COMPOSITION FOR REDUCING WEIGHT AND LOWERING LIPID, PREPARATION METHOD THEREFOR AND USE THEREOF

Abstract

A composition for reducing weight and lowering lipid, a preparation method therefor, and a use thereof. The pharmaceutical composition comprises the following crude drugs: 18-65 parts by weight of phloridzin or pharmaceutically acceptable salts thereof; and 15-78 parts by weight of a turmeric extract. The pharmaceutical composition has the effects of weight reducing and lipid lowering, and the pharmaceutical composition has better effects of weight reducing and lipid lowering than a single crude drug.

Claims

1. A pharmaceutical composition, comprising the following crude drugs: 18 to 65 parts by weight of phloridzin or a pharmaceutically acceptable salt thereof, and 15 to 78 parts by weight of an extract from Curcuma longa L., based on the weight of phloridzin.

2. The pharmaceutical composition of claim 1, comprising the following crude drugs: 22 to 65 parts by weight of phloridzin or a pharmaceutically acceptable salt thereof; and 35 to 78 parts by weight of an extract from Curcuma longa L., based on the weight of phloridzin.

3. The pharmaceutical composition of claim 1 or 2, further comprising the following crude drugs: 21 to 45 parts by weight of epigallocatechin gallate or a pharmaceutically acceptable salt thereof, based on the weight of epigallocatechin gallate.

4. The pharmaceutical composition of claim 3, comprising the following crude drugs: 19 to 60 parts by weight of phloridzin or a pharmaceutically acceptable salt thereof; and 15 to 36 parts by weight of an extract from Curcuma longa L., based on the weight of phloridzin; and 25 to 45 parts by weight of epigallocatechin gallate or a pharmaceutically acceptable salt thereof, based on the weight of epigallocatechin gallate.

5. The pharmaceutical composition of claim 1 or 2, further comprising the following crude drugs: 20 to 59 parts by weight of an extract from sennae folium.

6. The pharmaceutical composition of claim 5, comprising the following crude drugs: 18 to 37 parts by weight of phloridzin or a pharmaceutically acceptable salt thereof, 23 to 30 parts by weight of an extract from Curcuma longa L., and 33 to 59 parts by weight of an extract from sennae folium, based on the weight of phloridzin.

7. The pharmaceutical composition of claim 1, further comprising the following crude drugs: 21 to 45 parts by weight of epigallocatechin gallate or a pharmaceutically acceptable salt thereof, and 20 to 59 parts by weight of an extract from sennae folium, based on the weight of epigallocatechin gallate.

8. The pharmaceutical composition of claim 7, comprising the following crude drugs: 20 to 24 parts by weight of phloridzin or a pharmaceutically acceptable salt thereof; and 33 to 41 parts by weight of an extract from Curcuma longa L., based on the weight of phloridzin, and 19 to 23 parts by weight of epigallocatechin gallate or a pharmaceutically acceptable salt thereof, and 18 to 22 parts by weight of an extract from sennae folium, based on the weight of epigallocatechin gallate.

9. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is used as an active ingredient and mixed with a conventional auxiliary material and prepared according to a conventional process into a pharmaceutical formulation in a clinically acceptable dosage form selected from the group consisting of tablets, capsules, powders, pills, granules, syrups, injections, solutions, mixtures, lotions, liniments, membranes, plasters, ointments, suppositories, pastes, gelatins, aerosols and sprays.

10. A medicament or health care product for reducing weight or lowering lipid, comprising the pharmaceutical composition of claim 1.

11. A method of reducing weight or lowering lipid, comprising administering the pharmaceutical composition of claim 1 to a subject in need.

12. The method of claim 11, wherein the pharmaceutical composition comprises the following crude drugs: 22 to 65 parts by weight of phloridzin or a pharmaceutically acceptable salt thereof; and 35 to 78 parts by weight of an extract from Curcuma longa L., based on the weight of phloridzin.

