JPH05194262A - Oral liquid medicine of enzyme-containing crude drug - Google Patents

Abstract

PURPOSE:To obtain an enzyme-containing oral liquid medicine capable of stabilizing enzymatic activity for a long period by blending crude drug ingredients with a digestive enzyme and stabilizer. CONSTITUTION:The objective oral liquid medicine contains a water soluble ingredients of crude drug extract containing a secoiridoid glycoside, limonene, cinnamaldehyde, saponic acid as active ingredients, one or more kinds of digestive enzymes for starches, fats and proteins and one or more kinds of stabilizers of saccharides, calcium salts, proteins and polyhydric alcohols. As the blend ratio of the digestive enzyme, >=100 unit starch digestive enzyme, >=750 unit protein digestive enzyme, >=50 unit fat digestive enzyme and >=6 unit fiber digestive enzyme are used at the lowest dose per day alone or in combination. As the stabilizer, 5-40W/V% saccharide, 0.01-5W/V% calcium salt, 0.01-10W/V% protein and 0.01-10W/V% polyhydric alcohol are used alone or in combination. The water soluble ingredient of crude drugs is blended in an amount of 0.04-20W/V%.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a liquid drug for oral administration of an enzyme-containing crude drug, and more specifically to a drug-containing oral drug containing a digestive enzyme agent and a stabilizer in a water-soluble component of a crude drug. Regarding liquid medicine.

The enzyme-containing liquid drug for oral administration of herbal medicine of the present invention has not only the stomachic effect of the herbal medicine component, etc., but also the effective action against indigestion due to the digestive enzyme drug and the resulting stomach lean, chest tightness and the like. Used as a gastrointestinal drug for internal use.

[0003]

2. Description of the Related Art Generally, digestive enzyme preparations are easily affected by pH, temperature, ingredients and the like, and are particularly unstable in solution.

Conventionally, the product developed as a liquid medicine for oral administration of gastrointestinal drug is a stomachic agent containing crude drug as a main component, and a stomachic effect can be expected, but indigestion and stomach relieve caused by this, chest tightness, etc. However, it was not possible to exert a sufficient therapeutic effect against.

Although a herbal medicine oral preparation containing a powdery or granular enzyme has been known, it has the drawbacks that it is difficult to take and its efficacy is slow.

[0006]

An object of the present invention is to provide an enzyme-containing herbal medicine liquid for oral administration, in which the enzyme activity is kept stable.

Since the enzyme-containing oral solution is easy to take and has a rapid effect, its commercialization is expected.
However, digestive enzyme preparations are unstable when stored in solution.

The present inventors have found that when a crude drug component is added to this digestive enzyme preparation in solution, the enzyme activity becomes more unstable. Therefore, in order to produce a liquid drug for internal use of an enzyme containing a crude drug whose enzyme activity is kept stable,
There has been a demand for stabilization of digestive enzymes, particularly reduction or elimination of the effects of crude drug components.

[0009]

[Means for Solving the Problems]
As a result of intensive research, by blending a digestive enzyme agent and a stabilizer such as saccharides, calcium salts, proteins, and polyhydric alcohols with the crude drug, the digestive enzyme agent is stabilized in the solution for a long period of time even in the presence of the crude drug. I found out what could be done. The present invention is
It was completed based on this knowledge.

That is, the present invention is an enzyme-containing liquid drug for oral administration of a crude drug, which comprises a water-soluble component of a crude drug and a digestive enzyme agent and a stabilizer.

The enzyme-containing liquid drug for oral administration of herbal medicine of the present invention is not only stored in a cold place but also shows remarkable stability even under severe conditions, and can maintain its drug effect for a long period of time.

As the digestive enzyme preparation to be added to the liquid preparation for oral administration of an enzyme-containing herbal medicine of the present invention, any digestive enzyme preparation can be used as long as it is an enzyme used for medicinal purposes. , Protein digestive enzyme preparations, fat digestive enzyme preparations, fibrin digestive enzyme preparations and the like.

