Solid dosage form pharmaceutical composition for treating benign prostatic hyperplasia and preparation method thereof

Abstract

The invention discloses a solid dosage form pharmaceutical composition for treating benign prostatic hyperplasia and a preparation method thereof, and belongs to the technical field of medicines. The solid dosage form pharmaceutical composition for treating benign prostatic hyperplasia is prepared from the following components in parts by mass: 1 to 10 parts of epristeride, 1 to 10 parts of tadalafil, 100 to 200 parts of filler, 2 to 10 parts of adhesive, 1 part of lubricant and 50 to 150 parts of wetting agent. The compound preparation prepared by wet granulation can relieve the symptoms of patients with prostatic hyperplasia, reduce the prostate volume and reduce the adverse reaction in the aspect of sexual function; and by filling into hard capsules or pressing into tablets, the medicine is more convenient to take.

Description

Technical Field

[0001] The present invention belongs to the field of medical technology, and in particular relates to a solid dosage form pharmaceutical composition for treating benign prostatic hyperplasia and a preparation method thereof. Background Art

[0002] Benign prostatic hyperplasia (BPH) is a common chronic disease with urination disorder in middle-aged and elderly men, and is one of the most common diseases in the clinical diagnosis and treatment of urology. BPH generally occurs after the age of 40, and the incidence increases year by year with age. It is about 20% in men aged 50-60, 50% in men aged 61-70, and as high as 83% in men aged 81-90. BPH is mainly manifested by hyperplasia of prostatic stroma and glandular components in histology, enlarged prostate volume in anatomy, and bladder outlet obstruction in urodynamics, leading to elongation, compression deformation, stenosis and increased urethral resistance of the posterior urethra, causing bladder hypertension and lower urinary tract symptoms (LUTS). LUTS include storage symptoms (frequent urination, urgency, urinary incontinence, increased nocturia), voiding symptoms (hesitation, dysuria, intermittent urination), and post-micturition symptoms (feeling of incomplete urination and dripping after urination). In addition, middle-aged and elderly men with LUTS are more likely to suffer from erectile dysfunction (ED), and ED is related to the severity of LUTS, threatening the physical health of elderly men and significantly affecting their quality of life.

[0003] As the symptoms of the disease worsen, drug therapy plays an important role in the treatment of BPH. Currently, the drugs widely used in clinical practice mainly include chemical drugs, traditional Chinese medicine and herbal drugs. Among them, chemical drugs include α-adrenergic receptor blockers, 5α-reductase inhibitors, M receptor antagonists, PDE5 inhibitors and β3 receptor agonists, and also include combinations or compound prescriptions of the above chemical drugs.

[0004] Epristeride, chemical name 17-β (N-tert-butyl-amino-formyl) androsta-3,5-diene-3-carboxylic acid (structure see formula I below), is a selective and non-competitive steroid type II 5α-reductase inhibitor, which reduces the content of dihydrotestosterone in the prostate by inhibiting the conversion of testosterone to dihydrotestosterone, resulting in atrophy of the hyperplastic prostate, and treats benign prostatic hyperplasia. Its advantage is that it does not affect the testosterone level in the serum while reducing the volume of the prostate, and has little effect on the physiological functions of other parts of the body. In addition, the epithelial cells and stromal cells of prostatic hyperplasia both play an important role in the occurrence of BPH, and their common excessive proliferation leads to prostate enlargement. Compared with finasteride, Epristeride can not only inhibit epithelial cells, but also inhibit the proliferation of stromal cells.

[0005] Tadalafil, chemical name (6R-12aR)-6-(1,3-benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2'-1,6]-pyridino[3,4-b]indole-1,4-dione (see the structure of Formula II below), is a selective PDE5 inhibitor that can inhibit the process of PDE5 converting cGMP into 5-GMP, thereby maintaining cGMP activity in the penis and improving erectile function. Studies have shown that a 5 mg dose of tadalafil once a day can significantly improve the International Prostate Symptom Score (IPSS), and in 2011, tadalafil was approved for the treatment of BPH with ED.

