TWI782381B - Composite composition of clostridium butyricum, yeast and enzyme, oral composite including the same and application on serum lipid regulation - Google Patents

Abstract

The present invention relates to a composite composition of Clostridium butyricum, yeast and enzyme, an oral composite including the composite composition and its applications on liver protection and serum lipid regulation. The composite composition includes ingredients of Clostridium butyricum, at least one yeast, soybean powder fermented by Lactobacillus sp., at least one plant-based enzyme, lecithin and so on. The composite composition can be applied to preparation of the oral composition for regulating serum lipid.

Description

Clostridium butyricum, yeast and enzyme complex composition, oral composition containing it and its application for regulating serum lipids

The present invention relates to a composite composition of Clostridium butyricum, yeast and enzyme, in particular to a composite composition of Clostridium butyricum, yeast and enzyme with the function of regulating serum lipids and its application in oral composition.

Liver cancer, cerebrovascular disease and heart disease account for the top ten causes of death in China. The occurrence of liver cancer is highly correlated with chronic liver damage caused by chronic liver diseases such as cirrhosis, viral hepatitis and fatty liver, while cerebrovascular disease and heart disease are highly correlated with atherosclerosis Sex, and the content of various lipids or lipoproteins (lipoproteins) in serum can be used to assess the risk probability of suffering from atherosclerosis.

At present, the medical field uses ultrasound detection, serum GPT and GOT concentration, organ weight ratio, liver lipid, liver enzyme activity, liver tissue Slices and other methods were used to assess the degree of liver damage.

At present, there are many synthetic drugs on the market for the treatment of liver damage and hyperlipidemia. However, synthetic drugs generally have disadvantages such as high biological toxicity, large side effects in clinical trials, and easy drug resistance. Therefore, researchers are trying to screen active ingredients or compound components that have the function of regulating serum lipids from natural source ingredients, so as to provide the function of regulating serum lipids.

Therefore, one aspect of the present invention is to provide a composite composition of Clostridium butyricum, yeast and enzyme, which comprises Clostridium butyricum, at least one yeast, lactic acid bacteria fermented soybean powder, at least one plant-derived enzyme, lecithin and other ingredients.

Another aspect of the present invention is to provide an oral composition with the function of regulating serum lipids, which contains the above-mentioned composite composition of Clostridium butyricum, yeast and enzyme as active ingredients, and can be administered to a subject through the intestinal administration route.

According to the above aspects of the present invention, a composite composition of Clostridium butyricum, yeast and enzyme is proposed, which comprises 20% to 32% by weight of Clostridium butyricum ( Clostridium butyricum ) EC80, 20.4% to 25.6% by weight of at least A yeast, 20% to 25% by weight of lactic acid bacteria fermented soybean powder, 20% to 25% by weight of at least one plant-derived enzyme, 2.4% to 3.6% by weight of lecithin, 1.6% to 2.4% by weight % taurine, 0.4% to 0.6% by weight of choline bitartrate, 0.4% to 0.6% by weight of inositol, and 2.8% to 4.2% by weight of lactose. The above-mentioned Clostridium butyricum EC80 was deposited in the Biological Resource Preservation and Research Center of the Food Industry Development Institute, No. 331 Food Road, Hsinchu, Taiwan. The deposit date was February 15, 2019, and the deposit number was BCRC 910868.

According to an embodiment of the present invention, with the above-mentioned Clostridium butyricum, yeast and enzyme composite composition as 100% by weight, the above-mentioned at least one yeast may include, for example, 20% by weight to 25% by weight of Saccharomyces cerevisiae and/or 0.4% by weight to 0.6% by weight of selenium yeast.

According to an embodiment of the present invention, with the above-mentioned Clostridium butyricum, yeast and enzyme composite composition as 100% by weight, the above-mentioned at least one plant-derived enzyme may include 10% by weight to 13% by weight of starch liquefying enzyme and/or 10% by weight Percent to 13 percent by weight of bromelain.

According to an embodiment of the present invention, the above-mentioned lactic acid bacteria fermented soy powder can be produced, for example, by fermenting soybean milk with Enterococcus spp. at a temperature of 30°C to 45°C for 5 to 24 hours, followed by a drying step.

According to another aspect of the present invention, an oral composition with the function of regulating serum lipids is proposed, including the above-mentioned composite composition of Clostridium butyricum, yeast and enzyme, and the composite composition of Clostridium butyricum, yeast and enzyme is the active ingredient , can be administered to the subject through the enteral administration route, wherein the dosage of the aforementioned Clostridium butyricum, yeast and enzyme composite composition can be, for example, 0.07 grams to 0.70 grams per kilogram of body weight.

