AU2020104012A4 - Traditional Chinese Medicine Composition for Treating/Preventing Diabetes and Application Thereof - Google Patents

Traditional Chinese Medicine Composition for Treating/Preventing Diabetes and Application Thereof Download PDF

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AU2020104012A4
AU2020104012A4 AU2020104012A AU2020104012A AU2020104012A4 AU 2020104012 A4 AU2020104012 A4 AU 2020104012A4 AU 2020104012 A AU2020104012 A AU 2020104012A AU 2020104012 A AU2020104012 A AU 2020104012A AU 2020104012 A4 AU2020104012 A4 AU 2020104012A4
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group
parts
treating
diabetes
tcm
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AU2020104012A
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Tongxiang Lin
Xiangyi LIN
Yi Lin
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Fujian Agriculture and Forestry University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/90Smilacaceae (Catbrier family), e.g. greenbrier or sarsaparilla
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232Angelica
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00Preparations for use in therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Botany (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)

Abstract

The invention discloses a traditional Chinese medicine (TCM) composition for treating/preventing diabetes and application thereof, pertaining to the pharmacy and medical technical field. Specifically, the TCM composition comprises the following raw materials in parts by mass: 1-200 parts of Rhizoma Smilacis Glabrae, 1-30 parts of Astragalus membranaceus, 1-30 parts of Angelica sinensis (Oliv.) Diels, and 3-30 parts of Glycyrrhiza uralensis Fisch. With obvious hypoglycemic effect on diabetes, the TCM composition is suitable for patients with early diabetes or used as a general TCM composition to prevent the early occurrence of diabetes. Moreover, it can also be applied to auxiliary application of systematic treatment. -1/5 -0 G1- control group G2- model group< 30 G3- pre-administration group 2.G4- post-administration group, 28 26 S24 22. Week post dosing Figure -0- G0 - control group -O- G2- model group" e 4.0- -- 03- pre-administratione group b3 5 - - 4- post-admiistration group 3.0 2.0- r 0 6 9 12 16 20 23 26 Day post dosing Figure 2