[0006] According to the existing public literature (Tawfik A, Abo-Elenen M, Gaber M, et al. Tadalafil versus tamsulosin as combination therapy with 5-alpha reductase inhibitors in benign prostatic hyperplasia, urinary and sexual outcomes [J]. World Journal of Urology, 2024, 42(1): 70.), in an international multicenter, randomized, controlled, double-blind study, men aged 45 years and above with IPSS ≥ 13 and prostate volume ≥ 30 mL were selected as the research subjects. The subjects were randomly divided into two groups: (i) placebo / 5 mg finasteride once a day (n = 350) and (ii) 5 mg tadalafil / 5 mg finasteride once a day (n = 346) for 26 weeks. The study used IPSS and the International Index of Erectile Function (IIEF-EF) as evaluation methods to compare lower urinary tract symptoms (LUTS) and erectile function index (EF). The results showed that compared with the monotherapy group, the tadalafil / finasteride combination group (5 mg tadalafil and 5 mg finasteride per day) can significantly improve LUTS in patients with secondary LUTS and ED due to prostatic hyperplasia, and has a significant benefit on the improvement of the erectile function index.

[0007] In addition, in 2021, the FDA approved the marketing of a combination capsule of finasteride / tadalafil. Used to treat benign prostatic hyperplasia in men with enlarged prostate. It shows that 5α-reductase inhibitors combined with PDE5i can be used in BPH patients with erectile dysfunction to improve storage and urination symptoms, quality of life and erectile function. However, as a type II 5α-reductase inhibitor, Aprelet can reduce the level of DHT in the prostate, but also has side effects such as impotence and decreased libido. Therefore, it is necessary to develop a compound or pharmaceutical combination therapy for the treatment of prostatic hyperplasia, which can enhance the therapeutic effect while reducing adverse reactions related to sexual function.

[0008] Summary of the invention

[0009] The technical problem solved by the present invention is to provide a solid dosage form pharmaceutical composition for treating benign prostatic hyperplasia, which can effectively treat prostatic hyperplasia while overcoming the side effect of the drug on sexual desire. Another technical problem to be solved by the present invention is to provide a method for preparing a solid dosage form pharmaceutical composition for treating benign prostatic hyperplasia.

[0010] In order to solve the above technical problems, the technical solution adopted by the present invention is as follows:

[0011] A solid dosage form pharmaceutical composition for treating benign prostatic hyperplasia is composed of the following components in parts by mass: 1-10 parts of aprelet, 1-10 parts of tadalafil, 100-200 parts of a filler, 2-10 parts of a binder, 1 part of a lubricant and 50-150 parts of a wetting agent.

[0012] Preferably, the filler is selected from one or more of microcrystalline cellulose, lactose, lactose monohydrate, corn starch, mannitol, sucrose, pregelatinized starch, and inorganic salts.

[0013] Preferably, the binder is selected from one or more of hydroxypropyl cellulose, methyl cellulose, cross-linked sodium carboxymethyl cellulose, starch, and pregelatinized starch.

[0014] Preferably, the lubricant is selected from one or more of magnesium stearate, stearic acid, talc and silicon dioxide.

[0015] Preferably, the wetting agent is selected from one or more of water, ethanol and sodium lauryl sulfate.

[0016] Preferably, the solid dosage pharmaceutical composition for treating benign prostatic hyperplasia is composed of the following components in parts by mass: 2 to 8 parts of Aprelet, 1 to 4 parts of Tadalafil, 110 to 170 parts of filler, 3 to 8 parts of binder, 1 part of lubricant and 60 to 100 parts of wetting agent; wherein the filler is selected from one or more of corn starch, lactose monohydrate, lactose, and microcrystalline cellulose; the binder is selected from one or more of hydroxypropyl cellulose, methyl cellulose, and cross-linked sodium carboxymethyl cellulose; the lubricant is selected from one or more of magnesium stearate and stearic acid; the wetting agent is selected from one or more of water, ethanol, and sodium lauryl sulfate.

