CN112294883B - Stomach-strengthening tablet medicinal preparation and preparation method thereof - Google Patents
Stomach-strengthening tablet medicinal preparation and preparation method thereof Download PDFInfo
- Publication number
- CN112294883B CN112294883B CN202011320368.8A CN202011320368A CN112294883B CN 112294883 B CN112294883 B CN 112294883B CN 202011320368 A CN202011320368 A CN 202011320368A CN 112294883 B CN112294883 B CN 112294883B
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- weight
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- stomach
- pithecellobium clypearia
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- 238000002360 preparation method Methods 0.000 title claims abstract description 35
- 238000005728 strengthening Methods 0.000 title claims description 8
- 239000003814 drug Substances 0.000 claims abstract description 33
- 239000003826 tablet Substances 0.000 claims abstract description 24
- 210000002784 stomach Anatomy 0.000 claims abstract description 23
- 239000000825 pharmaceutical preparation Substances 0.000 claims abstract description 20
- 239000007939 sustained release tablet Substances 0.000 claims abstract description 14
- 229940126673 western medicines Drugs 0.000 claims abstract description 13
- 239000000463 material Substances 0.000 claims abstract description 12
- 230000000717 retained effect Effects 0.000 claims abstract description 12
- 229940126680 traditional chinese medicines Drugs 0.000 claims abstract description 8
- 239000002994 raw material Substances 0.000 claims abstract description 5
- 239000000843 powder Substances 0.000 claims description 41
- 244000033373 Pithecellobium clypearia Species 0.000 claims description 38
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- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 22
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 claims description 19
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- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 14
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- HWSISDHAHRVNMT-UHFFFAOYSA-N Bismuth subnitrate Chemical compound O[NH+]([O-])O[Bi](O[N+]([O-])=O)O[N+]([O-])=O HWSISDHAHRVNMT-UHFFFAOYSA-N 0.000 claims description 13
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 claims description 13
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- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 13
- 239000000395 magnesium oxide Substances 0.000 claims description 13
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 claims description 13
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- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims description 7
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- LNTHITQWFMADLM-UHFFFAOYSA-N gallic acid Chemical compound OC(=O)C1=CC(O)=C(O)C(O)=C1 LNTHITQWFMADLM-UHFFFAOYSA-N 0.000 abstract description 26
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Abstract
Discloses a tablet pharmaceutical preparation for treating gastric diseases, which is a sustained-release tablet retained in the stomach, and the raw materials comprise traditional Chinese medicines and western medicines; and an auxiliary material for forming the sustained-release tablet retained in the stomach. In addition, a preparation method thereof is also disclosed. The medicinal preparation can prolong the retention time of the medicament in the stomach and can continuously and uniformly release the medicament; in addition, the hydrophilic polymer auxiliary materials in the pharmaceutical preparation are beneficial to reducing the drug release difference of the gallic acid and the hesperidin, thereby improving the bioavailability of the gallic acid and the hesperidin.
Description
Technical Field
The invention belongs to the technical field of Chinese and western medicine compound pharmaceutical preparations, and particularly relates to a stomach-strengthening tablet pharmaceutical preparation and a preparation method thereof.
Background
The stomach-strengthening tablet belongs to a special compound preparation of Chinese and Western medicines, comprising Chinese medicines and chemical medicines. The former comprises fructus Pithecellobii Heterophylli, pericarpium Citri Tangerinae, radix aucklandiae, radix Schefflerae Arboricolae and Glycyrrhrizae radix; the latter include bismuth subnitrate, magnesium oxide and aluminum hydroxide. The stomach-strengthening tablet has the main functions of: clearing heat and cooling blood, strengthening spleen and stomach, and relieving hyperacidity and pain; can be used for treating stomach heat burning, abdominal pain, nausea, acid regurgitation, anorexia, listlessness, chronic gastritis, and gastric and duodenal ulcer. The compound preparation is recorded in the seventeenth volume of Chinese medicinal preparations in the standards of the drugs of the ministry of health.
After the compound preparation is orally taken, magnesium oxide and aluminum hydroxide are used for neutralizing gastric acid; part of active ingredients in Glycyrrhrizae radix, pericarpium Citri Tangerinae, and radix aucklandiae act on ulcer surface of stomach wall to protect gastric mucosa; the pithecellobium clypearia and bismuth subnitrate synergically remove helicobacter pylori; the active ingredients in scandent schefflera root have analgesic effect. However, due to the physiological emptying action of the stomach, the compound preparation is quickly brought into the small intestine by the gastric juice, so that the retention time of the compound preparation at the lesion part of the stomach wall is reduced, and the curative effect is greatly influenced.
