A tamsulosin hydrochloride preparation and preparation method thereof

Abstract

The present invention belongs to the technical field of urinary system drug preparations, and specifically relates to a tamsulosin hydrochloride preparation and a preparation method thereof. The prior art has the defects that tamsulosin hydrochloride is not effective in treating prostatic hyperplasia and has large side effects. The present invention combines tamsulosin hydrochloride with cinnamon extract, and uses animal experiments to prove that tamsulosin hydrochloride and cinnamon extract can not only play a synergistic effect, but also reduce the side effects of tamsulosin hydrochloride such as hypotension and fatigue.

Description

Technical Field

[0001] The invention belongs to the technical field of urinary system drug preparations, and particularly relates to a tamsulosin hydrochloride preparation and a preparation method thereof. Background Art

[0002] The information disclosed in this background technology section is only intended to enhance the understanding of the overall background of the invention, and should not necessarily be regarded as an admission or any form of suggestion that the information constitutes the prior art already known to a person skilled in the art.

[0003] Benign prostatic hyperplasia is a common disease in middle-aged and elderly men, and its incidence rate increases with age. The pathogenesis of prostatic hyperplasia is due to the disruption of the balance between epithelial and stromal cell proliferation and apoptosis, as well as androgens and their interactions with estrogens, the interaction between prostatic stroma and glandular epithelial cells, growth factors, inflammatory cells, neurotransmitters and genetic factors. The main symptoms of prostatic hyperplasia include: (1) frequent urination: the need to urinate frequently, especially at night (nocturia); (2) urgency: a sudden strong desire to urinate; (3) weak urine flow: slow flow rate and poor urine flow during urination; (4) dysuria: difficulty in starting urination, sometimes requiring force to urinate; (5) residual sensation: the feeling that the bladder is not completely emptied after urination. Before the advent of effective treatment drugs, surgery was the main means of treating the disease and the treatment of choice for patients with severe symptoms. It was effective, but there were still adverse prognoses such as sexual dysfunction and urinary incontinence. With the continuous development of prostate treatment drugs, non-surgical treatments are favored by most people and have gradually reduced the chances of surgery. Although there are many types of drugs on the market for the treatment of benign prostatic hyperplasia, they are mainly composed of three categories: α receptor inhibitors, anti-androgen drugs and herbal drugs.

[0004] Tamsulosin hydrochloride is an α1-adrenaline receptor antagonist with a highly selective blocking effect on the urethra, bladder neck and prostate smooth muscle. It can relax the prostate smooth muscle, reduce urethral compression, and improve urination disorders. It is mainly used to treat lower urinary tract symptoms caused by prostate hyperplasia.

[0005] Chinese patent with publication number CN103919735A discloses a tamsulosin hydrochloride sustained-release pellet and a preparation method thereof, comprising a drug-loaded sustained-release pellet and an enteric coating layer, wherein the drug-loaded sustained-release pellet comprises tamsulosin hydrochloride, an enteric material A, a solvent A, a water-insoluble material and a diluent. Although tamsulosin hydrochloride is generally well tolerated, some side effects may occur, including dizziness, headache, fatigue, hypotension, sexual dysfunction, etc.

[0006] Chinese patent publication number CN101128190A discloses a controlled-release preparation containing tamsulosin hydrochloride, which can release tamsulosin hydrochloride at a zero-order rate without being affected by environmental conditions in the stomach and small intestine, thereby reducing side effects and maintaining drug effects. However, this technical solution still cannot solve the problem of obvious side effects of tamsulosin hydrochloride. Summary of the invention

[0007] In order to overcome the deficiencies of the prior art, the present invention provides a tamsulosin hydrochloride preparation having significant effect in treating prostatic hyperplasia and few side effects.

[0008] Specifically, the tamsulosin hydrochloride preparation is composed of tamsulosin hydrochloride and cinnamon extract in a mass ratio of 1:5-15, as well as a filler, a lubricant, a disintegrant, and a sustained-release material; the filler is selected from one or more of starch, mannitol, lactose, microcrystalline cellulose, dextrin, and sucrose; the lubricant is selected from one or more of talc, magnesium stearate, and micropowdered silica gel; the disintegrant is selected from one or more of sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, and cross-linked polyvinylpyrrolidone; the sustained-release material is a mixture of ethyl cellulose and ethanol; it should be noted that the above-mentioned excipients (fillers, lubricants, disintegrants, and sustained-release materials) are all commonly used excipients by those skilled in the art in the preparation of pharmaceutical preparations, and their dosage is also based on the conventional dosage found out from conventional textbooks and practical experience, and can be adjusted as appropriate according to the specific circumstances such as the properties of the preparation.