Examples of the starch-digesting enzyme agent include α-amylase, β-amylase, glucoamylase and the like. Specific examples of trade names include diastase (pharmaceutical product), biodiastase, biodiastase 1000, biodiastase 2000 ( All are complex enzyme preparations that also include various digestive enzyme preparations, which are products of Amano Pharmaceutical Co., Ltd.), Diasmen, Klytase, Bio-Crytase (all are products of Daiwa Kasei Co., Ltd.), Biotamylase (complex enzyme preparations that also contain protein digestive enzyme preparations) , Products from Nagase & Co., Ltd.), amyloliquefase (product of Hankyu Kyoei Bussan Co., Ltd.), sanactase (product of Meiji Seika Co., Ltd.) and the like. The mixing ratio is not particularly limited as long as the starch-digesting enzyme preparation substantially acts,
Preferably, the minimum daily dose is 100 units or more.

Examples of protein digestive enzyme agents include endopeptidases and exopeptidases. Specific examples of trade names are biodiastase, biodiastase 1000, biodiastase 2000, prozyme, and neurase (all manufactured by Amano Pharmaceutical Co., Ltd.). , Sumiteam P, Sumiteam LP, Sumiteam RX, (all are products of Shin Nippon Chemical Co., Ltd.),
Examples include promen, protin A, protin P (all manufactured by Daiwa Kasei Co., Ltd.), biotamylase (manufactured by Nagase & Co., Ltd.), proteoliquiferase (manufactured by Hankyu Kyoei Co., Ltd.), procutase (manufactured by Meiji Seika Co., Ltd.) and the like. The mixing ratio is
There is no particular limitation as long as the protein digestive enzyme agent substantially acts, but the minimum daily dose is preferably 750 units or more.

As the fat-digesting enzyme preparation, any fat-digesting enzyme preparation of animal origin, plant origin or microbial origin can be used. Specific examples are lipase AP4 and lipase AP
6. Lipase MAP (all products of Amano Pharmaceutical Co., Ltd.), Lipase M
Y (a product of Meito Sangyo Sangyo Co., Ltd.) and the like. The blending ratio is not particularly limited as long as the fat digestive enzyme preparation substantially acts, but the minimum dose per day is preferable.
It should be 50 units or more.

As a fibrin digestive enzyme agent, C ₁ -enzyme, C _X
-Enzymes and the like, and specific examples thereof include cellulase
AP, cellulase AP3, biodiastase 1000, biodiastase 2000 (all manufactured by Amano Pharmaceutical Co., Ltd.), and macerase (manufactured by Meiji Pharmaceutical Co., Ltd.) are listed. The mixing ratio is
There is no particular limitation as long as the fibrin digestive enzyme agent substantially acts, but the minimum daily dose is preferably 6 units or more.

Even if these digestive enzyme agents are used alone, 2
You may use it in combination of 2 or more types.

As the water-soluble component of crude drug contained in the liquid preparation for oral administration of the enzyme-containing crude drug of the present invention, any component used as a crude drug can be used.

For example, an extract of a herbal medicine containing secoyridoid glycoside, limonene, cinnamaldehyde, saponin, etc. as an active ingredient, that is, aloe, fennel, fennel oil, sardine, sardine, sardine, zedoary, swordfish, cinnamon, cinnamon oil. , Gentian, kojin, koboku, goshuyu, colombo, conzulango, salamander,
Shuksha, Ginger, Owl, Assemblage, Sojutsu, Soyo, Rhubarb, Chikusets carrot, Clove, Clove oil, Chinpi, Capsicum, Spruce, Nigaki, Carrot, Mint, Mint oil, Sandalwood, Homika, Mokkou, Yakuchi, Yutan, Ryutan, Ryutan , Etc. Stomach crude drug of extracts such as licorice, akamega wrinkle, Engosaku, mucous membrane repairing drug of extracts such as yutan; digestive drug of extracts of yutan etc .; intestinal herbal medicine of extracts of acacia yam, ketsumeishi, genosho, etc .; kakuboku, peony, belladonna , An analgesic and antispasmodic crude drug of each extract such as funnel. Of course, crude drugs with various nourishing and tonic effects can also be applied.