In addition, the physical properties of the components of the compound preparation, such as the pithecellobium clypearia, the dried orange peel, the costustoot, the scandent schefflera root, the liquorice, and the like, are greatly different. The effective components of the pithecellobium clypearia and the dried orange peel which are used as monarch drugs in the compound preparation are respectively gallic acid and hesperidin, and the solubility of the effective components in an acid solution has large difference, so that the synergistic effect among the drugs of the compound preparation is not facilitated.
The inventor finds that the compound preparation is prepared into a sustained-release drug preparation retained in the stomach, so that the retention time of the drug in the stomach can be prolonged, and the drug can be continuously and uniformly released; in addition, the colloid formed by the hydrophilic polymer auxiliary materials in the medicinal preparation in gastric juice enables the medicaments in the compound preparation to be dispersed in the gastric juice, and is beneficial to reducing the medicament release difference of gallic acid and hesperidin, thereby improving the bioavailability of the gallic acid and the hesperidin.
Disclosure of Invention
In view of the above problems, it is an object of the present invention to provide a positive-gastric-tablet pharmaceutical preparation. The positive gastric tablet preparation is a sustained-release tablet retained in the stomach, and can prolong the retention time of the drug in the stomach and continuously and uniformly release the drug; in addition, the colloid formed by the hydrophilic polymer auxiliary materials in the medicinal preparation in gastric juice enables the medicament in the compound preparation to be dispersed in the gastric juice, which is beneficial to reducing the medicament release difference of the gallic acid and the hesperidin, thereby improving the bioavailability of the gallic acid and the hesperidin.
The second purpose of the invention is to provide a preparation method of the stomach-strengthening tablet pharmaceutical preparation.
In order to achieve the purpose, on one hand, the invention adopts the following technical scheme: the positive-stomach tablet pharmaceutical preparation is characterized in that the positive-stomach tablet pharmaceutical preparation is a sustained-release tablet retained in the stomach, and the raw materials comprise traditional Chinese medicines and western medicines; and an auxiliary material for forming the sustained-release tablet retained in the stomach.
The pharmaceutical preparation according to the present invention is characterized in that the Chinese medicine comprises: 140-240 parts of pithecellobium clypearia; the weight of the tangerine peel, the scandent schefflera root and the liquorice is 14-24 parts respectively; the weight of the costustoot is 6 to 14 parts.
Preferably, the traditional Chinese medicine comprises: the weight of the pithecellobium clypearia is 160-220 parts; the weight of the tangerine peel, the scandent schefflera root and the liquorice is 16 to 22 parts respectively; the weight of the costustoot is 8 to 12 parts.
In a specific embodiment, the Chinese medicine comprises: 187.5 parts of pithecellobium clypearia; the weight of the tangerine peel, the scandent schefflera root and the liquorice is respectively 18.75 parts; the weight of the costustoot is 9.75 parts.
The pharmaceutical preparation is characterized in that the western medicines comprise: 14-24 parts of bismuth subnitrate and magnesium oxide; the weight of the aluminum hydroxide is 24-33 parts.
Preferably, the western medicines include: 16-22 parts of bismuth subnitrate and magnesium oxide respectively; the weight of the aluminum hydroxide is 26-31 parts.
In a specific embodiment, the western medicines include: 18.75 parts of bismuth subnitrate and 18.75 parts of magnesium oxide; the weight of the aluminum hydroxide was 28.5 parts.
The pharmaceutical preparation is characterized in that the auxiliary materials comprise hydroxypropyl methyl cellulose, polyethylene glycol, polyvinylpyrrolidone, cetyl alcohol, sodium bicarbonate, sucrose and magnesium stearate.
The pharmaceutical preparation is characterized in that the weight of the hydroxypropyl methyl cellulose is 240-300 parts; 60-80 parts of polyvinylpyrrolidone; the weight of the hexadecanol is 130-170 parts; 35-45 parts of polyethylene glycol; the weight of the sodium bicarbonate is 35-45 parts; the weight of the sucrose is 16-24 parts; the weight of the magnesium stearate is 4-8 parts.
