TWI698258B - Pharmaceutical composition - Google Patents

Abstract

The present invention relates to a pharmaceutical composition comprising aluminum phosphate gel, magnesium hydroxide, simethicone, DL-carnitine hydrochloride and chlorhexidine salt. The pharmaceutical composition of the present invention is excellent in a preservative efficacy, and thus may be efficiently utilized as the pharmaceutical composition.

Description

Pharmaceutical composition

The present invention relates to a pharmaceutical composition comprising aluminum phosphate gel, magnesium hydroxide, dimethicone, DL-carnitine hydrochloride and loxidine salt.

The stomach is an organ that finely decomposes food that goes through the esophagus for easy storage and digestion, and controls the delivery of food to the duodenum to coordinate with the secretion of pancreatic enzymes, thereby contributing to the effective digestion and absorption of food. After the food enters, the stomach secretes strong acid, that is, stomach acid to digest the food. At that time, the gastric mucosal protective layer protects the gastric mucosa from such gastric acid damage.

However, the gastric mucosal protective layer is susceptible to damage caused by attacks from various factors. As representative aggressive factors, there are gastric acid, alcohol, smoking, steroids, non-steroidal anti-inflammatory drugs (NSAID) such as aspirin, bacteria such as Helicobacter pylori, irritating food, nutritional deficiency, stress, and the like. When the gastric mucosal layer is damaged by such factors, there is inflammation accompanied by erosion, redness, bleeding or edema. In severe cases, if the injury develops to form a hole in the gastric mucosa and even damage the bottom of the mucosa and the muscle layer, a gastric ulcer occurs.

In order to prevent and treat the above gastric injury, it is possible to use drugs that neutralize, absorb or inhibit gastric acid or are applied to the gastric mucosa to form a protective layer. Products that use aluminum phosphate gel, aluminum magnesium plus, and alginic acid as the main components are sold in the market. However, according to the diversification of the tastes of patients, there is a demand for products that have a milder and fresher intake sensation while maintaining gastric protection.

[ Prior technical references ]

[ Patent literature ]

(Patent Document 1) Korean Patent Registration No. 10-0903743

One purpose of the present invention is to provide a pharmaceutical composition with excellent antiseptic effect, which comprises aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-carnitine hydrochloride and loxidine salt .

In addition, the purpose of the present invention is to provide a pharmaceutical composition with excellent antiseptic effect for preventing or treating gastrointestinal disorders, which comprises aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-meat Alkali hydrochloride and loxidine salt, and a method for preparing them.

Another object of the present invention is to provide a method for the prevention or treatment of gastrointestinal disorders, which comprises administering to an individual containing aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-carnitine hydrochloric acid The steps of the pharmaceutical composition of salt and lohxidine salt.

In addition, another object of the present invention is to provide a use of a composition comprising aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-carnitine hydrochloride and loxidine salt, which is used To prevent or treat gastrointestinal disorders.

In addition, another object of the present invention is to provide a use of a composition comprising aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-carnitine hydrochloride and loxidine salt, which is used For the preparation of medicines for preventing or treating gastrointestinal disorders.

In order to achieve the above objectives, the inventors have continued to study and have therefore identified that the antibacterial degree of the pharmaceutical composition containing aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane and DL-carnitine hydrochloride can be achieved by including Lohexidine salt is improved, thereby completing the present invention.

The present invention provides a pharmaceutical composition comprising aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-carnitine hydrochloride and lohxidine salt.

The pharmaceutical composition of the present invention shows excellent activity for improving gastrointestinal disorders, and achieves the excellent antiseptic effect of the composition, the good preference of patients and the freshness of medicine treatment.