According to an embodiment of the present invention, the above-mentioned intestinal administration route may be, for example, Oral route.

According to an embodiment of the present invention, the above-mentioned subject is a mammal.

According to another aspect of the present invention, an oral composition with the function of regulating serum lipids is proposed, including the above-mentioned composite composition of Clostridium butyricum, yeast and enzyme, and the composite composition of Clostridium butyricum, yeast and enzyme is the active ingredient , can be administered to the subject through the enteral administration route, wherein the dosage of the aforementioned Clostridium butyricum, yeast and enzyme complex composition can be, for example, 0.14 grams to 0.42 grams per kilogram of body weight.

The composite composition of Clostridium butyricum, yeast and enzyme of the present invention has the function of regulating serum lipids and can be used as an active ingredient in oral compositions.

In order to make the above and other objects, features, advantages and embodiments of the present invention more comprehensible, the detailed description of the accompanying drawings is as follows:

[Fig. 1] is a graph showing the percentage change of serum total cholesterol (TC) after the hyperlipidemia experimental animals according to Example 2 of the present invention were fed with the composite composition of Clostridium butyricum, yeast and enzyme of experimental group 4 for 6 weeks Graphs, where the symbol * represents a statistically significant difference.

[Fig. 2] is a graph showing the percentage change of serum LDL cholesterol after the hyperlipidemia experimental animals according to Example 2 of the present invention are fed with the composite composition of Clostridium butyricum, yeast and enzyme of experimental group 4 for 6 weeks, The symbol * represents a statistically significant difference.

[Fig. 3] depicts the experiment of hyperlipidemia according to Example 2 of the present invention. The curve graph of the percentage change of serum HDL cholesterol after feeding the composite composition of Clostridium butyricum, yeast and enzyme in experimental group 4 for 6 weeks.

[Fig. 4] is a graph showing the percentage change of serum TG after the hyperlipidemia experimental animals according to Example 2 of the present invention were fed with the composite composition of Clostridium butyricum, yeast and enzyme of experimental group 4 for 6 weeks, wherein The symbol * represents a statistically significant difference.

As mentioned above, the present invention provides a composite composition of Clostridium butyricum, yeast and enzyme, which includes Clostridium butyricum, at least one yeast, lactic acid bacteria fermented soybean powder, at least one plant-derived enzyme, lecithin and other components, with Regulates serum lipid function.

In other words, the "Clostridium butyricum, yeast and enzyme composite composition" referred to in the present invention refers to a specific ratio of Clostridium butyricum, at least one yeast, lactic acid bacteria fermented soybean powder, and at least one plant-derived Enzymes, Lecithin, Taurine, Choline Bitartrate, Inositol and Lactose. In one embodiment, the composite composition of Clostridium butyricum, yeast and enzyme may include but not limited to Clostridium butyricum EC80 from 20% to 32.4% by weight, at least one of 25.4% to 35.6% by weight Yeast, 25% to 35% by weight of lactic acid bacteria fermented soybean powder, 24% to 36% by weight of at least one plant-derived enzyme, 2.4% to 3.6% by weight of lecithin, 1.6% to 2.4% by weight taurine, 0.4 to 0.6 weight percent choline bitartrate, 0.4 to 0.6 weight percent inositol, and 2.8 to 4.2 weight percent lactose. The above-mentioned Clostridium butyricum EC80 is deposited in the Biological Resource Preservation and Research Center of the Food Industry Development Institute of the Republic of China Foundation, No. 331 Food Road, Hsinchu, Taiwan. The deposit date is February 15, 2019, and the deposit number is BCRC 910868.

In the above-mentioned embodiment, with the above-mentioned Clostridium butyricum, yeast and enzyme composite composition as 100% by weight, the above-mentioned at least one yeast may include, but not limited to, Saccharomyces cerevisiae ( Saccharomyces cerevisiae ) and /or 0.4% by weight to 0.6% by weight of selenium yeast.

In one example, the brewer's yeast mentioned above may include but not limited to, for example, BCRC 20262, BCRC 20263, BCRC 20270, BCRC 20271, BCRC 20405, BCRC 20496, BCRC 20497, BCRC 20498 and/or BCRC 21680, but this is only an example , the present invention is not limited thereto, and other brewer's yeast strains deposited by the Bioresource Collection and Research Center (BCRC) of Taiwan's Hsinchu Food Industry Development Institute may also be used.