Preferably, the weight of the hydroxypropyl methyl cellulose is 250-290 parts; 65-75 parts of polyvinylpyrrolidone; the weight of the hexadecanol is 140 to 160 parts; 38-42 parts of polyethylene glycol; 38-42 parts of sodium bicarbonate; the weight of the sucrose is 18-22 parts; the weight of the magnesium stearate is 5-7 parts.
In a specific embodiment, the weight of hydroxypropyl methylcellulose is 268 parts; the weight of the polyvinylpyrrolidone is 70 parts; the weight of the hexadecanol is 150 parts; the weight of the polyethylene glycol is 40 parts; the weight of the sodium bicarbonate is 40 parts; the weight of the cane sugar is 20 parts; the weight of the magnesium stearate is 6 parts.
The pharmaceutical preparation according to the invention is characterized in that the hydroxypropylmethylcellulose is selected from HPMCE50.
The pharmaceutical preparation according to the invention is characterized in that the polyvinylpyrrolidone is selected from PVPK30.
The pharmaceutical preparation according to the invention is characterized in that the polyethylene glycol is selected from PEG 6000.
In another aspect, the present invention provides a method for preparing the above positive gastric tablet pharmaceutical preparation, comprising:
(1) Decocting Pithecellobium clypearia with water, concentrating the decoction, and drying to obtain Pithecellobium clypearia powder;
(2) Obtaining a solid dispersion containing the pithecellobium clypearia and the dried orange peel by a melting method;
(3) Mixing the solid dispersion, western medicines and other traditional Chinese medicines, hydroxypropyl methylcellulose, cetyl alcohol, the rest polyvinylpyrrolidone, sodium bicarbonate, sucrose and magnesium stearate, and tabletting to obtain the sustained-release tablet retained in stomach.
The preparation method is characterized in that the step (2) is specifically as follows: dissolving polyvinylpyrrolidone in small amount of anhydrous ethanol, adding Pithecellobium clypearia powder and pericarpium Citri Tangerinae powder, and stirring; adding the mixture into molten polyethylene glycol, and stirring to uniformly disperse the mixture; solidifying at-20 deg.C, drying, and pulverizing into powder.
The preparation method is characterized in that the sum of the weight of the pithecellobium clypearia powder and the weight of the dried orange peel powder is as follows: weight of polyethylene glycol: weight of polyvinylpyrrolidone =1: (0.9-1.1): (0.9-1.1).
In the invention, the traditional Chinese medicine materials all meet the relevant national standard or local medicinal material standard. Wherein the Pithecellobium clypearia is dried leaf of Pithecellobium clypearia of Leguminosae; radix aucklandiae is dried root of radix aucklandiae of Compositae; schefflera arboricola is dry whole plant of schefflera venulosa (Schw.) harms of Araliaceae; the pericarpium Citri Tangerinae is dried pericarp of Citrus reticulata Blanco of Rutaceae; the Glycyrrhrizae radix is dried root of Glycyrrhrizae radix of Leguminosae.
In the invention, the western medicines all accord with the related medicine standards of Chinese pharmacopoeia.
Advantageously, in the above-mentioned method for producing a tablet for positive stomach, the case involving pulverization is preferably pulverized into a powder of 100 to 150 mesh.
Advantageously, the hardness is controlled to be 3-4kg during tabletting.
In a specific embodiment, there is provided a specific preparation method of the above-mentioned positive-stomach tablet pharmaceutical preparation, comprising:
(1) Decocting Pithecellobium clypearia with water for 2 times, and adding 8-12 times of water each time; concentrating the decoction under reduced pressure to obtain fluid extract with relative density of 1.4, drying under reduced pressure, and pulverizing into 100-150 mesh Pithecellobium clypearia powder;
(2) Respectively pulverizing pericarpium Citri Tangerinae, radix aucklandiae, radix Schefflerae Arboricolae, glycyrrhrizae radix, bismuth subnitrate, magnesium oxide and aluminum hydroxide into 100-150 mesh powder;
(3) Dissolving polyvinylpyrrolidone in small amount of anhydrous ethanol, adding Pithecellobium clypearia powder and pericarpium Citri Tangerinae powder, stirring, adding into molten polyethylene glycol, and stirring to disperse uniformly; solidifying in a refrigerator at-20 deg.C, drying, and pulverizing into 100-150 mesh powder to obtain solid dispersion containing Pithecellobium clypearia and pericarpium Citri Tangerinae; wherein the sum of the weight of the pithecellobium clypearia powder and the weight of the dried orange peel powder is as follows: weight of polyethylene glycol: weight of polyvinylpyrrolidone =1: (0.9-1.1): (0.9-1.1);
(4) Mixing the solid dispersion, western medicines, the rest traditional Chinese medicines, hydroxypropyl methylcellulose, cetyl alcohol, the rest polyvinylpyrrolidone, sodium bicarbonate, sucrose and magnesium stearate uniformly, sieving with a 100-150 mesh sieve, and directly performing dry tabletting with hardness controlled at 3-4kg to obtain the gastric retention sustained release tablet.