[0009] The preparation method of the cinnamon extract is:

[0010] (1) Soak the cinnamon segments in 3-5 times the amount of distilled water for 30-60 min, heat under reflux at 80-100°C, and collect the volatile oil;

[0011] (2) The cinnamon residue in step (1) is dried at 45°C-55°C, ground into powder, added with 2-4 times the amount of 70%-90% ethanol for immersion for 3-5 hours, then heated at 50°C-60°C for extraction for 30-60 minutes, filtered, concentrated under reduced pressure to a relative density of 1.45±0.05, added with volatile oil, and mixed to obtain a cinnamon extract.

[0012] Furthermore, the content of cinnamaldehyde in the cinnamon extract is ≥2.3%, and the content of volatile oil is ≥1.8%.

[0013] In a preferred embodiment, considering the aggregation and agglomeration tendency of the filler as well as the mobile phase and compressibility, the filler is a mixture of starch, microcrystalline cellulose and mannitol, especially starch, microcrystalline cellulose and mannitol in a mass ratio of 2:1:0.5.

[0014] In a preferred embodiment, the lubricant is magnesium stearate.

[0015] In a preferred embodiment, the disintegrant is low-substituted hydroxypropyl cellulose.

[0016] Furthermore, the preparation is a tablet or a capsule.

[0017] The present invention also provides a method for preparing the above-mentioned tamsulosin hydrochloride preparation, which comprises:

[0018] (1) mixing cinnamon extract with a disintegrant and part of a filler, adding tamsulosin hydrochloride, the remaining filler and a lubricant, mixing, granulating and granulating to obtain drug-loaded particles;

[0019] (2) Ethyl cellulose is dissolved in 95% ethanol to form a sustained-release material solution, which is evenly sprayed on the drug-loaded particles, dried, and the particles are loaded into capsule shells to obtain capsules, or compressed to obtain tablets.

[0020] In order to improve the compression formability of the preparation, the partial filler is 1 / 3 to 2 / 3 parts by weight.

[0021] Compared with the prior art, the technical effects of the present invention are:

[0022] The prior art has the disadvantages of poor effect and large side effects of tamsulosin hydrochloride in treating prostatic hyperplasia. The present invention combines tamsulosin hydrochloride with cinnamon extract and uses animal experiments to prove that tamsulosin hydrochloride and cinnamon extract can not only play a synergistic role, but also reduce the side effects of tamsulosin hydrochloride such as hypotension and fatigue. It should be noted that the present invention also verifies that the animal experiment of directly using cinnamon powder as medicine has poor effect, so it is chosen to extract its effective ingredients for medicine. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 : Volatile oil and cinnamaldehyde contents in cinnamon extracts of Examples 1-3 and Comparative Examples 1-2.

[0024] Figure 2 : Statistical results of the frequency of side effects in each group of rats after administration. DETAILED DESCRIPTION

[0025] In order to make the purpose and technical solution of the present invention clearer, the present invention is further described below in conjunction with embodiments, but the protection scope of the present invention is not limited to these embodiments, and the embodiments are only used to explain the present invention. It should be understood by those skilled in the art that any changes or equivalent substitutions that do not deviate from the concept of the present invention are included in the protection scope of the present invention.

[0026] Preparation of cinnamon extract

[0027] Example 1 Preparation method of cinnamon extract

[0028] (1) Soak cinnamon slices in 4 times the amount of distilled water for 45 min, heat under reflux at 95°C, and collect the volatile oil;

[0029] (2) The cinnamon residue in step (1) is dried at 50° C., ground into powder, added with 3 times the amount of 80% ethanol and extracted for 4 h, then heated at 55° C. for extraction for 45 min, filtered, concentrated under reduced pressure to a relative density of 1.45±0.05, added with volatile oil, and mixed to obtain a cinnamon extract.

[0030] Example 2 Preparation method of cinnamon extract

[0031] (1) Soak cinnamon bark segments in 3 times the amount of distilled water for 30 min, heat under reflux at 80°C, and collect the volatile oil;

[0032] (2) The cinnamon residue in step (1) is dried at 45°C, ground into powder, added with twice the amount of 70% ethanol and extracted for 5 hours, then heated at 60°C for extraction for 30 minutes, filtered, concentrated under reduced pressure to a relative density of 1.45±0.05, added with volatile oil, and mixed to obtain a cinnamon extract.

