Bai-muxiang fruit peel extract, pharmaceutical composition thereof, and preparation method and application thereof

Abstract

To provide a Buxaceae Aquilaria plant Aquilaria sinensis[ Aquilaria sinensis ​ The application provides a fruit peel extract (PGB-B) of Aquilaria sinensis (Lour.) Spreng. and a pharmaceutical composition and a preparation method thereof, and application of the fruit peel extract in preparation of a medicine for treating psoriasis. The application belongs to the technical field of medicines. The fruit peel of dried Aquilaria sinensis is extracted by using water-containing ethanol, and PGB-B is prepared by using water solubility difference. In a mouse psoriasis model induced by imiquimod, after treatment by PGB-B, a psoriasis lesion area and a severity index (PASI) score are obviously reduced, skin thickness is reduced, and a spleen coefficient is reduced, which shows a significant treatment effect. PGB-B and different combinations thereof are new choices for treating psoriasis.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to the extract of Aquilaria sinensis (Lour.) Spreng. fruit peel (PGB-B), its pharmaceutical compositions and preparations, their preparation methods, and their application in the preparation of drugs for treating psoriasis. Background Technology

[0002] Psoriasis is a common chronic papular squamous skin disease that occurs worldwide, affecting more than 60 million adults and children globally, placing a huge burden on individuals and society [Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet, 2021, 397(10281):1301–1315]. Although there are currently various treatments for psoriasis, most patients only achieve clinical remission, and relapse remains a challenge in the treatment of psoriasis, which also causes serious psychological and physical harm to patients [Wang Wenqiu, Wang Rui, Li Chengxin. Progress in immunological research on psoriasis relapse. Chinese Journal of Leprosy and Dermatology, 2023, 39(11):845–850]. Therefore, the development of new drugs for the treatment of psoriasis is urgently needed.

[0003] Aquilaria sinensis (Lour.) Spreng., also known as native agarwood, is a plant belonging to the genus Aquilaria in the family Thymelaeaceae. It is the original plant of the traditional Chinese medicine agarwood, and the medicinal part is the resinous heartwood. There is no record of medicinal use for the pericarp of Aquilaria sinensis. The main planting areas of Aquilaria sinensis in my country are Guangdong, Hainan, Yunnan, Guangxi and Fujian. According to incomplete statistics, the planting area of ​​Aquilaria sinensis in China is about 30,000 hectares [Gan Changtao, He Haishan, Wang Yue, Qiu Jian. Study on the characteristics of Aquilaria sinensis bark fiber. Forest Products Industry, 2021, 58(12):1–6]. A large amount of pericarp is produced every year and is discarded, resulting in a great waste of biological resources. At present, there are no reports on the Aquilaria sinensis pericarp extract (PGB-B) and its use in the treatment of psoriasis. Summary of the Invention

[0004] The present invention addresses the aforementioned problems existing in the prior art by providing an extract of Aquilaria sinensis (Lour.) Spreng. fruit peel (PGB-B), its pharmaceutical composition, its pharmaceutical preparation and preparation method, and their application in the preparation of drugs for treating psoriasis.

[0005] To achieve the above-mentioned objectives of the present invention, the present invention provides the following technical solution:

[0006] A type of Aquilaria sinensis pericarp extract, PGB-B, is prepared by the following method: dried Aquilaria sinensis pericarp is taken, pulverized, and 5L of 60% ethanol aqueous solution is added. Extraction is performed at 60℃ with ultrasonic assistance for 30min. The resulting extract is filtered and concentrated using a rotary evaporator at 60℃ to obtain crude extract PGB-A. PGB-A is suspended in 2.7L of water, filtered, and the water-insoluble portion (filter residue) is dried to obtain Aquilaria sinensis pericarp extract PGB-B.

[0007] The application of the aforementioned Aquilaria sinensis peel extract PGB-B in the preparation of a drug for treating psoriasis.