In other embodiments, with the composite composition of Clostridium butyricum, yeast and enzyme as 100% by weight, the at least one plant-derived enzyme may include 12% to 18% by weight of starch liquefying enzyme and/or 12% by weight Bromelain (or claiming Bromelain) to 18% by weight.

The aforementioned lactic acid bacteria-fermented soybean powder can be produced by, for example, fermenting soybean milk with Enterococcus spp. (Repository No.: BCRC 80605) at a temperature of 30°C to 45°C for 5 to 24 hours, followed by a drying step. What is explained here is that not a single ingredient containing Clostridium butyricum, yeast, lactic acid bacteria fermented soybean powder, or plant-derived enzymes can regulate serum lipids. It must meet the above-mentioned specific formula ratios and can only be confirmed by animal experiments. . In addition, if the dosage of each component of the above-mentioned Clostridium butyricum, yeast and enzyme composite composition is outside the above-mentioned range, it has not been proved by experiments, and it is not expected to have the function of regulating serum lipids.

The "regulation of serum lipid function" referred to in the present invention refers to the evaluation of the regulation of serum lipid function of the compound composition of butyric acid bacteria, yeast and enzyme by using the high cholesterol animal test model. In one embodiment, the aforesaid regulation of serum lipid function can be evaluated by referring to the "Evaluation Method for Regulating Serum Lipid Function of Healthy Foods" as amended by Taiwan Department of Health Shizi No. 0960403114, which is hereby incorporated as a reference of the present invention. In short, this evaluation method for regulating serum lipid function is to combine different doses (one dose contains the recommended human intake) of butyric acid bacteria, yeast and enzymes after a high-cholesterol diet induces only elevated serum lipids. The composition is administered to the subject through the intestinal route for a period of time, and then the serum lipids of the subject are measured, such as cholesterol, serum triglycerides, serum total cholesterol, serum high-density lipoprotein cholesterol, serum low-density lipoprotein cholesterol, Serum low-density lipoprotein, serum low-density lipoprotein oxidation, etc.

The compound composition of Clostridium butyricum, yeast and enzyme obtained above has been evaluated by animal experiments, and it has been confirmed that it has the function of regulating serum lipids, and can be further applied to various dosage forms. Suitable compositions may include, but are not limited to oral composition. In one embodiment, the above-mentioned oral composition uses a composite composition of Clostridium butyricum, yeast and enzyme as active ingredients, so that the composition of the above-mentioned dosage form has the function of regulating serum lipids. What is explained here is that when the composite composition of Clostridium butyricum, saccharomyces and enzyme obtained above in the present invention is used as an oral composition, it all exhibits dose- and time-dependent (dose- and time-dependent) ) correlation protection.

Several examples are used below to illustrate the application of the present invention, but it is not intended to limit the present invention. Those with ordinary knowledge in the technical field of the present invention can make various modifications and changes without departing from the spirit and scope of the present invention. retouch.

Embodiment 1: Preparation of Clostridium butyricum, saccharomyces and enzyme composite composition

First, according to Table 1, the composite composition of Clostridium butyricum, yeast and enzyme of experimental groups 1 to 4 was prepared.

The Clostridium butyricum listed in Table 1 is Clostridium butyricum EC80, deposited in the Biological Resource Preservation and Research Center of the Food Industry Development Institute, No. 331, Hsinchu Food Road, Hsinchu, Taiwan. The date of deposit is February 15, 2019, and the deposit number is for BCRC 910868. Lactic acid bacteria fermented soybean powder is made from commercially available soymilk, fermented with enterococcus ( Enterococcus spp.; deposit number: BCRC 80605) at a temperature of 30°C to 45°C for 5 to 24 hours, and then dried And made.

After the above ingredients were uniformly mixed, the composite composition of Clostridium butyricum, yeast and enzyme was prepared and followed up for evaluation.

Example 2: Establishment of an animal test model for regulating serum lipid function assessment

For the assessment of serum lipid regulation function, please refer to the Taiwan Ministry of Health and Welfare No. 960718 Health Department Shizi No. 0960403114 "Evaluation Method for Blood Lipid Regulation Function of Healthy Foods" (URL: https://www.fda.gov.tw/tc/includes/ GetFile.ashx?id=f636694170742257494) for evaluation.

