TW201946612A - 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 an aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-carnitine hydrochloride, and lohexidine salt.

The stomach is an organ that finely breaks down the food passing through the esophagus for easy storage and digestion, and controls the delivery of food to the duodenum to coordinate the secretion of pancreatic enzymes, thereby helping the food to be effectively digested and absorbed. After food enters, the stomach secretes strong acid, which is stomach acid to digest food. At that time, the gastric mucosa protective layer protected the gastric mucosa from such gastric acid damage.

However, the gastric mucosa protective layer is susceptible to damage caused by attacks from various factors. As representative invasive 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 mucosa is damaged by these factors, there is inflammation with erosion, redness, bleeding, or edema. In severe cases, gastric ulcers occur if the damage develops to form holes in the gastric mucosa and even to the bottom and muscle layers of the mucosa.

In order to prevent and treat gastric damage as described above, it is possible to use a drug that neutralizes, absorbs or inhibits gastric acid or is applied to the gastric mucosa to form a protective layer. Products that use aluminum phosphate gel, aluminum magnesium plus, alginic acid and the like as main components are sold in the market. However, according to the diversified tastes of patients, there is a need for products that have a milder and fresher intake feeling while maintaining a gastric protective effect.

[ Prior art references ]

[ Patent literature ]

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

An object of the present invention is to provide a pharmaceutical composition having excellent antiseptic effect, which comprises an aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-carnitine hydrochloride, and lochsidine .

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

Another object of the present invention is to provide a method for preventing or treating gastrointestinal disorders, which comprises administering to a subject an aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-carnitine hydrochloride Steps of the pharmaceutical composition of salt and lochsidine salt.

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

In addition, another object of the present invention is to provide a use of a composition comprising an aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-carnitine hydrochloride, and lochsetin salt. In the preparation of a medicament for the prevention or treatment of gastrointestinal disorders.

In order to achieve the above object, the present inventors have continued research and thus identified that the antibacterial degree of a pharmaceutical composition containing aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, and DL-carnitine hydrochloride can be obtained by including The Lochsidine salt was raised, thereby completing the present invention.

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

The pharmaceutical composition of the present invention shows excellent activity for improving gastrointestinal disorders, and achieves excellent antiseptic effect of the composition, good affection of patients, and fresh feeling of medicinal treatment.

The pharmaceutical composition of the present invention maintains antibacterial quality even at high pH, so that the proliferation of microorganisms is greatly suppressed. In particular, even after the infiltration of microorganisms, the composition of the present invention can kill such microorganisms more quickly, so that the composition can be stably stored for a long period of time without being damaged by microorganisms. For example, the composition of the present invention may exhibit resistance over a long period of time.Staphylococcus aureus (S. aureus ),Pseudomonas aeruginosa (P. aeruginosa ),E.coli (E. coli ),Candida albicans (C. albicans ),Aspergillus brasil (A . brasiliensis ),Bacillus circulans (Bacillus circulans ) And its analogues have excellent antibacterial activity.

In addition, the pharmaceutical composition of the present invention can maintain a low content of the microorganisms present therein, even if such a composition is exposed to the outside for a longer period of time during the manufacturing process. As a result, a huge investment in management aimed at preventing microbial infiltration during the manufacturing process may not be required, making the composition advantageous for mass production and industrial use and 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, and it will not cause problems of absorption onto the outer wall of the container.

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

In the present invention, the content of the aluminum phosphate gel may be 5 w / w% to 30 w / w%, preferably 10 w / w% to 15 w / w% with respect to the total weight of the composition. The aluminum phosphate gel of the present invention can meet one of the requirements of the United States Pharmacopeia. The aluminum phosphate gel of the present invention can provide a fresh intake feeling while showing the gastric mucosal protective effect through the deacidification and neutralization of gastric acid in the content range. 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 relative to the total weight of the composition may be 0.5 w / w% to 10 w / w%, preferably 1 w / w% to 5 w / w%. The magnesium hydroxide can act as an antacid and function 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 exhibits a buffering effect that neutralizes gastric acid in the gastrointestinal tract and maintains a 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 such a way that the aluminum and magnesium salts work in a complementary manner.