[0008] The application of the aforementioned Aquilaria sinensis fruit peel extract PGB-B in the preparation of drugs for treating or improving skin scaling, erythema, thickening and abnormal epidermal differentiation.

[0009] The application of the aforementioned Aquilaria sinensis peel extract PGB-B in the preparation of drugs for treating local and systemic inflammatory diseases of the skin.

[0010] A pharmaceutical composition comprising the aforementioned Aquilaria sinensis pericarp extract PGB-B, and a pharmaceutically acceptable carrier.

[0011] A pharmaceutical preparation wherein PGB-B, an extract of Aquilaria sinensis fruit peel, is the active ingredient, and PGB-B accounts for 0.002% to 0.02% of the total mass of the pharmaceutical preparation.

[0012] The use of the aforementioned pharmaceutical composition or pharmaceutical preparation in the preparation of a medicament for treating psoriasis, in the preparation of a medicament for treating or improving skin scaling, erythema, thickening and abnormal epidermal differentiation, and in the preparation of a medicament for treating local and systemic inflammatory diseases of the skin.

[0013] The method for preparing the Aquilaria sinensis pericarp extract PGB-B includes the following steps: taking dried Aquilaria sinensis pericarp, pulverizing it, adding 5L of 60% ethanol aqueous solution, and extracting it with ultrasound assistance at 60℃ for 30min. Filtering the obtained extract, and concentrating it using a rotary evaporator at 60℃ to obtain crude extract PGB-A; preparing a suspension of PGB-A with 2.7L of water, filtering, and drying the water-insoluble portion (filter residue) to obtain Aquilaria sinensis pericarp extract PGB-B.

[0014] The method for preparing the pharmaceutical composition includes the following steps: taking dried pericarp of Aquilaria sinensis, pulverizing it, adding 5L of 60% ethanol aqueous solution, and extracting it with ultrasound assistance at 60℃ for 30min. Filtering the obtained extract, and concentrating it with a rotary evaporator at 60℃ to obtain crude extract PGB-A; preparing a suspension of PGB-A with 2.7L of water, filtering, and drying the water-insoluble part, i.e., the filter residue, to obtain Aquilaria sinensis pericarp extract PGB-B, and then adding a pharmaceutically acceptable carrier.

[0015] The method for preparing the pharmaceutical preparation includes the following steps: taking dried pericarp of Aquilaria sinensis, pulverizing it, adding 5L of 60% ethanol aqueous solution, and extracting it with ultrasound assistance at 60℃ for 30min. After filtering the obtained extract, it is concentrated by rotary evaporation at 60℃ to obtain crude extract PGB-A. PGB-A is made into a suspension with 2.7L of water, filtered, and the water-insoluble part, i.e., the filter residue, is dried to obtain Aquilaria sinensis pericarp extract PGB-B. Then, it is prepared into ointments, sprays, creams, tinctures, pastes, and pills according to the conventional preparation method of pharmaceutical preparations.

[0016] In the aforementioned pharmaceutical preparation, PGB-B accounts for 0.002%-0.02% of the total mass of the pharmaceutical preparation, and the administration method of the pharmaceutical preparation is local administration. The forms of the pharmaceutical preparation are mainly ointments, sprays, tinctures, etc.

[0017] Compared with the prior art, the present invention has the following advantages:

[0018] 1. At lower concentrations, such as 27 μg / mL, the extract of Aquilaria sinensis fruit peel (PGB-B) can exert its therapeutic effect in animal models.

[0019] 2. In animal models, the therapeutic effect of Aquilaria sinensis peel extract (PGB-B) was superior to that of the positive control drug carboplatin.

