CN113197873A - Preparation method of gastrodia tuber Toufengling tablet - Google Patents
Preparation method of gastrodia tuber Toufengling tablet Download PDFInfo
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/236—Ligusticum (licorice-root)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/287—Chrysanthemum, e.g. daisy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/46—Eucommiaceae (Eucommia family), e.g. hardy rubber tree
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/74—Rubiaceae (Madder family)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/80—Scrophulariaceae (Figwort family)
- A61K36/804—Rehmannia
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/80—Scrophulariaceae (Figwort family)
- A61K36/808—Scrophularia (figwort)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/898—Orchidaceae (Orchid family)
- A61K36/8988—Gastrodia
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61P25/00—Drugs for disorders of the nervous system
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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Abstract
The invention belongs to the field of pharmaceutical preparations, and discloses a preparation method of a gastrodia tuber Toufengling tablet. The invention prepares the rhizoma gastrodiae cephalomanni tablet by mixing dry extract powder of the rhizoma gastrodiae cephalomanni with calcium hydrophosphate, microcrystalline cellulose, sodium carboxymethyl starch and other auxiliary materials, granulating, drying, granulating and tabletting. The gastrodia tuber Toufengling tablet prepared by the preparation method provided by the invention has higher disintegration rate, thereby promoting the dissolution of the active ingredients of the medicine. The invention is suitable for preparing tablet medicines, in particular to the preparation of rhizoma gastrodiae cephalocathartic tablets.
Description
Technical Field
The invention belongs to the field of medicinal preparations, relates to a preparation method of a Chinese medicinal preparation, and particularly relates to a preparation method of a gastrodia tuber Toufengling tablet.
Background
A Chinese medicine in the form of tablet for treating intractable headache, numbness of limbs, chronic soreness of waist and legs, etc is prepared from gastrodia tuber, achyranthes root, scrophularia root, rehmannia root, Chinese angelica root, eucommia bark, Chuan-xiong rhizome, mistletoe, wild chrysanthemum flower, uncaria stem with hooks, etc.
Chinese patent application with application number CN03118521.5 discloses a method for preparing gastrodia tuber Toufengling tablets, wherein cyclodextrin can promote the dissolution of the drug to a certain extent, but needs the collocation of multiple auxiliary materials, and a large amount of auxiliary materials in the production process can also make the tablet structure too close in the tabletting process, thereby affecting the disintegration of the tablet, and meanwhile the tablet in this application belongs to the film coated tablet, the disintegration efficiency of the tablet can be further reduced because of the coating, according to the auxiliary material components in this application, under the condition of no coating, the hydrolysis is very easy to occur, thereby affecting the stability of the drug tablet.
Disclosure of Invention
In order to solve the defects in the prior art, the invention aims to provide a preparation method of a gastrodia tuber Toufengling tablet, so as to achieve the purposes of improving the disintegration efficiency of the tablet and improving the stability of the medicine.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
a method for preparing rhizoma Gastrodiae tablet for treating headache comprises respectively granulating main material and adjuvant, drying, grading, and tabletting to obtain rhizoma Gastrodiae tablet for treating headache;
as the limitation of the invention, the main material is dry paste powder of rhizoma gastrodiae and toufengling; the gastrodia tuber toufengling dry paste powder consists of 50 parts by weight of gastrodia tuber, 50 parts by weight of uncaria, 215 parts by weight of angelica, 50 parts by weight of ligusticum wallichii, 150 parts by weight of rehmannia root, 50 parts by weight of figwort, 43 parts by weight of eucommia bark, 215 parts by weight of mistletoe, 50 parts by weight of achyranthes root and 5 parts by weight of wild chrysanthemum;
as another limitation of the invention, the auxiliary materials comprise 100 parts by weight of calcium hydrogen phosphate, 100 parts by weight of microcrystalline cellulose, 450 parts by weight of sodium carboxymethyl starch, 50 parts by weight of silicon dioxide and 150 parts by weight of magnesium stearate;
as a third limitation of the invention, the stirring speed of the granulation is 50-100 r/min, and the time is 300-600 s;
as a fourth limitation of the present invention, the drying temperature is 50-60 ℃ and the drying time is 15-25 min;
as a fifth limitation of the invention, the hardness of the rhizoma gastrodiae cephalomanni tablet is 10-14 kg, and the water content is 4.5-7%.
