A tuberculin microneedle patch and its preparation method and application
A tuberculin and microneedle sticking technology, applied in the medical field, can solve problems such as large side effects, difficulty in distinguishing active tuberculosis patients, and waste, and achieve the effects of simple result judgment, avoiding adverse reactions, and eliminating input doses
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Embodiment 1
[0043] Example 1: A preparation method of tuberculin microneedle patch, the specific steps are as follows:
[0044] (1) On the aseptic operation table, transfer the purchased 5 commercial tuberculin pure protein derivative (PPD) injections (20IU / 1ml / ampule) to the sterilized EP (7ml), and place them in Frozen overnight in the refrigerator at -80℃; open the lid of the frozen EP tube and seal it with a parafilm, use a needle to make a small hole in the parafilm, then place it in a vacuum freeze dryer at -40℃ and drain until it becomes Powdery
[0045] (2) Dissolve the powdered PPD in step (1) with 1ml of sterile water, then the PPD specification after concentration is 100IU / ml;
[0046] (3) Weigh 150 mg of powdered hyaluronic acid (HA) and 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 100 mg of HA and mix well in 1 ml of sterile water to prepare a 10% base material solution for later...
Embodiment 2
[0054] Example 2: A PPD microneedle patch is used for a skin penetration test, the specific steps are as follows:
[0055] 1. According to the method of Example 1, make dyed microneedles that can be used to observe the results. In the specific preparation process, in step (3), 2 mg of rhodamine B dye (SRB) is added to the PPD-HA with a concentration of 15% In the mixed solution, place it at 4℃ and mix well, and then prepare a dyed microneedle patch (such as Figure 3-1 ) Shows;
[0056] 2. Take a Kunming mouse and inject 100l lidocaine hydrochloride injection into the abdominal cavity. After anesthesia, cut off the hair on the lower back, and use depilatory cream to remove the hair to expose the skin, and wipe the mouse's depilated skin surface with warm water; The prepared dyed microneedle patch was pressed vertically and quickly into the exposed skin of the mouse and pressed for 30 seconds. After the microneedle patch was applied to the mouse skin for 15 minutes, remove the micro...
Embodiment 3
[0058] Example 3, for the determination of the action time of the PPD microneedle patch prepared in Example 1, is 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 volunteers' arms at the same time, and take off one patch at 15min, 30min, 1h, 2h, and 4h. The microneedles on the patch removed from the section were observed under a microscope and photographed for comparison. The best action time after the patch penetrated the skin has been determined.
[0060] Before the PPD microneedle patch was pressed into the skin, the state of the microneedle was observed under a microscope. Pic 4-1 As shown, it has a conical shape; the state of the microneedle after 15 minutes of pressing into the skin of the volunteer’s forearm is as Figure 4-2 As shown, the tip of the microneedle began to slowly dissolve; a schematic diagram of the microneedle state after 30 minutes of pressing...
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