The pharmaceutical composition of the present invention maintains antibacterial qualities even at high pH, so that the proliferation of microorganisms is greatly inhibited. In particular, even after the infiltration of microorganisms, the composition of the present invention can kill such microorganisms quickly, so that the composition can be stored stably for a long period of time without being damaged by microorganisms. For example, the composition of the present invention can exhibit long-term resistance to Staphylococcus aureus ( S. aureus ), Pseudomonas aeruginosa ( P. aeruginosa ), Escherichia coli ( E. coli ), and Candida albicans ( C. albicans ). ), Brazil Aspergillus (A. brasiliensis), Bacillus circulans (Bacillus circulans) and its analogs excellent antibacterial activity.

In addition, the pharmaceutical composition of the present invention can maintain a low content of microorganisms present therein, even if the composition is exposed to the outside for a long period of time during the preparation process. As a result, it may not be necessary to make a huge investment in management aimed at preventing the infiltration of microorganisms during the preparation process, so that the composition is beneficial for mass production and industrial use and is economically beneficial.

In addition, the pharmaceutical composition of the present invention can maintain the antiseptic effect for a long time, no matter what type of external container is used to contain the composition, it will not cause the problem of being absorbed onto the outer wall of the container.

In the present invention, the composition may comprise 5 w/w% to 30 w/w% aluminum phosphate gel; 0.5 w/w% to 10 w/w% magnesium hydroxide relative to the total weight of the composition; 0.001 w/w% to 1 w/w% polydimethylsiloxane; 0.1 w/w% to 1.5 w/w% DL-carnitine hydrochloride; and 0.001 w/w% to 0.05 w/w % Of lohxidine salt. In particular, the composition of the present invention may comprise 10 w/w% to 15 w/w% aluminum phosphate gel; 1 w/w% to 5 w/w% magnesium hydroxide relative to the total weight of the composition ; 0.01 w/w% to 0.5 w/w% polydimethylsiloxane; 0.4 w/w% to 1 w/w% DL-carnitine hydrochloride; and 0.001 w/w% to 0.03 w/ w% lohxidine salt.

In the present invention, the content of aluminum phosphate gel may be 5 w/w% to 30 w/w%, preferably 10 w/w% to 15 w/w% relative to the total weight of the composition. The aluminum phosphate gel of the present invention can be one that meets the requirements of the United States Pharmacopoeia. The aluminum phosphate gel of the present invention exhibits a protective effect of gastric mucosa through deacidification and neutralization of gastric acid within the content range, and at the same time, it can produce a sense of fresh intake. In addition, the aluminum phosphate gel plays a role in preventing diarrhea that can be caused by magnesium hydroxide.

In the present invention, the content of magnesium hydroxide can be 0.5 w/w% to 10 w/w%, preferably 1 w/w% to 5 w/w% relative to the total weight of the composition. The magnesium hydroxide can act as an antacid and play a role in neutralizing gastric acid in the gastrointestinal tract. In addition, the aluminum phosphate gel plays a role in preventing constipation that can be caused by the aluminum phosphate gel.

The pharmaceutical composition of the present invention shows the buffering effect of neutralizing gastric acid in the gastrointestinal tract and maintaining high pH in the stomach by means of aluminum phosphate gel and magnesium hydroxide, and does not cause secondary acid rebound. In addition, the pharmaceutical composition of the present invention reduces the occurrence of gastrointestinal side effects in a way that the aluminum salt and the magnesium salt act in a complementary manner.

In addition to aluminum phosphate gel and magnesium hydroxide, the pharmaceutical composition of the present invention may further include an antacid. The additional antacid may be, for example, aluminum salt, magnesium salt, calcium salt, and sodium salt, especially aluminum hydroxide, aluminum silicate, magnesium carbonate, magnesium oxide, calcium carbonate, and sodium bicarbonate, but is not limited thereto.

The pharmaceutical composition of the present invention may further comprise a gastric acid inhibitor. The gastric acid inhibitor may be, for example, an H ₂ receptor antagonist and a proton pump inhibitor, especially histamine antagonist (cimetidine), ranitidine (ranitidine), famotidine (famotidine), nizatidine (nizatidine) ), omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole, but not limited thereto.