[0020] 3. Topical application of PGB-B can effectively protect against imiquimod-induced psoriasis-like skin lesions in mice, significantly reducing the area and severity index (PASI) of psoriasis lesions, decreasing skin thickness, and decreasing spleen coefficient, demonstrating significant therapeutic effects and having great potential for widespread application. Attached Figure Description

[0021] Figure 1 Psoriasis Skin Lesion Area and Severity Index (PASI) scoring criteria;

[0022] Figure 2Effects of PGB-B on PASI scores in BALB / c mice (M: model control group; NC: negative control group; PC: positive control group; L: high-dose PGB-B group; MID: medium-dose PGB-B group; H: high-dose PGB-B group);

[0023] Figure 3 Effects of PGB-B on skin lesions in BALB / c mice (M: model control group; PC: positive control group; L: high-dose PGB-B group; MID: medium-dose PGB-B group; H: high-dose PGB-B group);

[0024] Figure 4 Effects of PGB-B on skin pathological changes in BALB / c mice;

[0025] Figure 5 Effects of PGB-B on spleen coefficient in BALB / c mice (M: model control group; PC: positive control group; L: high-dose PGB-B group; MID: medium-dose PGB-B group; H: high-dose PGB-B group). Detailed Implementation

[0026] The following description, in conjunction with the accompanying drawings, uses embodiments of the present invention to further illustrate the substantive content of the invention, but does not limit the invention in this way.

[0027] Example 1

[0028] Preparation of Aquilaria sinensis pericarp extract:

[0029] 100g of dried pericarp of *Aquilaria sinensis* (Lour.) Spreng. was weighed, pulverized, and added to 5L of 60% ethanol aqueous solution. Extraction was performed at 60℃ with ultrasonic assistance for 30min. The resulting extract was filtered and concentrated using a rotary evaporator at 60℃ to obtain crude extract PGB-A (27.1g). PGB-A was suspended in 2.7L of water, filtered, and the water-insoluble fraction (filter residue) was dried to obtain PGB-B (5.6g); the water-soluble fraction (filtrate) was concentrated to obtain PGB-C (21.4g).

[0030] Example 2:

[0031] Experimental methods for evaluating the therapeutic effect of imiquimod-induced mouse psoriasis model:

[0032] 1. Laboratory animals.

[0033] SPF-grade male BALB / c mice, weighing 18–22 g, were provided by Beijing SPF Biotechnology Co., Ltd. All experimental animals were housed in an SPF-grade environment at a temperature of 18–24°C and humidity of 40%–50%. During the experiment, the animals had free access to food and water, and maintained normal circadian rhythms.

[0034] 2. Preparation of the drug solution for the treatment group.

[0035] Weigh 2.7 mg of PGB-B and dissolve it completely in 100 mL of 10% ethanol aqueous solution to prepare a low-dose dosing solution (concentration of 27 μg / mL); weigh 5.4 mg of PGB-B and dissolve it completely in 100 mL of 10% ethanol aqueous solution to prepare a medium-dose dosing solution (concentration of 54 μg / mL); weigh 10.8 mg of PGB-B and dissolve it completely in 100 mL of 10% ethanol aqueous solution to prepare a high-dose dosing solution (concentration of 108 μg / mL).

[0036] 3. Animal model establishment.

[0037] Forty-eight male BALB / c mice had their pubic hair shaved in a 2.5cm × 3cm area on their backs using an electric shaver, followed by removal of vellus hair with a mild depilatory cream. They were randomly divided into four groups: a blank control group, a model control group, a negative control group, and low, medium, and high dose PGB-B groups, with eight mice in each group. Except for the blank control group, all other groups received 62.5 mg / day of 5% imiquimod cream at the shaved area once daily for 9 consecutive days to establish a psoriasis-like skin lesion model. Successful modeling was indicated by the appearance of thickened skin, erythema, and scaly psoriasis.

[0038] 4. Administration to animals.

[0039] Different treatments are applied to the following groups.

[0040] (1) Blank control group: No treatment was given.

[0041] (2) Model control group: 5% imiquimod cream 62.5mg / d, once a day, for 9 consecutive days.

