Medicament for treating pulmonary tuberculosis

10772933 ยท 2020-09-15

Assignee

Inventors

Cpc classification

International classification

Abstract

A medicament for use in treating tuberculosis, the medicament is a glycoprotein, a mixture of polysaccharide and protein, a polypeptide or a protein.

Claims

1. A medicament for use in treating tuberculosis, comprising: a marine algae glycoprotein, indigo naturalis, dioscorea nipponica, and glucuronic acid in a ratio of 1:5:6:1 by weight, wherein, the marine algae glycoprotein is obtained from Nostoc flagelliforme, and comprises 26% saccharide and 74% protein by weight with a molecular weight of 8 kDa.

Description

DETAILED DESCRIPTION OF THE EMBODIMENTS

(1) The preferred embodiments of the present invention will be illustrated below, and the preferred embodiments described herein are merely intended to illustrate and explain the invention, but not limited to this invention.

Embodiment 1

(2) A Medicament for Use in Treating Tuberculosis

(3) Wherein the medicament is a marine algal glycoprotein;

(4) the marine algal glycoprotein comprises 1% saccharide and 99% protein by weight;

(5) the molecular weight is 0.2 kDa;

(6) the marine algae is blue-green algae;

(7) the saccharide is a polysaccharide;

(8) the polysaccharide comprises xylose, fucose, arabinose, glucose, galactose, mannose, and rhamnose;

(9) the protein comprises asparaginate, cysteine, lysine, arginine, serine, and threonine.

Embodiment 2

(10) A Medicament for Use in Treating Tuberculosis

(11) Wherein the medicament is a marine algal glycoprotein;

(12) the marine algal glycoprotein comprises 6% saccharide and 85% protein by weight;

(13) the molecular weight is 25 kDa;

(14) the marine algae is blue-green algae;

(15) the saccharide is a polysaccharide;

(16) the polysaccharide comprises xylose, fucose, arabinose, glucose, galactose, mannose, and rhamnose;

(17) the protein comprises asparaginate, cysteine, lysine, arginine, serine, and threonine.

Embodiment 3

(18) A Medicament for Use in Treating Tuberculosis

(19) Wherein the medicament is a marine algal glycoprotein;

(20) the marine algal glycoprotein comprises 31% saccharide and 64% protein by weight;

(21) the molecular weight is 3 kDa;

(22) the marine algae is blue-green algae;

(23) the saccharide is a polysaccharide;

(24) the polysaccharide comprises xylose, fucose, arabinose, glucose, galactose, mannose, and rhamnose;

(25) the protein comprises asparaginate, cysteine, lysine, arginine, serine, and threonine.

Embodiment 4

(26) A Medicament for Use in Treating Tuberculosis

(27) Wherein the medicament is a marine algal glycoprotein;

(28) the marine algal glycoprotein comprises 55% saccharide and 40% protein by weight;

(29) the molecular weight is 94 kDa;

(30) the marine algae is red algae;

(31) the saccharide is a polysaccharide;

(32) the polysaccharide comprises xylose, fucose, arabinose, glucose, galactose, mannose, and rhamnose;

(33) the protein comprises asparaginate, cysteine, lysine, arginine, serine, and threonine.

Embodiment 5

(34) A Medicament for Use in Treating Tuberculosis

(35) Wherein the medicament is a marine algal glycoprotein;

(36) the marine algal glycoprotein comprises 71% saccharide and 23% protein by weight;

(37) the molecular weight is 150 kDa;

(38) the marine algae is brown algae;

(39) the saccharide is a polysaccharide;

(40) the polysaccharide comprises xylose, fucose, arabinose, glucose, galactose, mannose, and rhamnose;

(41) the protein comprises asparaginate, cysteine, lysine, arginine, serine, and threonine.

Embodiment 6

(42) A Medicament for Use in Treating Tuberculosis

(43) Wherein the medicament is a marine algal glycoprotein;

(44) the marine algal glycoprotein comprises 99% saccharide and 1% protein by weight;

(45) the molecular weight is 3000 kDa;

(46) the marine algae is gold algae;

(47) the saccharide is a polysaccharide;

(48) the polysaccharide comprises xylose, fucose, arabinose, glucose, galactose, mannose, and rhamnose;

(49) the protein comprises asparaginate, cysteine, lysine, arginine, serine, and threonine.