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

The pharmaceutical composition of the present invention may further include a gastric acid inhibitor. The gastric acid inhibitor may be, for example, an H ₂ receptor antagonist and a proton pump inhibitor, especially cimetidine, ranitidine, famotidine, nizatidine ), Omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole, but are 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 may 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 lochsetin salt may be selected from the group consisting of lochsetin acetate, lochsetin gluconate, lochsetin hydrochloride, or a combination thereof, and may preferably be lochsetin acetate (diacetic acid Lochsidine), but not limited to this. In the present invention, the content of lochsidine may be 0.001 w / w% to 0.05 w / w%, preferably 0.001 w / w% to 0.03 w / w%, relative to the total weight of the composition. The lochsidine salt acts as a preservative. The pharmaceutical composition of the present invention can exhibit antibacterial effects against various environmental bacteria by including the lochsidine salt, making the pharmaceutical composition of the present invention excellent in antiseptic effect. The pharmaceutical composition of the present invention is excellent in antiseptic effect even at a low concentration of lochsidine 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 lochsidine salt. In addition, even after the infiltration of microorganisms, the pharmaceutical composition of the present invention can kill such microorganisms relatively quickly, so that the composition can be stably stored 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 the microorganisms present therein, even if such a composition is exposed to the outside for a longer period of time during the manufacturing process. As a result, a huge investment in management aimed at preventing microbial infiltration during the manufacturing process may not be required, making the composition advantageous for mass production and industrial use and economically beneficial.

In addition to lochsidine salt, the pharmaceutical composition of the present invention may further contain a preservative. The additional preservative may be, for example, aminobenzoic acid, hydrated wool wax, anhydrous sodium sulfite, sodium acetate dehydrate, dibutylhydroxytoluene, dichlorobenzyl alcohol, benzoic acid, sodium benzoate, benzyl alcohol, butylhydroxyanisole , Butyl hydroxytoluene, potassium sorbate, sorbic acid, methyl paraben, sodium methyl paraben, ethyl paraben, propyl paraben, sodium propyl paraben, Butyl p-hydroxybenzoate and phenoxyethanol are not limited thereto.

The pharmaceutical composition of the present invention may further include a viscosity control agent. The viscosity control agent may be, for example, agar, pectin, calcium sulfate, sansyl gum, polyvinylpyrrolidone, ethyl cellulose, sodium carboxymethyl cellulose, Chinese fish gelatin, alginic acid, alginate, monohard Aluminum stearate, bentonite, carbomer, carbomer copolymer, carrageenan, dextrin, gelatin, guar gum, and silicon dioxide, but are not limited thereto, and may be preferably selected from agar, pectin, Calcium sulphate, Sansin, 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 saponin. 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 residue in the oral cavity is reduced after its ingestion, and so easily swallowed through the throat, so that the patient's compliance with the medicinal treatment can be enhanced.

The pharmaceutical composition of the present invention may further include a sweetener. The sweetener may be selected from, for example, sucralose, white sugar, enzymatically 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, enzymatically 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 comprises white sugar and sucralose as sweeteners. Compared with other sweeteners, white sugar has such an extremely pure taste that it can promote the fresh ingestion feeling of the pharmaceutical composition of the present invention. In the present invention, the content of white sugar relative to the total weight of the pharmaceutical composition may be 5 w / w% to 20 w / w%, preferably 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 undesired bitterness of lochsidine, so that the intake feeling of the pharmaceutical composition of the present invention can be enhanced. 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 can 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 orange flavor, lavender flavor , Lemon flavor, peppermint flavor, peppermint flavor, and strawberry flavor, but are not limited thereto. 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 comprises a banana mixture flavor as a flavoring agent. In particular, the banana blend flavor may be a combination of banana flavor and strawberry flavor, and may be, for example, a commercially available banana blend flavor B-17026.

In particular, 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 may be 200 cps to 2200 cps, preferably 700 cps to 1900 cps and more preferably 900 cps to 1800 cps at 20 ° C. Patient preference may vary depending on the control of 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 its ingestion, and is easily swallowed through the throat. Therefore, the pharmaceutical composition of the present invention can enhance the patient's compliance with the medication and improve the adherence to the medication.

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

The pharmaceutical composition of the present invention contains aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-carnitine hydrochloride, and lochsetin salt per unit dosage form, thereby showing excellent deacidification. Effect, degassing effect and gastrointestinal prokinetic effect, and also shows a significantly high antibacterial activity, and thus shows a significantly excellent antiseptic effect.

The pharmaceutical composition of the present invention may further contain a pharmaceutically acceptable additive within a range that does not gradually impair the effects of the present invention. The additive may be, for example, but not limited to, a dissolution aid, a stabilizer, a suspending agent, a surfactant, an antioxidant, and a pH adjuster.

