Microporous osmotic pump sustained release tablet containing polydatin and preparation method thereof

Abstract

The invention discloses a microporous osmotic pump sustained release tablet containing polydatin and a preparation method of the microporous osmotic pump sustained release tablet, and relates to the technical field of production of polydatin medicine tablets. The microporous osmotic pump sustained release tablet comprises a tablet core and a film coating layer wrapping the tablet core, the tablet core comprises the following raw materials in parts by weight: 10-20 parts of polydatin or a polydatin-containing clathrate compound, 40-60 parts of an osmotic pressure accelerant, 2-5 parts of an adhesive, 10-15 parts of a filling agent, 2-5 parts of a suspending aid and 5-10 parts of a cosolvent; the film coating layer comprises the following raw materials in parts by weight: 3 parts of a film-forming material, 30-80 parts of a pore-foaming agent and 20-40 parts of a plasticizer; and the mass of the film coating layer is 2-6% of that of the tablet core. The prepared microporous osmotic pump controlled release tablet containing polydatin overcomes the problems of poor water solubility and low oral bioavailability of polydatin, and can be stably released for a long time within about 12 hours.

Description

Technical Field

[0001] The present invention relates to the technical field of the production of polydatin pharmaceutical tablets, and particularly to a microporous osmotic pump sustained-release tablet containing polydatin and a preparation method thereof. Background Art

[0002] Polydatin (PD), also known as resveratrol glucoside, with the chemical name of 3,4′,5-trihydroxydiphenylethylene-3-β-D-glucoside, is a polyphenolic monomer compound isolated from the traditional Chinese medicinal material Polygonum cuspidatum Sieb. et Zucc. of the Polygonaceae family. Its molecular formula is C 20 H 22 O8, with a molecular weight of 390.4, and it is a white needle-shaped crystalline powder. Polydatin is rich in resources and is widely distributed throughout the country. Polydatin promotes diuresis and subsides jaundice, clears heat and detoxifies, disperses stasis and relieves pain, relieves cough and reduces phlegm, and is used for damp-heat jaundice, gonorrhea, leukorrhea, rheumatic arthralgia, carbuncles and sores, scalds by fire and water, amenorrhea, mass in the abdomen, traumatic injury, and cough due to lung heat. Modern pharmacological studies have shown that polydatin not only has pharmacological activities such as protecting the liver and kidneys, improving bone marrow, anti-fibrosis, regulating glucose metabolism, lipid metabolism, anti-inflammatory, relieving asthma, and promoting wound healing; but also can protect the cardiovascular and cerebrovascular systems, protect the nervous system, and inhibit the proliferation of tumor cells. Thus, it can be seen that polydatin has broad prospects for development and utilization and is a potential therapeutic drug for various diseases such as atherosclerosis, liver, kidney and lung fibrosis, tumors, inflammation, hyperglycemia and hyperlipidemia.

[0003] Although polydatin is a traditional Chinese medicine widely used in clinical practice of traditional Chinese medicine, currently the commercially available preparations are only traditional oral decoctions, injection preparations and Chinese medicine products, and the sustained-release tablets with polydatin as the monomer active ingredient have not been marketed yet. Due to the poor water solubility and low oral bioavailability of polydatin, etc., the development of oral preparations of polydatin has become a difficult problem. Therefore, animal experiments are mostly carried out in the form of intragastric administration or tail vein injection in the form of suspension. At present, the injection preparation developed with polydatin as the main component has no hemolysis and allergic reactions, nor irritating effects, and has relatively high safety, but the injection preparation is not convenient to use.

