CN115770214A - Oral solution containing cetirizine hydrochloride - Google Patents
Oral solution containing cetirizine hydrochloride Download PDFInfo
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- CN115770214A CN115770214A CN202211556011.9A CN202211556011A CN115770214A CN 115770214 A CN115770214 A CN 115770214A CN 202211556011 A CN202211556011 A CN 202211556011A CN 115770214 A CN115770214 A CN 115770214A
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- CN
- China
- Prior art keywords
- parts
- cetirizine hydrochloride
- solution
- purified water
- stirring
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- ZKLPARSLTMPFCP-UHFFFAOYSA-N Cetirizine Chemical compound C1CN(CCOCC(=O)O)CCN1C(C=1C=CC(Cl)=CC=1)C1=CC=CC=C1 ZKLPARSLTMPFCP-UHFFFAOYSA-N 0.000 title claims abstract description 40
- 229960004342 cetirizine hydrochloride Drugs 0.000 title claims abstract description 38
- 229940100688 oral solution Drugs 0.000 title claims abstract description 15
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims abstract description 36
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 31
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims abstract description 24
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 24
- 238000002360 preparation method Methods 0.000 claims abstract description 19
- 239000008213 purified water Substances 0.000 claims abstract description 18
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims abstract description 14
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims abstract description 14
- 239000001632 sodium acetate Substances 0.000 claims abstract description 14
- 235000017281 sodium acetate Nutrition 0.000 claims abstract description 14
- 241000167854 Bourreria succulenta Species 0.000 claims abstract description 12
- 229960000583 acetic acid Drugs 0.000 claims abstract description 12
- 235000019693 cherries Nutrition 0.000 claims abstract description 12
- 239000003814 drug Substances 0.000 claims abstract description 12
- 239000012362 glacial acetic acid Substances 0.000 claims abstract description 12
- 239000003381 stabilizer Substances 0.000 claims abstract description 11
- 239000000463 material Substances 0.000 claims abstract description 6
- 239000002994 raw material Substances 0.000 claims abstract description 6
- 229940079593 drug Drugs 0.000 claims abstract description 5
- 239000007787 solid Substances 0.000 claims abstract description 5
- 239000000243 solution Substances 0.000 claims description 37
- 238000003756 stirring Methods 0.000 claims description 18
- 238000005303 weighing Methods 0.000 claims description 12
- 235000011187 glycerol Nutrition 0.000 claims description 11
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 10
- 239000000600 sorbitol Substances 0.000 claims description 10
- FTLYMKDSHNWQKD-UHFFFAOYSA-N (2,4,5-trichlorophenyl)boronic acid Chemical group OB(O)C1=CC(Cl)=C(Cl)C=C1Cl FTLYMKDSHNWQKD-UHFFFAOYSA-N 0.000 claims description 9
- 239000000203 mixture Substances 0.000 claims description 9
- 229940085605 saccharin sodium Drugs 0.000 claims description 9
- 239000008351 acetate buffer Substances 0.000 claims description 6
- 239000000796 flavoring agent Substances 0.000 claims description 6
- 235000013355 food flavoring agent Nutrition 0.000 claims description 6
- 239000000686 essence Substances 0.000 claims description 3
- 238000000034 method Methods 0.000 claims description 3
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 claims description 2
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 claims description 2
- 229960002216 methylparaben Drugs 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 5
- 208000019505 Deglutition disease Diseases 0.000 abstract description 2
- 230000007661 gastrointestinal function Effects 0.000 abstract description 2
- 210000001035 gastrointestinal tract Anatomy 0.000 abstract description 2
- 238000001727 in vivo Methods 0.000 abstract description 2
- 230000004044 response Effects 0.000 abstract description 2
- 239000007788 liquid Substances 0.000 abstract 1
- 239000000047 product Substances 0.000 description 8
- 238000009472 formulation Methods 0.000 description 6
- NTYJJOPFIAHURM-UHFFFAOYSA-N Histamine Chemical compound NCCC1=CN=CN1 NTYJJOPFIAHURM-UHFFFAOYSA-N 0.000 description 4
- 206010020751 Hypersensitivity Diseases 0.000 description 3
- 229930006000 Sucrose Natural products 0.000 description 3
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 3
- 208000026935 allergic disease Diseases 0.000 description 3