In the present invention, the content of polydimethylsiloxane relative to the total weight of the composition may be 0.001 w/w% to 1 w/w%, preferably 0.01 w/w% to 0.5 w/w%. The polydimethylsiloxane eliminates bloating and discomfort by removing gas from the stomach.

In the present invention, the content of DL-carnitine hydrochloride relative to the total weight of the composition can be 0.1 w/w% to 1.5 w/w%, preferably 0.4 w/w% to 1.0 w/w%. The DL-carnitine hydrochloride can stimulate the secretion of gastric juice and promote gastrointestinal motility.

In the present invention, the lohxidine salt may be selected from lohxidine acetate, lohxidine gluconate, lohxidine hydrochloride or a combination thereof, and preferably may be lohxidine acetate (diacetic acid Loxidine), but not limited to this. In the present invention, the content of lohxidine salt relative to the total weight of the composition may be 0.001 w/w% to 0.05 w/w%, preferably 0.001 w/w% to 0.03 w/w%. The loxidine salt can act as a preservative. The pharmaceutical composition of the present invention can exhibit antibacterial effects against various environmental bacteria by including the loxidine salt, so that the pharmaceutical composition of the present invention has an excellent antiseptic effect. The pharmaceutical composition of the present invention has excellent antiseptic efficacy even at low concentrations of loxidine salt. In addition, the pharmaceutical composition of the present invention can maintain excellent antibacterial activity at high pH, for example, even at pH 7 to 9, by including the loxidine salt. In addition, even after the infiltration of microorganisms, the pharmaceutical composition of the present invention can kill such microorganisms quickly, so that the composition can be stored stably for a long period of time without being damaged by microorganisms. In addition, the pharmaceutical composition of the present invention can maintain a low content of microorganisms present therein, even if the composition is exposed to the outside for a long period of time during the preparation process. As a result, it may not be necessary to make a huge investment in management aimed at preventing the infiltration of microorganisms during the preparation process, so that the composition is beneficial for mass production and industrial use and is economically beneficial.

In addition to loxidine salt, the pharmaceutical composition of the present invention may further include a preservative. The additional preservative can be, for example, aminobenzoic acid, hydrated wool wax, anhydrous sodium sulfite, sodium acetate, dibutylhydroxytoluene, dichlorobenzyl alcohol, benzoic acid, sodium benzoate, benzyl alcohol, butylhydroxyanisole , Butylated hydroxytoluene, potassium sorbate, sorbic acid, methyl p-hydroxybenzoate, sodium methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, Sodium butyl p-hydroxybenzoate and phenoxyethanol, but not limited to these.

The pharmaceutical composition of the present invention may further include a viscosity control agent. The viscosity control agent can be, for example, agar, pectin, calcium sulfate, sanxian gum, polyvinylpyrrolidone, ethyl cellulose, sodium carboxymethyl cellulose, Chinese fish gum, alginic acid, alginate, monohard Aluminum fatty acid, bentonite, carbomer, carbomer copolymer, carrageenan, dextrin, gelatin, guar gum and silica, but not limited to these, and can be preferably selected from agar, pectin, Calcium sulfate, Sanxian gum or a combination thereof. In a preferred embodiment of the present invention, the pharmaceutical composition of the present invention comprises agar, pectin, calcium sulfate and sanxian gum. These agars and pectins can enhance the effect of covering gastric mucosa by interacting with aluminum phosphate gel. The sanxian gum can effectively control the viscosity of the pharmaceutical composition. In the present invention, the content of Sanxian gum relative to the total weight of the composition may be 0.1 w/w% to 1 w/w%, preferably 0.1 w/w% to 0.7 w/w%. The pharmaceutical composition of the present invention has such an appropriate viscosity that the amount of residues in the oral cavity is reduced after ingestion, and is so easily swallowed through the throat, so that the patient's compliance with medication can be enhanced.

