A photosensitizing drug oral solution and preparation method thereof

Abstract

The present invention relates to the field of pharmaceutical preparations, and specifically provides a photosensitive drug oral solution and a preparation method thereof. The photosensitive drug oral solution comprises a pharmaceutical active ingredient and a carrier acrylic resin, wherein the acrylic resin is a copolymer of methacrylic acid and methyl methacrylate, wherein the ratio of methacrylic acid to methyl methacrylate is 1:1 to 1:2; and / or, the acrylic resin is a copolymer of methacrylic acid and ethyl acrylate, wherein the ratio of methacrylic acid to ethyl acrylate is 1:1 to 1:2. The photosensitive drug oral solution of the present invention contains a specific carrier acrylic resin, the surface of the acrylic resin has an electric charge, and relies on the charge attraction to form micelles with the pharmaceutical active ingredient to encapsulate it, which can effectively improve the light stability of the pharmaceutical active ingredient, and avoid the influence of metal elements in the glass bottle on the product quality, thereby improving the clinical effectiveness and safety of the product.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical preparations, and in particular to a photosensitizing drug oral solution and a preparation method thereof. Background Art

[0002] Sertraline hydrochloride, chemically known as (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthyridinamine hydrochloride, is indicated for the treatment of symptoms associated with depression, including depression with anxiety, with or without a history of mania. After achieving satisfactory treatment, continued use of sertraline hydrochloride can effectively prevent relapse and recurrence of depression. Sertraline hydrochloride is also used to treat obsessive-compulsive disorder. After a response to initial treatment, sertraline maintains its effectiveness, safety, and tolerability for up to two years in the treatment of obsessive-compulsive disorder.

[0003] Sertraline hydrochloride is unstable to light and easily degrades under light conditions to produce Impurity V [(1RS,4RS)-4-(3-chlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthylamine]. Currently, sertraline hydrochloride products on the market are primarily oral solid dosage forms, with some oral solution preparations also available. However, all oral solutions are packaged in brown glass bottles to protect against light. The brown glass bottle light-shielding principle is to add metal oxide masterbatches such as copper, manganese, cobalt, nickel, barium, and chromium to the glass material as a light-shielding material to achieve this purpose. Sertraline hydrochloride is sensitive to metal ions. If packaged in brown glass bottles, the metal oxide additives in the glass bottles will affect product quality over time, causing the increase of Impurity V and affecting the product's clinical safety.

[0004] There are many drugs that are unstable to light, such as sertraline hydrochloride. Therefore, it is necessary to provide an oral solution for photosensitive drugs to enhance their light stability so that they can be packaged in transparent glass bottles. Summary of the Invention

[0005] In view of the deficiencies in the prior art, the present invention provides a photosensitizing drug oral solution and a preparation method thereof.

[0006] The present invention provides a photosensitive drug oral solution, comprising a pharmaceutical active ingredient and a carrier acrylic resin, wherein the acrylic resin is a copolymer of methacrylic acid and methyl methacrylate, wherein the ratio of methacrylic acid to methyl methacrylate is 1:1 to 1:2;

[0007] And / or, the acrylic resin is a copolymer of methacrylic acid and ethyl acrylate, wherein the ratio of methacrylic acid to ethyl acrylate is 1:1 to 1:2.

[0008] The present invention uses a specific acrylic resin with an electric charge on its surface. By relying on the charge attraction, it forms micelles with the active pharmaceutical ingredient to coat the active pharmaceutical ingredient, effectively improving the light stability of the active pharmaceutical ingredient and preventing the degradation of light-sensitive drugs such as sertraline hydrochloride under light conditions to produce impurities. Furthermore, the present invention can use colorless transparent glass bottles to package oral solutions of photosensitive drugs, avoiding the use of brown glass bottles to package them, where metal elements may affect product quality. Acrylic resin is a general term for polymers of acrylic acid, methacrylic acid, and their derivatives. Those skilled in the art know that its solubility is pH-dependent, allowing it to withstand gastric acid erosion and can be used to coat enteric-coated tablets to prevent the drug from being released and absorbed in the stomach. However, the present invention unexpectedly discovered that a specific acrylic resin can form micelles around the active pharmaceutical ingredient in a solution state due to the adsorption effect of the surface charge, thereby effectively isolating the active pharmaceutical ingredient from light and metal ions. This is something that those skilled in the art would not have expected based on the properties of acrylic resin.

