荣生贺丹薛云
Owner HUBEI UNIV
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