Description

-1/5
-0 G1- control group
G2- model group<
30 G3- pre-administration group
2.G4- post-administration group, 28
26
S24
22. Week post dosing Figure
-0- G0 - control group
-O- G2- model group" e 4.0- -- 03- pre-administratione group b3 5 - - 4- post-admiistration group
3.0
2.0- r 0 6 9 12 16 20 23 26 Day post dosing
Figure 2
Traditional Chinese Medicine Composition for Treating/Preventing Diabetes and
Application Thereof
TECHNICAL FIELD
The invention relates to the technical field of pharmacy and medicine, in particular to a
TCM composition for treating/preventing diabetes and application thereof.
BACKGROUND
As a lifelong metabolic disease, diabetes mellitus is characterized by chronic
hyperglycemia, besides, it has extremely harm to human body, especially with high
incidence of various complications. Due to a long-term elevated blood sugar level, all
systems throughout the body are affected, including large and small blood vessels, heart,
brain, kidney, peripheral nerves, eyes, feet and so on. According to WHO statistics,
diabetes is currently known to be a disease with the most kinds of complications, more
than 100 complications. Continuous glucose and lipid metabolism disorder can lead to
many diseases in large and small blood vessels, microvessels, nerves and other systems,
resulting in abnormal tissue structure and function. Called "the source of all diseases" in
the medical field, diabetes endangers human health.
There are various kinds of hypoglycemic drugs in the market. However, most of the
hypoglycemic drugs are chemosynthesis or biosynthesis, with obvious hypoglycemic
effect as well as many side effects. In recent years, it has become a hot topic to extract
effective components from natural products for the prevention and treatment of diabetes.
Therefore, it is a great development trend to find high-efficiency, low-toxicity, cheap
natural medicines and health foods from the resourceful traditional Chinese medicines.
SUMMARY
The purpose of the present invention is to provide a TCM composition for
treating/preventing diabetes and its application, so as to solve the problems existing in the
prior art and achieve a good hypoglycemic effect.
To achieve the above purpose, the present invention provides the following scheme.
On one hand, the invention provides a TCM composition for treating/preventing diabetes,
which includes the following raw materials in parts by mass: 1-200 parts of Rhizoma
Smilacis Glabrae, 1-30 parts of Astragalus membranaceus, 1-30 parts of Angelica
sinensis.
Further, it comprising Glycyrrhiza uralensis in 3-30 parts by mass.
The TCM composition further contains its own comminuted powder and
pharmaceutically acceptable carriers.
Furthermore, it is decoction piece and / or an extractive of decoction pieces.
Further, the extractive of decoction pieces includes a combination of water extract and/
or alcohol extract.
The invention also indicates the application of the TCM composition in preparing
medicines for preventing and/or treating diabetes.
The following technical effects are disclosed by the present invention.
The TCM composition provided by the invention has no obvious influence on the weight
of mice, and their food intake. After the drug administration lasted for 3 weeks, the blood sugar of the normal blank control group remained basically the same and that of the disease model control group continued to rise, while the TCM group achieved obvious hypoglycemic effect, which was more remarkable than that of the traditional hypoglycemic health care product royal jelly. In conclusion, the TCM composition of the invention has the effect of auxiliary prevention and treatment of diabetes.
BRIEF DESCRIPTION OF THE FIGURES
In order to explain the embodiments of the present invention or the technical scheme in
the prior art more clearly, the figures needed in the embodiments will be briefly
introduced below. Obviously, the figures in the following description are only some
embodiments of the present invention, and for ordinary technicians in the field, other
figures can be obtained according to these figures without paying creative labor.
Figure is a detection chart of mice weight in each group of effect verification example 1.
(Note: the abscissa unit is: week/week).
Figure 2 is a detection chart of food intake of mice in each group of effect verification
example 1. (Note: the abscissa unit is: day/day).
Figure 3 is a blood glucose detection chart of mice in Day group of effect verification
example 1.
Figure 4 is a blood glucose detection chart of mice in Day26 group of effect verification
example 1.
Figure 5 is a detection chart of mice weight in each group of effect verification example
2.
Figure 6 is a detection chart of food intake of mice in each group of effect verification
example 2.
Figure 7 is a blood glucose detection chart of mice in each group before administration in
effect verification example 2.
Figure 8 is a blood glucose detection chart of mice in each group of effect verification
example 2 after administration for 1 week.
Figure 9 is a blood glucose detection chart of mice in each group of effect verification
example 2 after administration for 2 weeks.
Figure 10 is a blood glucose detection chart of mice in each group of effect verification
example 2 after administration for 3 weeks.
DESCRIPTION OF THE INVENTION
Various exemplary embodiments of the present invention will now be described in detail,
which should not be regarded as a limitation of the present invention, but rather as a more
detailed description of certain aspects, characteristics and embodiments of the present
invention.
It should be understood that the terms described in the present invention are only for
describing specific embodiments, and are not intended to limit the present invention. In
addition, as for the numerical range in the present invention, it should be understood that
every intermediate value between the upper limit and the lower limit of the range is also
specifically disclosed. Intermediate values within any stated value or stated range and
every smaller range between any other stated value or intermediate values within the stated range are also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded from the range.
Unless otherwise stated, all technical and scientific terms used herein have the same
meanings as commonly understood by those technicists in the art to which the present
invention relates. Although the present invention only describes preferred methods and
materials, any methods and materials similar or equivalent to those described herein may
be used in the practice or testing of the present invention. All documents mentioned in
this specification are incorporated by reference to disclose and describe methods and/or
materials related to the documents. In case of conflict with any incorporated documents,
the contents of this specification shall prevail.
Without departing from the scope or spirit of the invention, it is obvious to those
technicists in the art that many modifications and changes can be made to the specific
embodiments of the specification of the invention. Other embodiments derived from the
description of the present invention will be apparent to the technicists. The specification
and embodiments of this application are only exemplary.
As used herein, "comprising", "including", "having", "containing", etc., are all open
terms, which means including but not limited to.
Unless otherwise specified, "parts" mentioned in the present invention are calculated by
mass parts.
Embodiment 1
In this embodiment, the TCM composition for treating/preventing diabetes comprised the
following raw materials in parts by mass.
200 parts of Rhizoma Smilacis Glabrae, 1 part of Astragalus membranaceus, 1 part of
Angelica sinensis and 3 parts of Glycyrrhiza uralensis.
Embodiment 2
In this embodiment, the TCM composition for treating/preventing diabetes comprised the
following raw materials in parts by mass.
1 part of Rhizoma Smilacis Glabrae, 30 parts of Astragalus membranaceus, 30 part of