[0042] (3) Negative control group: 5% imiquimod cream 62.5mg / d once a day for 9 consecutive days. On the fifth day, 3mL of 10% ethanol aqueous solution was given, measured with a 1mL syringe. After each application, the solution was dried with a hair dryer and then applied again until all 3mL was used up. The treatment was continued for 5 consecutive days (from the fifth day to the ninth day).

[0043] (4) Positive control group: 5% imiquimod cream 62.5 mg / day, once a day, for 9 consecutive days. On the fifth day, carboplatinol cream (carboplatinol content 50 μg / g, 0.2 g cream / animal / day) was administered for 5 consecutive days (from day 5 to day 9).

[0044] (5) Treatment group: 5% imiquimod cream 62.5 mg / day, once a day, for 9 consecutive days. On the fifth day, low (27 μg / mL, 3 mL / animal / day), medium (54 μg / mL, 3 mL / animal / day), and high (108 μg / mL, 3 mL / animal / day) doses of PGB-B were administered for 5 consecutive days (from day 5 to day 9).

[0045] The body weight of the mice was weighed and recorded daily. After nine days, the trend of body weight change of the blank control group mice was analyzed using Graphpad. The body weight of the blank control group mice did not change significantly, which proved that the mice were in normal condition during the experiment.

[0046] 5. Psoriasis Skin Lesion Area and Severity Index (PASI).

[0047] The changes in mouse skin lesions were photographed and recorded, and the degree of erythema, scaling, and skin thickening at the lesion site was scored according to the PASI scoring criteria. Figure 1 0 points: Asymptomatic; 1 point: Mild; 2 points: Moderate; 3 points: Severe; 4 points: Extremely severe. The sum of the three scores is the PASI total score. The scoring results are obtained by a blind review by four people, after which unreasonable scores are excluded, and the average of the three scores is taken as the final score.

[0048] 6. Comparison of immune organs.

[0049] Mice were anesthetized with phenobarbital gas and blood was collected. After blood collection, the spleen and liver were quickly separated and weighed, which are the wet weights of the spleen and liver. The spleen and liver coefficients were then calculated.

[0050] Spleen coefficient = Spleen wet mass / Body mass

[0051] Liver coefficient = Liver wet weight / Body weight

[0052] 7. Histopathological observation.

[0053] After blood collection from mice, the skin at the lesion site was separated, subcutaneous fat was removed, and a portion was placed in an embedding cassette and fixed with 4% paraformaldehyde for 48 hours. The tissue was washed three times with PBS buffer for 5 minutes each time, followed by gradient ethanol dehydration (25% EtOH 20 min; 50% EtOH 20 min; 75% EtOH 20 min; 95% EtOH 60 min × 2 times; 100% EtOH 60 min × 2 times). Afterward, the tissue was permeabilized with xylene for approximately 20 minutes (adjusted according to tissue size and transparency). After permeabilization, the tissue was paraffin-insulated (paraffin I 30 min; paraffin II 30 min; paraffin III 60 min; paraffin IV 60 min), embedded, and sectioned. After unfolding, the sections were retrieved using a glass slide, baked at 60°C for 60 minutes, and then dewaxed in xylene for 5 minutes × 3 times. After removal, the sections were dewaxed again with gradient ethanol (100% EtOH 2 min × 2 times; 95% EtOH 2 min; 70% EtOH 60 min × 2 times). After EtOH for 2 min, rinse with running water for 5 min, drain and stain with hematoxylin for about 1 min, rinse with running water for 5 min after staining, wash away the excess stain, stain with eosin for about 1 min, and then rinse away the excess stain with running water. After eosin staining, dehydrate with a gradient of ethanol (70% EtOH for 2 min; 95% EtOH for 2 min; 100% EtOH for 2 min × 2) and xylene (5 min × 3), mount with neutral resin, and observe the pathological changes of skin tissue under a light microscope.