[0009] In some embodiments of the present invention, the acrylic resin is one or more of a 1:1 copolymer of methacrylic acid and methyl methacrylate, a 1:2 copolymer of methacrylic acid and methyl methacrylate, a 1:1 copolymer of methacrylic acid and ethyl acrylate, and a 1:2 copolymer of methacrylic acid and ethyl acrylate.

[0010] In some embodiments of the present invention, the acrylic resin is a product of Evonik Operations GmbH, Germany, wherein the 1:1 copolymer of methacrylic acid and methyl methacrylate is model L100, the 1:2 copolymer of methacrylic acid and methyl methacrylate is model S100, the 1:1 copolymer of methacrylic acid and ethyl acrylate is model L100-55, and the 1:2 copolymer of methacrylic acid and ethyl acrylate is model L30D-55.

[0011] Preferably, in some embodiments of the present invention, the acrylic resin is model L30D-55 produced by Evonik Operations GmbH of Germany.

[0012] According to the photosensitivity drug oral solution provided by the present invention, the molecular weight of the active ingredient of the drug is less than 400, the solubility in ethanol is greater than 50 mg / ml, and the drug is sensitive to light.

[0013] In some embodiments of the present invention, the pharmaceutically active ingredient is sertraline hydrochloride, atomoxetine hydrochloride, montelukast sodium or clenbuterol.

[0014] In some embodiments of the present invention, the mass of the acrylic resin is 1.5-2 times the mass of the active pharmaceutical ingredient. This amount is within the safe dosage range for oral administration of acrylic resin.

[0015] In some embodiments of the present invention, the oral solution for photosensitizing drugs also includes glycerol and ethanol. Ethanol serves as a solvent for dissolving the active pharmaceutical ingredient and the acrylic resin. Glycerol, a colorless, clear, viscous liquid, is fully miscible with ethanol and serves as both a solvent and a thickener in the oral solution of the present invention.

[0016] In some embodiments of the present invention, the photosensitizing drug oral solution further comprises a preservative, and the preservative is one or more of butylated hydroxytoluene, tert-butylated hydroxyanisole, vitamin E, and ascorbyl palmitate.

[0017] In some embodiments of the present invention, the photosensitizing drug oral solution further comprises a flavoring agent, wherein the flavoring agent is one or more of menthol and fruit flavor, for example, orange flavor or strawberry flavor.

[0018] In some embodiments of the present invention, the pharmaceutical active ingredient is sertraline hydrochloride. The composition of the sertraline hydrochloride oral solution is as follows, calculated by weight percentage:

[0019]

[0020]

[0021] Wherein, the acrylic resin is a copolymer of methacrylic acid and methyl methacrylate, wherein the ratio of methacrylic acid to methyl methacrylate is 1:1 to 1:2;

[0022] Alternatively, the acrylic resin is a copolymer of methacrylic acid and ethyl acrylate, wherein the ratio of methacrylic acid to ethyl acrylate is 1:1 to 1:2.

[0023] The sertraline hydrochloride oral solution provided by the present invention is light-stable and can be packaged in transparent glass bottles. This can effectively prevent sertraline hydrochloride from degrading under light conditions to produce impurity V, and avoid the impact of metal elements in the glass bottles on product quality, thereby improving the clinical effectiveness and safety of the product. The solution can be used to treat symptoms related to depression, including depression accompanied by anxiety, with or without a history of mania.

[0024] In a preferred embodiment of the present invention, the composition of the sertraline hydrochloride oral solution is as follows, calculated in percentage by mass:

[0025]

[0026] It should be noted that the sertraline hydrochloride used in the oral solution of the present invention is a sertraline hydrochloride bulk drug with a purity of 99.8% and a property of being an off-white crystalline powder.

[0027] On the other hand, the present invention also provides a method for preparing the above-mentioned photosensitizing drug oral solution.

[0028] The preparation method provided by the present invention comprises: mixing the active ingredient of the medicine, acrylic resin and ethanol at room temperature until they are completely dissolved, then adding a preservative, part of glycerin and a flavoring agent to dissolve them, adding the remaining glycerin to make up the volume, and filtering.

[0029] The preparation method of the present invention is simple, and after preparation, the product can be packaged in transparent glass bottles at a lower price. It will basically not deteriorate during long-term storage, thereby ensuring the clinical effectiveness and safety of the product.