[0017] Preferably, the solid dosage pharmaceutical composition for treating benign prostatic hyperplasia is composed of the following components in parts by mass: 4.05 parts of Aprelet, 2.02 parts of Tadalafil, 119.12 parts of filler, 4.08 parts of binder, 1 part of lubricant and 66.95 parts of wetting agent; wherein the filler is selected from one or more of corn starch, lactose monohydrate, lactose, and microcrystalline cellulose; the binder is selected from one or more of hydroxypropyl cellulose, methyl cellulose, and cross-linked sodium carboxymethyl cellulose; the lubricant is selected from one or more of magnesium stearate and stearic acid; the wetting agent is selected from one or more of water, ethanol, and sodium lauryl sulfate.

[0018] A method for preparing the solid dosage form pharmaceutical composition for treating benign prostatic hyperplasia comprises the following steps:

[0019] 1) mixing Aiplete and part of the first filler uniformly, then adding a proper amount of the first binder and the first wetting agent to prepare a soft material, and preparing wet granules by a granulator;

[0020] 2) drying the wet granules obtained in step 1), and adding part of the first filler and the first lubricant again, and mixing them evenly to obtain Aprelet granules;

[0021] 3) mixing tadalafil and the second filler uniformly, then adding an appropriate amount of a second binder and a second wetting agent to form a soft material, and forming wet granules by a granulator;

[0022] 4) Drying the wet granules obtained in step 3), and adding part of the second filler and the second lubricant again, mixing evenly, to obtain tadalafil granules.

[0023] 5) The Aprilate granules prepared in step 2) and the Tadalafil granules prepared in step 4) are mixed to prepare a solid preparation drug mixture.

[0024] Preferably, the solid dosage form is a capsule or a tablet.

[0025] Beneficial effects: Compared with the prior art, the present invention has the following advantages:

[0026] (1) The present invention mixes the granules of Aprilate and Tadalafil and then puts them into capsules or compresses them into tablets, thereby ensuring the uniformity of the content and facilitating commercial large-scale production;

[0027] (2) The drug prepared by the present invention is a compound preparation, which can reduce the number of medications for elderly patients and significantly improve patient compliance;

[0028] (3) Compared with a single prescription, the compound preparation prepared by the present invention can more effectively relieve the symptoms of patients with prostatic hyperplasia, reduce the size of the prostate, and reduce adverse reactions in sexual function. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 This is a comparison of the prostate volumes of the blank control group, model group, control group (3 mg / kg Aprelet) and combination group (3 mg / kg Aprelet+1.5 mg / kg Tadalafil) in Example 4;

[0030] Figure 2 The graphs of prostate epithelial thickness and prostate cavity area in the blank control group, model group, control group (3 mg / kg Aprelet) and combination group (3 mg / kg Aprelet + 1.5 mg / kg Tadalafil) in Example 4;

[0031] Figure 3 This is a comparison chart of the prostate wet weight of the blank control group, model group, control group (3 mg / kg Aprelet) and combination group (3 mg / kg Aprelet+1.5 mg / kg Tadalafil) in Example 4;

[0032] Figure 4 The graphs of prostate index changes in the blank control group, model group, control group (3 mg / kg Aprelet) and combined group (3 mg / kg Aprelet+1.5 mg / kg Tadalafil) in Example 4;

[0033] Figure 5 A diagram showing the effects of each group of the combination of aprelet and tadalafil on the peak pressure (ICP) after stimulation of the rat cavernous body; wherein, the blank control group was normal saline, the control group 1 was 3 mg / kg aprelet, the control group 2 was 1.5 mg / kg tadalafil, the control group 3 was 1 mg / kg aprelet, the control group 4 was 0.75 mg / kg tadalafil, the combination group 1 was 1 mg / kg aprelet + 0.75 mg / kg tadalafil, the combination group 2 was 1 mg / kg aprelet + 1.5 mg / kg tadalafil, the combination group 3 was 3 mg / kg aprelet + 0.75 mg / kg tadalafil, and the combination group 4 was 3 mg / kg aprelet + 1.5 mg / kg tadalafil. DETAILED DESCRIPTION

[0034] The present invention will be further illustrated below in conjunction with specific examples. The examples are implemented under the premise of the technical solution of the present invention. It should be understood that these examples are only used to illustrate the present invention and are not intended to limit the scope of the present invention. If specific conditions are not specified in the examples, they are carried out according to normal conditions or the conditions recommended by the manufacturer. If the manufacturer is not specified for the reagents or instruments used, they are all conventional products that can be purchased commercially.