[0054] Example 3

[0055] Experimental results evaluating the therapeutic effect of imiquimod-induced mouse psoriasis model:

[0056] 1. Phenotypic symptoms and PASI score results in mice.

[0057] Based on the apparent characteristics of the modeled area on the back of the mice, using protrusion, scaling, and erythema as criteria, the mice in each group were scored according to the clinical PASI scoring criteria. The PASI scores of mice showed the following results: The average PASI scores on days 0, 4, and 9 were 0, 6.54±0.13, and 0.88±0.21 in the high-dose PGB-B group, 6.62±0.15, and 2.71±0.11 in the medium-dose PGB-B group, 0, 6.62±0.15, and 2.71±0.11 in the medium-dose PGB-B group, 0, 6.88±0.11, and 2.92±0.18 in the low-dose PGB-B group, 0, 6.88±0.11, and 2.92±0.18 in the low-dose PGB-B group, 0, 7.00±0.15, and 4.25±0.19 in the calcipotriol group (positive control group), 0, 7.00±0.15, and 4.25±0.19 in the calcipotriol group, 0, 6.79±0.16, and 6.00±0.13 in the negative control group, and 0, 6.38±0.70 and 8.00±1.32 in the model control group. Compared with the model control group, the scores of each PGB-B dose group were significantly lower (see...). Figure 2 Two-way ANOVA (Graphpad) showed highly significant differences between the model control group and the low-dose group (P < 0.0001), medium-dose group (P < 0.0001), and high-dose group (P < 0.0001), indicating that PGB-B has a significant therapeutic effect on psoriasis symptoms, and that the therapeutic effect exhibits a certain gradient effect with increasing drug concentration.

[0058] 2. Observe the pathological changes.

[0059] from Figure 3 It can be seen that compared with the model control group (M), all treatment groups, including the positive control group (PC), low-dose PGB-B group (L), medium-dose PGB-B group (MID), and high-dose PGB-B group (H), showed a significant reduction in psoriasis lesions, erythema, and scaling, indicating that PGB-B has a certain therapeutic effect on the mouse psoriasis model. Furthermore, the medium-dose group showed a more significant concentration gradient effect relative to the low-dose group, while the gradient effect of the high-dose group relative to the medium-dose group was not very significant. Overall, the high, medium, and low-dose PGB-B groups showed significant improvement in skin lesions compared to the model control group, indicating that PGB-B has a significant therapeutic effect on the symptoms of psoriasis, and a certain concentration gradient effect exists with increasing dosage.

[0060] 3. Histopathological staining results.

[0061] like Figure 4As shown, HE staining results of BALB / c mouse skin tissue revealed that, compared with the control group, the 5% imiquimod-induced mouse psoriasis model group exhibited inflammatory cell infiltration, acanthosis, thinning or disappearance of the granular layer, and hyperkeratosis or parakeratosis of the stratum corneum. PGB-B at various doses significantly improved psoriatic skin lesions in mice, while the positive control group showed limited improvement in skin thickness. ImageJ software was used to measure the dermal thickness (in μm) of each group. The average thickness of the blank control group was l = 12.98 ± 2.42 μm; the average thickness of the model control group was l = 60.31 ± 12.33 μm; the average thickness of the positive control group was l = 36.67 ± 4.01 μm; the average thickness of the low-dose group was l = 36.36 ± 8.82 μm; the average thickness of the medium-dose group was l = 32.63 ± 2.14 μm; and the average thickness of the high-dose group was l = 29.76 ± 6.92 μm.

[0062] 4. Comparison of immune organs.

[0063] like Figure 5 As shown, the spleen size in the model control group was significantly larger than that in the positive control group and all drug-treated groups. The scatter plot reveals a clear distribution difference. The mean spleen coefficient in the model control group was 13.56±1.09, in the positive control group it was 7.94±2.55, in the low-dose group it was 7.52±1.56, in the medium-dose group it was 6.86±1.01, and in the high-dose group it was 6.54±0.68. The mean spleen coefficients in the medium-dose and high-dose groups were relatively close to those in normal mice (5.60±1.23). This indicates that PGB-B has a good restorative effect on the immune organs of psoriasis model mice and exhibits a clear gradient effect.