These crude drug extracts are produced by adding a suitable leaching agent to various crude drugs, leaching by cold leaching, warm leaching, etc. for a certain period of time, filtering the leaching solution, and concentrating by a suitable method. Is.

The blending ratio of the water-soluble ingredient of crude drug is 0.04 to 20 W /
V%, preferably 0.4 to 4.0 W / V%. These crude drug water-soluble components may be used alone or in combination of two or more kinds, but usually, they are used in combination of several kinds. Be done.

Examples of the stabilizer to be added to the water-soluble ingredient of crude drug together with the digestive enzyme agent include saccharides, calcium salts, proteins, polyhydric alcohols, etc., alone or in combination.

Specific examples of the sugar include glucose, sucrose, maltose, sorbitol, fructose, xylitol and the like. The blending ratio of these is 5 to 40 W / V%, more preferably 10 to 30 W / V%, and it is possible to use not only a single sugar but also a mixture of a plurality of sugars.

Specific examples of calcium salts include calcium chloride, calcium lactate, calcium glycerophosphate, calcium gluconate and the like. The blending ratio of these is 0.01 to 5.0 W / V%, preferably 0.03 to
It is 2.0 W / V%, and it is possible to use not only a single calcium salt but also a plurality of calcium salts mixed together.

Further, specific examples of proteins include casein, albumin, gelatin and the like, partially decomposed products thereof, various amino acids and the like, and particularly preferably,
It is casein. The mixing ratio of these is 0.01-10 W / V
%, Preferably 0.03 to 5.0 W / V%, and it is possible to use not only a single protein but also a mixture of a plurality of proteins.

Furthermore, specific examples of the polyhydric alcohol include polyvinyl alcohol (PVA) and polyethylene glycol (PEG). The blending ratio of these is 0.01 to 10 W / V%, preferably 0.03 to 5.0 W / V%, and a plurality of polyhydric alcohols can be used not only alone but also as a mixture.

As for the liquid drug for oral administration of an enzyme-containing crude drug, as long as it does not adversely affect the stabilization of the enzyme and does not reduce the taste, the above-mentioned compounding agent may be further added with a fragrance such as L-menthol; an antacid, For example, precipitated calcium carbonate, magnesium silicate, synthetic aluminum silicate; a bile agent such as ursodeoxycholic acid; and other components such as aminoacetic acid, ethanol, xanthan gum and the like can be incorporated.

The enzyme-containing galenical drug solution for oral administration according to the present invention can be prepared by dissolving each of the above components by conventional means, filtering if necessary, and aseptically filling the container. Next, the present invention will be described with reference to test examples and examples, but the present invention is not limited to these examples.

The methods for measuring the starch digestive power, protein digestive power and fat digestive power used in the test examples and examples of the present invention are as follows.

Starch digestibility: When starch-digesting enzyme acts on 100 mg of potato starch at 37 ° C. (pH 5.0), the iodine-derived blue color of potato starch is produced in the first minute of the reaction.
One unit is the amount of enzyme that reduces 10% of color.

Protein digestibility: When proteolytic enzyme acts on milk casein at 37 ° C (pH 6.0), increase of non-protein Folin reagent coloring substance corresponding to 1 µg of tyrosine in 1 minute of the initial reaction. The amount of enzyme that produces

Fat digestibility: When the lipolytic enzyme is used as a substrate for olive oil emulsified liquid at 37 ° C. (pH 6.0) and measured for 20 minutes reaction, the amount of enzyme that releases 1 μmol of fatty acid per minute is 1
Use as a unit.

Test Example 1 Effect of saccharides and calcium salts on stability of enzyme when digestive enzyme preparation was added to water-soluble ingredient of crude drug

[0034] Crude drug Water-soluble ingredients containing only digestive enzyme agents (N
o.1), No.1 prescription with saccharides (No.2), No.1
The storage stability at 40 ° C was examined for the enzyme solution of each component formulation of the formulation containing calcium salt (No.3) and the formulation containing sugar and calcium salt (No.4). .. The results are shown in Table 1. As a control, the storage stability of only the digestive enzyme preparation was measured.