(50) The glycoprotein as described in the above Embodiments 1-6 further includes a pigment; the pigment is a natural pigment contained in an algal substances.

(51) The above Embodiments 1-6 could be summarized as:

(52) A Medicament for Use in Treating Tuberculosis

(53) Wherein the medicament is a glycoprotein;

(54) the glycoprotein comprises, by weight, 1%-99% of saccharide and 1%-99% of protein;

(55) the molecular weight of the glycoprotein is 0.2-30000 kDa;

(56) the saccharide is a polysaccharide;

(57) the medicament comprises synthetic glycoprotein, synthetic polysaccharide and synthetic protein.

(58) The protein comprises 20 kinds of amino acids and 8 kinds of synthetic amino acids.

(59) The preparation method of the medicament: the glycoprotein is prepared into capsules and tablets etc. according to a conventional process; the mixture of the polysaccharide and the protein is prepared into capsules and tablets etc. according to a conventional process.

Embodiment 7

(60) Application of the Medicament in the Treatment of Tuberculosis

(61) An experimental method comprises the following steps: selecting mice, disinfecting the tails by using 75% alcohol, intravenously injecting 0.2 ml of 5 mg/ml Mycobacterium Tuberculosis suspension into each mouse, compressing the puncture positions for stopping bleeding 1 minute after injection, observing for one day after animal modeling, and if there was pale swelling in the tails of the mice or the tails had local necrosis and fell off, indicating that the liquid was not completely injected into the blood vessels of the tails of the mice and sacrificing such mice; finally, selecting satisfactory mice and randomly dividing the mice into groups, 12 mice in each group, including a model control group, and groups 1-6 of the present invention; additionally, randomly selecting 12 mice as blank control group.

(62) Administration was performed on the second day after modeling. The groups of the present invention were provided with the medicament as described in examples 1-6 of the present invention at the dose of 3 g/day, three times a day, by means of intragastric administration continuously for 28 days. The blank control group and the model control group were intragastrically provided with normal saline of the same volume. Various indexes were measured 3 months days after the administration.
Organ index=organ weight/mouse weight

(63) TABLE-US-00001 TABLE 1 Therapeutic effects after three months Sputum Focus Number of Number of negative absorp- Cavity bacterial bacterial conver- tion closure colonies colonies sion rate rate rate in lungs in spleens (%) (%) (%) (10.sup.4CFU) (10.sup.4CFU) Model 123.5 5.98 control group Embodiment 80.2 60.3 62.5 82.3 3.68 1 Embodiment 85.6 68.9 66.8 62.3 2.98 2 Embodiment 90.6 73.2 73.4 52.6 2.43 3 Embodiment 86.6 70.3 71.2 63.4 2.65 4 Embodiment 83.8 69.1 68.4 72.9 2.71 5 Embodiment 81.6 62.3 63.4 80.9 3.26 6

(64) The medicament of the present invention has a good treatment effect on tuberculosis. The sputum negative conversion rate of 80.2-90.6%, the focus absorption rate of 60.3-73.2%, and the cavity closure rate of 62.5-73.4% has been achieved. The number of bacterial colonies in lungs and spleens could be reduced.

(65) The number of bacterial colonies in lungs could be 19.510.sup.4 CFU, and the number of the bacterial colonies in spleens could be 0.810.sup.4 CFU.

(66) TABLE-US-00002 TABLE 2 Effects of the medicament of the present invention on the T lymphocytes CD4 + T, the thymic weight index and the cytokines IFN- of mice CD4 + Thymic weight IFN- T/L index ng/mL Blank control 41.57 5.68 0.323 0.040 121.85 14.2 group Model control 24.56 8.59 0.205 0.052 65.21 10.42 group Embodiment 1 27.52 7.56 0.225 0.043 67.58 11.26 Embodiment 2 29.56 6.89 0.236 0.056 69.25 10.89 Embodiment 3 30.25 7.23 0.246 0.052 69.89 11.36 Embodiment 4 28.12 6.59 0.240 0.048 69.06 12.56 Embodiment 5 28.43 6.45 0.232 0.053 68.23 12.65 Embodiment 6 28.00 7.02 0.228 0.049 67.69 12.05

(67) The medicament of the present invention can increase the number of T lymphocytes CD4+T of mice, increase the thymus index of mice and increase the content of IFN- of multi-drug resistant tuberculosis mice. IFN- is the key of effective antibacterial immunity, which attract and gather monocytes/macrophagocytes to enhance its effect of killing the multi-drug resistant Mycobacterium Tuberculosis. The number of CD4+T could be 27.52-30.25/L and the thymic weight index could be 0.225-0.246. In addition, the content of IFN- could be 67.58-69.89 ng/mL.