Due to the adoption of the technical scheme, compared with the prior art, the invention has the following beneficial effects:
calcium hydrogen phosphate, microcrystalline cellulose and sodium carboxymethyl starch are used in a matched manner in the preparation method of the gastrodia tuber Toufengling tablet, so that the disintegration rate of the medicine tablet is accelerated, the dissolution of active ingredients in gastrodia tuber Toufengling dry paste powder is accelerated, the phenomenon that the medicine is not completely dissolved and is discharged out of a body along with food residues in the stomach is avoided, the bioavailability of the medicine is reduced, and meanwhile, the combination can also reduce the hydrolysis probability of the medicine in the storage process and improve the stability of the medicine;
in conclusion, the gastrodia tuber cephalomanni tablet prepared by the preparation method of the gastrodia tuber cephalomanni tablet provided by the invention has good disintegration speed and improves the stability of the medicine.
Detailed Description
Preferred embodiments of the present invention are explained below. It should be understood that the description of the preferred embodiment is only for purposes of illustration and understanding, and is not intended to limit the invention.
Example 1A method for preparing Gastrodia elata Toufengling tablets A1
The embodiment provides a preparation method of a gastrodia tuber Toufengling tablet A1, which comprises the following steps:
1) respectively weighing 50g of uncaria, 215g of angelica, 50g of ligusticum wallichii, 150g of rehmannia, 50g of figwort, 43g of eucommia ulmoides, 215g of mistletoe, 50g of achyranthes and 50g of chrysanthemum indicum, adding 9.23L of water into the nine medicines, decocting for three times, 2h each time, combining decoction liquids, filtering, concentrating filtrate to obtain thick paste with the relative density of 1.39(50 ℃), adding 50g of rhizoma gastrodiae which is crushed into fine powder, uniformly mixing, drying, crushing and sieving by a 80-mesh sieve to obtain 800g of rhizoma gastrodiae toufengling dry paste powder;
2) respectively weighing 800g of rhizoma gastrodiae toufengling dry paste powder, 100g of calcium hydrophosphate, 100g of microcrystalline cellulose and 250g of sodium carboxymethyl starch, adding the materials into a granulator with the stirring speed of 50r/min, stirring and mixing for 600s, adding 0.2L of 95% ethanol, continuously stirring for 600s, and sieving by using a 16-mesh sieve to obtain rhizoma gastrodiae toufengling wet granules;
3) sucking the obtained rhizoma Gastrodiae toufengling wet granules into a fluidized bed dryer, drying at 50 deg.C for 25min, detecting water content of the dried granules to be 4.5%, and sieving the dried granules with 16 mesh sieve to obtain rhizoma Gastrodiae toufengling dry granules;
4) firstly, putting half of the dry rhizoma gastrodiae cephalomanni granules into a mixer, then adding 200g of sodium carboxymethyl starch, 50g of silicon dioxide, 150g of magnesium stearate and the rest of the dry rhizoma gastrodiae cephalomanni granules, mixing for 30min, then moving into a tablet machine for tabletting, and measuring by a tablet hardness tester to obtain the rhizoma gastrodiae cephalomanni tablet A1 with the hardness of 11 kg.
It should be noted that this example is only for illustrating a preferred embodiment of the rhizoma gastrodiae cephalomanni tablet provided by the present invention, and is not used to further limit the preparation method, and the rhizoma gastrodiae cephalomanni tablet obtained in step 4) in this example may be directly packaged as a dispersible tablet, or may be coated with a coating agent (e.g., a gastric-soluble film-coated premix) to be made into a film-coated tablet or a sugar-coated tablet, or may be made into other dosage forms by a simple conventional processing method.
Example 2-6 preparation of Gastrodia elata Toufengling tablets A2-A6
The preparation methods of the rhizoma gastrodiae cephalomanni tablets a 2-a 6 provided in the embodiments 2-6 are basically the same as the preparation method provided in the embodiment 1, and only the differences are that part of process parameters are different, and the specific process parameters are shown in table 1.
Table 1: preparation process parameter table of rhizoma gastrodiae toufengling tablets A2-A6
The other steps were the same as in example 1.