[0004] Therefore, it is of great significance to develop an oral preparation of polydatin to make it safe and effective, improve its water solubility and bioavailability, and facilitate clinical auxiliary application. Summary of the Invention

[0005] Aiming at the deficiencies of the above prior art, the present invention provides a microporous osmotic pump sustained-release tablet containing polydatin and a preparation method thereof, which overcomes the problem of poor water solubility of polydatin through the synergistic effect of sodium chloride and lactose. Specifically, it is achieved through the following technologies:

[0006] In the first aspect of the present invention, there is provided a microporous osmotic pump sustained-release tablet containing polydatin, which comprises a tablet core and a film coating layer wrapped outside the tablet core;

[0007] By weight, the raw materials of the tablet core include 10-20 parts of polydatin or polydatin inclusion compound, 40-60 parts of osmotic pressure promoter, 2-5 parts of binder, 10-15 parts of filler, 2-5 parts of suspending agent, and 5-10 parts of solubilizer; the raw materials of the film coating layer include 3 parts of film-forming material, 30-80 parts of pore-forming agent, and 20-40 parts of plasticizer; the mass of the film coating layer is 2-6% of the tablet core;

[0008] The osmotic pressure promoter includes sodium chloride and lactose with a mass ratio of 3:1.

[0009] Further, the raw materials of the tablet core include 14.5 parts of polydatin or polydatin inclusion compound, 59.5 parts of osmotic pressure promoter, 3.5 parts of binder, 12.7 parts of filler, 3.5 parts of suspending agent, and 7 parts of solubilizer; the raw materials of the film coating layer include 3 parts of film-forming material, 55 parts of pore-forming agent, and 40 parts of plasticizer; the mass of the film coating layer is 2% of the tablet core.

[0010] Further, the above-mentioned film coating layer is prepared by dissolving all the raw materials of the film coating layer in an organic solvent to form a coating solution, atomizing the coating solution, then uniformly spraying it on the surface of the tablet core, and drying.

[0011] Furthermore, the atomization pressure for atomizing the coating solution is 0.5-0.7 MPa, and the spraying flow rate is 5-8 mL / min.

[0012] Further, the above-mentioned polydatin inclusion compound is prepared by inclusion of polydatin with an inclusion material, and the inclusion material is HP-β-cyclodextrin.

[0013] Furthermore, in the above-mentioned polydatin inclusion compound, the mass ratio of polydatin to the inclusion material is 1:1.

[0014] Further, the above-mentioned binder is polyvinylpyrrolidone K30 (PVP K30), the filler is compressible starch, the suspending agent is hydroxypropyl methylcellulose (HPMC K4M), the solubilizer is sodium dodecyl sulfate or sodium bicarbonate, the film-forming material is cellulose acetate, the pore-forming agent is polyethylene glycol, and the plasticizer is dibutyl phthalate.

[0015] Furthermore, the above-mentioned solubilizer is sodium dodecyl sulfate.

[0016] In the second aspect of the present invention, there is provided a preparation method of the above-mentioned microporous osmotic pump sustained-release tablet containing polydatin, which comprises the following steps:

[0017] S1. Pass the polydatin or the polydatin inclusion complex, osmotic pressure promoter, binder, filler, suspending agent and solubilizer through a 100-mesh sieve according to the above parts by mass, mix them by the equal increment method, then pass through a 24-mesh sieve and mix again, and use a shallow round punch to make a tablet core with a diameter of 10 mm.

[0018] S2. Dissolve the film-forming material, pore-forming agent and plasticizer in an organic solvent to prepare a coating solution, coat the tablet core prepared in step S1, and then dry to remove the organic solvent to obtain the finished product.

[0019] For ordinary oral tablets, the entire drug release process cannot last for 12 h after oral administration. The microporous osmotic pump sustained-release tablets containing polydatin provided by the present invention start to release half an hour after oral administration, and the drug release process can last for 12 h. The osmotic pressure difference inside and outside the film coating layer is the main driving force for the drug release of the osmotic pump sustained-release tablets, and a suitable osmotic pressure promoter is the key to the success of the preparation. Since the solubility of polydatin itself is small, its saturated solution cannot generate a high osmotic pressure, so lactose and sodium chloride are added as osmotic pressure promoters. At the same time, the ratio of the two will also affect the drug release effect. The higher the lactose ratio, the greater the drug release rate and the higher the cumulative release rate, but it will also cause a sudden release of the drug in the early stage, resulting in an uneven drug release curve. Therefore, adding a certain proportion of sodium chloride can effectively avoid the sudden release phenomenon in the early stage. Only when the mass ratio of sodium chloride to lactose is 3:1, sodium chloride and lactose act synergistically to obtain the microporous osmotic pump sustained-release tablets containing polydatin with the best sustained-release effect.