The pharmaceutical composition of the present invention may further include a sweetener. The sweetener can be selected from, for example, sucralose, white sugar, enzyme-modified stevia, xylitol, saccharin, saccharin salt, stevioside, sorbitol, dextrose, glycyrrhizin or a combination thereof, but is not limited thereto, And it can be preferably selected from sucralose, white sugar, enzyme-modified stevia or a combination thereof. The amount of the sweetener can be appropriately selected by those skilled in the art. In a preferred embodiment of the present invention, the pharmaceutical composition of the present invention contains white sugar and sucralose as sweeteners. Compared with other sweeteners, white sugar has such an extremely pure taste, so that it can promote the inventive pharmaceutical composition to have a fresh intake sensation. In the present invention, the content of white sugar relative to the total weight of the pharmaceutical composition may range from 5 w/w% to 20 w/w%, preferably from 5 w/w% to 15 w/w%. In a preferred exemplary embodiment of the present invention, sucralose has such an excellent effect of covering the undesirable bitterness of loxidine, so that it can enhance the sense of ingestion of the pharmaceutical composition of the present invention. The content of the sucralose relative to the total weight of the pharmaceutical composition may be 0.001 w/w% to 0.1 w/w%, preferably 0.005 w/w% to 0.03 w/w%.

The pharmaceutical composition of the present invention may further include a flavoring agent. The flavoring agent may be, for example, synthetic flavor oils, natural oils, plant extracts and the like, especially banana flavor, apple flavor, orange flavor, banana blend flavor, grapefruit flavor, mixed berry flavor, lime flavor, lavender flavor , Lemon flavor, mint flavor, peppermint flavor and strawberry flavor, but not limited to this. The amount of the flavoring agent can be appropriately selected by those skilled in the art. In a preferred embodiment of the present invention, the pharmaceutical composition of the present invention contains banana spice mixture as a flavoring agent. Specifically, the banana blend flavor can be a combination of banana flavor and strawberry flavor, and can be, for example, the commercially distributed banana blend flavor B-17026.

Specifically, the dosage form of the pharmaceutical composition of the present invention may be an oral liquid composition, preferably a suspension. The suspension may contain water, preferably purified water, as an excipient. The viscosity of the suspension can be 200 cps to 2200 cps at 20°C, preferably 700 cps to 1900 cps and more preferably 900 cps to 1800 cps. The patient's preference can be changed by controlling the viscosity of the pharmaceutical composition. The pharmaceutical composition of the present invention exhibits such an appropriate viscosity that the amount of residue in the oral cavity is reduced after ingestion, and it is easy to swallow through the throat. Therefore, the pharmaceutical composition of the present invention can enhance the patient's compliance with medication and improve the adherence to medication.

The amount of aluminum phosphate gel, magnesium hydroxide, dimethicone, DL-carnitine hydrochloride, and loxidine salt per unit dosage form of the pharmaceutical composition of the present invention can be determined by those skilled in the art.

The amount of aluminum phosphate gel per unit dosage form of the pharmaceutical composition of the present invention may preferably be 5 g to 30 g, more preferably 10 g to 15 g, and most preferably about 12.5 g per 100 g unit dosage form of the pharmaceutical composition; The amount of magnesium can be 0.5 g to 10 g, more preferably 1 g to 5 g, and most preferably about 2 g per 100 g of the unit dosage form of the pharmaceutical composition; the amount of polydimethylsiloxane can be per 100 g of the pharmaceutical composition The unit dosage form of DL-carnitine is 0.001 g to 1 g, more preferably 0.01 g to 0.5 g, and most preferably about 0.225 g; the amount of DL-carnitine hydrochloride can be 0.1 g to 1.5 g per 100 g unit dosage form of the pharmaceutical composition, and more Preferably 0.4 g to 1.0 g and most preferably about 0.75 g; and the amount of loxidine salt can be 0.001 g to 0.05 g per 100 g of the unit dosage form of the pharmaceutical composition, preferably 0.001 g to 0.03 g and most preferably about 0.015 g.

The pharmaceutical composition of the present invention contains aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-carnitine hydrochloride and lohxidine salt in the range of each unit dosage form, thereby showing excellent deacidification Action, degassing action and gastrointestinal prokinetic action, and also show significantly high antibacterial activity, and therefore show a significantly excellent antiseptic effect.