[0030] The present invention provides a photosensitizing drug oral solution and a preparation method thereof. The oral solution contains a specific carrier acrylic resin. The acrylic resin has an electric charge on its surface and forms micelles with the active pharmaceutical ingredient by charge attraction to encapsulate the active pharmaceutical ingredient. This can effectively improve the light stability of the active pharmaceutical ingredient, avoid the influence of metal elements in the glass bottle on the product quality, and improve the clinical effectiveness and safety of the product.

[0031] In the description of this specification, the reference terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" mean that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the embodiment of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art can combine and combine different embodiments or examples described in this specification and features of different embodiments or examples without contradiction. DETAILED DESCRIPTION

[0032] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention are clearly and completely described below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0033] Unless otherwise specified, the raw materials involved in the embodiments of the present invention can be obtained commercially.

[0034] In the following examples, the acrylic resin used is a product of Evonik Operations GmbH, Germany, and the chemical composition of each type is as follows:

[0035] L30D-55 (30% aqueous dispersion): methacrylic acid and ethyl acrylate (1:2) copolymer;

[0036] L100-55 (100%): methacrylic acid and ethyl acrylate (1:1) copolymer;

[0037] L100 (100%): methacrylic acid and methyl methacrylate (1:1) copolymer;

[0038] S100 (100%): methacrylic acid and methyl methacrylate (1:2) copolymer;

[0039] E100 (100%): butyl methacrylate, dimethylaminoethyl methacrylate and methyl methacrylate (1:2:1) copolymer;

[0040] NE30D (100%): copolymer of ethyl acrylate and methyl methacrylate (2:1).

[0041] Example 1

[0042] This embodiment provides a sertraline hydrochloride oral solution, which has the following composition:

[0043]

[0044] Note: Acrylic resin L30D-55 is a 30% aqueous dispersion. The feeding amount is 8.3g×30%=2.5g, which is equivalent to 2.5g of acrylic resin L30D-55.

[0045] This embodiment also provides a preparation method of the above-mentioned sertraline hydrochloride oral solution, which is as follows:

[0046] (1) Liquid preparation: At room temperature, weigh the prescribed amount of ethanol into a beaker, add the prescribed amount of sertraline hydrochloride API and acrylic resin L30D-55, and stir continuously for 3 hours until completely dissolved. Then, add the prescribed amount of butylated hydroxytoluene and stir to dissolve. Add 50% of the prescribed amount of glycerol and stir evenly. Then, add the prescribed amount of menthol and stir to dissolve.

[0047] (2) Make up the volume: add glycerol to the prescribed volume;

[0048] (3) Filtration: Filter using a 10 μm polypropylene membrane;

[0049] (4) Filling: Packed in colorless transparent glass bottles, 60ml / bottle.

[0050] Example 2

[0051] This embodiment provides a sertraline hydrochloride oral solution, which has the following composition:

[0052]

[0053]

[0054] Note: Acrylic resin L30D-55 is a 30% aqueous dispersion. The feeding amount is 8.3g×30%=2.5g, which is equivalent to 2.5g of acrylic resin L30D-55.

[0055] This embodiment also provides a preparation method of the above-mentioned sertraline hydrochloride oral solution, which is as follows:

[0056] (1) Liquid preparation: At room temperature, weigh the prescribed amount of ethanol into a beaker, add the prescribed amount of sertraline hydrochloride API and acrylic resin L30D-55, and stir continuously for 3 hours until completely dissolved. Then, add the prescribed amount of butylated hydroxytoluene and stir to dissolve. Add 50% of the prescribed amount of glycerol and stir evenly. Then, add the prescribed amount of menthol and stir to dissolve.

[0057] (2) Make up the volume: add glycerol to the prescribed volume;

[0058] (3) Filtration: Filter using a 10 μm polypropylene membrane;

[0059] (4) Filling: Packaged in brown transparent glass bottles, 60ml / bottle.

[0060] Example 3

[0061] This embodiment provides a sertraline hydrochloride oral solution, which has the following composition:

[0062]

[0063] Note: Acrylic resin L30D-55 is a 30% aqueous dispersion. The feeding amount is 8.0g×30%=2.4g, which is equivalent to 2.4g of acrylic resin L30D-55.

[0064] This embodiment also provides a preparation method of the above-mentioned sertraline hydrochloride oral solution, which is as follows:

[0065] (1) Liquid preparation: At room temperature, weigh the prescribed amount of ethanol into a beaker, add the prescribed amount of sertraline hydrochloride API and acrylic resin L30D-55, and stir continuously for 3 hours until completely dissolved. Then, add the prescribed amount of butylated hydroxytoluene and stir to dissolve. Add 50% of the prescribed amount of glycerol and stir evenly. Then, add the prescribed amount of menthol and stir to dissolve.