[0020] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0021] 1. By preparing the microporous osmotic pump controlled-release tablets containing polydatin, the present invention overcomes the problems of poor water solubility and low oral bioavailability of polydatin through the synergistic effect of sodium chloride and lactose, and can achieve long-term stable release within about 12 h.

[0022] 2. The present invention overcomes the disadvantages of high cost, high technical level requirements for the process and cumbersome preparation process of traditional laser-drilled osmotic pump tablets, and is more suitable for industrial production.

[0023] 3. The dosage form provided by the present invention is a long-acting sustained-release preparation, which reduces the number of drug administrations, improves the compliance of drug taking, and further reduces or avoids the toxic and side effects caused by blood drug concentration fluctuations. Description of the Drawings

[0024] Figure 1 It is the release curve graph of the microporous osmotic pump sustained-release tablets with different types of osmotic pressure promoters in Experimental Example 1;

[0025] Figure 2 It is the release curve graph of the microporous osmotic pump sustained-release tablets with different formulation ratios of osmotic pressure promoters in Experimental Example 2;

[0026] Figure 3 Release curves of the microporous osmotic pump sustained-release tablets with different dosages of suspending agents in Experimental Example 3;

[0027] Figure 4 Release curves of the microporous osmotic pump sustained-release tablets with different dosages of fillers in Experimental Example 4;

[0028] Figure 5 Release curves of the microporous osmotic pump sustained-release tablets with different cosolvents in Experimental Example 5;

[0029] Figures 6 - 9 3D response surface plot of the microporous osmotic pump sustained-release tablets with polydatin in the film coating layer optimized by the response surface method in Experimental Example 6;

[0030] Figure 10 Structural schematic diagram of the microporous osmotic pump sustained-release tablets containing polydatin prepared in Example 1;

[0031] Figure 11 Release curves of the microporous osmotic pump sustained-release tablets in Experimental Examples 1-6 and Example 1. Detailed implementation manners

[0032] The technical solutions of the present invention will be described clearly and completely below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0033] The microporous osmotic pump sustained-release tablets containing polydatin in the following experimental examples and examples include a tablet core and a film coating layer wrapped outside the tablet core;

[0034] By weight, the raw materials of the tablet core include 10-20 parts of polydatin or polydatin inclusion complex, 40-60 parts of osmotic pressure promoter, 2-5 parts of binder, 10-15 parts of filler, 2-5 parts of suspending agent, and 5-10 parts of cosolvent; the raw materials of the film coating layer include 3 parts of film-forming material, 30-80 parts of pore-forming agent, and 20-40 parts of plasticizer; the mass of the film coating layer is 2-6% of the tablet core. The polydatin inclusion complex is prepared by encapsulating polydatin with an encapsulating material, and the encapsulating material is HP-β-cyclodextrin, and the mass ratio of polydatin to the encapsulating material is 1:1.

[0035] If not otherwise specified, they are all prepared according to the following preparation method:

[0036] S1. Mix polygonum cuspidatum glycoside or the inclusion complex containing polygonum cuspidatum glycoside with appropriate excipients such as fillers, penetration enhancers, suspending agents, binders, and solubilizers through a 100-mesh sieve, mix them evenly according to the prescription dosage by the equal increment method, then pass through a 24-mesh sieve for mixing, and use a shallow round punch to make a tablet core with a diameter of 10 mm.