Compared with the prior art, the medicinal preparation can prolong the detention time of the medicament in the stomach and can continuously and uniformly release the medicament; in addition, the colloid formed by the hydrophilic polymer auxiliary materials in the medicinal preparation in gastric juice enables the medicament in the compound preparation to be dispersed in the gastric juice, which is beneficial to reducing the medicament release difference of the gallic acid and the hesperidin, thereby improving the bioavailability of the gallic acid and the hesperidin.
Without wishing to be bound by any theory, the solid dispersion comprising pithecellobium clypearia and dried orange peel and the further formed gastro-retentive sustained release tablet of the present invention play a key role in achieving the above technical effects.
Detailed Description
The following examples are put forth so as to provide those of ordinary skill in the art with a complete disclosure and description of how the compounds, compositions, articles, devices, and/or methods described and claimed herein are made and evaluated, and are intended to be purely exemplary and are not intended to limit the scope of what the inventors regard as their invention. Efforts have been made to ensure accuracy with respect to numbers (e.g., amounts, temperature, etc.) but some errors and deviations should be accounted for.
Unless otherwise indicated, parts are parts by weight, temperatures are in degrees celsius or at ambient temperature, and pressures are at or near atmospheric. There are many variations and combinations of reaction conditions (e.g., component concentrations, desired solvents, solvent mixtures, temperatures, pressures, and other reaction ranges) and conditions that can be used to optimize the purity and yield of the product obtained by the process. Only reasonable routine experimentation will be required to optimize such process conditions.
Example 1
Raw materials:
the weight of the pithecellobium clypearia is 187.5g; the weight of the tangerine peel, the scandent schefflera root and the liquorice is respectively 18.75g; the weight of the costustoot is 9.75g; the weights of bismuth subnitrate and magnesium oxide are respectively 18.75g; the weight of the aluminum hydroxide is 28.5g; the weight of HPMCE50 is 268g; the weight of the polyvinylpyrrolidone PVPK30 is 70g; the weight of the hexadecanol is 150g; the weight of the polyethylene glycol PEG6000 is 40g; the weight of the sodium bicarbonate is 40g; the weight of the sucrose is 20g; the weight of magnesium stearate was 6g.
The preparation method comprises the following steps:
(1) Decocting Pithecellobium clypearia with water for 2 times, and adding 10 times of water each time; the decoction was concentrated under reduced pressure at 70 ℃ and 0.1MPa to a fluid extract with a relative density of 1.4, followed by drying under reduced pressure and pulverizing to 120 mesh powder of Pithecellobium clypearia, and the weight was 23.8g.
(2) Respectively pulverizing pericarpium Citri Tangerinae, radix aucklandiae, radix Schefflerae Arboricolae and Glycyrrhrizae radix, bismuth subnitrate, magnesium oxide and aluminum hydroxide into 120 mesh powder.
(3) Dissolving 40 parts of polyvinylpyrrolidone (PVPK) 30 in a small amount of anhydrous ethanol, adding pithecellobium clypearia powder and dried orange peel powder, stirring uniformly, adding the pithecellobium clypearia powder and dried orange peel powder into 40 parts of molten polyethylene glycol (PEG 6000), and stirring to disperse uniformly; solidifying in a refrigerator at-20 deg.C, drying, and pulverizing into 120 mesh powder to obtain solid dispersion containing Pithecellobium clypearia and pericarpium Citri Tangerinae.
(4) Mixing the solid dispersion, western medicines and other traditional Chinese medicines, hydroxypropyl methylcellulose HPMCE50, cetyl alcohol, the rest polyvinylpyrrolidone PVPK30, sodium bicarbonate, sucrose and magnesium stearate, sieving with 120 mesh sieve, directly performing dry tabletting with hardness of 3-4kg, and making into 1000 tablets to obtain the delayed release tablet retained in stomach.