[0035] Example 1

[0036] 1. Formulation

[0037]

[0038]

[0039] 2. Preparation process

[0040] 1) Preparation of Aprelet wet granules: 16.29 g Aprelet, 162.9 g lactose, 81.45 g corn starch and 32.58 g microcrystalline cellulose were mixed evenly, and then 3.26 g methyl cellulose, 127.05 g water and 81.96 g ethanol were added to prepare a soft material, and wet granules were prepared by a granulator;

[0041] 2) preparing aplite dry granules: drying the wet granules prepared in step (1), adding 48.85 g lactose, 29.31 g corn starch, 0.85 g magnesium stearate and 2.44 g stearic acid, and mixing well to obtain aplite granules;

[0042] 3) preparing tadalafil wet granules: 16.29 g tadalafil, 175 g lactose and 43.98 g microcrystalline cellulose were mixed evenly, and then 18.70 g croscarmellose sodium, 7.62 g hydroxypropyl cellulose, 0.81 g sodium lauryl sulfate and 119.88 g water were added to prepare a soft material, and wet granules were prepared by a granulator;

[0043] 4) preparing tadalafil dry granules: drying the wet granules prepared in step (3), adding 29.32 g lactose monohydrate and 1.46 g magnesium stearate, and mixing well to obtain tadalafil granules;

[0044] 5) The Aprilete granules and Tadalafil granules prepared in step (2) and step (4) are filled into capsules with a content weight of 306.97 mg to prepare a composite preparation (the first active ingredient in the capsule is 5 mg, and the second active ingredient is 5 mg).

[0045] Example 2

[0046] 1. Formulation

[0047]

[0048]

[0049] 2. Preparation process

[0050] 1) Preparation of Aprelet wet granules: 20.53 g Aprelet, 205.30 g lactose, 102.65 g corn starch and 41.06 g microcrystalline cellulose were mixed uniformly, and then 4.11 g methyl cellulose, 160.12 g water and 103.30 g ethanol were added to prepare a soft material, and wet granules were prepared by a granulator;

[0051] 2) preparing aplite dry granules: drying the wet granules prepared in step (1), adding 61.56 g lactose, 36.94 g corn starch, 1.07 g magnesium stearate and 3.08 g stearic acid, and mixing well to obtain aplite granules;

[0052] 3) preparing tadalafil wet granules: 10.26 g tadalafil, 110.28 g lactose and 27.71 g microcrystalline cellulose were mixed evenly, and then 11.78 g croscarmellose sodium, 4.80 g hydroxypropyl cellulose, 0.51 g sodium lauryl sulfate and 75.54 g water were added to prepare a soft material, and wet granules were prepared by a granulator;

[0053] 4) preparing tadalafil dry granules: drying the wet granules prepared in step (3), adding 18.48 g lactose monohydrate and 0.92 g magnesium stearate, and mixing well to obtain tadalafil granules;

[0054] 5) The aprilate granules and tadalafil granules prepared in step (2) and step (4) were mixed uniformly and tableted to obtain tablets of 487.14 mg / tablet (the first active ingredient in the tablet was 10 mg, and the second active ingredient was 5 mg).