[0037] S2. Dissolve the film-forming material, pore-forming agent, and plasticizer in an organic solvent to prepare a coating solution; place the tablet core in a coating pan, keep the tablet bed temperature at about 35°C, atomize the coating solution, and then evenly spray it on the surface of the tablet core. The atomization pressure is 0.5 - 0.7 MPa, the spraying flow rate is 5 - 8 mL / min, the rotation speed of the coating pan is 30 r / min, and after coating, cure it at 40°C for 24 h to obtain the microporous osmotic pump sustained-release tablet containing polygonum cuspidatum glycoside.

[0038] For convenient comparison, the specific dosages of each raw material and the preparation method for each experimental example and example are as follows: Experimental Example 1: Study on the effects of lactose, sodium chloride, and lactose-sodium chloride as osmotic pressure promoters

[0039] The microporous osmotic pump sustained-release tablet containing polygonum cuspidatum glycoside provided in this experimental example includes a tablet core and a film coating layer wrapped outside the tablet core. The raw materials of the tablet core include 14.5 parts of polygonum cuspidatum glycoside, 5.9 parts of compressible starch (filler, purchased from Aladdin), 59.5 parts of osmotic pressure regulator, 3.5 parts of polyvinylpyrrolidone K30 (binder), 7.3 parts of hydroxypropyl methylcellulose (suspending agent), 5 parts of sodium dodecyl sulfate (solubilizer); the raw materials of the film coating layer include 3 parts of cellulose acetate (film-forming material), 60 parts of polyethylene glycol (pore-forming agent), 20 parts of dibutyl phthalate (plasticizer); the mass of the film coating layer is 6% of that of the tablet core.

[0040] To compare the effects of different osmotic pressure promoters on the release effect, lactose, sodium chloride, and lactose-sodium chloride (the mass ratio of lactose to sodium chloride is 1:1) are respectively selected as osmotic pressure promoters.

[0041] The atomization pressure in step S2 of this experimental example is 0.5 MPa, and the spraying flow rate is 6 mL / min.

[0042] The sustained-release microporous osmotic pump tablets containing polydatin obtained in this experimental example were studied for in vitro release. The release detection method was in accordance with the regulations in Part IV of the Chinese Pharmacopoeia 2020 Edition. The dissolution medium was phosphate buffer solution (pH 6.8, without adding trypsin), the detection temperature was 37±0.5 °C, the rotation speed was 75 rpm. Samples were taken at 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 5.0 h, 6.0 h, 8.0 h, and 12 h after the start of the experiment, 3 mL of each sample was taken each time, and the same volume of blank medium was replenished. After filtering the samples to be tested through a 0.45 μm microporous filter membrane, the standard control method was used to calculate the cumulative release amount of each sample. With time as the abscissa and the cumulative release amount as the ordinate, the release curve of polydatin was plotted. The release curve of the sustained-release microporous osmotic pump tablets containing polydatin prepared in this experimental example is as shown in Figure 1 shown.

[0043] It can be seen from Figure 1 that the type of osmotic pressure promoter has a certain influence on the release. This is because the drug release rate of the sustained-release microporous osmotic pump tablets is related to the magnitude of the osmotic pressure. The different saturated osmotic pressures of the three osmotic agents result in different drug release rates. When using lactose alone, the osmotic promoting effect is obvious at the beginning, the drug release rate in the early stage is relatively fast, which is likely to cause too high drug concentration, while the release slows down in the later stage; when using sodium chloride alone, the release curve is flatter than that of lactose, but there is a time lag in the early stage, and the osmotic pressure cannot provide sufficient and lasting drug release driving force, and the release degree is low; when lactose and sodium chloride are used in combination, the release behavior is relatively ideal. This is because an appropriate amount of lactose can also improve the compressibility of the tablets. Therefore, sodium chloride and lactose are jointly selected as the osmotic agents, which can not only ensure a certain osmotic pressure but also ensure the compressibility of the drug.