The pharmaceutical composition of the present invention may further include pharmaceutically acceptable additives within a range that does not gradually impair the effects of the present invention. The additives may be, for example, dissolution aids, stabilizers, suspending agents, surfactants, antioxidants and pH adjusters, but are not limited thereto.

The pharmaceutical composition of the invention can be used to prevent and treat gastrointestinal disorders. Specifically, the pharmaceutical composition of the present invention can prevent and treat gastrointestinal disorders by absorbing and neutralizing intestinal gas, bacteria, toxins, viruses or the like. In particular, the pharmaceutical composition of the present invention can also be used to prevent and treat hyperacidity, heartburn, hiccup, vomiting, stomach upset, or overeating by neutralizing gastric acid. In particular, the pharmaceutical composition of the present invention can also relieve the sensation of bloating or discomfort by removing gas from the gastrointestinal tract. In particular, the pharmaceutical composition of the present invention also stimulates the secretion of gastric juice and promotes gastrointestinal motility, so that the composition can enhance the digestive ability of the stomach and can be used to prevent and treat loss of appetite and anorexia. In particular, the pharmaceutical composition of the present invention is also applied to the gastric mucosa, deposited thereon, and forms a protective layer on the surface of the ulcer, so that the composition can be used to prevent and treat nausea, vomiting or stomach pain.

Therefore, the pharmaceutical composition of the present invention can be intended to prevent or treat gastrointestinal disorders selected from, for example, hyperacidity, heartburn, gastric discomfort, bloating, gastric discomfort, nausea, vomiting, stomach pain, hiccups Acid vomit, loss of appetite, anorexia, indigestion, overeating, or a combination thereof.

The pharmaceutical composition of the present invention can significantly reduce the content of environmental bacteria by including the loxidine salt. Therefore, the pharmaceutical composition of the present invention is excellent in antiseptic efficacy.

The pharmaceutical composition of the invention has good taste and appropriate viscosity. Therefore, the pharmaceutical composition of the present invention can enhance the patient's liking with the light and fresh intake sensation and improve the patient's compliance and adherence to medication.

The present invention provides a method for preparing a pharmaceutical composition for preventing or treating gastrointestinal disorders, the pharmaceutical composition comprising aluminum phosphate gel, magnesium hydroxide, dimethicone, DL-carnitine hydrochloride And lohxidine salt.

The method for preparing the pharmaceutical composition according to the present invention may include: a first mixing step of mixing magnesium hydroxide and polydimethylsiloxane with purified water; heating the resulting mixed solution obtained from the first mixing step, thereby The step of dissolving the mixed solution; the second mixing step of adding aluminum phosphate gel to the solution, thereby mixing the solution; the step of cooling the mixture; the second mixing step of mixing the cooled mixture with loxidine salt Three mixing steps; and a step of cooling the mixture obtained from the third mixing step; and a fourth mixing step of mixing the cooled mixture with DL-carnitine hydrochloride.

The present invention provides a method for preventing or treating gastrointestinal disorders, which comprises administering aluminum phosphate gel, magnesium hydroxide, dimethicone, DL-carnitine hydrochloride, and Lohesi to individuals in need The steps of determining the pharmaceutical composition of the salt.

This gastrointestinal disorder means hyperacidity, heartburn, stomach upset, bloating, stomach upset, nausea, vomiting, stomach pain, hiccuping a little sour vomit, loss of appetite, anorexia, indigestion, overeating, etc. symptom.

The prevention means reducing the pathological appearance of gastrointestinal disorders or symptoms caused by gastrointestinal disorders. The treatment means improving at least one symptom of gastrointestinal disorder or stopping its progression, and can encompass the meaning of conventionally used treatment.

The administration may be oral administration. In the case of administering the pharmaceutical composition to an individual, such composition can be administered in an effective amount necessary to prevent or treat gastrointestinal disorders.

