# US 2022/0031791 A1 · Traditional chinese medicine composition for treating metabolic syndrome and preparations thereof

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2022/0031791 A1
- Document ID: US20220031791A1
- Status: Published application
- Kind: A1
- Application number: 17/274,968
- Filed: 2019-09-17
- Published: 2022-02-03
- Earliest claimed: 2018-09-17
- Assignees: Jiangsu Jiuxu Haitian Pharmaceutical Co., Ltd.; Hong LI
- Applicants: Jiangsu Jiuxu Haitian Pharmaceutical Co., Ltd.
- Inventors: Ximing LIU; Hong LI
- Web page: https://patentgrep.com/patent/US20220031791A1

## CPC

- A61K 36/718: Coptis (goldthread)
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61K 31/366: having six-membered rings, e.g. delta-lactones
- A61K 31/4375: the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
- A61K 31/7048: having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin {, digitoxin or digoxin}
- A61K 36/062: Ascomycota
- A61K 36/428: Trichosanthes
- A61K 36/54: Lauraceae (Laurel family), e.g. cinnamon or sassafras
- A61K 36/752: Citrus, e.g. lime, orange or lemon
- A61K 36/8888: Pinellia
- A61K 36/899: Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
- A61P 3/06: Antihyperlipidemics
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Disclosed are a traditional Chinese medicine composition and a traditional Chinese medicine extract composition for treating metabolic syndrome. The traditional Chinese medicine composition consists of the following raw materials in the following weight ratio: 5-80% of Coptidis Rhizoma, 5-70% of Aurantii Fructus Immaturus, 0-60% of Pinelliae Rhizoma, 0-40% of Trichosanthis Fructus, 0-12% of Cinnamomi Cortex, and 10-60% of red yeast rice. The traditional Chinese medicine extract composition consists of the following raw materials in the following weight ratio: 2-30% of Coptidis Rhizoma extract, and 70-98% of a mixed extract from five traditional Chinese medicines comprising Aurantii Fructus Immaturus, Pinelliae Rhizoma, red yeast rice, Trichosanthis Fructus, and Cinnamomi Cortex. The traditional Chinese medicine composition or the traditional Chinese medicine extract composition contains the following active ingredients (mg/g): 6-122 mg/g of total alkaloids, which comprises 4-89 mg/g of berberine, 30-315 mg/g of total flavonoids, which comprises 20-186 mg/g of neohesperidin: and 0.5-9 mg/g of lovastatin. Further provided are preparation methods and applications of the above compositions.

## Claims

### Claim at position 1

1-5. (canceled)

### Claim 6

A traditional Chinese medicine composition, wherein the composition comprises Coptidis Rhizoma, Aurantii Fructus Immaturus, red yeast rice, and one or a plurality of optional selections from the group consisting of Pinelliae Rhizoma, Trichosanthis Fructus, and Cinnamomi Cortex, a daily administration dosage of the traditional Chinese medicine composition is 10-50 g, preferably 14-38 g.

### Claim 7 (depends on 6)

The traditional Chinese medicine composition according to claim 6, wherein the composition comprises 5-80 wt % of Coptidis Rhizoma, 5-70 wt % of Aurantii Fructus Immaturus, 0-60 wt % of Pinelliae Rhizoma, 0-40 wt % of Trichosanthis Fructus, 0-12 wt % of Cinnamomi Cortex, and 10-60 wt % of red yeast rice; preferably, the composition comprises 5-80 wt % of Coptidis Rhizoma, 5-70 wt % of Aurantii Fructus Immaturus, 10-60 wt % of Pinelliae Rhizoma, 5-40 wt % of Trichosanthis Fructus, 2-12 wt % of Cinnamomi Cortex, and 10-60 wt % of red yeast rice; more preferably, the composition comprises 10-30 wt % of Coptidis Rhizoma, 10-30 wt % of Aurantii Fructus Immaturus, 10-30 wt % of Pinelliae Rhizoma, 5-30 wt % of Trichosanthis Fructus, 2-10 wt % of Cinnamomi Cortex, and 12-36 wt % of red yeast rice; more preferably, a preferred ratio combination in the composition is as follows: 19.6 wt % of Coptidis Rhizoma, 19.6 wt % of Aurantii Fructus Immaturus, 19.6 wt % of Pinelliae Rhizoma, 26.1 wt % of Trichosanthis Fructus, 2.1 wt % of Cinnamomi Cortex, and 13.0 wt % of red yeast rice.

### Claim at position 4

8-18. (canceled)

### Claim 19

A traditional Chinese medicine extract composition, prepared by mixing extracts of Coptidis Rhizoma, Aurantii Fructus Immaturus, red yeast rice, and optional one or more selections from the group consisting of Pinelliae Rhizoma, Trichosanthis Fructus, and Cinnamomi Cortex, a daily administration dosage of the traditional Chinese medicine extract composition is 1-15 g, preferably 2-10 g.