[0044] Experimental Example 2: Study on the effects of lactose and sodium chloride with different mass ratios as osmotic pressure promoters

[0045] Based on the relatively ideal release result obtained when lactose and sodium chloride are used in combination in Experimental Example 1, this experimental example compared the effects of different ratios of lactose and sodium chloride on the release effect. The difference from Experimental Example 1 is that the ratios of lactose and sodium chloride used as osmotic pressure promoters in the tablet core were three different treatments of 3:1, 4:1, and 5:1, in order to compare the effects of different mass ratios of lactose and sodium chloride used in combination on the release effect.

[0046] The sustained-release microporous osmotic pump tablets containing polydatin obtained in this experimental example were studied for in vitro release. The release detection method was the same as that in Experimental Example 1. The release curve of the sustained-release microporous osmotic pump tablets containing polydatin prepared in this experimental example is as shown in Figure 2 shown.

[0047] It can be seen from Figure 2It can be seen that lactose and sodium chloride in different proportions have a certain impact on the drug release. The higher the proportion of lactose, the greater the drug release rate and the cumulative release rate. The osmotic promoting effect of lactose is more obvious at the beginning. As the proportion of lactose increases, the initial drug release lag time is effectively reduced, and the release is also more complete in the later stage. However, when the proportion of lactose increases, burst release is likely to occur in the early stage of drug release, and the release curve is not smooth enough. Therefore, the proportion of lactose and sodium chloride is selected as 3:1.

[0048] Experimental Example 3: Study on the effect of the amount of suspending agent on the sustained-release effect

[0049] The microporous osmotic pump sustained-release tablets containing polydatin provided in this experimental example are different from those in Experimental Example 1 in terms of their structural composition and preparation method: in the tablet core, the amount of hypromellose (HPMC K4M) used as the suspending agent is different. Specifically, 3.5 parts, 5.5 parts, and 7 parts of HPMC are used for different treatments to compare the effect of the amount of suspending agent on the release effect. The osmotic pressure promoter only uses lactose combined with an equal proportion of sodium chloride.

[0050] Take the microporous osmotic pump sustained-release tablets containing polydatin obtained in this experimental example for the study of in vitro release. The release detection method is the same as that in Experimental Example 1, and the release curve diagram is as Figure 3 shown.

[0051] It can be seen from Figure 3 that when 3.5 parts of HPMC are used, the microporous osmotic pump sustained-release tablets containing polydatin have good release effects in the early, middle, and late stages, and can be released completely.

[0052] Experimental Example 4: Study on the effect of the amount of suspending agent on the release effect

[0053] The microporous osmotic pump sustained-release tablets containing polydatin provided in this experimental example are different from those in Experimental Example 1 in terms of their structural composition and preparation method: in the tablet core, the amount of compressible starch used as the filler is different. Specifically, 5.9 parts, 9.3 parts, and 12.7 parts of compressible starch are used for different treatments to compare the effect of the amount of suspending agent on the release effect. At the same time, the amount of HPMC K4M used as the suspending agent is 3.5 parts, and the osmotic pressure promoter uses lactose combined with an equal proportion of sodium chloride.

[0054] Take the microporous osmotic pump sustained-release tablets containing polydatin obtained in this experimental example for the study of in vitro release. The release detection method is the same as that in Experimental Example 1, and the release curve diagram is as Figure 4 shown.

[0055] It can be seen from Figure 4 that when 12.7 parts of compressible starch are used as the filler, the microporous osmotic pump sustained-release tablets containing polydatin have a better release effect in the early stage than when 5.9 parts are used, and a better release effect in the later stage than when 9.3 parts are used.

[0056] Experimental Example 5: Study on the Influence of Different Solubilizers on the Release Effect

[0057] The microporous osmotic pump sustained-release tablets containing polydatin provided in this experimental example are different from those in Experimental Example 1 in terms of their structural composition and preparation method: in the tablet core, different treatments are adopted for the solubilizers sodium dodecyl sulfate and sodium bicarbonate. At the same time, the dosage of HPMC K4M as a suspending agent is 3.5 parts, and the dosage of compressible starch as a filler is 12.7 parts. Only lactose combined with sodium chloride in equal proportion is used as the osmotic pressure promoter.