The present invention provides a use of a composition comprising aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-carnitine hydrochloride and lohxidine salt, which is used to prevent or treat gastrointestinal disorders.

The present invention provides a use of a composition comprising aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-carnitine hydrochloride and lohxidine salt, which is used for preparation for preventing or treating gastrointestinal Drugs for tract disorders. The composition for preparing the medicine according to the present invention may be mixed with an acceptable carrier, etc., and further contain other agents.

If there is no contradiction with each other, the substances mentioned in the composition, treatment method and use of the present invention are equally applicable.

Advantageous effects The pharmaceutical composition of the present invention maintains the antibacterial quality even at high pH, which greatly inhibits the proliferation of microorganisms. Even after the infiltration of microorganisms, the composition can kill such microorganisms quickly, so that the composition can be stored stably for a long period of time without being damaged by microorganisms. Therefore, the pharmaceutical composition of the present invention is significantly excellent in antiseptic efficacy.

In addition, the pharmaceutical composition of the present invention can maintain the antiseptic effect for a long time, no matter what type of external container is used to contain the composition, it will not cause the problem of being absorbed onto the outer wall of the container.

In addition, the pharmaceutical composition of the present invention can maintain a low content of microorganisms present therein, even if the composition is exposed to the outside for a long period of time during the preparation process. As a result, it may not be necessary to make a huge investment in management aimed at preventing the infiltration of microorganisms during the preparation process, so that the composition is beneficial for mass production and industrial use and is economically beneficial.

In addition, the pharmaceutical composition of the present invention has a not too bitter taste, and also has such an appropriate viscosity, so that the amount of residues in the oral cavity is reduced after its ingestion, and it is so easy to swallow through the throat, so that it is highly appreciated by patients Degree and significantly enhance the compliance and adherence to medication.

In addition, the pharmaceutical composition of the present invention shows excellent activity for improving gastrointestinal disorders.

Therefore, the pharmaceutical composition of the present invention can be effectively used as a pharmaceutical composition because of its excellent antiseptic effect; its preparation process is conducive to mass production and economically effective; it enhances drug compliance and adherence to drugs; And the activity of improving gastrointestinal disorders is also excellent.

Best Mode of the Invention Hereinafter, the present invention will be described in more detail through specific exemplary embodiments. However, the following exemplary embodiments are provided only for the purpose of illustrating the present invention, and therefore the present invention is not limited thereto.

Example 1 Magnesium hydroxide, dimethicone, agar, pectin, trixian gum, calcium sulfate, and white sugar were mixed in purified water at 25° C. at the amount indicated in Table 1 below. The resulting mixed solution is heated up to 70°C, so that the mixture is dissolved for 10 to 20 minutes. Aluminum phosphate gel was added and mixed into it in this amount as indicated in Table 1, and the mixture was cooled to 50°C to 60°C. Loxidine acetate was added and mixed in the cooled mixture in this amount as indicated in Table 1. Lohexidine acetate (lohexidine diacetate) was mixed therein and cooled to 30°C or lower, and then DL-carnitine hydrochloride was added thereto in the amount indicated in Table 1 below, And further add a suitable amount of sucralose (0.005 g to 0.03 g), mix and cool at room temperature. Finally, the banana mixture flavor was added thereto in the amount indicated in Table 1, and then the resulting mixture was mixed, ground, and filled to prepare a total suspension of 100 g. [Table 1]

Instance 2 And examples 3 The suspension was prepared by the same method as shown in Example 1, except that the content of loxidine acetate used was 0.02 g and 0.03 g, respectively.