- 230000007815 allergy Effects 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 239000012488 sample solution Substances 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 239000005720 sucrose Substances 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- 108010011485 Aspartame Proteins 0.000 description 2
- 239000000605 aspartame Substances 0.000 description 2
- 235000010357 aspartame Nutrition 0.000 description 2
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical group OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 description 2
- 229960003438 aspartame Drugs 0.000 description 2
- 229960001803 cetirizine Drugs 0.000 description 2
- 229960001340 histamine Drugs 0.000 description 2
- 239000000938 histamine H1 antagonist Substances 0.000 description 2
- 239000000523 sample Substances 0.000 description 2
- QZAYGJVTTNCVMB-UHFFFAOYSA-N serotonin Chemical compound C1=C(O)C=C2C(CCN)=CNC2=C1 QZAYGJVTTNCVMB-UHFFFAOYSA-N 0.000 description 2
- 102000003834 Histamine H1 Receptors Human genes 0.000 description 1
- 108090000110 Histamine H1 Receptors Proteins 0.000 description 1
- 238000013494 PH determination Methods 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
- 230000008499 blood brain barrier function Effects 0.000 description 1
- 210000001218 blood-brain barrier Anatomy 0.000 description 1
- 230000000747 cardiac effect Effects 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 210000000170 cell membrane Anatomy 0.000 description 1
- 230000012292 cell migration Effects 0.000 description 1
- OEYIOHPDSNJKLS-UHFFFAOYSA-N choline Chemical compound C[N+](C)(C)CCO OEYIOHPDSNJKLS-UHFFFAOYSA-N 0.000 description 1
- 229960001231 choline Drugs 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 235000021552 granulated sugar Nutrition 0.000 description 1
- 210000004969 inflammatory cell Anatomy 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 231100000989 no adverse effect Toxicity 0.000 description 1
- 239000012466 permeate Substances 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
Abstract
The invention discloses a cetirizine hydrochloride-containing oral solution which is prepared from the following raw material medicines and auxiliary materials in parts by weight: 0.8-1.2 parts of cetirizine hydrochloride, 200-300 parts of glycerol, 100-200 parts of propylene glycol, 100-500 parts of stabilizer, 0.2-0.6 part of corrigent, 1-2 parts of methyl hydroxybenzoate, 0.08-0.12 part of cherry essence, 0.8-1.2 parts of glacial acetic acid, 3-5 parts of sodium acetate and 3-5 parts of sodium acetate, wherein the initial water addition amount is 10-30% (W/V), and finally, a proper amount of purified water is added to achieve a constant volume of 1L. The cetirizine hydrochloride-containing oral solution is an oral liquid preparation, and has quicker in-vivo effect and quicker response compared with a solid preparation; can be conveniently applied to the old, children and patients with dysphagia and poor gastrointestinal function, and can reduce the burden of the medicine on the gastrointestinal tract and improve the bioavailability of the medicine and the compliance of the patients.
Description
The technical field is as follows: the invention relates to an oral medicinal preparation, in particular to an oral solution containing cetirizine hydrochloride.
The background art comprises the following steps:
cetirizine is a potent H1 receptor antagonist, enters the body orally, rapidly binds to histamine H1 receptors on target cell membranes, and blocks histamine from activating target cells. Cetirizine has no obvious effects of resisting choline and 5-hydroxytryptamine. Under normal dosage, the blood brain barrier is not easy to permeate. The product can inhibit histamine transfer in early stage of allergy, reduce inflammatory cell migration activity and transmitter release in late stage of allergy, and is also effective in late stage allergy. The product is a high-selectivity H1 receptor antagonist, and has no adverse effect on cardiac electrical activity.
The invention content is as follows: aiming at the prior art, the invention provides an oral solution containing cetirizine hydrochloride, which has quicker in-vivo action and quicker response compared with a solid preparation; can be conveniently applied to the old, children and patients with dysphagia and poor gastrointestinal function, and can reduce the burden of the medicine on the gastrointestinal tract and improve the bioavailability of the medicine and the compliance of the patients.