Experimental example 1 comparative disintegration speed test of Gastrodia elata Toufengling tablets
To further illustrate the preparation method of the rhizoma gastrodiae cephalocathartic tablet provided by the present invention, the experimental example selects the preparation method in the chinese patent application with application number of 03118521.5 to prepare the rhizoma gastrodiae cephalocathartic tablet as the comparative group 1 and the purchased rhizoma gastrodiae cephalocathartic tablet (benevolence and medicine industry, 0.38 x 9s) as the comparative group 2.
The Gastrodia elata Toufengling tablets A1-A6 prepared in examples 1-6 provided by the invention are respectively used as test groups 1-6.
Respectively taking 24 rhizoma Gastrodiae Toufengling tablets out of the comparison groups 1 and 2 and the test groups 1-6, placing into a disintegration apparatus, performing test for four times, selecting 6 tablets for each group, performing test in liquid environment of water, 0.1N hydrochloric acid solution, pH4.5 acetate buffer solution and pH6.8 phosphate buffer solution, setting disintegration temperature to 37 deg.C, and recording dissolution time of each group of tablets, wherein the specific test data is shown in Table 2.
Table 2: data table for disintegration speed contrast test of gastrodia tuber Toufengling tablets
The test data show that the disintegration speed of the gastrodia tuber cephalomannia tablets prepared by the preparation method provided by the invention is higher than that of the gastrodia tuber cephalomannia tablets in the comparison groups 1 and 2, so that the effective components of the medicine are released more quickly after being taken, the medicine is prevented from being discharged along with food residues in the stomach without being completely dissolved out, the medicine effect is further influenced, and the bioavailability of the medicine is reduced.
Experimental example 2 drug stability test of Gastrodia elata Toufengling tablets
The test samples used in this example were the same as those used in example 1.
The storage environments are respectively set as follows: continuous illumination environment, high humidity environment with relative humidity of 60% and high temperature environment with temperature of 40 deg.C, three extreme environment groups;
30 tablets were selected from the comparative groups 1 and 2 and the test groups 1 to 6, 10 tablets were placed in each group for 14 days in each environment, and the state of the tablets in different groups in different environments was observed and recorded as shown in table 3.
Table 3: medicine stability test result table of gastrodia tuber Toufengling tablets
Note: "●" indicates a regular shape with a smooth surface; "very" indicates a slight change in shape, a rough surface or a mottled appearance; ". smallcircle" indicates severe deformation or pulverization, rough surface and large-area discoloration.
The test results show that the gastrodia tuber Toufengling tablets prepared by the preparation method provided by the invention have better stability than the gastrodia tuber Toufengling tablets in the comparison groups 1 and 2, and even in extreme environments, the tablets do not have serious quality change, which is enough to fully show that the gastrodia tuber Toufengling tablets provided by the invention can be stored for a long time in normal storage environment, and avoid the influence on drug effect due to long-time storage.
Although the present invention has been described in detail with reference to the above embodiments, it will be apparent to those skilled in the art that modifications and equivalents can be made in the embodiments described above, or some features of the present invention may be substituted. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (9)
1. A preparation method of rhizoma gastrodiae cephalocathartic tablets is characterized by comprising the following steps: the preparation method comprises respectively taking the main material and the auxiliary material, granulating, drying, granulating, and tabletting to obtain the rhizoma gastrodiae cephalomannic tablet.
2. The method for preparing rhizoma gastrodiae cephalomanni tablets according to claim 1, which is characterized by comprising the following steps: the main material is dry paste powder of rhizoma gastrodiae and toufengling; the rhizoma gastrodiae and toufengling dry paste powder consists of 50 parts by weight of rhizoma gastrodiae, 50 parts by weight of uncaria, 215 parts by weight of angelica, 50 parts by weight of ligusticum wallichii, 150 parts by weight of rehmannia, 50 parts by weight of radix scrophulariae, 43 parts by weight of eucommia ulmoides, 215 parts by weight of mistletoe, 50 parts by weight of radix achyranthis bidentatae and 5 parts by weight of chrysanthemum indicum.