[0055] Example 3

[0056] 1. Formulation

[0057]

[0058] 2. Preparation process

[0059] 1) Preparation of Aprelet wet granules: 22.48 g Aprelet, 224.80 g lactose, 112.40 g corn starch and 44.96 g microcrystalline cellulose were mixed uniformly, and then 4.50 g methyl cellulose, 175.33 g water and 113.11 g ethanol were added to prepare a soft material, and wet granules were prepared by a granulator;

[0060] 2) preparing aplite dry granules: drying the wet granules prepared in step (1), adding 67.42 g lactose, 40.45 g corn starch, 1.17 g magnesium stearate and 3.37 g stearic acid, and mixing well to obtain aplite granules;

[0061] 3) preparing tadalafil wet granules: 7.49 g of tadalafil, 80.50 g of lactose and 20.23 g of microcrystalline cellulose were mixed evenly, and then 8.60 g of croscarmellose sodium, 3.51 g of hydroxypropyl cellulose, 0.37 g of sodium lauryl sulfate and 55.15 g of water were added to prepare a soft material, and wet granules were prepared by a granulator;

[0062] 4) preparing tadalafil dry granules: drying the wet granules prepared in step (3), adding 13.49 g lactose monohydrate and 0.67 g magnesium stearate, and mixing well to obtain tadalafil granules;

[0063] 5) The aplit granules and tadalafil granules prepared in step (2) and step (4) are respectively pressed into plain tablets (aplit 540.51 mg / tablet, tadalafil 126.80 mg / tablet), and filled into capsules together to prepare a composite preparation (the first active ingredient in the capsule is 15 mg, and the second active ingredient is 5 mg).

[0064] Example 4

[0065] A study on the therapeutic effect of aprilite / tadalafil drug combination on benign prostatic hyperplasia in a testosterone-induced benign prostatic hyperplasia rat model.

[0066] Experimental method: The benign prostatic hyperplasia rat model was established by removing the bilateral testicles of male SD rats. After a week of recovery, testosterone propionate (0.5 mg / 0.1 mL / rat) dissolved in olive oil was subcutaneously injected once a day for one month to increase the number of prostate glands and induce the occurrence of BPH. At the same time, 40 male SD rats were randomly divided into 4 groups, 10 rats in each group, namely blank control group (castrated rats), model group (castrated rats + testosterone propionate), control group (3 mg / kg aprelet), and combined group (3 mg / kg aprelet + 1.5 mg / kg tadalafil). The drug was administered by gavage once a day for one month, and the prostate volume, prostate wet weight, and prostate index were measured. The results are as follows: Figure 1 , 2 , 3, 4 and Table 1.

[0067] In order to confirm the inhibitory effect of the combined group and the control group on prostate cell proliferation, the thickness of the prostate epithelium and the area of ​​the cavities were observed by histological staining. Figure 2 shown.

[0068] Table 1 Comparison of prostate wet weight in blank control group, model group, control group (3 mg / kg Aprelet) and combined group (3 mg / kg Aprelet + 1.5 mg / kg Tadalafil) (n=10)

[0069] Group Prostate wet weight (g) Weight (g) Prostate index (%) Negative control group 0.74±0.12 365±8.50 0.20±0.03％ Model Group 1.56±0.20*** 373±10.82 0.42±0.06％*** Control group 0.89±0.10### 373±2.31 0.24±0.03％### Joint Group 0.71±0.11### 384±11.93* 0.18±0.03％###

[0070] In Table 1, * indicates: P < 0.05 compared with the negative control group, ** indicates: P < 0.01 compared with the negative control group, *** indicates: P < 0.001 compared with the negative control group; # indicates: P < 0.05 compared with the model group, ## indicates: P < 0.01 compared with the model group, ### indicates: P < 0.001 compared with the model group.

[0071] Depend on Figure 1 It can be seen that compared with the blank control group, the prostate hypertrophy of rats in the model group indicated that the rat BPH model was successfully established.

[0072] Depend on Figures 2 to 4 As shown in Table 1, compared with the model group, the single use of 3mg / kg Aprelet and the combined administration of 3mg / kg Aprelet + 1.5mg / kg tadalafil reduced the prostate volume, prostate wet weight, prostate index and prostate epithelial cell thickness, and increased the lumen area. Compared with the Aprelet single-drug group, the combined administration group was more effective in reducing the prostate wet weight and prostate index, and improving the therapeutic effect (for the single-drug group and the combined administration group, the prostate wet weight was 0.89±0.10 and 0.71±0.11g, respectively; the prostate index (%) was 0.24±0.03% and 0.18±0.03%, respectively). In summary, the combination of Aprelet and tadalafil can have a significant improvement effect on benign prostatic hyperplasia.