The invention is realized by the following technical scheme:
an oral solution containing cetirizine hydrochloride is prepared from the following raw material medicines and auxiliary materials in parts by weight: 0.8-1.2 parts of cetirizine hydrochloride, 200-300 parts of glycerol, 100-200 parts of propylene glycol, 100-500 parts of stabilizer, 0.2-0.6 part of corrigent, 1-2 parts of methyl hydroxybenzoate, 0.08-0.12 part of cherry essence, 0.8-1.2 parts of glacial acetic acid, 3-5 parts of sodium acetate and 3-5 parts of sodium acetate, wherein the initial water addition amount is 10-30% (W/V), and finally, a proper amount of purified water is added to fix the volume to 1L.
Preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines and auxiliary materials in parts by weight: 1 part of cetirizine hydrochloride, 250 parts of glycerin, 150 parts of propylene glycol, 300 parts of stabilizer, 0.4 part of corrigent, 1.5 parts of methyl hydroxybenzoate, 0.1 part of cherry essence, 1 part of glacial acetic acid and 4 parts of sodium acetate, wherein the initial water addition amount is 20% (W/V), and finally, a proper amount of purified water is added to achieve a constant volume of 1L.
The stabilizer is selected from sorbitol solids and 70% sorbitol solution, preferably 70% sorbitol solution. Sorbitol solids dissolve endothermically, leading to a lower solution temperature during preparation and a risk of affecting product quality. The 70% sorbitol solution does not have a dissolving process, so that the solution temperature in the preparation process is not influenced, and the product quality is stable.
Said flavoring agent is selected from aspartame and saccharin sodium, preferably saccharin sodium. Taking the sweetness of sucrose (white granulated sugar) as reference, aspartame is 200 times of sucrose, and saccharin sodium is 300 to 500 times of sucrose. Therefore, the sweetness threshold of the saccharin sodium is larger, the flavoring effect can be achieved by adding less saccharin sodium, the price is low, and the production cost is saved.
The preparation method of the oral solution containing cetirizine hydrochloride comprises the following steps:
(1) Weighing and batching:
respectively weighing cetirizine hydrochloride, glycerin, propylene glycol, a stabilizer, a flavoring agent, methylparaben, cherry essence, glacial acetic acid and sodium acetate according to the formula for later use;
(2) Solution (1) preparation:
adding the methyl hydroxybenzoate with the prescription amount into the propylene glycol with the prescription amount, and stirring to dissolve completely to obtain a solution (1);
(3) Preparing an acetate buffer solution:
adding glacial acetic acid and sodium acetate according to the prescription amount to 20g of purified water, and stirring and dissolving completely to obtain the product;
(4) Preparation of solution (2):
weighing 20% (W/V) of purified water into a beaker, adding the stabilizer, the glycerol, the flavoring agent and the cherry essence according to the prescription amount, stirring at 300rpm, dissolving and uniformly mixing to obtain a solution (2);
(5) Weighing cetirizine hydrochloride with the prescription amount, adding the cetirizine hydrochloride into 20g of purified water, stirring until the cetirizine hydrochloride is completely dissolved, adding the cetirizine hydrochloride into the solution (2), and stirring and uniformly mixing;
(6) Adding the solution (1) into the solution, stirring and mixing uniformly, adding acetate buffer solution to adjust the pH value to 4.8;
(7) Volume fixing:
the whole volume is transferred to a 1L volumetric flask, and purified water is added to the volume to be 1L.
Detailed Description
The present invention will be further described with reference to the following examples.
Example 1: 1L of oral solution containing cetirizine hydrochloride is prepared, 1g of cetirizine hydrochloride is contained, and the dosage of raw materials and auxiliary materials is as follows: 1g of cetirizine hydrochloride, 250g of glycerol, 150g of propylene glycol, 300g of 70% sorbitol solution, 0.4g of saccharin sodium, 1.5g of methyl hydroxybenzoate, 0.1g of cherry essence, 1g of glacial acetic acid and 4g of sodium acetate, wherein the initial water addition amount is 200g, and finally, a proper amount of purified water is added to achieve a constant volume of 1L.