Embodiment 8

(68) A Medicament for Use in Treating Tuberculosis

(69) The medicament comprises, by weight, 1 portion of marine algal glycoprotein and 1 portion of glucuronic acid.

(70) The marine algal glycoprotein comprises 11% saccharide and 85% protein by weight;

(71) the molecular weight is 8 kDa;

(72) the marine algae is spirulina;

(73) the saccharide is a polysaccharide;

(74) the polysaccharide comprises xylose, fucose, arabinose, glucose, galactose, mannose, and rhamnose;

(75) the protein comprises asparaginate, cysteine, lysine, arginine, serine, and threonine.

Embodiment 9

(76) A Medicament for Use in Treating Tuberculosis

(77) Similar to Embodiment 8, only the proportions of the marine algal glycoprotein and the glucuronic acid by weight are changed as follows:

(78) the medicament comprises, by weight, 36 portions of marine algal glycoprotein and 7 portions of glucuronic acid.

Embodiment 10

(79) A Medicament for Use in Treating Tuberculosis

(80) Similar to Embodiment 8, only the proportions of the marine algal glycoprotein and the glucuronic acid by weight are changed as follows:

(81) the medicament comprises, by weight, 68 portions of marine algal glycoprotein and 13 portions of glucuronic acid.

Embodiment 11

(82) A Medicament for Use in Treating Tuberculosis

(83) Similar to Embodiment 8, only the proportions of the marine algal glycoprotein and the glucuronic acid by weight are changed as follows:

(84) the medicament comprises, by weight, 99 portions of marine algal glycoprotein and 27 portions of glucuronic acid.

Embodiment 12

(85) A Medicament for Use in Treating Tuberculosis

(86) The medicament comprises, by weight, 1 portion of marine algal glycoprotein, 1 portion of glucuronic acid and 2 portions of indigo naturalis;

(87) the marine algal glycoprotein comprises 23% saccharide and 79% protein by weight;

(88) the molecular weight of the marine algal glycoprotein is 12 kDa;

(89) the marine algae is chlorella;

(90) the saccharide is a polysaccharide;

(91) the polysaccharide comprises xylose, fucose, arabinose, glucose, galactose, mannose, and rhamnose;

(92) the protein comprises asparaginate, cysteine, lysine, arginine, serine, and threonine.

Embodiment 13

(93) A Medicament for Use in Treating Tuberculosis

(94) Similar to Embodiment 2, only the proportions of the marine algal glycoprotein, the glucuronic acid and indigo naturalis by weight are changed as follows:

(95) the medicament comprises, by weight, 34 portions of marine algal glycoprotein, 10 portions of glucuronic acid and 5 portions of indigo naturalis.

Embodiment 14

(96) A Medicament for Use in Treating Tuberculosis

(97) Similar to Embodiment 12, only the proportions of the marine algal glycoprotein, the glucuronic acid and indigo naturalis by weight are changed as follows:

(98) the medicament comprises, by weight, 58 portions of marine algal glycoprotein, 22 portions of glucuronic acid and 9 portions of indigo naturalis.

Embodiment 15

(99) A Medicament for Use in Treating Tuberculosis

(100) Similar to Embodiment 12, only the proportions of the marine algal glycoprotein, the glucuronic acid and indigo naturalis by weight are changed as follows:

(101) the medicament comprises, by weight, 99 portions of marine algal glycoprotein, 31 portions of glucuronic acid and 11 portions of indigo naturalis.