1. Experimental animals

Take 32 7-week-old mature male hamsters (Syrian hamster), follow the relevant experimental animal management guidelines announced by the National Institutes of Health, and keep them in an animal room with independent air conditioning (IVC system, TECNIPLAST, Italy), and keep the temperature at 23± 1°C, humidity maintained at 60±10%, and maintained at a 12-hour light-dark cycle, no restriction on feed (Laboratory Rodent Diet 5001) and water (reverse osmosis) during feeding water supply). After the hamsters were acclimatized for one week, subsequent assessments of serum lipid function were carried out.

2. Establish an experimental animal model of hypercholesterolemia

The above 32 hamsters were randomly divided into 4 groups, 8 in each group, respectively normal group (N=8), control group (N=8), experimental group 4 (feeding 0.07 g/kg body weight of Clostridium butyricum, yeast Compound composition with enzyme, N=8), experimental group 4 (feeding 0.70 g/kg body weight of Clostridium butyricum, yeast and enzyme compound composition, N=8).

In the case of hypercholesterolemia, the feed was changed to Laboratory Rodent Diet 5001 (model: 51575; Test-Diet Company) with 0.5% cholesterol added, and the water was reverse osmosis water treated with ultraviolet light, and the supply of feed and water was not limited.

The compound composition of Clostridium butyricum, yeast and enzyme in experimental group 4 (0.14 g/kg body weight, N=8) is based on the recommended amount for the human body (70kg), that is, 10g/person/day (low dose, equivalent to 0.14g /kg body weight/day), converted into hamsters (200g) is 0.018g/hamster/day (10×0.018=0.18g/hamster/day, equivalent to 0.0009g/g body weight/day). When evaluating various functions of regulating serum lipids, feed 2 times a day with a nasogastric tube, 1 mL/hamster (0.09 g/mL) each time, and continue feeding for 6 weeks, in which the concentration of Clostridium butyricum and yeast is 10 ^8 to 10^10 CFU/mL.

The compound composition of Clostridium butyricum, yeast and enzyme in experimental group 4 (0.42 g/kg body weight, N=8) was 3 times the recommended amount for human body, that is, 30 g/person/day (high dose, equivalent to 0.42g/kg body weight/ days), converted into hamsters (200g) is 0.54g/hamster/day (30×0.018=0.54g/hamster/day, equivalent to 0.0027g/g body weight/day). During the various evaluations of regulating serum lipid function, the rats were fed twice a day by nasogastric tube, 1 mL/hamster (0.27 g/mL) each time, and fed continuously for 6 weeks.

The evaluation of regulating serum lipid function lasted for 6 weeks in total. All experimental animals were measured every 2 weeks (Table 3), fasted for about 16 hours before blood collection, and serum biochemical functions (such as serum triglycerides (TG) were detected by orbital blood collection. , serum total cholesterol (Figure 1), serum high-density lipoprotein cholesterol (HDL) (Figure 3), serum low-density lipoprotein cholesterol (LDL)) (Table 2, Table 4 to Table 6, Figure 2). At the end of the 8th week, all experimental animals were sacrificed, and the livers were weighed and recorded (Table 7).

At the end of the 8th week, all experimental animals were tested for liver tissue lipids (including total cholesterol (TC), triglyceride (triglyceride; TG)]. The liver lipid content was analyzed with reference to the method published by Folch et al. in 1957. First, take 0.2g of the largest lobe of the lower right liver of the experimental animal, add 0.5mL of the extract (containing a mixed solution of chloroform and methanol at a volume ratio of 2:1), and use a commercially available homogenizer (model: Micromot IB/E, Proxxon , Germany) at a speed of 10,000 rpm for about 20 seconds, then add 1 mL of extract to rinse the residual tissue on the tube wall, and then add 3.5 mL of extract to obtain liver lipid extract. Take 250 μL of liver lipid extract and add 250 μL of Triton X-100 (Sigma) to mix evenly, then analyze the content of liver tissue lipid [total cholesterol (TC), triglyceride (triglyceride; TG)]. See Table 7 and Figure 4.

Relevant values are expressed as mean (mean) ± standard error (SEM; standard error of mean), and statistical analysis is performed using commercially available statistical software (such as SPAA version 10.0), and Mann-Whitney U test is used to test the difference between the two groups Condition. It is supplemented that since the number of samples in each group is less than 30, the Kruskal-Wallis H test was used to analyze the differences among the groups using nonparametric statistics.