13. The method of claim 11, wherein the pharmaceutical composition further comprises the following crude drugs: 21 to 45 parts by weight of epigallocatechin gallate or a pharmaceutically acceptable salt thereof, based on the weight of epigallocatechin gallate.

14. The method of claim 13, wherein the pharmaceutical composition comprises the following crude drugs: 19 to 60 parts by weight of phloridzin or a pharmaceutically acceptable salt thereof; and 15 to 36 parts by weight of an extract from Curcuma longa L., based on the weight of phloridzin; and 25 to 45 parts by weight of epigallocatechin gallate or a pharmaceutically acceptable salt thereof, based on the weight of epigallocatechin gallate.

15. The method of claim 11, wherein the pharmaceutical composition further comprises the following crude drugs: 20 to 59 parts by weight of an extract from sennae folium.

16. The method of claim 15, wherein the pharmaceutical composition comprises the following crude drugs: 18 to 37 parts by weight of phloridzin or a pharmaceutically acceptable salt thereof, 23 to 30 parts by weight of an extract from Curcuma longa L., and 33 to 59 parts by weight of an extract from sennae folium, based on the weight of phloridzin.

17. The method of claim 11, wherein the pharmaceutical composition further comprises the following crude drugs: 21 to 45 parts by weight of epigallocatechin gallate or a pharmaceutically acceptable salt thereof, and 20 to 59 parts by weight of an extract from sennae folium, based on the weight of epigallocatechin gallate.

18. The method of claim 17, wherein the pharmaceutical composition comprises the following crude drugs: 20 to 24 parts by weight of phloridzin or a pharmaceutically acceptable salt thereof; and 33 to 41 parts by weight of an extract from Curcuma longa L., based on the weight of phloridzin, and 19 to 23 parts by weight of epigallocatechin gallate or a pharmaceutically acceptable salt thereof, and 18 to 22 parts by weight of an extract from sennae folium, based on the weight of epigallocatechin gallate.

19. The method of claim 11, wherein the pharmaceutical composition is administered at a dosage of 80 mg/kg.

20. The method of claim 19, wherein the pharmaceutical composition is administered once daily for 7 continuous weeks.

Description

DETAILED DESCRIPTION

[0057] Materials used in the following examples and experiment examples of the invention:

[0058] (1) Phloridzin, which is commercially available and has a purity of more than or equal to 98%.

[0059] (2) An extract from Curcuma longa L., which is prepared according to the following steps: collecting and pulverizing dried rhizomes of Curcuma longa L., extracting the rhizomes by heating under reflux for 2 times, each time extracting for 1 hour with an aqueous solution of ethanol having a volume concentration of 30% in an amount of 8 times the weight of the rhizomes, merging the resulted extraction solutions, followed by concentrating and drying.

[0060] (3) An extract from sennae folium, which is prepared according to the following steps: collecting and pulverizing dried sennae folium, extracting the sennae folium by heating under reflux for 2 times, each time extracting for 1 hour with an aqueous solution of ethanol having a volume concentration of 15% in an amount of 10 times the weight of the sennae folium, merging the resulted extraction solutions, followed by concentrating and drying.

Example 1

[0061] Provided is a pharmaceutical composition, comprising the following crude drugs: 65 g of phloridzin and 35 g of the extract from Curcuma longa L.

[0062] The pharmaceutical composition is prepared with a method comprising the following steps: respectively weighing out the above selected weight of phloridzin and the extract from Curcuma longa L., and mixing them well by grinding.

[0063] The pharmaceutical composition is mixed with a conventional auxiliary material and prepared into tablets according to a conventional process.

Example 2

[0064] Provided is a pharmaceutical composition, comprising the following crude drugs: 22 g of phloridzin and 78 g of the extract from Curcuma longa L.

[0065] The pharmaceutical composition is prepared with a method comprising the following steps: respectively weighing out the above selected weight of phloridzin and the extract from Curcuma longa L., and mixing them well by grinding.