[0066] (2) Make up the volume: add glycerol to the prescribed volume;

[0067] (3) Filtration: Filter using a 10 μm polypropylene membrane;

[0068] (4) Filling: Packed in colorless transparent glass bottles, 60ml / bottle.

[0069] Example 4

[0070] This embodiment provides a sertraline hydrochloride oral solution, which has the following composition:

[0071]

[0072] This embodiment also provides a preparation method of the above-mentioned sertraline hydrochloride oral solution, which is as follows:

[0073] (1) Liquid preparation: At room temperature, weigh the prescribed amount of ethanol into a beaker, add the prescribed amount of sertraline hydrochloride API and acrylic resin S100, and stir continuously for 3 hours until completely dissolved. Then, add the prescribed amount of butylated hydroxytoluene and stir to dissolve. Add 50% of the prescribed amount of glycerol and stir evenly. Then, add the prescribed amount of menthol and stir to dissolve.

[0074] (2) Make up the volume: add glycerol to the prescribed volume;

[0075] (3) Filtration: Filter using a 10 μm polypropylene membrane;

[0076] (4) Filling: Packed in colorless transparent glass bottles, 60ml / bottle.

[0077] Example 5

[0078] This embodiment provides a sertraline hydrochloride oral solution, which has the following composition:

[0079]

[0080]

[0081] This embodiment also provides a preparation method of the above-mentioned sertraline hydrochloride oral solution, which is as follows:

[0082] (1) Liquid preparation: At room temperature, weigh the prescribed amount of ethanol into a beaker, add the prescribed amount of sertraline hydrochloride API and acrylic resin L100-55, and stir continuously for 3 hours until completely dissolved. Then, add the prescribed amount of butylated hydroxyanisole and stir to dissolve. Add 50% of the prescribed amount of glycerol and stir evenly. Then, add the prescribed amount of strawberry essence and stir to dissolve.

[0083] (2) Make up the volume: add glycerol to the prescribed volume;

[0084] (3) Filtration: Filter using a 10 μm polypropylene membrane;

[0085] (4) Filling: Packed in colorless transparent glass bottles, 60ml / bottle.

[0086] Example 6

[0087] This embodiment provides a sertraline hydrochloride oral solution, which has the following composition:

[0088]

[0089] This embodiment also provides a preparation method of the above-mentioned sertraline hydrochloride oral solution, which is as follows:

[0090] (1) Liquid preparation: At room temperature, weigh the prescribed amount of ethanol into a beaker, add the prescribed amount of sertraline hydrochloride API and acrylic resin L100, and stir continuously for 3 hours until completely dissolved. Then, add the prescribed amount of butylated hydroxyanisole and stir to dissolve. Add 50% of the prescribed amount of glycerol and stir evenly. Then, add the prescribed amount of strawberry essence and stir to dissolve.

[0091] (2) Make up the volume: add glycerol to the prescribed volume;

[0092] (3) Filtration: Filter using a 10 μm polypropylene membrane;

[0093] (4) Filling: Packed in colorless transparent glass bottles, 60ml / bottle.

[0094] Example 7

[0095] This embodiment provides an atomoxetine hydrochloride oral solution, which has the following composition:

[0096]

[0097] Note: Acrylic resin L30D-55 is a 30% aqueous dispersion. The dosage is 1.5g x 30% = 0.45g, which is equivalent to 0.45g of acrylic resin L30D-55.

[0098] This embodiment also provides a preparation method of the atomoxetine hydrochloride oral solution, which is as follows:

[0099] (1) Liquid preparation: At room temperature, weigh the prescribed amount of ethanol into a beaker, add the prescribed amount of atomoxetine hydrochloride API and acrylic resin L30D-55, and stir continuously for 3 hours until completely dissolved. Then, add the prescribed amount of butylated hydroxyanisole and stir to dissolve. Add 50% of the prescribed amount of glycerol and stir evenly. Then, add the prescribed amount of strawberry essence and stir to dissolve.

[0100] (2) Make up the volume: add glycerol to the prescribed volume;

[0101] (3) Filtration: Filter using a 10 μm polypropylene membrane;

[0102] (4) Filling: Packed in colorless transparent glass bottles, 60ml / bottle.