(102) Application of the Medicament as Described in the Above Embodiment 8 to Embodiment 15 in the Treatment of Tuberculosis:

(103) Using the test method of Embodiment 7, the medicament of Embodiment 8-Embodiment 15 in this invention groups have the following application effects:

(104) TABLE-US-00003 TABLE 3 Therapeutic effects after three months Sputum Focus Number of Number of negative absorp- Cavity bacterial bacterial conver- tion closure colonies colonies sion rate rate rate in lungs in spleens (%) (%) (%) (10.sup.4CFU) (10.sup.4CFU) Model 123.5 5.98 control group Embodiment 87.2 71.3 72.5 50.3 2.28 8 Embodiment 87.6 72.9 73.8 49.8 2.13 9 Embodiment 93.3 79.2 80.4 30.5 1.33 10 Embodiment 87.3 72.3 73.6 48.4 2.05 11 Embodiment 86.9 73.5 74.6 48.5 2.03 12 Embodiment 86.7 73.3 74.7 49.9 2.15 13 Embodiment 94.5 79.0 80.2 31.9 1.25 14 Embodiment 87.2 73.4 75.0 48.6 1.98 15

(105) TABLE-US-00004 TABLE 4 Effects of the medicament of the present invention on the T lymphocytes CD4 + T, the thymic weight index and the cytokines IFN- of mice CD4 + Thymic weight IFN- T/L index ng/mL Blank control 41.57 5.68 0.323 0.040 121.85 14.2 group Model control 24.56 8.59 0.205 0.052 65.21 10.42 group Embodiment 8 33.52 6.56 0.255 0.043 69.58 10.26 Embodiment 9 34.56 6.25 0.256 0.056 70.25 11.89 Embodiment 10 40.25 7.06 0.315 0.050 74.89 10.36 Embodiment 11 33.12 6.79 0.248 0.049 70.06 11.56 Embodiment 12 34.43 6.65 0.247 0.043 70.23 11.65 Embodiment 13 33.20 7.12 0.252 0.044 70.69 12.05 Embodiment 14 41.89 6.59 0.313 0.051 74.23 11.36 Embodiment 15 32.56 6.26 0.255 0.044 70.28 10.36

(106) In Embodiments 8-11, only the weight ratio of the marine algal glycoprotein and the glucuronic acid was changed. From the experimental results, Embodiment 10 is the most preferred example.

(107) In Embodiments 12-15, only the weight ratio of the marine algal glycoprotein, the glucuronic acid and indigo naturalis was changed. From the experimental results, Embodiment 14 is the most preferred example.

Embodiment 16

(108) A Medicament for Use in Treating Tuberculosis

(109) The medicament comprises, by weight, 1 portion of marine algal glycoprotein, 5 portions of indigo naturalis, 6 portions of dioscorea nipponica, and 1 portion of glucuronic acid.

(110) The marine algal glycoprotein comprises 26% saccharide and 74% protein by weight;

(111) the molecular weight is 8 kDa;

(112) the marine algae is nostoc flagelliforme;

(113) the saccharide is a polysaccharide;

(114) the polysaccharide comprises xylose, fucose, arabinose, glucose, galactose, mannose, and rhamnose;

(115) the protein comprises asparaginate, cysteine, lysine, arginine, serine, and threonine.

Embodiment 17

(116) A Medicament for Use in Treating Tuberculosis

(117) Similar to Embodiment 16, only the proportions of the marine algal glycoprotein, indigo naturalis, dioscorea nipponica and the glucuronic acid by weight are changed as follows:

(118) the medicament comprises, by weight, 49 portions of marine algal glycoprotein, 8 portions of indigo naturalis, 11 portions of dioscorea nipponica, and 8 portions of glucuronic acid.

Embodiment 18

(119) A Medicament for Use in Treating Tuberculosis

(120) Similar to Embodiment 16, only the proportions of the marine algal glycoprotein, indigo naturalis, dioscorea nipponica and the glucuronic acid by weight are changed as follows:

(121) the medicament comprises, by weight, 99 portions of marine algal glycoprotein, 15 portions of indigo naturalis, 16 portions of dioscorea nipponica, and 17 portions of glucuronic acid.

Embodiment 19

(122) A Medicament for Use in Treating Tuberculosis

(123) The medicament comprises, by weight, 1 portion of marine algal glycoprotein, 5 portions of indigo naturalis, 6 portions of Ningpo yam rhizome, 7 portions of fructus trichosanthis and 8 portions of cicada slough.