[0066] The pharmaceutical composition is mixed with a conventional auxiliary material and prepared into capsules according to a conventional process.

Example 3

[0067] Provided is a pharmaceutical composition, comprising the following crude drugs: 45 g of phloridzin and 55 g of the extract from Curcuma longa L.

[0068] The pharmaceutical composition is prepared with a method comprising the following steps: respectively weighing out the above selected weight of phloridzin and the extract from Curcuma longa L., and mixing them well by grinding.

[0069] The pharmaceutical composition is mixed with a conventional auxiliary material and prepared into granules according to a conventional process.

Example 4

[0070] Provided is a pharmaceutical composition, comprising the following crude drugs: 60 g of phloridzin, 15 g of the extract from Curcuma longa L., and 25 g of epigallocatechin gallate.

[0071] The pharmaceutical composition is prepared with a method comprising the following steps: respectively weighing out the above selected weight of phloridzin, the extract from Curcuma longa L. and epigallocatechin gallate, and mixing them well by grinding.

[0072] The pharmaceutical composition is mixed with a conventional auxiliary material and prepared into tablets according to a conventional process.

Example 5

[0073] Provided is a pharmaceutical composition, comprising the following crude drugs: 19 g of phloridzin, 36 g of the extract from Curcuma longa L., and 45 g of epigallocatechin gallate.

[0074] The pharmaceutical composition is prepared with a method comprising the following steps: respectively weighing out the above selected weight of phloridzin, the extract from Curcuma longa L. and epigallocatechin gallate, and mixing them well by grinding.

[0075] The pharmaceutical composition is mixed with a conventional auxiliary material and prepared into granules according to a conventional process.

Example 6

[0076] Provided is a pharmaceutical composition, comprising the following crude drugs: 18 g of phloridzin, 23 g of the extract from Curcuma longa L., and 59 g of the extract from sennae folium.

[0077] The pharmaceutical composition is prepared with a method comprising the following steps: respectively weighing out the above selected weight of phloridzin, the extract from Curcuma longa L. and the extract from sennae folium, and mixing them well by grinding.

[0078] The pharmaceutical composition is mixed with a conventional auxiliary material and prepared into capsules according to a conventional process.

Example 7

[0079] Provided is a pharmaceutical composition, comprising the following crude drugs: 37 g of phloridzin, 30 g of the extract from Curcuma longa L., and 33 g of the extract from sennae folium.

[0080] The pharmaceutical composition is prepared with a method comprising the following steps: respectively weighing out the above selected weight of phloridzin, the extract from Curcuma longa L. and the extract from sennae folium, and mixing them well by grinding.

[0081] The pharmaceutical composition is mixed with a conventional auxiliary material and prepared into tablets according to a conventional process.

Example 8

[0082] Provided is a pharmaceutical composition, comprising the following crude drugs: 22 g of phloridzin, 37 g of the extract from Curcuma longa L., 21 g of epigallocatechin gallate, and 20 g of the extract from sennae folium.

[0083] The pharmaceutical composition is prepared with a method comprising the following steps: respectively weighing out the above selected weight of phloridzin, the extract from Curcuma longa L., epigallocatechin gallate, and the extract from sennae folium, and mixing them well by grinding.

[0084] The pharmaceutical composition is mixed with a conventional auxiliary material and prepared into tablets according to a conventional process.

Experiment Example 1: Study of Weight Reducing and Lipid Lowering Effect of Compositions of the Invention

1. Experimental Materials

[0085] Cholesterol and sodium cholate are purchased from Shanghai Great Wall Pharmaceutical Co., Ltd. (Shanghai, China).

[0086] The feed is commercially available. The high-fat feed comprises 75% base feed, 2% cholesterol, 0.5% sodium cholate, 15% lard, and 7.5% egg yolk. 150 male Spague-Dawlay (SD) Rats of clean grade, each aged 4 weeks and weighed 150-180 g, are provided by Shanghai Lingchang Biotechnology Co., Ltd. The rats are fed in separate plastic cages, given free access to water and feed for 7 days to adapt to the environment, and then quarantined.