Angelica sinensis and 30 parts of Glycyrrhiza uralensis.
Embodiment 3
In this embodiment, the TCM composition for treating/preventing diabetes comprised the
following raw materials in parts by mass.
200 parts of Rhizoma Smilacis Glabrae, 3 parts of Astragalus membranaceus and 1 part
of Angelica sinensis.
Embodiment 4
In this embodiment, the TCM composition for treating/preventing diabetes comprised the
following raw materials in parts by mass.
1 part of Rhizoma Smilacis Glabrae, 1 part of Astragalus propinquu and 30 parts of
Angelica sinensi.
Embodiment 5
In this embodiment, the TCM composition for treating/preventing diabetes comprised the
following raw materials in parts by mass.
6 parts of Rhizoma Smilacis Glabrae, 1 part of Astragalus membranaceus and 1 part of
Angelica sinensis.
I. Effect Verification Example 1
1. Experimental animals: 72 C57BL male mice aged 7-8W, totally 4 groups with 12 mice
in each group.
(1) G1- control group, G2- model group, G3- pre-administration group, G4- post
administration group.
GI was the normal blank control group, that was, mice, without diabetes and STZ
injection induction, were given normal saline by gavage at the dosage of 10ml/kg.
G2 was STZ-induced diabetic mice. Wherein, intragastric administration was carried out
with normal saline at a dosage of 10ml/kg.
G3 was STZ induced diabetic mice, pre-administered with TCM. The water extract of the
TCM composition of Embodiment 1 (the concentration of the water extract is 3g/kg) was
used for intragastric administration at the dosage od 10ml/kg.
G4 was STZ induced diabetic mice, with TCM given later. The water extract of the TCM
composition of Embodiment 1 (the concentration of the water extract is 3g/kg) was used
for intragastric administration, and the dosage was 10ml/kg.
(2) Mice were intragastric administration every day for two to three weeks.
(3) The first administration time of pre-administration was 4 hours before Dayl STZ
injection, and the first administration time of post-administration was from Day6.
Weight: all mice were weighed once a day.
Food intake: the 24-hour food intake of mice was measured twice every Tuesday and
Friday.
From Day7 to Day, 7-week-old mice adapted to feeding for 7 days to adapt to the
environment.
On Dayl, STZ induced diabetes. 12 mice were fasted for 12 hours.
The STZ used in this invention was purchased from Sigma (SO130), and dissolved with
the sodium citrate solution with pH 4.5, to be uses right after it was ready and used up
within 15 minutes after dissolution. IP intraperitoneal injection with STZ dose of
mg/kg was kept for 5 days (fasting for 4 hours in the last four days). Blood glucose
was measured on Day26 to evaluate the modeling and efficacy.
2. Experimental results
a. Weight
The weight test results are shown in fig.1.
Results Analysis: the weight test showed that the drugs had no obvious effect on the
weight of mice.
b. Food Intake Results
The food intake test results are shown in fig.2.
Results Analysis: the food intake test showed that the drugs had no obvious effect on the
food intake of mice.
c. Blood Sugar Results
The blood glucose detection results of DayO and Day26 are shown in fig.3 and fig.4
respectively.
3. Result Analysis
Comparing the blood glucose test results of DayO and Day26, it can be seen that the
blood glucose of the blank normal control group remained basically the same after
continuous administration for 3 weeks, and the blood glucose of each administration
group showed different degrees of decline compared with the model control group, which
indicated that the Chinese medicinal composition had hypoglycemic effect.
II. Effect Verification Example 2
1. Experimental Animal Information
T002407 BKS-DB48gKO/KO, 13gWT/WT, birthday at March 25th, 2019.
2. Experimental Equipment and Materials
Blood biochemical analyzer (HITACHI 7020, Japan Care Co., Ltd. Japan)
Japan WAKO imported matching reagents
3. Experimental Scheme
3.1 Demand of donor mice: 10 BKS blank normal control male mice aged 7-8w; 30 type
II diabetes mellitus model (db/db) male mice aged 7-8w.
3.2 Experimental Grouping
Group Medicament Number of animals Admistration
lean PBS 10 PO
Vehicle PBS 10 PO
db/db- Royal Jelly Royal Jelly 10 PO
db/db- TCM TCM 10 PO (Note: lean represents male mice in BKS blank normal control group, that is, male mice
without diabetes; Vehicle represents the male rats of type II diabetes model control
group. )
In the lean group, each mouse weighing about 25g was intragastrically administered with
PBS solution, with the volume of 400ul/per mouse, once a day for 3 weeks.
In the Vehicle group, each mouse weighing about 40g was intragastrically administered
with PBS solution, with the volume of 400ul/per mouse, once a day for 3 weeks.
In the db/db- TCM group, every 10 mice weighing about 40g were fed with a mixture of
TCM water extracts equivalent to 6g of Rhizoma Smilacis Glabrae, Ig of Angelica
sinensis and Ig of Astragalusmembranaceus, once a day for 3 weeks.
In db/db- royal jelly group, every 10 mice weighing about 40g were fed with 0.72g of
royal jelly freeze-dried powder and the dosage volume was 200ul/ per mouse, once a day
for 3 weeks.
3.3 Experimental Contents and Detection Indexes
(1) Weight: all mice were weighed once a day.
(2) Food intake: the 24-hour food intake of mice was measured twice every Tuesday and
Friday.
(3) Random blood glucose: the random blood glucose of mice in each group was detected
once a week.
4. Experimental Results
4.1 The weight test results are shown in fig.5.
Results Analysis: the weight test showed that the weight growth trend of each
administration group was consistent with that of diabetes model control group.
4.2 Food Intake Results
The food intake test results were shown in fig.6.
Results Analysis: the food intake test showed that the trend of food intake level of each
administration group was consistent with that of diabetes model control group.
4.3 Blood Glucose Results
The blood glucose test results are shown in figs.7-10.
4.4 Result Analysis
The weekly random blood glucose test indicated that the blood glucose of each
administration group showed a decreasing trend in different degrees compared with the
diabetes model control group after 3 weeks of administration. There was no significant
difference between the diabetic model control group and the royal jelly and TCM group
after 0 week and 1 week administration. However, the blood glucose levels of royal jelly
group and TCM group after 2 weeks administration were lower than that of diabetic
model control group, and the TCM group had significant difference (*P < 0.05).
Compared with the diabetic model control group, the royal jelly and TCM groups showed
a downward trend after 3 weeks administration, among which the TCM group had a
much significant difference (****P<0.0001) and the royal jelly group had a significant
difference (*P<0.05).
5. Conclusion
5.1 Weight
Compared with the diabetes model control group, the weight growth trend of each
administration group was consistent, and the drugs had no obvious effect on the weight of
mice.
5.2 Food intake
Compared with the control group of diabetes model, the trend of food intake in each
administration group was consistent, and the drugs had no obvious effect on the food
intake of mice.
5.3 Blood Sugar
After three weeks of administration, the blood glucose of the blank normal control group
remained basically the same, while that of the diabetes model control group continued to rise, while that of the royal jelly group and the TCM group decreased, which indicated that the TCM composition had hypoglycemic effect.
The above embodiments only describe the preferred mode of the invention, but do not
limit the scope of the invention. On the premise of not departing from the design spirit of
the invention, various modifications and improvements made by ordinary technicians in
the field to the technical scheme of the invention shall fall within the protection scope
determined by the claims of the invention.