[0073] Example 5

[0074] Effect of aprilite / tadalafil combination on corpus cavernosum pressure induced by electrical stimulation in SD rats.

[0075] Experimental method: 56 healthy male SD rats were selected and randomly divided into 7 groups, 8 rats in each group. The benign prostatic hyperplasia rat model was established by removing the bilateral testicles of male SD rats. After a week of recovery, testosterone propionate (0.5 mg / 0.1 mL / rat) dissolved in olive oil was subcutaneously injected once a day for one month to increase the number of prostate glands and induce the occurrence of BPH. After the prostatic hyperplasia model was established, the animals were anesthetized, the limbs were fixed, the carotid artery was isolated, and the carotid artery blood pressure was recorded using a multi-channel physiological signal acquisition system. The erection-related nerves and cavernous blood vessels were isolated, the sensors were connected, and the cavernous pressure was recorded using a physiological signal recording and analysis system. The drugs were administered via duodenum and divided into blank control group (normal saline), control group 1 (3 mg / kg aprelet), control group 2 (1.5 mg / kg tadalafil), control group 3 (1 mg / kg aprelet), control group 4 (0.75 mg / kg tadalafil), combination group 1 (1 mg / kg aprelet + 0.75 mg / kg tadalafil), combination group 2 (1 mg / kg aprelet + 1.5 mg / kg tadalafil), combination group 3 (3 mg / kg aprelet + 0.75 mg / kg tadalafil), combination group 4 (3 mg / kg aprelet + 1.5 mg / kg tadalafil). The erectile nerves of rats were electrically stimulated 15 min before administration; 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min after administration, and the changes of carotid trough blood pressure (BP) and corpus cavernosum peak pressure (ICP) were detected. The results are shown in Table 1. Figure 5 And as shown in Table 2.

[0076] Table 2 Effect of the combination of Aprelet and Tadalafil on the cavernous body pressure of rats (n=8)

[0077]

[0078] In Table 2, * indicates: P < 0.05 compared with the negative control group, ** indicates: P < 0.01 compared with the negative control group, *** indicates: P < 0.001 compared with the negative control group; # indicates: P < 0.05 compared with control group 1, ## indicates: P < 0.01 compared with control group 1, ### indicates: P < 0.001 compared with control group 1; ^ indicates: P < 0.05 compared with control group 3, ^^ indicates: P < 0.01 compared with control group 3, ^^^ indicates: P < 0.001 compared with control group 3.

[0079] From Table 2 and Figure 5It can be seen that after administration of SD rats, electrical stimulation of the erectile nerves of SD rats caused changes in carotid artery blood pressure and corpus cavernosum pressure. The results of the changes were as follows: the effects on the peak corpus cavernosum pressure (ICP) value and the relative ICP value of rats: control group 1 (3 mg / kg aprelet), control group 2 (1.5 mg / kg tadalafil), control group 3 (1 mg / kg aprelet), control group 4 (0.75 mg / kg tadalafil), combination group 1 (1 mg / kg aprelet + 0.75 mg / kg tadalafil), combination group 2 (1 mg / kg aprelet + 1.5 mg / kg tadalafil), combination group 3 (3 mg / kg The peak ICP values ​​of group 1 (100 mg / kg aprilate + 0.75 mg / kg tadalafil) and group 4 (3 mg / kg aprilate + 1.5 mg / kg tadalafil) were 28.3±3.79, 20.0±2.65, 44.3±9.29, 22.3±5.03, 37.3±1.53, 32.3±3.06, 42.7±3.06, 30.0±14.5, and 39.3±1.53 mmHg, respectively, which were -29.4%, 56.5%, -21.2%, 31.8%, 14.1%, 50.6%, 5.88%, and 38.8% higher than those of the negative control group. The results showed that the relative value of the peak ICP pressure of the corpus cavernosum caused by electrical stimulation of the erectile nerve was reduced after the administration of 1 or 3 mg / kg aprilate to SD rats. Compared with the aplidite monotherapy group, the combined administration group can significantly increase the relative value of the cavernous body peak pressure ICP caused by electrical stimulation of the erectile nerve, enhance the penile erectile function of SD rats, and improve the erectile dysfunction caused by aplidite.