[0033] Example 3 Preparation method of cinnamon extract

[0034] (1) Soak cinnamon bark segments in 5 times the amount of distilled water for 60 min, heat under reflux at 100°C, and collect the volatile oil;

[0035] (2) The cinnamon residue in step (1) is dried at 55°C, ground into powder, added with 4 times the amount of 90% ethanol and extracted for 3 hours, then heated at 50°C for extraction for 60 minutes, filtered, concentrated under reduced pressure to a relative density of 1.45±0.05, added with volatile oil, and mixed to obtain a cinnamon extract.

[0036] Comparative Example 1 Preparation method of cinnamon extract

[0037] (1) Heat cinnamon slices with 4 times the amount of distilled water at 95°C and reflux to collect the volatile oil;

[0038] (2) The cinnamon residue in step (1) is dried at 50° C., ground into powder, added with 3 times the amount of 80% ethanol and extracted for 4 h, then heated at 55° C. for extraction for 45 min, filtered, concentrated under reduced pressure to a relative density of 1.45±0.05, added with volatile oil, and mixed to obtain a cinnamon extract.

[0039] Comparative Example 2 Preparation method of cinnamon extract

[0040] (1) Soak cinnamon powder in 4 times the amount of distilled water for 45 min, heat under reflux at 95°C, and collect the volatile oil;

[0041] (2) Add 3 times the amount of 80% ethanol to the cinnamon residue in step (1) and extract for 4 hours, then heat at 55°C for 45 minutes, filter, and concentrate under reduced pressure to a relative density of 1.45±0.05, add volatile oil, and mix to obtain a cinnamon extract.

[0042] The cinnamaldehyde (C9H8O) content was determined by HPLC according to the 2020 edition of the Chinese Pharmacopoeia.

[0043] Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel is used as filler; acetonitrile-water (35:75) is used as mobile phase; detection wavelength is 290nm. The number of theoretical plates calculated based on the cinnamaldehyde peak should not be less than 3000. Preparation of reference solution: Take an appropriate amount of cinnamaldehyde reference, accurately weigh it, add methanol to make a solution containing 10μg per 1ml, and then obtain it. Preparation of test solution: Take about 0.5g of the powder of this product (passed through No. 3 sieve), accurately weigh it, put it in a stoppered conical bottle, accurately add 25ml of methanol, weigh it, ultrasonically treat it (power 350W, frequency 35kHz) for 10 minutes, leave it overnight, ultrasonically treat it once in the same way, weigh it again, make up the lost weight with methanol, shake it well, and filter it. Accurately measure 1ml of the filtrate, put it in a 25ml volumetric bottle, add methanol to the scale, shake it well, and then obtain it. Determination method: Accurately pipette 10 μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine.

[0044] The volatile oil content of cinnamon was determined according to the volatile oil determination method of the 2020 edition of the "Chinese Pharmacopoeia".

[0045] Take about 300ml of water and a few glass beads, place them in a flask, and connect the volatile oil analyzer. Add water from the upper end of the analyzer until it fills the scale part and overflows into the flask, then use a pipette to add 1ml of xylene, and then connect the reflux condenser. Heat the contents of the flask to boiling and continue distillation at a speed that keeps the middle of the condenser in a cool state. After 30 minutes, stop heating, let it stand for more than 15 minutes, and read the volume of xylene. Take an appropriate amount of the test sample (equivalent to 0.5~1.0ml of volatile oil), weigh it (accurate to 0.01g), place it in a flask, add 300~500ml of water (or appropriate amount) and a few glass beads, shake and mix, and connect the volatile oil analyzer and the reflux condenser. Add water from the upper end of the condenser until it fills the scale part of the volatile oil analyzer and overflows into the flask. Place in an electric heating jacket or use other appropriate methods to slowly heat to boiling, and keep it at a slight boil for about 5 hours, until the amount of oil in the tester no longer increases, stop heating, leave it for a while, open the piston at the lower end of the tester, and slowly release water until the upper end of the oil layer reaches 5mm above the scale 0 line. Leave it for more than 1 hour, then open the piston again to let the oil layer drop until its upper end is just flush with the scale 0 line, subtract the amount of xylene from the amount of the oil layer, which is the amount of volatile oil, and then calculate the content of volatile oil in the test sample (%).