### Claim 20 (depends on 19)

The traditional Chinese medicine extract composition according to claim 19, wherein the Coptidis Rhizoma extract accounts for 2-30%, preferably 3-25%, more preferably 5-15%, and the extracts of the remaining traditional Chinese medicinal materials account for 70-98%, preferably 75-97%, more preferably 85-95%.

### Claim 21 (depends on 19)

The traditional Chinese medicine extract composition according to claim 19, wherein the traditional Chinese medicine extract composition contains the following active ingredients (mg/g): 6-122 mg/g of total alkaloids, 30-315 mg/g of total flavonoids, and 0.5-9 mg/g of lovastatin, the total alkaloids comprise four alkaloids: berberine hydrochloride, jatrorrhizine hydrochloride, coptisine hydrochloride, and Barmartine hydrochloride, and the total flavonoids comprise three flavonoid glycosides: neohesperidin, hesperidin, and naringin; preferably, the traditional Chinese medicine extract composition contains the following active ingredients (mg/g): 6-122 mg/g of total alkaloids, which comprise 4-89 mg/g of berberine; 30-315 mg/g of total flavonoids, which comprise 20-186 mg/g of neohesperidin; and 0.5-9 mg/g of lovastatin.

### Claim at position 8

22-33. (canceled)

### Claim 34 (depends on 19)

A method for preparing the traditional Chinese medicine extract composition according to claim 19, wherein:
(a-1) Coptidis Rhizoma is extracted by using acid water, and filtration, concentration, alkali precipitation, salting-out, filtration, drying, pulverization are performed to prepare a total alkaloids extract of Coptidis Rhizoma;
(a-2) four medicinal materials consisting of: red yeast rice (10-100% of the prescribed dosage), Aurantii Fructus Immaturus, Pinelliae Rhizoma, and Cinnamomi Cortex, are extracted by using 50-90% ethanol, and filtration is performed;
(a-3) Trichosanthis Fructus is extracted by using 75-95% ethanol, a Trichosanthis Fructus extraction solution is merged with an extraction solution of the four traditional Chinese medicinal materials, decompression is performed to recover ethanol, concentration, drying, and pulverization are performed to prepare a mixed extract of five traditional Chinese medicinal materials consisting of: Aurantii Fructus Immaturus, Pinelliae Rhizoma, red yeast rice, Cinnamomi Cortex, and Trichosanthis Fructus; and
(a-4) the total alkaloids extract of Coptidis Rhizoma, the mixed extract of the five traditional Chinese medicinal materials, and red yeast rice fine powder (0-90% of the prescribed dosage) are well mixed to prepare the traditional Chinese medicine extract composition.

### Claim at position 10

35-41. (canceled)

### Claim 42 (depends on 19)

A pharmaceutical preparation, comprising the traditional Chinese medicine extract composition according to claim 19, wherein the pharmaceutical preparation comprises injections, tablets, capsules, granules, and oral liquids.

### Claim 43

(canceled)

### Claim 44 (depends on 19)

Use of the traditional Chinese medicine extract composition according to claim 19 in one or a plurality of the following indications or functions at an effective therapeutic dosage:
a. treating one or a plurality of the following: metabolic syndrome, obesity, hyperglycemia, hyperlipidemia, and hypertension;
b. treating one or a plurality of the following: disorder of blood glucose and lipid metabolism, obesity, hyperglycemia, hyperlipidemia, and hypertension, in the early stage of metabolic syndrome;
c. one or a plurality of the following: reducing blood glucose, reducing the hypoglycemic insulin level, improving oral glucose tolerance abnormality, reducing the glycated hemoglobin (HbAlc) level, increasing the insulin sensitivity index, improving insulin resistance, reducing the blood triglyceride level, reducing total cholesterol, and reducing the blood pressure; and
d. major functions: clearing heat, eliminating phlegm, and promoting qi circulation to relieve distension; and treating symptoms caused by the stagnation of phlegm-heat, such as obesity, enlarged abdomen, chest distress, excessive phlegm, inappetence and feeling of fullness in stomach and abdomen, dry mouth, thirst, polydipsia, and easy hunger, irritability, flushing and oily face, snoring at night, loose or dry stool, yellow urine, red tongue with yellow coating and slippery pulse.

### Claim 45

(canceled)

### Claim 46

(canceled)

### Claim 47 (depends on 6)

The traditional Chinese medicine composition according to claim 6, wherein the Aurantii Fructus Immaturus is preferably Aurantii Fructus Immaturus parched with bran, the Pinelliae Rhizoma is preferably Pinelliae Rhizoma Praeparatumcum Zingibere Et Alumine, and the Trichosanthis Fructus is preferably whole Trichosanthis Fructus.