[0080] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A solid dosage pharmaceutical composition for treating benign prostatic hyperplasia, characterized in that: The invention is composed of the following components in parts by weight: 1 to 10 parts of Aprelet, 1 to 10 parts of Tadalafil, 100 to 200 parts of filler, 2 to 10 parts of adhesive, 1 part of lubricant and 50 to 150 parts of wetting agent.

2. The solid dosage pharmaceutical composition for treating benign prostatic hyperplasia according to claim 1, characterized in that: The filler is selected from one or more of microcrystalline cellulose, lactose, lactose monohydrate, corn starch, mannitol, sucrose, pregelatinized starch, and inorganic salts.

3. The solid dosage pharmaceutical composition for treating benign prostatic hyperplasia according to claim 1, characterized in that: The adhesive is selected from one or more of hydroxypropyl cellulose, methyl cellulose, cross-linked sodium carboxymethyl cellulose, starch, and pregelatinized starch.

4. The solid dosage pharmaceutical composition for treating benign prostatic hyperplasia according to claim 1, characterized in that: The lubricant is selected from one or more of magnesium stearate, stearic acid, talc and silicon dioxide.

5. The solid dosage pharmaceutical composition for treating benign prostatic hyperplasia according to claim 1, characterized in that: The wetting agent is selected from one or more of water, ethanol and sodium lauryl sulfate.

6. The solid dosage pharmaceutical composition for treating benign prostatic hyperplasia according to claim 1, characterized in that: The invention is composed of the following components in parts by mass: 2 to 8 parts of Aprelet, 1 to 4 parts of Tadalafil, 110 to 170 parts of fillers, 3 to 8 parts of binders, 1 part of lubricants and 60 to 100 parts of wetting agents; wherein the fillers are selected from one or more of corn starch, lactose monohydrate, lactose and microcrystalline cellulose; the binders are selected from one or more of hydroxypropyl cellulose, methyl cellulose and cross-linked sodium carboxymethyl cellulose; the lubricants are selected from one or more of magnesium stearate and stearic acid; and the wetting agents are selected from one or more of water, ethanol and sodium lauryl sulfate.

7. The solid dosage pharmaceutical composition for treating benign prostatic hyperplasia according to claim 6, characterized in that: The invention is composed of the following components in parts by mass: 4.05 parts of Aprelet, 2.02 parts of Tadalafil, 119.12 parts of filler, 4.08 parts of binder, 1 part of lubricant and 66.95 parts of wetting agent; wherein the filler is selected from one or more of corn starch, lactose monohydrate, lactose and microcrystalline cellulose; the binder is selected from one or more of hydroxypropyl cellulose, methyl cellulose and cross-linked sodium carboxymethyl cellulose; the lubricant is selected from one or more of magnesium stearate and stearic acid; the wetting agent is selected from one or more of water, ethanol and sodium lauryl sulfate.

8. A method for preparing the solid dosage pharmaceutical composition for treating benign prostatic hyperplasia according to claim 1, characterized in that: The following steps are involved: 1) mixing Aiplete and part of the first filler uniformly, then adding a proper amount of the first binder and the first wetting agent to prepare a soft material, and preparing wet granules by a granulator; 2) drying the wet granules obtained in step 1), and adding part of the first filler and the first lubricant again, and mixing them evenly to obtain Aprelet granules; 3) mixing tadalafil and the second filler uniformly, then adding an appropriate amount of a second binder and a second wetting agent to form a soft material, and forming wet granules by a granulator; 4) Drying the wet granules obtained in step 3), and adding part of the second filler and the second lubricant again, mixing evenly, to obtain tadalafil granules. 5) The Aprilate granules prepared in step 2) and the Tadalafil granules prepared in step 4) are mixed to prepare a solid preparation drug mixture.

9. The solid dosage pharmaceutical composition for treating benign prostatic hyperplasia according to claim 1, characterized in that: Solid dosage forms are capsules or tablets.

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