Comparative example 1
Weighing polyvinylpyrrolidone PVP K30, polyethylene glycol PEG6000, pithecellobium clypearia powder and dried orange peel powder according to the corresponding proportion of the solid dispersion in the step (3) in the embodiment 1, and grinding to uniformly mix the powder; the other steps and conditions were the same as in example 1 to obtain a sustained-release tablet retained in the stomach.
Comparative example 2
Raw materials:
the weight of the pithecellobium clypearia is 750g; the weight of the tangerine peel, the scandent schefflera root and the liquorice is 75g respectively; the weight of the costustoot is 39g; the weight of bismuth subnitrate and the weight of magnesium oxide are respectively 75g; the weight of the aluminum hydroxide is 114g; 118g of cane sugar; 7.5g of glycoprotein; silica gel micropowder 1.5g.
The preparation method comprises the following steps:
(1) Decocting Pithecellobium clypearia with water for 2 times, and adding 10 times of water each time; the decoction was concentrated under reduced pressure at 70 ℃ and 0.1MPa to a clear paste with a relative density of 1.4, then dried under reduced pressure and pulverized into 120 mesh monkey ear ring powder, weighing 95.4g.
(2) Respectively pulverizing pericarpium Citri Tangerinae, radix aucklandiae, radix Schefflerae Arboricolae and Glycyrrhrizae radix, bismuth subnitrate, magnesium oxide and aluminum hydroxide into 120 mesh powder.
(3) Mixing the above extract powder, western medicine, other Chinese medicinal materials, aspartame, sucrose and silica gel micropowder uniformly, sieving with 120 mesh sieve, directly tabletting by dry method, controlling hardness at 3-4kg, and making into 1000 tablets to obtain common tablet.
In vitro floating performance
The gastro-retentive sustained release tablets of example 1 and comparative example 1 were placed in a 0.1M hydrochloric acid solution, and the rise time (min), duration (h) and appearance during floating were measured.
The results are shown in Table 1.
TABLE 1
| Rising drift time (min) | Duration (h) | Appearance during floating | |
| Example 1 | 1.8 | 12 | Complete without cracking |
| Comparative example 1 | 5.7 | 11 | Partial cleavage |
In vitro Release Properties
According to the relevant regulations of Chinese pharmacopoeia 2015 year edition, the tablets of example 1 and comparative examples 1-2 are placed in a rotating basket of 300ml artificial gastric juice, samples are taken according to the specified time, and after filtration by using a 0.8 mu m microporous filter membrane, the subsequent filtrate is taken; then, the content of gallic acid and hesperidin in the zhengwei tablets was measured by the HPLC method of Tang De Zhi "(national folk medicine of China, 2016, 02, 25, 3 rd edition, pages 12-13) to prepare a control solution and a test solution, and the cumulative release rates (%) of gallic acid and hesperidin in example 1 and comparative examples 1-2 at different times were measured according to their chromatographic conditions.
The results are shown in Table 2.
TABLE 2
The results show that, compared with comparative examples 1-2, the pharmaceutical formulation of example 1 of the present invention can not only prolong the retention time of the drug in the stomach but also continuously and uniformly release the drug; in addition, the colloid formed by the hydrophilic polymer auxiliary materials in the medicinal preparation in gastric juice enables the medicaments in the compound preparation to be dispersed in the gastric juice, and is beneficial to reducing the medicament release difference of gallic acid and hesperidin, thereby improving the bioavailability of the gallic acid and the hesperidin.
Without wishing to be bound by any theory, the solid dispersion comprising pithecellobium clypearia and dried orange peel and the further formed gastro-retentive sustained release tablet of the present invention play a key role in achieving the above technical effects.
It should be understood that the detailed description of the invention is intended to illustrate the spirit and principles of the invention, and is not intended to limit the scope of the invention. Furthermore, it should be understood that various changes, substitutions, deletions, modifications or adjustments may be made by those skilled in the art after reading the disclosure of the present invention, and such equivalents are also within the scope of the invention as defined in the appended claims.