2. Experimental Methods

[0087] 2.1 Grouping

[0088] 140 rats of similar weight are selected from the 150 rats, randomly divided into 14 groups, with 10 rats in each group, including experimental groups 1-8, comparative experiment groups 1-4, a model control group and a blank control group. Rats in the blank control group are fed with the base feed, and rats in other groups are fed with the high-fat feed.

[0089] 2.2 Administration Methods

[0090] Rats in the experimental groups 1-8 are respectively administered via lavage with 80 mg/kg of the pharmaceutical compositions prepared in Examples 1-8; rats in the comparative experiment groups 1-4 are respectively administered via lavage with 80 mg/kg of phloridzin, 80 mg/kg of the extract from Curcuma longa L., 80 mg/kg of epigallocatechin gallate and 80 mg/kg of the extract from sennae folium; and rats in the model control group and the blank control group are administered via lavage with equivalent amounts of saline.

[0091] Rats in each group receive administration once daily for 7 continuous weeks.

3. Testing and Processing of Experimental Data

[0092] 3.1 Testing Index

[0093] (1) After 7 weeks of administration, the weight and weight gain of rats in each group are observed and recorded;

[0094] (2) Rats are anesthetized with ether, and fat pads surrounding the genitalia and kidney and the fat of the omentum are separated and weighed. A fat-to-weight ratio is calculated according to the following equation:

fat-to-weight ratio (%)=(weight of fat surrounding the genitalia+weight of fat surrounding kidney+weight of fat of the omentum)/body weight100%;

[0095] (3) After 7 weeks of administration, blood are collected from orbital posterior venous plexus of the rats and analyzed with an enzymatic method on a full-automatic biochemical analyzer to quantitatively determine levels of triglycerides (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), and low density lipoprotein cholesterol (LDL-C) in serum.

[0096] 3.2 Statistical Analysis

[0097] Data processing is performed using SPSS 20.0 software. Differences between the groups are analyzed using a single-factor variance analysis.

4. Experimental Results

[0098] 4.1 Weight Reducing Results

[0099] After 7 weeks of administration, the weight gain and fat-to-weight ratio results of rats of each group are shown in Table 1.

TABLE-US-00001 TABLE 1 Body weight gain and fat-to-weight ratio of rats of each group (x s, n = 10) Body weight Fat-to-weight Groups gain (g) ratio (%) Blank Control Group 131.52 22.75 3.68 0.38 Model Control Group 197.11 17.43.sup.## 7.82 0.87.sup.## Experimental Group 1 141.55 19.98** 4.21 0.42** Experimental Group 2 142.37 20.06** 4.09 0.39** Experimental Group 3 145.33 20.67** 4.23 0.52** Experimental Group 4 149.47 18.96** 4.29 0.36** Experimental Group 5 142.51 19.51** 4.03 0.44** Experimental Group 6 148.89 20.04** 4.35 0.46** Experimental Group 7 147.39 18.28** 4.30 0.52** Experimental Group 8 152.33 20.37** 5.27 0.55* Comparative experiment 161.35 20.01* 5.87 0.72* Group 1 Comparative experiment 175.19 24.41 7.18 0.76 Group 2 Comparative experiment 189.76 22.25 7.48 0.53 Group 3 Comparative experiment 186.33 19.59 7.37 0.49 Group 4 Note: Compared with the blank control group, P.sup.## < 0.01, and compared with the model control group, P** < 0.01, and P* < 0.05.