(124) The marine algal glycoprotein comprises 41% saccharide and 59% protein by weight;

(125) the molecular weight is 12 kDa;

(126) the marine algae is laver;

(127) the saccharide is a polysaccharide;

(128) the polysaccharide comprises xylose, fucose, arabinose, glucose, galactose, mannose, and rhamnose;

(129) the protein comprises asparaginate, cysteine, lysine, arginine, serine, and threonine.

Embodiment 20

(130) A Medicament for Use in Treating Tuberculosis

(131) Similar to Embodiment 19, only the proportions of the marine algal glycoprotein, indigo naturalis, Ningpo yam rhizome, fructus trichosanthis and cicada slough by weight are changed as follows:

(132) the medicament comprises, by weight, 55 portions of marine algal glycoprotein, 14 portions of indigo naturalis, 9 portions of Ningpo yam rhizome, 15 portions of fructus trichosanthis and 10 portions of cicada slough.

Embodiment 21

(133) A Medicament for Use in Treating Tuberculosis

(134) Similar to Embodiment 19, only the proportions of the marine algal glycoprotein, indigo naturalis, Ningpo yam rhizome, fructus trichosanthis and cicada slough by weight are changed as follows:

(135) the medicament comprises, by weight, 99 portions of marine algal glycoprotein, 15 portions of indigo naturalis, 16 portions of Ningpo yam rhizome, 17 portions of fructus trichosanthis and 14 portions of cicada slough.

(136) Application of the Medicament as Described in the Above Embodiment 16 to Embodiment 21 in Treating Tuberculosis:

(137) Using the test method as described in Embodiment 7, the medicament as described in Embodiment 16-Embodiment 21 in this invention groups have the following application effects:

(138) TABLE-US-00005 TABLE 5 Therapeutic effects after three months Sputum Focus Number of Number of negative absorp- Cavity bacterial bacterial conver- tion closure colonies colonies sion rate rate rate in lungs in spleens (%) (%) (%) (10.sup.4CFU) (10.sup.4CFU) Model 123.5 5.98 control group Embodiment 90.5 73.3 79.5 30.3 1.58 16 Embodiment 95.3 85.9 85.8 20.8 0.83 17 Embodiment 90.9 73.2 80.4 31.5 1.42 18 Embodiment 91.3 76.3 79.6 31.4 1.46 19 Embodiment 96.9 84.5 86.6 18.5 0.85 20 Embodiment 91.7 77.3 79.7 32.9 16.5 21

(139) TABLE-US-00006 TABLE 6 Effects of the medicament of the present invention on the T lymphocytes CD4 + T, the thymic weight index and the cytokines IFN- of mice CD4 + Thymic weight IFN- custom character T/L index ng/mL Blank control 41.57 5.68 0.323 0.040 121.85 14.2 group Model control 24.56 8.59 0.205 0.052 65.21 10.42 group Embodiment 16 34.52 5.46 0.285 0.043 71.58 10.58 Embodiment 17 41.56 6.75 0.325 0.057 76.85 11.34 Embodiment 18 35.25 7.46 0.296 0.053 71.89 10.36 Embodiment 19 36.12 6.99 0.288 0.046 71.46 11.58 Embodiment 20 42.43 6.35 0.328 0.047 76.73 11.34 Embodiment 21 35.20 7.22 0.272 0.045 72.69 10.05

(140) In Embodiments 16-18, only the weight ratio of the marine algal glycoprotein, indigo naturalis, Ningpo yam rhizome and the glucuronic acid was changed. From the experimental results, Embodiment 17 is the most preferred embodiment.

(141) In Embodiments 19-21, only the weight ratio of the marine algal glycoprotein, indigo naturalis, Ningpo yam rhizome, fructus trichosanthis, cicada slough, and the glucuronic acid was changed. From the experimental results, Embodiment 20 is the most preferred embodiment.

Embodiment 22

(142) A Medicament for Use in Treating Tuberculosis

(143) The medicament comprises the following components by weight:

(144) 70 portions of marine algal glycoprotein, 8 portions of bulbus fritillariae, 3 portions of radix psammosilenes, 7 portions of radix acanthopanacis senticosi, 5 portions of herba inulae, 3 portions of flos inulae, 8 portions of radix ranunculi ternati, 9 portions of radix aconiti, and 12 portions of radix physochlainae.