[0064] Example 4

[0065] Ointment.

[0066] formula:

[0067] Aqueous phase: 1.9 mL distilled water, 200 mg glycerol, 10 mg triethanolamine, 10 mg methylparaben;

[0068] Oil phase: 50 mg stearyl alcohol, 280 mg stearic acid, 50 mg liquid paraffin, 300 μg PGB-B

[0069] preparation:

[0070] Aqueous phase: Measure 1.9 mL of distilled water, place it in a beaker and heat it to 75 °C. Add the prescribed amounts of glycerol, methylparaben, and triethanolamine to the hot water in sequence, stir to dissolve and mix evenly.

[0071] Oil phase: Measure the prescribed amounts of octadecyl alcohol, stearic acid, and liquid paraffin into another beaker, heat to 85°C, stir to dissolve and mix thoroughly. Add the active pharmaceutical ingredient PGB-B to the oil phase medium, stir thoroughly to ensure the active ingredient is mixed, dissolved, and dispersed. Continuously stir the aqueous phase compound while slowly adding the oil phase mixture to the aqueous phase mixture, stirring in the same direction until condensation, thus obtaining the ointment formulation.

[0072] Example 5

[0073] Spray formulation: First, prepare a concentrated solution of PGB-B with a crude drug concentration of approximately 0.2 mg / mL. Then, prepare the aqueous phase: mix water, dipropylene glycol, and butylene glycol in a volume ratio of 20:10:5. Next, measure 4 mL of olive oil into a beaker, and separately measure 35 mL of the aqueous phase into another beaker, adding 5 mL of stearic acid emulsifier PEG-32. Slowly pour the oil phase into the aqueous phase, add 2 mL of propylene glycol (transdermal penetration enhancer), 2 mL of glycerin (moisturizer), and preservatives. Add 1 mL of acetophenone and stir to form a pre-emulsion. Then, slowly add 1 mL of PGB-B concentrate while stirring. Once the solution is completely mixed with the pre-emulsion, stop stirring. Remove the solution and add distilled water to bring the volume to 100 mL. For final filling: Use nitrogen or dry compressed air as a propulsion device to add the prepared solution into the spray container.

[0074] Example 6

[0075] Droplets: PGB-B 1mg

[0076] Polyethylene glycol 6000 9g

[0077] Preparation method: Preparation of PGB-B 6000 molten liquid: Weigh PGB-B according to the above prescription, add an appropriate amount of anhydrous ethanol, dissolve by gentle heating, and then add to the prescribed amount of polyethylene glycol molten liquid (keep warm in a 60℃ water bath). Stir and mix evenly until the ethanol evaporates completely. Let it stand in a 60℃ water bath for 30 minutes until the air bubbles are removed. Then transfer the above-mentioned well-mixed molten liquid with the air bubbles removed into a storage cylinder. Under the condition of keeping warm at 80-85℃, control the dripping rate and drip it drop by drop into the condensate. After complete condensation, pour off the condensate, collect the pellets, drain them, and remove the condensate on the pellets with filter paper. Place them in a silica gel desiccator or let them air dry.

[0078] Example 7

[0079] Cream: Composed of the following ingredients in the indicated weight ratios: glyceryl stearate 16%, glyceryl tricaprylate 5.0%, cetyl alcohol 1.0%, lanolin 5.0%, propylene glycol 5.0%, PGB-B 0.02%, and deionized water 62%.

[0080] Example 8

[0081] Ointment: Composed of the following ingredients in the indicated weight ratios: PGB-B 0.02%, urea 20%, petrolatum 40%, stearyl alcohol 4.5%, beeswax 20%, polyoxyethylene oleyl alcohol ether 0.5%, and deionized water 10.5%.