[0058] Take the microporous osmotic pump sustained-release tablets containing polydatin obtained in this experimental example for the study of in vitro release. The release detection method is the same as that in Experimental Example 1, and the release curve is as Figure 5 shown.

[0059] It can be seen from Figure 5 that when sodium dodecyl sulfate is used as the solubilizer, the release effect of the microporous osmotic pump sustained-release tablets is better.

[0060] Experimental Example 6: Response Surface Study on Pore-Forming Agents, Plasticizers, and Film-Coating Layers

[0061] In the film-coating process, the quality of the pore-forming agent, plasticizer, and film-coating layer has a great influence on the in vitro drug release of the sustained-release tablets. In this experimental example, the response surface method is used to optimize the dosages of the pore-forming agent, plasticizer, and film-coating layer. The preparation method and the dosages of other raw materials are the same as those in Experimental Example 1.

[0062] Take the microporous osmotic pump sustained-release tablets containing polydatin obtained in this experimental example for the study of in vitro release. The release detection method is the same as that in Experimental Example 1, and the 3D response surface diagram obtained by the response surface method is as Figures 6 - 9 shown.

[0063] It can be seen from Figures 6 - 9 that the optimal coating formulation obtained by the response surface method is: 55 parts of polyethylene glycol (PEG) as the pore-forming agent, 40 parts of dibutyl phthalate (DBP) as the plasticizer, and the quality of the film-coating layer is 2% of the tablet core. The sustained-release effect is obvious. In the time period of 0.5 - 12 h, the drug is slowly released, and the drug release rate reaches more than 90% at 12 h, with sufficient drug release and improved drug utilization rate.

[0064] Example 1

[0065] Based on the above Experimental Examples 1 - 6, the microporous osmotic pump sustained-release tablets containing polydatin provided in this embodiment include a tablet core and a film coating layer wrapped around the tablet core. The raw materials of the tablet core include 14.5 parts of polydatin inclusion complex, 12.7 parts of compressible starch (filler, purchased from Aladdin), 59.5 parts of sodium chloride and lactose with a mass ratio of 3:1 (osmotic pressure regulator), 3.5 parts of polyvinylpyrrolidone K30 (binder), 3.5 parts of hydroxypropyl methylcellulose (suspending agent), 7 parts of sodium dodecyl sulfate (cosolvent); the raw materials of the film coating layer include 3 parts of cellulose acetate (film-forming material), 55 parts of polyethylene glycol (pore-forming agent), 40 parts of dibutyl phthalate (plasticizer); the mass of the film coating layer is 2% of the tablet core.

[0066] In step S2 of this experimental example, the atomization pressure is 0.6 MPa and the spraying flow rate is 8 mL / min.

[0067] The structural schematic diagram of the microporous osmotic pump sustained-release tablets containing polydatin prepared in this embodiment is as Figure 10 shown.

[0068] The in vitro release of the microporous osmotic pump sustained-release tablets prepared in the above experimental examples and embodiments was studied, and the release curve of polydatin was plotted as Figure 11 shown. It can be seen from the figure that the dosage of each raw material in the tablet core, the dosage of each raw material in the film coating layer, and the mass ratio of the tablet core to the film coating layer all have a certain influence on the sustained-release effect of the microporous osmotic pump sustained-release tablets. When there are 14.5 parts of polydatin or polydatin inclusion complex, 59.5 parts of osmotic pressure promoter, 3.5 parts of binder, 12.7 parts of filler, 3.5 parts of suspending agent, 7 parts of cosolvent; the dosage of each raw material in the film coating layer is 3 parts of film-forming material, 55 parts of pore-forming agent, 40 parts of plasticizer; the mass of the film coating layer is 2% of the tablet core, and the osmotic pressure promoter is sodium chloride and lactose with a mass ratio of sodium chloride to lactose of 3:1, and the cosolvent is sodium dodecyl sulfate, the release effect of the prepared microporous osmotic pump sustained-release tablets is the best.