Ingredients Enzyme preparation Complex enzyme preparation Biodiastase Starch digestive power 1500 units Protein digestive power 1500 units Fat digestive enzyme preparation Lipase AP4 Fat digestive power 680 units Crude drug water-soluble ingredient Carrot extract 0.30 g Gentiana extract 0.15 g Chinpi extract 0.24 g Keihi extract 0.22 g Assemblage extract 0.09 g Sugar Glucose 13.00 g White sugar 1.00 g Calcium salt Calcium lactate 0.36 g Aminoacetic acid 0.44 g Water 90 ml −−−−−−−−−−−−−−−−−−−−−−−−−− --- PH 6.0

[0036]

[Table 1]

As is clear from Table 1, when the digestive enzyme preparation was mixed with the crude drug (No. 1), all the enzymes were very unstable as compared with the control, but due to the combination of saccharides. (No.2) The starch digestive enzyme and protein digestive enzyme are more stabilized, and the fat digestive enzyme is also stabilized. It was also found that the compound of calcium salt (No. 3) stabilizes the starch digestive enzyme and the fat digestive enzyme in particular. It was also found that by blending both calcium salt and saccharide (No. 4), the starch-digesting enzyme was more stabilized, and the stability of fat-digesting enzyme and protein-digesting enzyme was simultaneously maintained.

Test Example 2 Effect of polyhydric alcohol on stability of enzyme when digestive enzyme preparation was mixed with water-soluble ingredient of crude drug

Preservation at 40 ° C. of the enzyme solution of each component formulation of the crude drug water-soluble component containing only digestive enzyme agent (No. 1) and the formulation containing No. 1 polyhydric alcohol (No. 2) Stability was investigated. The results are shown in Table 2.
As a control, the storage stability of only the digestive enzyme preparation was measured.

Ingredients Enzyme preparation Complex enzyme preparation Biodiastase Protein digestive power 1500 units Starch digestive power 1500 units Fat digestive enzyme preparation Lipase AP6 Fat digestive power 680 units Crude drug water-soluble ingredient assembly extract 0.06 g gentian extract 0.04 g chimpi extract 0.24 g cinnamon extract 0.22 g Carrot extract 0.60 g Cucumber extract 0.09 g Engosaku extract 0.30 g Squid grass extract 0.05 g Gourd tincture 0.10 g Anhydrous caffeine 0.20 g Pyridoxine hydrochloride 0.05 g Polyhydric alcohol PVA 1.35 g Water 90 ml --------------- −−−−−−−−−−−−−−−−− PH 4.5

[0041]

[Table 2]

As is clear from Table 2, when only the digestive enzyme agent was used as the water-soluble component of the crude drug (No. 1), both enzymes were unstable, but due to the addition of polyhydric alcohol (No. 2). )
Both enzymes were found to be stabilized.

Test Example 3 Effect of protein and calcium salt on stability of enzyme when digestive enzyme preparation was mixed with water-soluble ingredient of crude drug

[0044] Crude drug Water-soluble ingredients containing only digestive enzyme agents (No. 1), No. 1 formulation containing protein (No. 2),
No.1 prescription with calcium salt (No.3) and N
The storage stability at 40 ℃ was investigated for the enzyme solution of each component formulation of o.1 formulation containing protein and calcium salt. The results are shown in Table 3. As a control, the storage stability of only the digestive enzyme preparation was measured.