Instance 4 And examples 5 The suspension was prepared by the same method as shown in Example 1, with the exception that Sanxian gum was further added to purified water in the amount indicated in Table 2 below. [Table 2]

Experimental Example 1. Identification of preservative efficacy by means of Korean "preservative efficacy test methods" Common test methods for the identification of the Pharmacopoeia preservative efficacy according to examples 1-3 combination of things. In order to confirm that the antiseptic effect is sufficient, when inoculating with bacteria, the number of bacteria should be reduced from the number of inoculated bacteria to 10% or less in 14 days after inoculation, and also in the following 28 days, the number of bacteria It should be maintained or reduced to a level equal to or lower than the amount of bacteria measured in the following 14 days. And in the case of fungi, it has been confirmed that if the number of fungi is equal to or lower than the number of fungi inoculated in 14 days after inoculation with fungi, and also if the number of fungi is equal to or lower than that of fungi inoculated in 28 days after inoculation The other number shows the antiseptic effect. In other words, the reduction rate (%) is measured according to the following formula, that is, (number of inoculated bacteria-number of live bacteria)/number of inoculated bacteria×100. If the reduction rate is 90% or higher, it is determined that the antiseptic effect of the preservative exists. If there is an antiseptic effect in all the tested bacteria, the antiseptic effect is judged to be suitable.

As test strains, the following: Standard bacteria, i.e., Staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli; Standard fungi, i.e., Candida albicans and A. brasiliensis (Aspergillus brasiliensis); and environmental bacteria, i.e., ring Bacillus spp . Bacteria were cultured in tryptic soy agar medium, and fungi were cultured in Sabouraud Dextrose Agar medium.

As a result of this test on the antiseptic efficacy, the composition according to Example 1 of the present invention not only satisfies the criteria for the antiseptic efficacy of all these strains, but also showed a remarkable excellent antibacterial activity with a reduction rate of 99% or higher .

Claims (14)

A pharmaceutical composition comprising aluminum phosphate gel, magnesium hydroxide, dimethicone, DL-carnitine hydrochloride, and chlorhexidine salt, wherein the chlorhexidine salt is acetic acid Lohxidine. The pharmaceutical composition of claim 1, which further comprises a sweetener. The pharmaceutical composition of claim 2, wherein the sweetener is selected from enzyme-modified stevia, xylitol, saccharin, saccharin salt, stevioside, sorbitol, dextrose, glycyrrhizin, white sugar, sucralose or Its combination. The pharmaceutical composition of claim 2, wherein the sweetener is white sugar and sucralose. The pharmaceutical composition of claim 4, wherein the content of white sugar relative to the total weight of the pharmaceutical composition is 5w/w% to 20w/w%, and the content of sucralose relative to the total weight of the pharmaceutical composition is 0.001w /w% to 0.1w/w%. The pharmaceutical composition of claim 1, wherein a viscosity control agent selected from agar, pectin, calcium sulfate, sanxian gum or a combination thereof is further contained therein. The pharmaceutical composition of claim 1, which further comprises a flavoring agent. The pharmaceutical composition according to claim 1, wherein the dosage form is a suspension. The pharmaceutical composition of claim 8, wherein the viscosity of the suspension is 700 cps to 1500 cps at 20°C. The pharmaceutical composition of claim 1, wherein the composition comprises 10w/w% to 15w/w% of aluminum phosphate gel relative to the total weight of the composition; 1w/w% to 5w/w% of magnesium hydroxide ; 0.01w/w% to 0.5w/w% polydimethylsiloxane; 0.4w/w% to 1.0w/w% DL-carnitine hydrochloride; and 0.001w/w% to 0.03w/ w% lohxidine salt. The pharmaceutical composition according to claim 10, wherein the loxidine salt is loxidine acetate. The pharmaceutical composition of claim 1, wherein the composition is intended for the prevention or treatment of gastrointestinal disorders selected from the group consisting of hyperacidity, heartburn, gastric discomfort, bloating, gastric discomfort, nausea, vomiting, and stomach pain , Isolate a little acid vomit, loss of appetite, anorexia, indigestion, overeating or a combination thereof. The pharmaceutical composition of claim 1, wherein the composition is intended for oral composition. A use of a pharmaceutical composition for the manufacture of a medicament for preventing or treating gastrointestinal disorders, wherein the pharmaceutical composition comprises aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, and DL-carnitine hydrochloride Salt and loxidine acetate.