The preparation method comprises the following steps:
(1) Weighing and batching:
respectively weighing cetirizine hydrochloride, glycerin, propylene glycol, 70% sorbitol solution, saccharin sodium, methyl hydroxybenzoate, cherry essence, glacial acetic acid and sodium acetate according to the formula for later use;
(2) Preparation of solution (1):
adding the methyl hydroxybenzoate with the prescription amount into the propylene glycol with the prescription amount, and stirring to dissolve completely to obtain a solution (1);
(3) Preparing an acetate buffer solution:
adding glacial acetic acid and sodium acetate according to the prescription amount to 20g of purified water, and stirring and dissolving completely to obtain the product;
(4) Solution (2) preparation:
weighing 20% (W/V) of purified water into a beaker, adding 70% sorbitol solution, glycerol, saccharin sodium and cherry essence according to the prescription amount, stirring at 300rpm, dissolving and uniformly mixing to obtain a solution (2);
(5) Weighing cetirizine hydrochloride with the prescription amount, adding the cetirizine hydrochloride into 20g of purified water, stirring until the cetirizine hydrochloride is completely dissolved, adding the cetirizine hydrochloride into the solution (2), and stirring and uniformly mixing;
(6) Adding the solution (1) into the solution, stirring and mixing uniformly, adding acetate buffer solution to adjust the pH value to 4.8;
(7) And (3) volume fixing:
the whole volume is transferred to a 1L volumetric flask, and purified water is added to the volume to be 1L.
Comparative example 1 cetirizine hydrochloride oral solution (reference preparation)
Experimental comparison of oral solutions containing cetirizine hydrochloride (prepared in example 1) with a reference formulation.
(I) taste test
The experimental method comprises the following steps: appropriate amounts of the sample solutions of the example 1 and the reference preparation were taken, 6 different experimenters were found for taste tests, and data were recorded.
The experimental results are as follows: as shown in table 1, it can be seen from table 1 that the mouthfeel of the preparation is similar to or even superior to that of the reference preparation.
TABLE 1 taste test results
(II) determination of relative Density and viscosity
The experimental method comprises the following steps: the example 1 and reference formulation sample solutions were subjected to relative density and viscosity measurements.
The experimental results are as follows: as shown in Table 2, it can be seen from Table 2 that the relative density and viscosity of the product are similar to those of the reference formulation.
TABLE 2 relative Density and viscosity measurements
Sample name | Relative Density (g/ml) | Viscosity (mm) 2 /s) |
Self-contained articles | 1.1501 | 6.39 |
Reference formulation | 1.1523 | 6.45 |
(III) determination of pH, content and related substances
The experimental method comprises the following steps: the sample solutions of example 1 and the reference formulation were subjected to pH, content and related substance determination.
The experimental results are as follows: as shown in Table 3, it can be seen from Table 3 that the pH, the content and the related substances of the product are all similar to those of the reference preparation, and all meet the related quality standards.
TABLE 3 results of pH and content measurement
Sample name | pH value (4.5-5.0) | Content (95% -105%) |
Self-contained articles | 4.82 | 99.5% |
Reference formulation | 4.80 | 99.8% |
Claims (5)
1. An oral solution containing cetirizine hydrochloride, which is characterized in that: the traditional Chinese medicine composition is prepared from the following raw material medicines and auxiliary materials in parts by weight: 0.8-1.2 parts of cetirizine hydrochloride, 200-300 parts of glycerin, 100-200 parts of propylene glycol, 100-500 parts of stabilizer, 0.2-0.6 part of corrigent, 1-2 parts of methyl hydroxybenzoate, 0.08-0.12 part of cherry essence, 0.8-1.2 parts of glacial acetic acid, 3-5 parts of sodium acetate, 10-30% W/V of initial water addition amount, and finally adding a proper amount of purified water to achieve a constant volume of 1L.
2. The cetirizine hydrochloride-containing oral solution of claim 1, wherein: the traditional Chinese medicine composition is prepared from the following raw material medicines and auxiliary materials in parts by weight: 1 part of cetirizine hydrochloride, 250 parts of glycerin, 150 parts of propylene glycol, 300 parts of stabilizer, 0.4 part of corrigent, 1.5 parts of methyl hydroxybenzoate, 0.1 part of cherry essence, 1 part of glacial acetic acid and 4 parts of sodium acetate, wherein the initial water addition amount is 20 w/V, and finally, a proper amount of purified water is added to fix the volume to 1L.