The pharmaceutical composition of the invention can be used for preventing and treating gastrointestinal disorders. In particular, the pharmaceutical composition of the present invention can prevent and treat gastrointestinal disorders by absorbing and neutralizing intestinal gases, 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, exudation of a little acid and vomit, stomach upset or overeating by neutralizing gastric acid. In particular, the pharmaceutical composition of the present invention can also relieve the feeling of bloating or upset 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 capacity of the stomach and can be used to prevent and treat anorexia 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 is intended to be used for preventing or treating gastrointestinal disorders selected from, for example, hyperacidity, heartburn, upset stomach, bloating feeling, upset stomach, nausea, vomiting, stomach pain, a little bit 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 lochsidine salt. Therefore, the pharmaceutical composition of the present invention is excellent in antiseptic effect.

The pharmaceutical composition of the invention has good taste and proper viscosity. Therefore, the pharmaceutical composition of the present invention can enhance the patient's preference and improve the patient's compliance and adherence to the medication by means of mild and fresh intake sensation.

The invention provides a method for preparing a pharmaceutical composition for preventing or treating gastrointestinal disorders. The pharmaceutical composition comprises an aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, and DL-carnitine hydrochloride. And lochsidine salt.

The method for preparing a pharmaceutical composition according to the present invention may include: a first mixing step of mixing magnesium hydroxide and polydimethylsiloxane with purified water; heating the obtained mixed solution obtained from the first mixing step, whereby A step of dissolving the mixed solution; a second mixing step of adding aluminum phosphate gel to the solution, thereby mixing the solution; a step of cooling the mixture; a step of mixing the cooled mixture with lochsidine 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 to an individual in need thereof an aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-carnitine hydrochloride, and lochsi Steps for determining a salt pharmaceutical composition.

The gastrointestinal disorder means such things as hyperacidity, heartburn, upset stomach, bloating, upset, nausea, vomiting, stomach pain, scooping out of a little acid 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 is intended to improve at least one symptom of gastrointestinal disorders or to stop its progression, and may encompass the meaning of a conventionally used treatment.

The administration may be by oral administration. Where the pharmaceutical composition is administered to an individual, such a composition can be administered in an effective amount necessary to prevent or treat gastrointestinal disorders.

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

The present invention provides the use of a composition comprising aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-carnitine hydrochloride, and lohexidine salt, which is used for preparing for preventing or treating gastrointestinal Dysregulation drugs. The composition for preparing a medicament according to the present invention may be mixed with an acceptable carrier and the like, and further contains other agents.

If not contradictory, the substances mentioned in the composition, treatment method and use of the present invention are equally applicable.

Advantageous effect <br/> The pharmaceutical composition of the present invention maintains antibacterial quality even at high pH, so that the proliferation of microorganisms is greatly suppressed. The composition can kill such microorganisms more quickly even after the infiltration of the microorganisms, so that the composition can be stably stored for a long period of time without being damaged by the microorganisms. Therefore, the pharmaceutical composition of the present invention is remarkably excellent in antiseptic effect.

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, and it will not cause problems of absorption onto the outer wall of the container.

In addition, the pharmaceutical composition of the present invention can maintain a low content of the microorganisms present therein, even if such a composition is exposed to the outside for a longer period of time during the manufacturing process. As a result, a huge investment in management aimed at preventing microbial infiltration during the manufacturing process may not be required, making the composition advantageous for mass production and industrial use and economically beneficial.

In addition, the pharmaceutical composition of the present invention has a less bitter taste, and also has such an appropriate viscosity that the amount of residue in the oral cavity is reduced after its ingestion, and so easily swallowed through the throat, so that it achieves the high favorite of 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 it is excellent in antiseptic effect; its preparation process is conducive to mass production and is economically beneficial; it enhances compliance with drugs and adherence to drugs; And the activity of improving gastrointestinal disorders is also excellent.

Best Mode of the Invention The present invention will be described in more detail below 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, polydimethylsiloxane, agar, pectin, xanthan gum, calcium sulfate, and sugar were mixed in purified water at 25 ° C in the amounts indicated in Table 1 below. The resulting mixed solution was heated up to 70 ° C, so that the mixture was dissolved for 10 to 20 minutes. Aluminum phosphate gel was added and mixed into this amount as indicated in Table 1, and the mixture was cooled to 50 ° C to 60 ° C. Add lochsetin acetate and mix in the cooled mixture in this amount as indicated in Table 1. Lochsetin acetate (lochsetin diacetate) was mixed therein, and cooled to 30 ° C or lower, and thereafter DL-carnitine hydrochloride was added thereto in an amount as indicated in Table 1 below, A suitable amount of sucralose (0.005 g to 0.03 g) is further added, mixed and cooled at room temperature. Finally, a banana mixture spice was added thereto in this amount as indicated in Table 1, after which the resulting mixture was mixed, ground, and filled to prepare a total of 100 g of a suspension.
[Table 1]

Example 2 and Example 3
Suspensions were prepared by the same method as shown in Example 1, with the exception that the contents of lochsetin acetate were 0.02 g and 0.03 g, respectively.