[0046] Figure 1 The volatile oil and cinnamaldehyde contents in the cinnamon extracts of Examples 1 to 3 and Comparative Examples 1 to 2 are shown in Table 1. The present invention improves the cinnamon extraction method and increases the volatile oil and cinnamaldehyde contents. It is common sense that extraction with drug powder should have a higher extraction efficiency than extraction with drug segments, because drug powder has a larger surface area to contact the extractant and is easier to extract the effective ingredients. However, the present invention finds that the extraction rate with cinnamon segments is higher. Comparative Examples 1 to 2 are single factor experiments made according to the preparation method of Example 1. Compared with the schemes of Comparative Examples 1 and Comparative Example 2, Example 1 has a higher cinnamon volatile oil and cinnamaldehyde content, which also lays the foundation for its therapeutic effect.

[0047] Example 4 Tamsulosin Hydrochloride Capsules

[0048] formula:

[0049] ;

[0050] Preparation method:

[0051] (1) Mixing cinnamon extract with a disintegrant and 1 / 3 of a filler, adding tamsulosin hydrochloride, the remaining filler, and a lubricant, mixing, granulating, and granulating to obtain drug-loaded particles;

[0052] (2) Ethyl cellulose is dissolved in 95% ethanol to form a sustained-release material solution, which is evenly sprayed on the drug-loaded particles, dried, and the particles are loaded into a suitable capsule shell to obtain a capsule.

[0053] Example 5 Tamsulosin Hydrochloride Capsules

[0054] formula:

[0055] ;

[0056] Preparation method:

[0057] (1) Mixing cinnamon extract with a disintegrant and 1 / 3 of a filler, adding tamsulosin hydrochloride, the remaining filler, and a lubricant, mixing, granulating, and granulating to obtain drug-loaded particles;

[0058] (2) Ethyl cellulose is dissolved in 95% ethanol to form a sustained-release material solution, which is evenly sprayed on the drug-loaded particles, dried, and the particles are loaded into a suitable capsule shell to obtain a capsule.

[0059] Example 6 Tamsulosin Hydrochloride Capsules

[0060] formula:

[0061] ;

[0062] Preparation method:

[0063] (1) Mixing cinnamon extract with a disintegrant and 2 / 3 of a filler, adding tamsulosin hydrochloride, the remaining filler, and a lubricant, mixing, granulating, and granulating to obtain drug-loaded particles;

[0064] (2) Ethyl cellulose is dissolved in 95% ethanol to form a sustained-release material solution, which is evenly sprayed on the drug-loaded particles, dried, and the particles are loaded into a suitable capsule shell to obtain a capsule.

[0065] Example 7 Tamsulosin Hydrochloride Tablets

[0066] formula:

[0067] ;

[0068] Preparation method:

[0069] (1) Mixing cinnamon extract with a disintegrant and 1 / 3 of a filler, adding tamsulosin hydrochloride, the remaining filler, and a lubricant, mixing, granulating, and granulating to obtain drug-loaded particles;

[0070] (2) Ethyl cellulose is dissolved in 95% ethanol to form a sustained-release material solution, which is evenly sprayed on the drug-loaded particles, dried, and tableted to obtain tamsulosin hydrochloride tablets.

[0071] Example 8 Tamsulosin Hydrochloride Tablets

[0072] formula:

[0073] ;

[0074] Preparation method:

[0075] (1) Mixing cinnamon extract with a disintegrant and 1 / 3 of a filler, adding tamsulosin hydrochloride, the remaining filler, and a lubricant, mixing, granulating, and granulating to obtain drug-loaded particles;

[0076] (2) Ethyl cellulose is dissolved in 95% ethanol to form a sustained-release material solution, which is evenly sprayed on the drug-loaded particles, dried, and tableted to obtain tamsulosin hydrochloride tablets.

[0077] Example 9 Tamsulosin Hydrochloride Tablets

[0078] formula:

[0079] ;

[0080] Preparation method:

[0081] (1) Mixing cinnamon extract with a disintegrant and 2 / 3 of a filler, adding tamsulosin hydrochloride, the remaining filler, and a lubricant, mixing, granulating, and granulating to obtain drug-loaded particles;

[0082] (2) Ethyl cellulose is dissolved in 95% ethanol to form a sustained-release material solution, which is evenly sprayed on the drug-loaded particles, dried, and tableted to obtain tamsulosin hydrochloride tablets.