[0069] The above specific embodiments have described the implementation of the present invention in detail. However, the present invention is not limited to the specific details in the above embodiments. Within the scope of the claims and technical concept of the present invention, various simple modifications and changes can be made to the technical solutions of the present invention, and these simple variations all fall within the protection scope of the present invention.

Claims

1. A microporous osmotic pump sustained-release tablet containing polydatin, characterized in that, It includes a tablet core and a film coating layer wrapped around the tablet core; By weight parts, the raw materials of the tablet core include 10 - 20 parts of polydatin or polydatin inclusion compound, 40 - 60 parts of osmotic pressure promoter, 2 - 5 parts of binder, 10 - 15 parts of filler, 2 - 5 parts of suspending agent, and 5 - 10 parts of solubilizer; the raw materials of the film coating layer include 3 parts of film-forming material, 30 - 80 parts of pore-forming agent, and 20 - 40 parts of plasticizer; the mass of the film coating layer is 2 - 6% of the tablet core; The osmotic pressure promoter includes sodium chloride and lactose with a mass ratio of 3:

1.

2. The sustained-release microporous osmotic pump tablet containing polydatin according to claim 1, wherein, By weight parts, the raw materials of the tablet core include 14.5 parts of polydatin or polydatin inclusion compound, 59.5 parts of osmotic pressure promoter, 3.5 parts of binder, 12.7 parts of filler, 3.5 parts of suspending agent, and 7 parts of solubilizer; the raw materials of the film coating layer include 3 parts of film-forming material, 55 parts of pore-forming agent, and 40 parts of plasticizer; the mass of the film coating layer is 2% of the tablet core.

3. The sustained-release microporous osmotic pump tablet containing polydatin according to claim 1, characterized in that, The film coating layer is prepared by dissolving all the raw materials of the film coating layer in an organic solvent to form a coating solution, atomizing the coating solution, then uniformly spraying it on the surface of the tablet core, and drying.

4. The microporous osmotic pump sustained-release tablet containing polydatin according to claim 3, wherein, The atomizing pressure for atomizing the coating solution is 0.5 - 0.7 MPa, and the spraying flow rate is 5 - 8 mL / min.

5. The microporous osmotic pump sustained-release tablet containing polydatin according to claim 1, wherein The polydatin inclusion compound is prepared by inclusion of polydatin with an inclusion material, and the inclusion material is HP-β-cyclodextrin.

6. The microporous osmotic pump sustained-release tablet containing polydatin according to claim 5, characterized in that, In the polydatin inclusion compound, the mass ratio of polydatin to the inclusion material is 1:

1.

7. The microporous osmotic pump sustained-release tablet containing polydatin according to claim 1, characterized in that, The binder is polyvinylpyrrolidone K30; the filler is compressible starch; the suspending agent is hydroxypropyl methylcellulose; the solubilizer is sodium dodecyl sulfate or sodium bicarbonate; the film-forming material is cellulose acetate; the pore-forming agent is polyethylene glycol; the plasticizer is dibutyl phthalate.

8. The sustained-release microporous osmotic pump tablet containing polydatin according to claim 1, characterized in that The solubilizer is sodium dodecyl sulfate.

9. The preparation method of the microporous osmotic pump sustained-release tablet containing polydatin according to claim 1, characterized in that, It includes the following steps: S1. Pass polydatin or polydatin inclusion compound, osmotic pressure promoter, binder, filler, suspending agent, and solubilizer through a 100-mesh sieve, mix them by the equal increment method, then pass through a 24-mesh sieve and mix again to form a tablet core with a diameter of 10 mm; S2. Dissolve the film-forming material, pore-forming agent, and plasticizer in an organic solvent to form a coating solution, perform coating treatment on the tablet core prepared in step S1, and then dry to remove the organic solvent to obtain a microporous osmotic pump sustained-release tablet.

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