Composition, preparation method and use of the same in manufacture of a product for relieving thyroid nodules

Abstract

The present disclosure relates to the technical field of health care products and foodstuffs, in particular to a composition, a preparation method, and the use thereof in preparation of products for relieving thyroid nodules. The composition provided by the invention uses AtractylodisMacrocephalaeRhizoma and ChuanxiongRhizoma as raw materials, which show synergistic effect through rational combination. Experiments show that the composition provided by the invention can improve thyroid epithelial cell proliferation and reduce the thyroid index of thyroid nodules, and has the advantages of relieving thyroid nodules and protecting thyroid function. The invention has the advantages of simple combination, high safety, simple and easy handling and definite cure effect.

Claims

1. A method for relieving thyroid nodules comprising administrating an effective amount of a composition to a human subject in need thereof; wherein the composition is made from 10 to 100 parts by mass of Atractylodis Macrocephalae Rhizoma and 10 to 100 parts by mass of Chuanxiong Rhizoma, wherein Atractylodis Macrocephalae Rhizoma and Chuanxiong Rhizoma are used as the only active materials.

Description

BRIEF DESCRIPTION OF DRAWINGS

(1) FIG. 1 shows the thyroid index in each group of animals; *p<0.05, indicates significant difference with model group.

(2) FIG. 2 shows the proliferation of thyroid cells in each group of animals; *p<0.05, indicates significant difference with model group.

(3) FIG. 3 shows morphological changes of thyroid follicles after administration of the composition; wherein, FIG. 3-1 shows the volume of thyroid follicles in blank group; FIG. 3-2 shows the volume of thyroid follicles in model group; FIG. 3-3 shows the volume of thyroid follicles after administration of the composition prepared in Example 1.

DETAILED DESCRIPTION

(4) The present disclosure provides a composition and its preparation method and its use in manufacture of products for relieving thyroid nodules. Those skilled in the art can learn from the contents herein and improve the process parameters as appropriate. It is specifically to be noted that all similar substitutions and modifications will be apparent to those skilled in the art and are to be considered as included in the present disclosure. The method and application of the present disclosure have been described with reference to the preferred embodiments. Apparently, those skilled in the art can make modifications and changes to the methods and applications herein without departing from the content, spirit and scope of the present disclosure, to realize and use the present disclosure.

(5) The reagents and equipment used in the present disclosure are all commercially available in the market.

(6) The present disclosure is further illustrated with reference to the examples below.

EXAMPLE 1

(7) 1000 g water was added to 50 g Macrocephalae Rhizoma and 50 g Chuanxiong Rhizoma; the mixture was boiled and kept boiling (100 C.) for 2 h. Extraction solution was isolated and the filtration residue was collected. 1000 g water was added again to the residue, which was then boiled and kept boiling (100 C.) for 2 h. The two filtrates were combined and concentrated to 100 mL to obtain the extract.

EXAMPLE 2

(8) 1000 g water was added to 30 g Macrocephalae Rhizoma and 70 g Chuanxiong Rhizoma; the mixture was boiled and kept boiling (100 C.) for 2 h. Extraction solution was isolated and the filtration residue was collected. 1000 g water was added again to the residue, which was then boiled and kept boiling (100 C.) for 2 h. The two filtrates were combined and concentrated to 100 mL to obtain the extract.

EXAMPLE 3

(9) 1000 g water was added to 70 g Macrocephalae Rhizoma and 30 g Chuanxiong Rhizoma; the mixture was boiled and kept boiling (100 C.) for 2 h. Extraction solution was isolated and the filtration residue was collected. 1000 g water was added again to the residue, which was then boiled and kept boiling (100 C.) for 2 h. The two filtrates were combined and concentrated to 100 mL to obtain the extract.

EXAMPLE 4

(10) 1100 g water was added to 10 g Macrocephalae Rhizoma and 100 g Chuanxiong Rhizoma; the mixture was boiled and kept boiling (100 C.) for 2 h. Extraction solution was isolated and the filtration residue was collected. 1100 g water was added again to the residue, which was then boiled and kept boiling (100 C.) for 2 h. The two filtrates were combined and concentrated to 110 mL to obtain the extract.

EXAMPLE 5

(11) 1100 g water was added to 100 g Macrocephalae Rhizoma and 10 g Chuanxiong Rhizoma; the mixture was boiled and kept boiling (100 C.) for 2 h. Extraction solution was isolated and the filtration residue was collected. 1100 g water was added again to the residue, which was then boiled and kept boiling (100 C.) for 2 h. The two filtrates were combined and concentrated to 110 mL to obtain the extract.

Comparative Example 1

(12) 1100 g water was added to 5 g Macrocephalae Rhizoma and 110 g Chuanxiong Rhizoma; the mixture was boiled and kept boiling (100 C.) for 2 h. Extraction solution was isolated and the filtration residue was collected. 1100 g water was added again to the residue, which was then boiled and kept boiling (100 C.) for 2 h. The two filtrates were combined and concentrated to 110 mL to obtain the extract.

Comparative Example 2

(13) 1100 g water was added to 105 g Macrocephalae Rhizoma and 5 g Chuanxiong Rhizoma; the mixture was then boiled and kept boiling (100 C.) for 2 h. Extraction solution was isolated and the filtration residue was collected. 1100 g water was added again to the residue, which was then boiled and kept boiling (100 C.) for 2 h. The two filtrates were combined and concentrated to 110 mL to obtain the extract.