(145) The marine algal glycoprotein comprises 10% saccharide and 80% protein by weight;

(146) the molecular weight of the marine algal glycoprotein is 8 kDa;

(147) the marine algae is blue-green algae;

(148) the saccharide comprises the following components by weight: 16 portions of xylose, 12 portions of fucose, and 17 portions of arabinose;

(149) the protein comprises the following components by weight: 19 portions of asparaginate, 13 portions of cysteine, and 19 portions of lysine.

(150) Using the test method as described in Embodiment 7, the medicament as described in Embodiment 22 in this invention groups have the following application effects:

(151) the medicament of the present invention has a good treatment effect on tuberculosis. The sputum negative conversion rate of 96.8%, the focus absorption rate of 86.3% and the cavity closure rate of 86.0% has been achieved. The number of bacterial colonies in lungs and spleens could be reduced. The number of bacterial colonies in lungs could be 19.5104 CFU, and the number of the bacterial colonies in spleens could be 0.8104 CFU.

(152) The medicament of the present invention can increase the number of T lymphocytes CD4+T of mice, increase the thymus index of mice and increase the content of IFN- of multi-drug resistant tuberculosis mice. IFN- is the key of effective antibacterial immunity, which attract and gather monocytes/macrophagocytes to enhance its effect of killing the multi-drug resistant Mycobacterium Tuberculosis. The number of CD4+T could be 41.98/L and the thymic weight index could be 0.328. In addition, the content of IFN- could be 77.23 ng/mL.

Embodiment 23

(153) A Method for Preparing a Medicament for Use in Treating Tuberculosis

(154) The Following Steps of the Method were Performed:

(155) (1) Weighing

(156) weighing all the components according to the formula;

(157) (2) Cleaning of Chinese Herbal Medicines

(158) cleaning all the Chinese herbal medicine components except for the glycoprotein;

(159) (3) Extracting of Chinese Herbal Medicines

(160) adding the Chinese herbal medicines to clear water of 12 times of volume for soaking 1 h under the condition of 50 DEG C., then increasing the temperature to 60 DEG C. and the pressure to 29 kPa and carrying out ultrasonic-assisted extraction, with the ultrasonic power being 130 W, the ultrasonic frequency being 250 kHz, the treatment time being 4-5 s, and the chill time being 2-6 s; after one hour, filtering, collecting the filtrate, and carrying out spray-drying, thereby obtaining a Chinese herbal medicine powder;

(161) (4) Adding of the Glycoprotein

(162) mixing the marine algal glycoprotein powder and the above Chinese herbal medicine powder uniformly, and then preparing the mixture into different dose forms, such as capsules, tablets and the like.

(163) The medicament of the present invention has a pH of 5.3-9.8, preferably 6.5-7.5.

(164) Lots of experiments were done on the present invention. Multiple experiments were done with the glycoproteins and mixtures of polysaccharides and proteins extracted from sea shells, bones of the livestock, and skeletons of marine animals, and the objectives of the present invention could also be achieved.

Embodiment 24

(165) A Medicament for Use in Treating Tuberculosis

(166) The medicament is a mixture of a polysaccharide and a protein;

(167) the medicament comprises 1%-99% of polysaccharide and 1%-99% of protein by weight;

(168) the polysaccharide comprises xylose, fucose, arabinose, glucose, galactose, mannose, and rhamnose;

(169) the protein comprises asparagamide, cysteine, lysine, arginine, serine, threonine, alanine, aspartic acid, glutamine, glutamic acid, histidine, isoleucine, glycine, leucine, methionine, phenylalanine, proline, tyrosine and valine;

(170) the molecular weight of polysaccharide in the mixture of polysaccharide and protein is 0.2-3000 kDa;

(171) the molecular weight of protein in the mixture of algae polysaccharide and protein is 0.2-3000 kDa.

(172) The mixture of polysaccharide and protein can become the mixture of algal polysaccharide and algal protein;

(173) the mixture of algal polysaccharide and algal protein comprises pigment;

(174) the pigment is a natural pigment contained in an algal substance;

(175) the algal protein could be one of the phycocyanin, phycoerythrin, or the yellow-algal protein.