Ingredients Enzyme agent Complex enzyme agent Biodiastase Starch digestive power 1500 units Protein digestive power 1500 units Crude drug water-soluble ingredient Cembly extract 0.06 g Gentian extract 0.04 g Chinpi extract 0.24 g Keihi extract 0.22 g Carrot extract 0.60 g Cuco extract 0.09 g Engosaku extract 0.30 g squid grass extract 0.05 g ginkgo tincture 0.10 g anhydrous caffeine 0.20 g pyridoxine hydrochloride 0.05 g protein casein 1.35 g calcium salt calcium chloride 0.20 g water 90 ml −−−−−−−−−−−−−−−−−−− −−−−−−−−−− pH 7.0

[0046]

[Table 3]

As is clear from Table 3, when only the digestive enzyme agent was used as the water-soluble ingredient of crude drug (No. 1), the starch digestive power, protein digestive power and fat digestive power were all very unstable. However, it was found to be stabilized by the combination of proteins (No. 2).

Test Example 4 Effect of various saccharides on enzyme stability in the case of a formulation in which a starch-digesting enzyme agent and a calcium salt were mixed in a water-soluble ingredient of crude drug

Prescription crude drug Water-soluble ingredients Gentian extract 0.1 g Keihi extract 0.06 g Ginger 0.02 g Calcium salt calcium chloride 0.20 g Enzyme complex enzyme Enzyme biodiastase Starch digestion 3600 units Protein digestion 1500 units

The following various sugars were added to the above formulation, and water was further added to make 60 ml (pH 6.0).
The storage stability was investigated. The results are shown in Table 4.

[0051]

[Table 4]

As is clear from Table 4, it was found that the starch-digesting enzyme was stabilized by any of the sugars tested, and in particular, sorbitol, glucose and sucrose alone or a combination of grape and sucrose was used. It turned out that the effect was excellent. It was also found that the compounding amount of 5 to 30% is effective.

[0053]

[Examples] Example 1 Formulation (in 20 ml) Senburi extract 0.02 g Keihi extract 0.07 g Bioenzyme complex enzyme agent Biodiastase Starch digestive power 2300 units Protein digestive power 1500 units Calcium chloride 0.40 g Glucose 7.0 g --------------- −−−−−−−−−−−−−−−−−−−− pH 6.0

Manufacturing Method According to the above formulation, first, calcium chloride and glucose are weighed and dissolved by adding about 1/2 amount of water of a predetermined liquid volume, and then each crude drug extract is added and well stirred, and water is added. substantially the entire amount, then a modification of the pH to 6.0 with sodium hydroxide 1 N, double coupling enzyme agent Biodiastase (Amano Pharmaceutical Co. product)
Is added to dissolve, and water is added to make a predetermined liquid amount. The liquid is sterilized and the container is aseptically filled. This enzyme-containing herbal medicine oral administration solution retained 83% residual starch digestive power and 42% residual protein digestive power even when stored at 40 ° C for 3 months.

Example 2 Formulation (in 20 ml) Assembly extract 0.02 g Chinpi extract 0.08 g Keihi extract 0.06 g Complex enzyme agent Biodiastase 1000 Starch digestive power 3800 units Protein digestive power 1500 units Fat digestive enzyme agent Lipase AP6 Fat digestive power 680 units Calcium lactate 0.12 g Aminoacetic acid 0.12 g Glucose 2.4 g White sugar 0.6 g −−−−−−−−−−−−−−−−−−−−−−−−−−− pH 6.1

Manufacturing Method According to the above formulation, first, calcium lactate, glucose, sucrose and aminoacetic acid are respectively weighed, about 1/2 amount of water is added to dissolve them, and then each crude drug extract is added and well stirred, and water is added. To about the total amount and pH with 1N sodium hydroxide.
Was corrected to 6.1, then the combined enzyme agent Biodiastase 100
0 and lipase AP6 (both manufactured by Amano Pharmaceutical Co., Ltd.) are added and dissolved, and water is added to a predetermined liquid amount. The liquid is sterilized and the container is aseptically filled. The obtained enzyme-containing herbal medicine oral solution solution retained 85% residual starch digestive power, 52% residual protein digestive power and 47% residual fat digestive power even when stored at 40 ° C for 2 months. .