[0103] Comparative Example 1

[0104] This comparative example provides a sertraline hydrochloride oral solution, which has the following composition:

[0105]

[0106] This comparative example also provides a preparation method of the above-mentioned sertraline hydrochloride oral solution, which is as follows:

[0107] (1) Liquid preparation: At room temperature, weigh the prescribed amount of ethanol into a beaker, add the prescribed amount of sertraline hydrochloride API and stir until completely dissolved, then add the prescribed amount of butylated hydroxytoluene and stir to dissolve, add 50% of the prescribed amount of glycerol and stir evenly, then add the prescribed amount of menthol and stir to dissolve;

[0108] (2) Make up the volume: add glycerol to the prescribed volume;

[0109] (3) Filtration: Filter using a 10 μm polypropylene membrane;

[0110] (4) Filling: Packed in colorless transparent glass bottles, 60ml / bottle.

[0111] Comparative Example 2

[0112] This comparative example provides a sertraline hydrochloride oral solution, which has the following composition:

[0113]

[0114] This comparative example also provides a preparation method of the above-mentioned sertraline hydrochloride oral solution, which is as follows:

[0115] (1) Liquid preparation: At room temperature, weigh the prescribed amount of ethanol into a beaker, add the prescribed amount of sertraline hydrochloride API and stir until completely dissolved, then add the prescribed amount of butylated hydroxytoluene and stir to dissolve, add 50% of the prescribed amount of glycerol and stir evenly, then add the prescribed amount of menthol and stir to dissolve;

[0116] (2) Make up the volume: add glycerol to the prescribed volume;

[0117] (3) Filtration: Filter using a 10 μm polypropylene membrane;

[0118] (4) Filling: Packaged in brown transparent glass bottles, 60ml / bottle.

[0119] Comparative Example 3

[0120] This comparative example provides a sertraline hydrochloride oral solution, which has the following composition:

[0121]

[0122]

[0123] This comparative example also provides a preparation method of the above-mentioned sertraline hydrochloride oral solution, which is as follows:

[0124] (1) Liquid preparation: At room temperature, weigh the prescribed amount of ethanol into a beaker, add the prescribed amount of sertraline hydrochloride API and acrylic resin E100, and stir continuously for 3 hours until completely dissolved. Then, add the prescribed amount of butylated hydroxytoluene and stir to dissolve. Add 50% of the prescribed amount of glycerol and stir evenly. Then, add the prescribed amount of menthol and stir to dissolve.

[0125] (2) Make up the volume: add glycerol to the prescribed volume;

[0126] (3) Filtration: Filter using a 10 μm polypropylene membrane;

[0127] (4) Filling: Packed in colorless transparent glass bottles, 60ml / bottle.

[0128] Comparative Example 4

[0129] This comparative example provides a sertraline hydrochloride oral solution, which has the following composition:

[0130]

[0131] This comparative example also provides a preparation method of the above-mentioned sertraline hydrochloride oral solution, which is as follows:

[0132] (1) Liquid preparation: At room temperature, weigh the prescribed amount of ethanol into a beaker, add the prescribed amount of sertraline hydrochloride API and acrylic resin NE30D, and stir continuously for 3 hours until completely dissolved. Then, add the prescribed amount of butylated hydroxytoluene and stir to dissolve. Add 50% of the prescribed amount of glycerol and stir evenly. Then, add the prescribed amount of menthol and stir to dissolve.

[0133] (2) Make up the volume: add glycerol to the prescribed volume;

[0134] (3) Filtration: Filter using a 10 μm polypropylene membrane;

[0135] (4) Filling: Packed in colorless transparent glass bottles, 60ml / bottle.

[0136] Performance testing

[0137] The stability of the sertraline hydrochloride oral solutions obtained in the examples and comparative examples was tested, and the test results are shown in Table 1. Liquid chromatography was used to detect the content of each impurity, and the detection conditions were in accordance with USP2022 standards. The chemical names of the impurities are as follows:

[0138] Impurity III: (1RS,4RS)-N-methyl-4-phenyl-1,2,3,4-tetrahydro-1-naphthylamine;

[0139] Impurity IV: (1RS,4RS)-4-(4-chlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthylamine;

[0140] Impurity V: (1RS,4RS)-4-(3-chlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthylamine;

[0141] Impurity VI: (2R)-hydroxyphenylacetic acid (R-mandelic acid);

[0142] Impurity VII: (4R)-4-(3,4-dichlorophenyl)-3,4-dihydro-1(2H)-naphthalenone;

[0143] Impurity IX: (1RS,4RS)-4-(2,3-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthylamine.