3. The method for preparing rhizoma gastrodiae cephalomanni tablets according to claim 1 or 2, which is characterized by comprising the following steps: the auxiliary materials comprise, by weight, 100 parts of calcium hydrophosphate, 100 parts of microcrystalline cellulose, 450 parts of sodium carboxymethyl starch, 50 parts of silicon dioxide and 150 parts of magnesium stearate.
4. The method for preparing rhizoma gastrodiae cephalomanni tablets according to claim 1 or 2, which is characterized by comprising the following steps: the rotating speed of the granulation is 1000-1600 r/min, and the time is 300-600 s.
5. The method for preparing rhizoma gastrodiae cephalomanni tablets according to claim 1 or 2, which is characterized by comprising the following steps: the drying temperature is 50-60 ℃ and the drying time is 15-25 min.
6. The method for preparing rhizoma gastrodiae cephalomanni tablets according to claim 1 or 2, which is characterized by comprising the following steps: the rhizoma gastrodiae cephalomanni tablet has the hardness of 10-14 kg and the water content of 4.5-7%.
7. The method for preparing rhizoma gastrodiae cephalotusol tablet according to claim 3, characterized in that: the rotating speed of the granulation is 1000-1600 r/min, and the time is 300-600 s; the drying temperature is 50-60 ℃, and the drying time is 15-25 min; the rhizoma gastrodiae cephalomanni tablet has the hardness of 10-14 kg and the water content of 4.5-7%.
8. The method for preparing rhizoma gastrodiae cephalotusol tablet according to claim 4, characterized in that: the drying temperature is 50-60 ℃, and the drying time is 15-25 min; the rhizoma gastrodiae cephalomanni tablet has the hardness of 10-14 kg and the water content of 4.5-7%.
9. The method for preparing rhizoma gastrodiae cephalotusol tablet according to claim 5, characterized in that: the rhizoma gastrodiae cephalomanni tablet has the hardness of 10-14 kg and the water content of 4.5-7%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110391397.1A CN113197873A (en) | 2021-04-13 | 2021-04-13 | Preparation method of gastrodia tuber Toufengling tablet |
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| CN202110391397.1A CN113197873A (en) | 2021-04-13 | 2021-04-13 | Preparation method of gastrodia tuber Toufengling tablet |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1374117A (en) * | 2002-03-22 | 2002-10-16 | 通化利民药业有限责任公司 | Chinese medicine for treating intractable headache and dizziness and its prepn process |
| CN1456223A (en) * | 2003-01-22 | 2003-11-19 | 毛友昌 | Preparation of gastrodia tuber Toufengling pills |
| CN1569142A (en) * | 2004-04-23 | 2005-01-26 | 贵州益伯制药股份有限公司 | Gastrodia tuber contained refractory headache treating formulation and its preparation technique and quality control method |
| CN1733255A (en) * | 2005-08-01 | 2006-02-15 | 湖南敬和堂制药有限公司 | Preparation method of gastrodia tuber headwear medicine |
-
2021
- 2021-04-13 CN CN202110391397.1A patent/CN113197873A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1374117A (en) * | 2002-03-22 | 2002-10-16 | 通化利民药业有限责任公司 | Chinese medicine for treating intractable headache and dizziness and its prepn process |
| CN1456223A (en) * | 2003-01-22 | 2003-11-19 | 毛友昌 | Preparation of gastrodia tuber Toufengling pills |
| CN1569142A (en) * | 2004-04-23 | 2005-01-26 | 贵州益伯制药股份有限公司 | Gastrodia tuber contained refractory headache treating formulation and its preparation technique and quality control method |
| CN1733255A (en) * | 2005-08-01 | 2006-02-15 | 湖南敬和堂制药有限公司 | Preparation method of gastrodia tuber headwear medicine |
Non-Patent Citations (4)
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| 安书麟等译: "《最新药物制剂技术及应用》", 31 October 1992, 中国医药科技出版社 * |
| 来源：健客: "天麻头风灵片的作用是怎样的？", 《网址：JIANKE.COM/A/20180911/5519988.HTML》 * |
| 潘震宇等: "高效液相色谱法测定天麻头风灵片中天麻素的含量研究", 《中医药导报》 * |
| 罗杰英，等: "《现代物理药剂学理论与实践》", 30 April 2005, 上海科学技术文献出版社 * |
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