Claims (6)

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:
1. A TCM composition for treating/preventing diabetes is characterized by including the
following raw materials in parts by mass: 1-200 parts of Rhizoma Smilacis Glabrae, 1-30
parts of Astragalus membranaceus, 1-30 parts of Angelica sinensis.
2. The TCM composition for treating/preventing diabetes according to claim 1, is
characterized by further comprising Glycyrrhiza uralensis in 3-30 parts by mass.
3. The TCM composition for treating/preventing diabetes according to claim 1 or claim 2,
is characterized by containing its own comminuted powder and pharmaceutically
acceptable carriers.
4. The TCM composition for treating/preventing diabetes according to claim 3, is
characterized in that it is decoction piece and / or an extractive of decoction piece.
5. The TCM composition for treating/preventing diabetes according to claim 4, is
characterized in that the extractive of decoction pieces includes a combination of water
extract and / or alcohol extract.
6. Application of the TCM composition for treating/preventing diabetes based on any one
of claims 1-5 in preparing medicines for preventing and/or treating diabetes.
-1/5-
Figure1
Figure 2
-2/5- 11 Dec 2020 2020104012
Figure 3
Figure 4
-3/5- 11 Dec 2020 2020104012
Figure 5
Figure 6
-4/5- 11 Dec 2020 2020104012
Figure 7
Figure 8
-5/5- 11 Dec 2020 2020104012
Figure 9
Figure 10
AU2020104012A 2020-12-11 2020-12-11 Traditional Chinese Medicine Composition for Treating/Preventing Diabetes and Application Thereof Ceased AU2020104012A4 (en)

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Application Number Priority Date Filing Date Title
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Application Number Priority Date Filing Date Title
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Publications (1)

Publication Number Publication Date
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