Example 4 and Example 5
Suspensions were prepared by the same method as shown in Example 1, with the exception that Sanxan was further added to purified water in the amount indicated in Table 2 below.
[Table 2]

Experimental example 1 . Identify antiseptic effect
The preservative efficacy of the compositions according to Examples 1 to 3 was identified by means of the "Preservative efficacy test method", a general test method of Korean Pharmacopoeia. In order to confirm that the antiseptic effect is sufficient, when inoculated with bacteria, the number of bacteria should be reduced to 10% or less from the number of bacteria inoculated 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 that measured in the 14 days following the above. 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 the fungus, and also if the number of fungi is equal to or lower than the number of fungi inoculated in the following 28 The other number shows antiseptic effect. In other words, the reduction rate (%) is measured according to the following formula, that is, (the number of inoculated bacteria-the number of live bacteria) / the number of inoculated bacteria × 100. If the reduction rate is 90% or more, it is judged that the preservative effect of the preservative is present. If a preservative effect is present in all the tested bacteria, the preservative effect is determined to be appropriate.

As test strains, the following were used: standard bacteria, that is,Staphylococcus aureus ,Pseudomonas aeruginosa andE.coli ; Standard fungi, that is,Candida albicans andAspergillus brasil (Aspergillus brasiliensis ); And environmental bacteria, that is,Bacillus circulans . Bacteria were cultured in trypsin soy agar medium, and fungi were cultured in Sabouraud Dextrose Agar medium.

As a result of this test for preservative efficacy, the composition according to Example 1 of the present invention not only met the criteria regarding the preservative efficacy of all such strains, but also showed a significantly excellent antibacterial activity with a reduction rate of 99% or more .

Claims (16)

A pharmaceutical composition comprises an aluminum phosphate gel, magnesium hydroxide, polydimethylsiloxane, DL-carnitine hydrochloride, and chlorhexidine salt. The pharmaceutical composition according to claim 1, wherein the lochsidine salt is lochsidine acetate, lochsidine gluconate, lochsidine hydrochloride, or a combination thereof. The pharmaceutical composition according to claim 1, wherein the lochsidine salt is lochsidine acetate. The pharmaceutical composition according to claim 1, wherein the sweetener is further included therein. The pharmaceutical composition of claim 4, wherein the sweetener is selected from the group consisting of enzymatically modified stevia, xylitol, saccharin, saccharin salt, stevioside, sorbitol, dextrose, glycyrrhizin, white sugar, sucralose, or Its combination. The pharmaceutical composition according to claim 4, wherein the sweetener is white sugar and sucralose. The pharmaceutical composition according to claim 6, wherein the content of white sugar relative to the total weight of the pharmaceutical composition is 5 w / w% to 20 w / w%, and the content of sucralose relative to the total weight of the pharmaceutical composition is 0.001 w / w% to 0.1 w / w%. The pharmaceutical composition according to claim 1, wherein a viscosity control agent selected from the group consisting of agar, pectin, calcium sulfate, Sanxian gum, or a combination thereof is further included therein. The pharmaceutical composition according to claim 1, wherein the flavoring agent is further contained therein. The pharmaceutical composition according to claim 1, wherein the dosage form is a suspension. The pharmaceutical composition according to claim 10, wherein the viscosity of the suspension is 700 cps to 1500 cps at 20 ° C. The pharmaceutical composition according to claim 1, wherein the composition comprises an aluminum phosphate gel of 10 w / w% to 15 w / w% relative to the total weight of the composition; 1 w / w% to 5 w / w% Magnesium hydroxide; 0.01 w / w% to 0.5 w / w% polydimethylsiloxane; 0.4 w / w% to 1.0 w / w% of DL-carnitine hydrochloride; and 0.001 w / w% To 0.03 w / w% of lochsidine salt. The pharmaceutical composition of claim 12, wherein the lochsidine salt is lochsidine acetate. The pharmaceutical composition according to claim 1, wherein the composition is intended to prevent or treat a gastrointestinal disorder selected from the group consisting of hyperacidity, heartburn, upset stomach, bloating feeling, upset stomach, nausea, vomiting, stomach pain , Scoop out a little acid vomit, loss of appetite, anorexia, indigestion, overeating, or a combination thereof. A pharmaceutical composition as claimed in claim 1, wherein the composition is intended for use in an oral composition. 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, DL-carnitine hydrochloride Salt and lochsidine.