Composition of 5-aminolevulinic acid and derivative thereof as well as application thereof
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A technology of aminolevulinic acid and a composition, applied in the field of medicine, can solve problems such as poor treatment effect, decreased dosage, gel shedding, etc., so as to improve bioavailability, increase permeability, and improve patient discomfort. Effect
Active Publication Date: 2010-06-23
上海复旦张江生物医药股份有限公司
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Problems solved by technology
Therefore, although the gel will adhere to the inner wall of the cavity according to the physiological structure of the administration site after entering, reducing the loss of ALA to a certain extent, it is still necessary to clean the cavity before administration, especially with the
Method used
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Embodiment 1
[0028] Prescription: (based on 1000 bottles)
[0029] Aminolevulinic acid hydrochloride 400g
[0030] Ethylparaben 0.9g
[0031] Edetate Disodium 7.5g
[0032] Povidone 30.0g
[0033] Pepsin 9.0g
[0034] Accurately weigh ethylparaben, povidone, and disodium edetate and put them in a 100ml beaker, add 100ml of 10% ethanol solution, stir to dissolve each auxiliary material, filter through a 0.8μm microporous membrane, and use the filtrate Small spray dryer (Buchi191 spray dryer, Switzerland) spray drying, spray drying conditions are as follows: inlet temperature: 140 ° C; outlet temperature: 86 ~ 94 ° C; vortex mixer: 80%; compressed air flow: 600 ~ 700 L / h ; Feed rate: 10%. Collect the powder in a collector.
[0035] Grind aminolevulinic acid hydrochloride through 80 mesh sieve, then mix with pepsin and the above powder, pass through 80 mesh sieve twice, add appropriate amount of ethanol solution, make soft material, granulate with 20 mesh sieve, and dry at 30°C with c...
Embodiment 2
[0038] Prescription: (based on 1000 bottles)
[0039] Aminolevulinic acid hydrochloride 100g
[0040] Pepsin 30.0g
[0041] Weigh 100g of aminolevulinic acid hydrochloride and pulverize it through an 80-mesh sieve, then mix it evenly with 30.0g of pepsin powder, pass through an 80-mesh sieve twice to obtain a powdery solid, and pack it separately.
[0042] When using, dissolve the powder in an appropriate amount of water and rub it on.
Embodiment 3
[0044] Prescription: (based on 1000 bottles)
[0045] Aminolevulinic acid hydrochloride 2000g
[0046] Pepsin 0.06g
[0047] Weigh 2000g of aminolevulinic acid hydrochloride and pulverize it through an 80-mesh sieve, then mix it evenly with 0.06g of pepsin powder, pass through an 80-mesh sieve twice to obtain a powdery solid, and pack it separately.
[0048] When using, dissolve the powder in an appropriate amount of water and rub it on.
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Abstract
The invention relates to the technical field of medicines, in particular relating to a composition of 5-aminolevulinic acid and a derivative thereof as well as application thereof. The composition of the 5-aminolevulinic acid and the derivative thereof disclosed in the invention comprises an effective dose of active constituent of the 5- aminolevulinic acid and the derivative thereof, and is characterized in that the composition also comprises proteolytic enzyme which is 0.035-277U per gram of the composition. The invention simultaneously discloses the application of the composition in the preparation of medicines for treating gynecological diseases. The composition can effectively improve the influence of cervical mucus on an active constituent ALA and a derivative thereof, enhances the permeability of the active constituent ALA and the derivative thereof in the cervical part, and improves the bioavailability of the ALA and the derivative thereof. The composition not only greatly improves the effect of the ALA and the derivative thereof on treating the gynecological diseases and in particular the cervical diseases, but also ameliorates the disamenity of the patients in the traditional treating process.
Description
technical field [0001] The invention relates to the technical field of medicine, in particular to a composition of 5-aminolevulinic acid and its derivatives and its application. Background technique [0002] 5-Aminolevulinic acid (δ-aminolevulinic acid, ALA) and its derivatives are commonly used photodynamic therapy drugs, and the products already on the market include 5-aminolevulinic acid hydrochloride, 5-aminolevulinic acid methyl and hexyl 5-aminolevulinate. After entering the human body, it is transformed into hematoporphyrin (ProtorphyrinIX, PpIX) and stays in the body. After being illuminated by a specific wavelength, it will generate reactive oxygen species such as singlet oxygen and other free radicals and kill pathogenic cells (cancer cells, HPV and HSV infected cells) cells, wart cells), while adjacent normal tissue cells are not affected in any way. Clinically, 5-aminolevulinic acid (ALA) and its derivatives are used to treat acne, genital warts, actinic kerato...
Claims
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