[0082] Example 9

[0083] Tincture: PGB-B is dissolved directly in 10% ethanol to the required amount.

[0084] In conclusion, PGB-B has significant medicinal value in the treatment of psoriasis. Drug compositions made with PGB-B as the active ingredient can alleviate the symptoms of psoriasis patients and improve their quality of life, thus possessing good medical and market economic value.

Claims

1. A white sandalwood fruit peel extract PGB-B for treating psoriasis, characterized in that... The Aquilaria sinensis pericarp extract PGB-B was prepared by the following method: dried Aquilaria sinensis pericarp was taken, pulverized, and 5 L of 60% ethanol aqueous solution was added. The extract was extracted with ultrasound assistance at 60°C for 30 min. The resulting extract was filtered and concentrated by rotary evaporation at 60°C to obtain crude extract PGB-A. PGB-A was made into a suspension with 2.7 L of water, filtered, and the water-insoluble part, i.e., the filter residue, was dried to obtain Aquilaria sinensis pericarp extract PGB-B.

2. A pharmaceutical composition, characterized in that, The composition comprises PGB-B, an extract of Aquilaria sinensis peel for treating psoriasis as described in claim 1, and a pharmaceutically acceptable carrier.

3. A pharmaceutical preparation, characterized in that: The pharmaceutical preparation uses PGB-B, an extract of Aucklandia lappa fruit peel for treating psoriasis as described in claim 1, as its active ingredient, with PGB-B accounting for 0.002% to 0.02% of the total mass of the pharmaceutical preparation.

4. The use of the Aucklandia lappa fruit peel extract PGB-B for treating psoriasis as described in claim 1, or the pharmaceutical composition as described in claim 2, or the pharmaceutical preparation as described in claim 3, in the preparation of a medicament for treating psoriasis.

5. The preparation method of PGB-B, an extract of Aucklandia lappa fruit peel for treating psoriasis, as described in claim 1, is characterized in that... The method includes the following steps: take dried pericarp of Aquilaria sinensis, crush it, add 5 L of 60% ethanol aqueous solution, and extract it by ultrasonication at 60 °C for 30 min. After filtering the obtained extract, concentrate it by rotary evaporation at 60 °C to obtain crude extract PGB-A. PGB-A is made into a suspension with 2.7 L of water, filtered, and the water-insoluble part, i.e. the filter residue, is dried to obtain Aquilaria sinensis pericarp extract PGB-B.

6. The method for preparing the pharmaceutical composition according to claim 2, characterized in that... The method includes the following steps: take dried pericarp of Aquilaria sinensis, crush it, add 5 L of 60% ethanol aqueous solution, and extract with ultrasound assistance at 60 °C for 30 min. After filtering the obtained extract, concentrate it with a rotary evaporator at 60 °C to obtain crude extract PGB-A. PGB-A is made into a suspension with 2.7 L of water, filtered, and the water-insoluble part, i.e. the filter residue, is dried to obtain Aquilaria sinensis pericarp extract PGB-B, which is then added to a pharmaceutically acceptable carrier.

7. The method for preparing the pharmaceutical formulation according to claim 3, characterized in that... The method includes the following steps: take dried pericarp of Aquilaria sinensis, crush it, add 5 L of 60% ethanol aqueous solution, and extract it with ultrasound assistance at 60 °C for 30 min. After filtering the obtained extract, concentrate it with a rotary evaporator at 60 °C to obtain crude extract PGB-A. PGB-A is made into a suspension with 2.7 L of water, filtered, and the water-insoluble part, i.e. the filter residue, is dried to obtain Aquilaria sinensis pericarp extract PGB-B. Then, it is prepared into spray, cream, tincture, ointment, and pill according to the conventional preparation method of pharmaceutical preparations.

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