[0100] Table 1 indicates that:

[0101] (1) After 7 weeks of administration, rats in the model control group exhibit very significant body weight gain and fat-to-weight (P<0.01) when compared with the blank control group, indicating obesity model is successfully established;

[0102] (2) Compared with the model control group, the weight gain of the rats in the experimental groups 1-8 is significantly reduced (P<0.01), which indicates that the pharmaceutical compositions prepared in Examples 1-8 can significantly reduce weight and slow weight gain;

[0103] (3) Compared with the model control group, the rats in the comparative experiment groups 1-4 have a tendency to reduce body weight, but the body weight reducing effect is not as significant as the body weight reducing effect in experimental groups 1-8.

[0104] 4.2 Blood Lipid Lowering Results

[0105] After 7 weeks of administration, experimental results of the blood biochemical parameters of rats of each group are shown in Table 2.

TABLE-US-00002 TABLE 2 Blood biochemical parameters of rats of each group (x s, n = 10) TG TC HDL-C LDL-C Groups (mmol/L) (mmol/L) (mmol/L) (mmol/L) Blank Control Group 1.21 0.39 1.78 0.36 0.69 0.11 0.29 0.08 Model Control Group 1.98 0.46.sup.## 2.65 0.47.sup.## 0.58 0.15 0.57 0.11.sup.## Experimental Group 1 1.43 0.37* 2.11 0.35* 0.71 0.12 0.41 0.11* Experimental Group 2 1.39 0.31* 2.08 0.40* 0.68 0.14 0.37 0.10** Experimental Group 3 1.41 0.29* 1.95 0.41** 0.72 0.13 0.33 0.09** Experimental Group 4 1.38 0.41* 1.91 0.33** 0.84 0.17 0.42 0.06* Experimental Group 5 1.29 0.38** 2.12 0.49* 0.70 0.08 0.37 0.08** Experimental Group 6 1.44 0.44* 1.92 0.53** 0.68 0.14 0.41 0.09* Experimental Group 7 1.50 0.51* 2.02 0.45* 0.77 0.09 0.43 0.12* Experimental Group 8 1.49 0.48* 2.05 0.51* 0.71 0.16 0.40 0.07* Comparative experiment 1.56 0.39* 2.21 0.51 0.72 0.10 0.49 0.10 Group 1 Comparative experiment 1.61 0.24 2.45 0.50 0.79 0.07 0.58 0.09 Group 2 Comparative experiment 1.77 0.41 2.55 0.43 0.59 0.12 0.55 0.12 Group 3 Comparative experiment 1.82 0.46 2.58 0.49 0.62 0.11 0.52 0.08 Group 4 Note: Compared with the blank control group, P.sup.## < 0.01, and compared with the model control group, P** < 0.01, and P* < 0.05.

[0106] Table 2 indicates that:

[0107] (1) After 7 weeks of administration, rats in the model control group exhibit very significant increase (P<0.01) in the blood biochemical parameters of TG, TC and LDL-C when compared with the blank control group, indicating hyperlipemia model is successfully established;

[0108] (2) Compared with the model control group, the reduction in the blood biochemical parameters of TG, TC, LDL-C of rats in the experimental groups 1-8 is significant or very significant (P<0.05 or P<0.01);

[0109] (3) Compared with the model control group, the reduction in the blood biochemical parameters of TG, TC, LDL-C of rats in the comparative experiment groups 1-4 is not significant.

5. Experimental Conclusions

[0110] (1) The pharmaceutical composition of the present invention has a remarkable weight-reducing effect which is significantly better than that of a single crude drug, showing a synergistic effect; and (2) the pharmaceutical composition of the present invention has a balanced reduction effect on the levels of TG, TC and LDL-C of the hyperlipemia rats, and the blood lipid reducing effect of the pharmaceutical composition is significantly better than that of a single crude drug, showing a synergistic effect.

[0111] It is to be understood that the above-described embodiments are merely illustrative of the embodiments and are not intended to be limiting of the embodiments. It will be apparent to one of ordinary skill in the art that other different forms of changes or variations can be made on the basis of the above description. The embodiments need not be exhaustive. It is to be understood that various changes or modifications may be made herein without departing from the scope of the invention as defined by the appended claims.