[0083] Comparative Example 3 Tamsulosin Hydrochloride Capsules

[0084] formula:

[0085] ;

[0086] Preparation method:

[0087] (1) Mixing cinnamon extract with a disintegrant and 1 / 3 of a filler, adding tamsulosin hydrochloride, the remaining filler, and a lubricant, mixing, granulating, and granulating to obtain drug-loaded particles;

[0088] (2) Ethyl cellulose is dissolved in 95% ethanol to form a sustained-release material solution, which is evenly sprayed on the drug-loaded particles, dried, and the particles are loaded into a suitable capsule shell to obtain a capsule.

[0089] Comparative Example 4 Tamsulosin Hydrochloride Capsules

[0090] formula:

[0091] ;

[0092] Preparation method:

[0093] (1) Mixing cinnamon extract with a disintegrant and 1 / 3 of a filler, adding tamsulosin hydrochloride, the remaining filler, and a lubricant, mixing, granulating, and granulating to obtain drug-loaded particles;

[0094] (2) Ethyl cellulose is dissolved in 95% ethanol to form a sustained-release material solution, which is evenly sprayed on the drug-loaded particles, dried, and the particles are loaded into a suitable capsule shell to obtain a capsule.

[0095] Pharmacodynamics experiment of tamsulosin hydrochloride of the present invention

[0096] Experimental animals

[0097] SD male rats, SPF grade, 180-220 g, experimental animal license number: SYXK (Lu) 20180008, were adaptively fed under standard conditions for 1 week before the experiment.

[0098] Modeling method and grouping

[0099] Several rats were taken and a prostatic hyperplasia model was made by subcutaneous injection of testosterone propionate after castration. The rats were anesthetized, the scrotal skin was disinfected, the bilateral testicles were removed under aseptic conditions, sutured, and penicillin was injected intramuscularly at the medial thigh muscle at 200,000 U / kg / d for 7 consecutive days. The rats with successful modeling were randomly divided into a model group, an embodiment 4 group, an embodiment 5 group, an embodiment 6 group, a comparative example 3 group, a comparative example 4 group, and a commercially available group, with 20 rats in each group. 20 uncastrated rats were subjected to sham surgery as a blank group.

[0100] Drug administration

[0101] The rats in the model group, Example 4 group, Example 5 group, Example 6 group, Comparative Example 3 group, and Comparative Example 4 group were subcutaneously injected with 5 mg·kg of testosterone propionate injection (dissolved in olive oil) -1 ·d -1 The blank group was injected with the same amount of solvent olive oil for 7 consecutive days. At the same time, the rats in each group were given the corresponding drugs by gavage. The commercially available drug was the national medicine standard H20000681, and the dose was 0.018 mg / kg in terms of tamsulosin hydrochloride. The blank group and the model group were given the same amount of normal saline by gavage, once a day, for 7 consecutive days.

[0102] Experimental results and analysis

[0103] Prostate Index

[0104] Twelve hours after the last administration, the rats in each group were weighed, the prostate glands were dissected and separated, and weighed to calculate the prostate index.

[0105] Prostate index = prostate wet weight / rat body weight (mg / g).

[0106] Table 1 Statistics of rat prostate index

[0107] ;

[0108] Compared with the model group, *P < 0.01;

[0109] Compared with the commercially available group, *P<0.01.

[0110] Table 1 shows the statistical situation of the prostate index of rats in each group, which is an indicator for evaluating the health status of the prostate. After administration, the prostate index of rats in Example 4, Example 5, and Example 6 groups was significantly different from that in the model group, P < 0.01; the prostate index of rats in Example 4, Example 5, and Example 6 groups was significantly different from that in the commercially available group, P < 0.01, indicating that the combined use of sutamrosin hydrochloride and cinnamon extract can play a synergistic role.

[0111] Rat blood pressure statistics

[0112] The normal blood pressure range of SD rats is generally between 120-140 mmHg for systolic pressure and 70-90 mmHg for diastolic pressure. In order to evaluate the side effects of Sutentrosin hydrochloride, the blood pressure of rats was measured 2 hours after daily administration and statistically analyzed.

[0113] Table 2 Statistics of blood pressure in rats

[0114] ;

[0115] Compared with the model group, *P < 0.01;

[0116] Compared with the commercially available group, *P<0.01.