Claims (2)
1. The positive-stomach tablet pharmaceutical preparation is characterized in that the positive-stomach tablet pharmaceutical preparation is a sustained-release tablet retained in the stomach, and the raw materials comprise traditional Chinese medicines and western medicines; and, an adjuvant for forming a gastro-retentive, sustained release tablet;
the traditional Chinese medicine comprises the following components: the weight of the pithecellobium clypearia is 187.5g; the weight of the tangerine peel, the scandent schefflera root and the liquorice is respectively 18.75g; the weight of the costustoot is 9.75g;
the western medicine comprises the following components: the weights of bismuth subnitrate and magnesium oxide are respectively 18.75g; the weight of the aluminum hydroxide is 28.5g;
the auxiliary materials consist of hydroxypropyl methyl cellulose, polyethylene glycol, polyvinylpyrrolidone, cetyl alcohol, sodium bicarbonate, sucrose and magnesium stearate; wherein the weight of the hydroxypropyl methyl cellulose is 268g; the weight of the polyvinylpyrrolidone is 70g; the weight of the hexadecanol is 150g; the weight of the polyethylene glycol is 40g; the weight of the sodium bicarbonate is 40g; the weight of the sucrose is 20g; the weight of magnesium stearate is 6g;
the hydroxypropyl methylcellulose is selected from HPMC E50; the polyvinylpyrrolidone is selected from PVP K30; the polyethylene glycol is selected from PEG 6000;
the preparation method of the stomach-strengthening tablet pharmaceutical preparation comprises the following steps:
(1) Decocting Pithecellobium clypearia with water for 2 times, and adding 10 times of water each time; concentrating the decoction at 70 deg.C under 0.1MPa vacuum degree to obtain fluid extract with relative density of 1.4, drying under reduced pressure, pulverizing into 120 mesh powder, and weighing 23.8g;
(2) Respectively crushing dried orange peel, costustoot, scandent schefflera root and liquorice, bismuth subnitrate, magnesium oxide and aluminum hydroxide into 120-mesh powder;
(3) Adding 40 parts of polyvinylpyrrolidone PVP K30 into a small amount of absolute ethyl alcohol for dissolving, adding pithecellobium clypearia powder and dried orange peel powder, stirring uniformly, adding the pithecellobium clypearia powder and dried orange peel powder into 40 parts of molten polyethylene glycol PEG6000, and stirring to disperse uniformly; solidifying in a refrigerator at-20 deg.C, drying, and pulverizing into 120 mesh powder to obtain solid dispersion containing Pithecellobium clypearia and pericarpium Citri Tangerinae;
(4) Mixing the solid dispersion, western medicines and other traditional Chinese medicines, hydroxypropyl methylcellulose HPMC E50, cetyl alcohol, the rest polyvinylpyrrolidone PVP K30, sodium bicarbonate, sucrose and magnesium stearate, sieving with 120 mesh sieve, directly dry-tabletting, and making into 1000 tablets with hardness of 3-4kg to obtain the sustained-release tablet retained in stomach.
2. A method for preparing the positive gastric tablet pharmaceutical formulation of claim 1, comprising:
(1) Decocting Pithecellobium clypearia with water for 2 times, and adding 10 times of water each time; concentrating the decoction at 70 deg.C under 0.1MPa vacuum degree to obtain fluid extract with relative density of 1.4, drying under reduced pressure, pulverizing into 120 mesh powder, and weighing 23.8g;
(2) Respectively crushing dried orange peel, costustoot, scandent schefflera root and liquorice, bismuth subnitrate, magnesium oxide and aluminum hydroxide into 120-mesh powder;
(3) Adding 40 parts of polyvinylpyrrolidone PVP K30 into a small amount of absolute ethyl alcohol for dissolving, adding pithecellobium clypearia powder and dried orange peel powder, stirring uniformly, adding the pithecellobium clypearia powder and dried orange peel powder into 40 parts of molten polyethylene glycol PEG6000, and stirring to disperse uniformly; solidifying in a refrigerator at-20 deg.C, drying, and pulverizing into 120 mesh powder to obtain solid dispersion containing Pithecellobium clypearia and pericarpium Citri Tangerinae;
(4) Mixing the solid dispersion, western medicines and other traditional Chinese medicines, hydroxypropyl methylcellulose HPMC E50, cetyl alcohol, the rest polyvinylpyrrolidone PVP K30, sodium bicarbonate, sucrose and magnesium stearate, sieving with 120 mesh sieve, directly performing dry tabletting with hardness of 3-4kg, and making into 1000 tablets to obtain the delayed release tablet retained in stomach.
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