Example 3 Formulation (in 20 ml) Assembly extract 0.03 g Gentian extract 0.05 g Chinpi extract 0.08 g Keihi extract 0.078 g Diastase 100 units Calcium chloride 0.20 g Calcium lactate 0.12 g Aminoacetic acid 0.16 g White sugar 3.00 g ----- −−−−−−−−−−−−−−−−−−−−−−− pH 6.0

Manufacturing Method According to the above formulation, first, calcium chloride, calcium lactate, sucrose and aminoacetic acid are weighed, about 1/2 amount of water is added and dissolved, and then each crude drug extract is added and well stirred, and water is added. To about the total amount and pH with 1N sodium hydroxide.
After adjusting to 6.0, add malt diastase (pharmaceutical product) to dissolve, and add water to make a predetermined liquid volume. The liquid is sterilized and the container is aseptically filled. 88% of the obtained enzyme-containing crude drug oral solution was stored at 40 ° C for 2 months.
Retained the remaining starch digestive power.

Example 4 Formulation (in 30 ml) Assembly extract 0.03 g Gentian extract 0.05 g Chinpi extract 0.08 g Cayhi extract 0.05 g Carrot extract 0.25 g Glycyrrhiza extract 0.30 g Calcium lactate 0.12 g Aminoacetic acid 0.20 g L-menthol Suitable amount casein 4.00 g Complex Enzyme agent Biodiastase 1000 Starch digestion 2000 units Protein digestion 1500 units −−−−−−−−−−−−−−−−−−−−−−−−−−−−− pH 7.1

Manufacturing Method According to the above formulation, first, calcium lactate, aminoacetic acid, L
-Weigh menthol and casein, add about 1/2 amount of water to dissolve, then add each crude drug extract and stir well,
Add water to make almost the whole amount, and add 1N sodium hydroxide.
After adjusting the pH to 7.1, the complex enzyme agent biodiastase 1
Add 000 (manufactured by Amano Pharmaceutical Co., Ltd.) to dissolve, and add water to obtain a predetermined liquid volume. The liquid is sterilized and the container is aseptically filled. The obtained enzyme-containing galenical drug solution retained 82% of residual starch digestive power and 45% of residual protein digestive power even when stored at 40 ° C. for 2 months.

Example 5 Formulation (in 20 ml) Senburi extract 0.03 g Gentian extract 0.05 g Chinpi extract 0.08 g Keihi extract 0.07 g Complex enzyme agent biodiastase protein digestive power 1500 units Starch digestive power 2000 units Fat digestive enzyme lipase AP6 fat digestive power 680 Unit PVA 0.30 g Aminoacetic acid 0.16 g −−−−−−−−−−−−−−−−−−−−−−−−−−−−− pH 6.0

Manufacturing Method According to the above prescription, first, polyvinyl alcohol (PV
A) and aminoacetic acid are weighed and dissolved by adding about 1/2 amount of water, and then adding each crude drug extract and stirring well, adding water to almost the total amount and adjusting pH to 4.5 with 1N hydrochloric acid. After correction, complex enzyme agents biodiastase and lipase AP6
(All products are manufactured by Amano Pharmaceutical Co., Ltd.) and dissolved, and water is added to obtain a predetermined liquid amount. The liquid is sterilized and the container is aseptically filled. The resulting solution containing the enzyme-containing crude drug for oral administration was 2
It retained 85% residual fat digestive power, 45% residual protein digestive power and 23% residual starch digestive power even when stored for months.

Example 6 Formulation (in 90 ml) Ursodeoxycholic acid 0.05 g Chinpi extract 0.22 g Keihi extract 0.24 g Calcium carbonate 1.50 g Glucose 10.00 g White sugar 2.00 g Calcium lactate 0.012 g Xanthan gum 0.225 g L-menthol 0.008 g Complex enzyme agent biodiastase 1000 Starch digestion 2000 units Protein digestion 1500 units Fat digestive enzyme Lipase AP6 Fat digestion 700 units −−−−−−−−−−−−−−−−−−−−−−−−−−−−− pH 6.1