Comparative Example 3

(14) 1000 g water was added to 100 g Macrocephalae Rhizoma; the mixture was boiled and kept boiling (100 C.) for 2 h. Extraction solution was isolated and the filtration residue was collected. 1000 g water was added again to the residue, which was then boiled and kept boiling (100 C.) for 2 h. The two filtrates were combined and concentrated to 100 mL to obtain the extract.

Comparative Example 4

(15) 1000 g water was added to 100 g Chuanxiong Rhizoma; the mixture was boiled and kept boiling (100 C.) for 2 h. Extraction solution was isolated and the filtration residue was collected. 1000 g water was added again to the residue, which was then boiled and kept boiling (100 C.) for 2 h. The two filtrates were combined and concentrated to 100 mL to obtain the extract.

(16) Pharmacodynamics Study

(17) In order to verify the efficacy of the Chinese traditional medicine composition, extracts from Examples 1-5 and Comparative Examples 1-6 are subjected to efficacy test as follows: 1. Purpose

(18) Study the efficacy of a Chinese traditional medicine composition. 2. Materials 2.1 Samples

(19) The extracts from Examples 1-5 and Comparative Examples 1-6 2.2 Experimental Animals

(20) Healthy SD female rat, weigh 160180 g, SPF class. 3 Experimental Procedures 3.1 Model establishment and drug administration

(21) The rats were randomly divided into three groups: blank control group, model group, model group with extract from Example 1, Example 2, Example 3, Example 4, Example 5, Comparative Example 1, Comparative Example 2, Comparative Example 3, Comparative Example 4, Comparative Example 5 and Comparative Example 6, respectively. The blank control group was administered with the same amount of normal saline while other groups were administered intragastrically with 0.2% propylthiouracil (PTU) (0.5 ml/100 g body weight) once a day, for three consecutive weeks. After three weeks, the animals in each group were administrated with the corresponding drugs by gavage once a day for five consecutive weeks, meanwhile, PTU was added into drinking water to reach the maintenance dose. The model group was given PTU maintenance dose; the blank control group was given equal amount of distilled water. 3.2 Thyroid Weight

(22) The animals were sacrificed at the end of the administration. Thyroid tissues of which were isolated and weighed, and the thyroid index (thyroid/body weight (10.sup.3100%)) of each group was compared. 3.3 Proliferation of Thyroid Cells

(23) The expression of Ki-67 was detected by immunochemistry. Ten visual fields under high magnification were selected randomly, and the number of Ki-67 positive cells in 200 thyroid cells was counted in each field to compare the proliferation of thyroid cells (K-67 positive thyroid cells/total thyroid cells100%). 3.4 Pathological Examination

(24) The rats were sacrificed at the end of the administration. The thyroid tissues of which were isolated, fixed with 4% paraformaldehyde and subjected to paraffin embedding and sectioning for HE staining. 4. Results 4.1 Thyroid Index (see FIG. 1)

(25) The thyroid index in model group was significantly higher than the blank control group when comparing the thyroid index. The extracts (Examples 1-5 and Comparative examples 1-4) reduced the thyroid index to some extent in each group; extracts of Comparative Examples 1 to 4 have a significantly (p<0.05) lower efficacy than those of Examples 1 to 5. The rats administered with extracts of Examples 1 to 5 has significantly lower thyroid index, indicating that the extracts of Examples 1 to 5 remarkably relieved the formation of thyroid nodules, wherein the extract of Example 1 has the most prominent protective effect which is significantly (p<0.05) better than those of Examples 2 to 5. 4.2 Proliferation of Thyroid Cells

(26) The proliferation in model group was significantly higher than the blank control group when comparing proliferation of thyroid cells. The extracts (Examples 1-5 and Comparative examples 1-4) could reduce the proliferation to some extent in each group; however, extracts of Comparative examples 1 to 4 have minor protective effect which is significantly (p<0.05) less than those of Examples 1 to 5. The extract of Example 1 has the most prominent effect of inhibiting the proliferation of thyroid cells among those of Examples 1 to 5, which is significantly (p<0.05) higher than those of Examples 2 to 5. 4.3 Pathological Examination

(27) As shown in FIG. 3, under optic microscope (HE200), FIG. 3-1 shows that the thyroid follicles have a medium size and a round or oval shape, with full follicular cavities, rich in colloid. The follicular epithelial cells are in regular cubic shape and arranged into a single layer, without interstitial hyperplasia. FIG. 3-2 shows that the model group has more follicles while smaller cavities, and the colloid inside the cavities is reduced significantly or absent. The follicular epithelial cells have both hyperplasia and hypertrophy with irregular multi-layer arrangement. FIG. 3-3 shows that the hyperplasia of thyroid follicles in in rats administered with the extracts of Example 1 is alleviated significantly. The proliferation of cells in rats administered with the extracts of other Examples (Examples 2 to 5) was similar to that of Example 1, but none of the results is better than Example 1. The extracts of Comparative examples 1 to 4 have poor effect.

(28) The above are only the preferred embodiments of the present disclosure, and it should be noted that those skilled in the art may make some improvements and modifications without departing from the principle of the present disclosure, and these improvements and modifications should also be deemed within the scope of the present disclosure.