[0117] Table 2 shows the blood pressure of each group of rats after administration. The blood pressure of the blank group rats is basically the same as that of the model group rats, indicating that the prostate hyperplasia model does not affect the blood pressure of rats. The prostate index of the commercially available group of rats is significantly lower than that of the blank group rats, indicating that suttenrosin hydrochloride has the side effect of lowering blood pressure. However, the diastolic and systolic blood pressure of the rats in Example 4, Example 5, and Example 6 groups after administration are basically similar to those in the blank group, and there is no significant change in blood pressure, indicating that the drugs in each group of Examples 4 to 6 will not cause blood pressure fluctuations, eliminating or weakening the side effects of suttenrosin hydrochloride.

[0118] Sutentrosin hydrochloride side effect score

[0119] Common side effects of tamsulosin hydrochloride include fatigue, vomiting, runny nose, eye discomfort, etc. After daily administration, the symptoms of rats in each group were observed, and the occurrence of the above symptoms was scored as 1 point. The frequency of side effects of rats in each group within 7 days of administration was counted.

[0120] Figure 2 The results are statistical results of the frequency of side effects of each group of rats after administration. The results show that compared with the commercially available group of rats, the frequency of side effects of rats in Example 4, Example 5, and Example 6 groups was significantly reduced, with a significant difference, P < 0.01.

[0121] Statistical processing

[0122] SPSS 22.0 software was used to analyze the data, and quantitative data were analyzed by ( The comparison among multiple groups was performed by one-way analysis of variance, and the comparison between two groups was performed by independent sample T test. P < 0.05 was considered statistically significant.

Claims

1. A tamsulosin hydrochloride preparation, characterized in that: The tamsulosin hydrochloride preparation consists of tamsulosin hydrochloride, cinnamon extract, filler, lubricant, disintegrant and sustained-release material; The mass ratio of tamsulosin hydrochloride to cinnamon extract is 1:5-15, the filler is selected from one or more of starch, mannitol, lactose, microcrystalline cellulose, dextrin, and sucrose; the lubricant is selected from one or more of talc, magnesium stearate, and micropowdered silica gel; the disintegrant is selected from one or more of sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, and cross-linked polyvinylpyrrolidone; the sustained-release material is a mixture of ethyl cellulose and ethanol; The preparation method of the cinnamon extract is: (1) Soak the cinnamon bark in 3-5 times the amount of distilled water for 30-60 minutes, heat under reflux at 80-100°C, and collect the volatile oil; (2) The cinnamon residue in step (1) is dried at 45°C-55°C, ground into powder, added with 2-4 times the amount of 70%-90% ethanol for immersion for 3-5 hours, then heated at 50°C-60°C for extraction for 30-60 minutes, filtered, concentrated under reduced pressure to a relative density of 1.45±0.05, added with volatile oil, and mixed to obtain a cinnamon extract.

2. The tamsulosin hydrochloride preparation according to claim 1, characterized in that: The content of cinnamaldehyde in the cinnamon extract is ≥2.3%.

3. The tamsulosin hydrochloride preparation according to claim 1, characterized in that: The volatile oil content in the cinnamon extract is ≥1.8%.

4. The tamsulosin hydrochloride preparation according to claim 1, characterized in that: The filler is a mixture of starch, microcrystalline cellulose and mannitol.

5. The tamsulosin hydrochloride preparation according to claim 1 or 4, characterized in that: The filler is starch, microcrystalline cellulose and mannitol in a mass ratio of 2:1:0.

5.

6. The tamsulosin hydrochloride preparation according to claim 1, characterized in that: The lubricant is magnesium stearate.

7. The tamsulosin hydrochloride preparation according to claim 1, characterized in that: The disintegrant is low-substituted hydroxypropyl cellulose.

8. The tamsulosin hydrochloride preparation according to claim 1, characterized in that: The preparation is a tablet or a capsule.

9. A method for preparing the tamsulosin hydrochloride preparation according to claim 1, characterized in that: The method is: (1) mixing cinnamon extract with a disintegrant and part of a filler, adding tamsulosin hydrochloride, the remaining filler and a lubricant, mixing, granulating and granulating to obtain drug-loaded particles; (2) Ethyl cellulose is dissolved in 95% ethanol to form a sustained-release material solution, which is evenly sprayed on the drug-loaded particles, dried, and the particles are loaded into capsule shells to obtain capsules, or compressed to obtain tablets.

10. The method according to claim 9, characterized in that The partial filler is 1 / 3 to 2 / 3 parts by weight.

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