Table 4

table 5

The results of Table 2 and Figure 1 show that compared with the normal group, the control The total cholesterol (TC) and LDL concentrations of the hamsters in the group and the two groups fed the composite composition of Clostridium butyricum, yeast and enzymes all increased significantly (p<0.05), but there was no significant difference between them, indicating hypercholesterolemia Indeed, the disease was successfully created.

The results in Table 3 show that after feeding 0.14 g/kg body weight and 0.42 g/kg body weight of Clostridium butyricum, yeast and enzyme composite composition for 4 to 6 weeks, the weight gain and food intake of the two groups of hamsters were significantly different from those of Compared with the control group, there was no significant difference.

The results in Table 4 show that after feeding 0.14 g/kg body weight and 0.42 g/kg body weight of Clostridium butyricum, yeast and enzyme composite composition for 6 weeks, the serum total cholesterol (TC) and serum LDL of the two groups of hamsters The concentration of cholesterol was significantly lower than that of the control group (p<0.05), but there was no significant difference in the concentrations of serum TG and serum HDL.

The results of Table 5 and Figure 2 to Figure 3 show that after feeding 0.14 g/kg body weight and 0.42 g/kg body weight of Clostridium butyricum, yeast and enzyme composite composition for 6 weeks, the serum total cholesterol of the two groups of hamsters The increase percentages of (TC) and serum LDL concentrations were significantly lower than those of the control group (p<0.05), but there were no statistically significant differences in the increase percentages of serum TG and serum HDL concentrations.

The results in Table 6 show that after feeding 0.14 g/kg body weight and 0.42 g/kg body weight of Clostridium butyricum, yeast and enzyme composite composition for 6 weeks, LDL/HDL or TC/HDL have no difference compared with the control group. Statistically significant difference.

The results in Table 7 and Figure 4 show that after feeding 0.14 g/kg body weight and 0.42 g/kg body weight of Clostridium butyricum, yeast and yeast After 6 weeks, the concentration of TC in the liver was significantly lower than that of the control group (p<0.05), but there was no statistically significant difference in the concentration of TG in the liver compared with the control group.

In summary, Example 2 proves that the composite composition of Clostridium butyricum, yeast and enzyme has the function of regulating serum lipids, and can be used as an active ingredient and applied to oral compositions.

Secondly, the composite composition of Clostridium butyricum, yeast and enzyme in experimental group 4 was adjusted at various doses such as low dose (0.07 g/kg body weight) or high dose (0.70 g/kg body weight) during serum lipid function assessment, or adjusted Low-dose (0.14 g/kg body weight) or high-dose (0.42 g/kg body weight) doses for serum lipid function assessment were administered orally to test animals (mice, hamsters, at least three times) using a nasogastric tube ), the experiment was carried out for 6 to 8 weeks, and did not cause death and adverse clinical signs. There were no significant dose-related changes in daily body weight gain, drinking water, feed consumption, morphology, behavioral activity, and organ tissue weight. The results of blood analysis and biochemical index detection showed that the composite composition of Clostridium butyricum, yeast and enzyme in feeding experimental group 4 had no significant difference from the comparative example or the control group, which proved that there was no obvious subchronic toxicity and met the food safety standard ( The figure is not shown), and the no-observed-adverse-effect-level (NOAEL) of the composite composition of Clostridium butyricum, yeast and enzyme in experimental group 4 was estimated to be 0.70 g/kg body weight/day.

In summary, it is confirmed by the above several examples that the complex composition of Clostridium butyricum, saccharomyces and enzyme of the present invention can reduce high Concentration of serum total cholesterol and LDL cholesterol in blood lipid test animals, inhibition of increase percentage of serum total cholesterol, LDL and triglyceride in hyperlipidemia test animals, reduction of liver cholesterol concentration, and for hyperlipidemia test animals, all present dosage And time-dependent (dose-and time-dependent) related protective effect, indeed has the function of regulating serum lipids, etc., and can be applied to the preparation of oral compositions or pharmaceutical compositions capable of regulating serum lipids.

What needs to be supplemented is that although the present invention uses a specific manufacturing process, a specific analysis method or a specific instrument as an example, it illustrates the composite composition of Clostridium butyricum, yeast and enzyme, the oral composition containing it and its use in regulating The application of serum lipids is known to anyone with common knowledge in the technical field of the present invention, and the present invention is not limited thereto. Without departing from the spirit and scope of the present invention, the compound composition of Clostridium butyricum, yeast and enzyme of the present invention The substance can also be performed using other processes, other analytical methods, or other instruments.