[0144] Table 1

[0145]

[0146]

[0147]

[0148] Stability test results show that oral solutions prepared with acrylic resin-coated sertraline hydrochloride API are relatively stable under light conditions, regardless of whether packaged in colorless, transparent glass bottles or brown glass bottles. However, oral solutions prepared without acrylic resin-coated sertraline hydrochloride API exhibited rapid growth of impurity V under light conditions when packaged in colorless, transparent glass bottles, and at elevated temperatures when packaged in brown glass bottles, indicating product instability. The acrylic resin is preferably a copolymer of methacrylic acid and methyl methacrylate, wherein the ratio of methacrylic acid to methyl methacrylate is between 1:1 and 1:2; or preferably a copolymer of methacrylic acid and ethyl acrylate, wherein the ratio of methacrylic acid to ethyl acrylate is between 1:1 and 1:2.

[0149] Similarly, the stability test of the atomoxetine hydrochloride oral solution of Example 7 was carried out. The results showed that the oral solution preparation prepared by coating the atomoxetine hydrochloride raw material with acrylic resin was not easily degraded and had stable quality.

[0150] In summary, the oral solution preparation prepared by coating the photosensitive drug with a specific acrylic resin has good stability and can be packaged in either colorless transparent glass bottles or brown glass bottles.

[0151] Although the present invention has been described in detail above using general descriptions and specific embodiments, it will be apparent to those skilled in the art that modifications and improvements may be made based on the present invention. Therefore, such modifications and improvements, which do not depart from the spirit of the present invention, are intended to be within the scope of protection claimed herein.

Claims

1. A photosensitizing drug oral solution, characterized in that: The invention comprises a pharmaceutical active ingredient, a carrier acrylic resin, glycerol and ethanol, wherein the pharmaceutical active ingredient is sertraline hydrochloride, and the acrylic resin is a copolymer of methacrylic acid and methyl methacrylate, wherein the ratio of methacrylic acid to methyl methacrylate is 1:1 to 1:2; And / or, the acrylic resin is a copolymer of methacrylic acid and ethyl acrylate, wherein the ratio of methacrylic acid to ethyl acrylate is 1:1 to 1:

2.

2. The photosensitizing drug oral solution according to claim 1, characterized in that: The acrylic resin is one or more of a 1:1 copolymer of methacrylic acid and methyl methacrylate, a 1:2 copolymer of methacrylic acid and methyl methacrylate, a 1:1 copolymer of methacrylic acid and ethyl acrylate, and a 1:2 copolymer of methacrylic acid and ethyl acrylate.

3. The photosensitizing drug oral solution according to claim 1, characterized in that: The molecular weight of the active pharmaceutical ingredient is less than 400, the solubility in ethanol is greater than 50 mg / ml, and the active pharmaceutical ingredient is sensitive to light.

4. The photosensitizing drug oral solution according to claim 1, characterized in that: The mass of the acrylic resin is 1.5-2 times that of the active ingredient of the medicine.

5. The photosensitizing drug oral solution according to claim 2, characterized in that: The mass of the acrylic resin is 1.5-2 times that of the active ingredient of the medicine.

6. The photosensitizing drug oral solution according to claim 3, characterized in that: The mass of the acrylic resin is 1.5-2 times that of the active ingredient of the medicine.

7. The photosensitizing drug oral solution according to any one of claims 1 to 6, characterized in that: The photosensitive drug oral solution further comprises a preservative, which is one or more of butylated hydroxytoluene, tert-butylated hydroxyanisole, vitamin E, and ascorbyl palmitate.

8. The oral solution for photosensitizing drugs according to any one of claims 1 to 6, characterized in that: The photosensitizing drug oral solution further comprises a flavoring agent, which is one or more of menthol and fruit flavor.

9. The photosensitizing drug oral solution according to claim 3, characterized in that: The active ingredient of the drug is sertraline hydrochloride. Calculated by mass percentage, the composition of the sertraline hydrochloride oral solution is as follows: Sertraline hydrochloride 1.5-2.5% Glycerol 80-85% Ethanol 10-15% Preservatives 0.01-0.1% Flavoring agent 0.01-0.1% Acrylic resin 2.5-5%.

10. The method for preparing the oral solution of photosensitizing drug according to any one of claims 1 to 9, characterized in that: include: At room temperature, the active pharmaceutical ingredient, acrylic resin and ethanol are mixed until completely dissolved, and then a preservative, part of the glycerin and a flavoring agent are added to dissolve them, and the remaining glycerin is added to make up the volume and filtered.

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