Manufacturing Method According to the above-mentioned formulation, xanthan gum is first weighed out to about 1/2.
Add a certain amount of water and dissolve, then add calcium carbonate, glucose, sucrose, calcium lactate, L-menthol, complex enzyme agent biodiastase 1000, fat digestive enzyme agent lipase AP
Dissolve 6 (all products manufactured by Amano Pharmaceutical Co., Ltd.) and various crude drug extracts, adjust the pH to 7.2, and then add sterilized liquid and sterilized water to obtain a predetermined liquid amount. Aseptically fill the container with this liquid. The enzyme-containing herbal medicine oral solution obtained was 2 at 40 ° C.
It retained 90% residual starch digestive power, 61% residual fat digestive power, and 55% residual protein digestive power even after storage for months.

Example 7 In each of the formulations of Examples 1 to 6 , when the enzyme preparation was changed to another digestive enzyme preparation and the storage stability was measured in the same manner, long-term storage was carried out as in each embodiment. Stability was observed.

Example 8 The storage stability was measured in the same manner by using a partially decomposed product of gelatin in place of the calcium chloride of Example 1 . As a result, 78
% Of residual starch and 45% of residual protein.

Example 9 PVA was used in place of the glucose of Example 2 and the storage stability was measured in the same manner. As a result, 92% of residual starch digestive power, 62% of residual protein digestive power and 39% of residual fat digestive power were retained.

Example 10 In place of sucrose in Example 3 , casein was used, and calcium chloride and calcium lactate were replaced with PEG, and the storage stability was measured in the same manner. As a result, 83% of residual starch digestion was retained.

Example 11 The storage stability was measured in the same manner as in Example 4 with the addition of PVA. As a result, 85% residual starch digestibility and
It retained 53% residual protein digestion.

[0070]

Industrial Applicability As described in detail above, the liquid preparation for oral administration of an enzyme-containing crude drug of the present invention is a formulation in which the contained enzyme is stably maintained, and it can be easily ingested at the time of use, and exhibits a rapid effect. In addition to the effects, it is a drug that can exert a sufficient therapeutic effect on dyspepsia, stomach swelling, chest tightness, etc. resulting from it, so that its industrial value is great.

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[Procedure amendment]

[Submission date] July 29, 1992

[Procedure Amendment 1]

[Document name to be amended] Statement

[Name of item to be corrected] 0045

[Correction method] Change

[Correction content]

Ingredients Oxygen agent Complex oxygen agent Biodiastase Starch digestive power 1500 units Protein digestive power 1500 units Sebaceous gland digestive oxygen agent Lipase AP6 Fat digestive power 1200 units Crude drug water-soluble ingredients Sembri extract 0.06 g Gentiana extract 0.04 g Tendopiquis 0.24 g Keihi extract 0.22 g Carrot extract 0.60 g Cucumber extract 0.09 g Engosaku extract 0.30 g Squid grass extract 0.05 g Gourd tincture 0.10 g Anhydrous caffeine 0.20 g Pyridoxine hydrochloride 0. 05 g protein casein 1.35 g calcium salt calcium chloride 0.20 g water 90 ml −−−−−−−−−−−−−−−−−−−−−−−−−−−−− pH 7 .0

Claims (4)

[Claims] 1. A liquid preparation for oral administration of an enzyme-containing crude drug, which comprises a water-soluble component of a crude drug and a digestive enzyme agent and a stabilizer. 2. The digestive enzyme preparation is one or more of a starch digestive enzyme preparation, a fat digestive enzyme preparation and a protein digestive enzyme preparation.
A liquid preparation for oral administration containing the enzyme described in the above. 3. The enzyme-containing herbal medicine liquid for oral administration according to claim 1, wherein the stabilizer is one or more of sugars, calcium salts, proteins and polyhydric alcohols. 4. The enzyme-containing liquid drug for oral administration of a herbal medicine according to claim 1, wherein the water-soluble ingredient of the herbal medicine is one or more kinds of herbal medicine extracts containing secoiridoid glycoside, limonene, cinnamaldehyde or saponin as an active ingredient.