It can be seen from the above examples that the Clostridium butyricum, yeast and enzyme composite composition, the oral composition containing it and its application for regulating serum lipids of the present invention have the advantage of utilizing a specific ratio of Clostridium butyricum, at least one Yeast, lactic acid bacteria fermented soybean powder, at least one plant-derived enzyme, lecithin and other ingredients can be used as active ingredients to prepare oral or pharmaceutical compositions with the function of regulating serum lipids.

Although the present invention has been disclosed as above with several embodiments, it is not intended to limit the present invention. Anyone with ordinary knowledge in the technical field of the present invention can make various embodiments without departing from the spirit and scope of the present invention. Changes and retouching, so the protection scope of the present invention should be regarded as the appended patent application Those defined by the perimeter shall prevail.

【Biological Material Storage】 Domestic storage information

Clostridium butyricum ( Clostridium butyricum ) EC80 was deposited at the Biological Resource Preservation and Research Center of the Food Industry Development Institute, No. 331, Food Road, Hsinchu, Taiwan. The deposit date was February 15, 2019, and the deposit number was BCRC 910868.

Claims (9)

A composite composition of Clostridium butyricum, yeast and enzyme, including: Clostridium butyricum ( Clostridium butyricum ) EC80 of 20% to 32% by weight, and the Clostridium butyricum EC80 is deposited in Foodstuffs of the Republic of China Foundation, No. 331, Food Road, Hsinchu, Taiwan Industrial Development Institute Biological Resources Conservation and Research Center, the deposit date is February 15, 2019, and the deposit number is BCRC 910868; 20.4% to 25.6% by weight of at least one yeast, wherein the at least one yeast includes Saccharomyces cerevisiae ( Saccharomyces cerevisiae ) and/or selenium-enriched yeast; 20% by weight to 25% by weight of lactic acid bacteria fermented soybean powder, wherein the lactic acid bacteria fermented soybean powder is obtained from a soybean milk with Enterococcus spp. (Deposit number : BCRC 80605) fermented at a temperature of 30°C to 45°C for 5 to 24 hours, followed by a drying step; 20% to 25% by weight of at least one plant-derived enzyme, wherein the at least one plant The source of enzymes includes starch liquefying enzyme and/or bromelain; 2.4% to 3.6% by weight of lecithin; 1.6% by weight to 2.4% by weight of taurine; 0.4% by weight to 0.6% by weight of choline bitartrate; Inositol to 0.6 weight percent; and 2.8 to 4.2 weight percent lactose. The composite composition of Clostridium butyricum, yeast and enzyme as described in claim 1, wherein the composite composition of Clostridium butyricum EC80, the yeast and enzyme is 100% by weight, and the at least one yeast includes 20% by weight to 25% by weight of the beer yeast and/or 0.4% to 0.6% by weight of the selenium yeast. The composite composition of Clostridium butyricum, yeast and enzyme as described in claim 1, wherein the composite composition of Clostridium butyricum EC80, the yeast and enzyme is 100% by weight, and the enzyme of at least one plant source includes 12% by weight % to 18% by weight of the starch liquefying enzyme and/or 12% to 18% by weight of the bromelain, and the ratio of any two of the Clostridium butyricum EC80, the yeast and the enzyme composite composition is 2:1 to 1:2. An oral composition with the effect of regulating serum lipids, comprising the composite composition of Clostridium butyricum, yeast and enzyme as described in any one of the first to third items of the patent application scope, the Clostridium butyricum, the yeast and The enzyme complex composition is an active ingredient to be administered to an object via an intestinal route, wherein the Clostridium butyricum is Clostridium butyricum EC80 (BCRC 910868), the Clostridium butyricum EC80, yeast and enzyme complex composition One dosage is 0.07 grams to 0.70 grams per kilogram of body weight. The oral composition having the effect of regulating serum lipids according to claim 4, wherein the enteral administration route is an oral route. The oral composition having the effect of regulating serum lipids as described in Claim 4, wherein the subject is a human. The oral composition having the effect of regulating serum lipids as described in claim 4, wherein the subject is a hyperlipidemia experimental animal. The oral composition with the effect of regulating serum lipid as described in Claim 4, wherein the effect of regulating serum lipid includes reducing serum total cholesterol, reducing the concentration of LDL cholesterol and reducing the concentration of liver cholesterol. The oral composition with the effect of regulating serum lipid as described in Claim 4, wherein the effect of regulating serum lipid includes inhibiting the increase percentage of serum total cholesterol, LDL and triglyceride.

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