(176) According to the Above Embodiments 13-18, an Experiment on Airway Hyperresponsiveness was Conducted, with an Experimental Method and Effects being Shown Below:

(177) (1) mice for the experiment: the male mice for this experiment were 6 weeks old;

(178) (2) dose: the dose for each mouse was 3 g/day, 3 times a day;

(179) (3) antigen sensitization, allergy attack and treatment: 200 g of conalbumin (CA) and 2 mg of dinitrobenzene (DNP)-bound albumin were dissolved in 0.3 ml of buffer solution PBS and then intrathecally injected into mice for sensitization twice at an interval of one week. The mice were anesthetized 7 days later after the second sensitization, and were intratracheally provided with 0.05 ml of buffer solution PBS containing 100 g of conalbumin (CA) to induce an allergy attack. On the 20th day and the 30th day, a further allergy attack was induced by the same method at twice dose. The mice having an allergy attack were divided into 9 groups 24 hours later after the first allergy attack. Groups 1-6 were treated with the medicament as described in Embodiments 13-18 of the present invention that was intragastrically administrated by using a type 25 metering blunt stainless steel needle, 1 g each time and three times a day, continuously for 17 days. The mice having an allergy attack were divided into 9 groups 24 hours later after the first allergy attack. Groups 1-6 were treated with the medicament as described in Embodiments 13-18 of the present invention that was intragastrically administrated by using a type 25 metering blunt stainless steel needle, 1 g each time and three times a day, continuously for 17 days. Group 7 was treated with dexamethasone and intraperitoneally injected with 0.5 ml/kg dexamethasone every day. Group 8 served as a model control group and was intraperitoneally provided with saline solution every day. Group 9 was blank control group without any treatment;

(180) (4) measurement of late-phase airway response: on the third day after the last allergy attack, the mice of the above 8 groups were intravenously injected with acetylcholine, and then the airway pressure changes of these mice and those of group 9 were all measured to reflect airway responses. The specific steps were as follows: anesthetizing the mice by using pentobarbital and keeping the respiratory tract unblocked by using an 18# endotracheal tube; keeping 120 breaths per minute by using an RSP 1002 type pressure controllable respiratory system, and keeping the tidal volume constant at 0.2 ml; intravenously injecting dodecyl ammonium bromide into each mouse by 25 mg/kg to induce muscle relaxation; connecting a pressure transducer to the endotracheal tube to measure the airway pressure; intravenously injecting acetyl choline into each mouse by 50 g/kg after the airway pressure was stabilized for 2 minutes, observing and recording the airway pressure changes in 4 minutes by using a VENTP software system, calculating the time of airway pressure peaks with reference to airway pressure-time index (APTI) (centimeter water column per second), combining changes to reflect the airway responses. The measured specific values are shown in table 7.

(181) TABLE-US-00007 TABLE 7 Number APTI (centimeter water Group of mice column per second) Embodiment 13 15 600 23 Embodiment 14 15 534 24 Embodiment 15 15 613 22 Embodiment 16 15 580 25 Embodiment 17 15 480 27 Embodiment 18 15 595 31 Group treated 15 565 31 with dexamethasone Model control 15 1245 110 group Blank control 15 430 26 group

(182) The airway pressure-time index (APTI) levels of the groups treated with the medicament as described in Embodiments 13-18 of the present invention and dexamethasone were significantly lower than that of the model control group. There was no significant difference between the groups treated with the medicament of the present invention and the group treated with dexamethasone, and the airway hyperresponsibility could be completely eliminated.

(183) The no-toxic-effect dose of the medicament of the present invention for oral administration to dogs for 12 weeks was 1.6 g/kg, which was equivalent to 50 times the equivalent dose for human. Therefore, it would be believed that the safety of clinical trials could be guaranteed.

(184) The medicine described in the invention can also be a health care product or a food.

(185) The basic principles and main features of the present invention and the advantages of the present invention are shown and described above. It should be understood by those skilled in the art that the present invention is not limited by the Embodiments described above. The descriptions of the above Embodiments and the description are merely illustrative of the principles of the present invention. Various variations and modifications can be made to the invention without departing from the spirit and scope of the invention. Such variations and modifications all fall within the scope of the claimed invention. The scope of the present invention is defined by the appended claims and their equivalents.