3. The cetirizine hydrochloride-containing oral solution according to claim 1 or 2, wherein: the selected stabilizer is selected from sorbitol solid, 70% sorbitol solution.
4. The cetirizine hydrochloride-containing oral solution according to claim 1 or 2, wherein: the flavoring agent is saccharin sodium.
5. The method for preparing cetirizine hydrochloride-containing oral solution according to claims 1 to 4, characterized in that: the method comprises the following steps:
1) Weighing and batching:
respectively weighing cetirizine hydrochloride, glycerol, propylene glycol, a stabilizer, a flavoring agent, methylparaben, cherry essence, glacial acetic acid and sodium acetate according to the formula for later use;
2) Preparation of solution (1):
adding the methyl hydroxybenzoate with the prescription amount into the propylene glycol with the prescription amount, and stirring to dissolve completely to obtain a solution (1);
3) Preparing an acetate buffer solution:
adding glacial acetic acid and sodium acetate according to the prescription amount to 20g of purified water, and stirring and dissolving completely to obtain the product;
4) Preparation of solution (2):
weighing 20% (W/V) of purified water into a beaker, adding the stabilizer, the glycerol, the flavoring agent and the cherry essence according to the prescription amount at 300rpm, stirring, dissolving and uniformly mixing to obtain a solution (2);
5) Weighing cetirizine hydrochloride with the prescription amount, adding the cetirizine hydrochloride into 20g of purified water, stirring until the cetirizine hydrochloride is completely dissolved, adding the cetirizine hydrochloride into the solution (2), and stirring and uniformly mixing;
6) Adding the solution (1) into the solution, stirring and mixing uniformly, and adding acetate buffer solution to adjust the pH value to 4.8;
7) Volume fixing:
the total amount was transferred to a 1L volumetric flask and purified water was added to a constant volume of 1L.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN202211556011.9A CN115770214A (en) | 2022-12-06 | 2022-12-06 | Oral solution containing cetirizine hydrochloride |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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CN202211556011.9A CN115770214A (en) | 2022-12-06 | 2022-12-06 | Oral solution containing cetirizine hydrochloride |
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Publication Number | Publication Date |
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CN115770214A true CN115770214A (en) | 2023-03-10 |
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CN202211556011.9A Pending CN115770214A (en) | 2022-12-06 | 2022-12-06 | Oral solution containing cetirizine hydrochloride |
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Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102133179A (en) * | 2011-03-11 | 2011-07-27 | 重庆健能医药开发有限公司 | Stable cetirizine oral solution |
CN106491522A (en) * | 2016-09-24 | 2017-03-15 | 北京万全德众医药生物技术有限公司 | A kind of levo-cetirizine hydrochloride Oral drops and preparation method thereof |
CN111096949A (en) * | 2018-10-25 | 2020-05-05 | 北京万全德众医药生物技术有限公司 | Cetirizine hydrochloride oral drop and preparation method thereof |
CN112006982A (en) * | 2017-12-14 | 2020-12-01 | 重庆华邦制药有限公司 | Stable levocetirizine hydrochloride oral solution and preparation method thereof |
CN114601794A (en) * | 2022-03-16 | 2022-06-10 | 广东九明制药有限公司 | Levocetirizine hydrochloride oral drop and preparation method thereof |
-
2022
- 2022-12-06 CN CN202211556011.9A patent/CN115770214A/en active Pending
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102133179A (en) * | 2011-03-11 | 2011-07-27 | 重庆健能医药开发有限公司 | Stable cetirizine oral solution |
CN106491522A (en) * | 2016-09-24 | 2017-03-15 | 北京万全德众医药生物技术有限公司 | A kind of levo-cetirizine hydrochloride Oral drops and preparation method thereof |
CN112006982A (en) * | 2017-12-14 | 2020-12-01 | 重庆华邦制药有限公司 | Stable levocetirizine hydrochloride oral solution and preparation method thereof |
CN111096949A (en) * | 2018-10-25 | 2020-05-05 | 北京万全德众医药生物技术有限公司 | Cetirizine hydrochloride oral drop and preparation method thereof |
CN114601794A (en) * | 2022-03-16 | 2022-06-10 | 广东九明制药有限公司 | Levocetirizine hydrochloride oral drop and preparation method thereof |
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