CN113559053A - Povidone-iodine suppository and preparation method thereof - Google Patents
Povidone-iodine suppository and preparation method thereof Download PDFInfo
- Publication number
- CN113559053A CN113559053A CN202110818972.1A CN202110818972A CN113559053A CN 113559053 A CN113559053 A CN 113559053A CN 202110818972 A CN202110818972 A CN 202110818972A CN 113559053 A CN113559053 A CN 113559053A
- Authority
- CN
- China
- Prior art keywords
- suppository
- povidone
- iodine
- peg
- parts
- Prior art date
- 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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- CPKVUHPKYQGHMW-UHFFFAOYSA-N 1-ethenylpyrrolidin-2-one;molecular iodine Chemical compound II.C=CN1CCCC1=O CPKVUHPKYQGHMW-UHFFFAOYSA-N 0.000 title claims abstract description 49
- 229920000153 Povidone-iodine Polymers 0.000 title claims abstract description 49
- 229960001621 povidone-iodine Drugs 0.000 title claims abstract description 49
- 239000000829 suppository Substances 0.000 title claims abstract description 48
- 238000002360 preparation method Methods 0.000 title description 12
- 239000003814 drug Substances 0.000 claims abstract description 30
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 claims abstract description 16
- 239000007864 aqueous solution Substances 0.000 claims abstract description 16
- 239000011159 matrix material Substances 0.000 claims abstract description 11
- 239000008118 PEG 6000 Substances 0.000 claims abstract description 10
- 229920002584 Polyethylene Glycol 6000 Polymers 0.000 claims abstract description 10
- 238000002844 melting Methods 0.000 claims abstract description 6
- 230000008018 melting Effects 0.000 claims abstract description 6
- 239000002904 solvent Substances 0.000 claims abstract description 6
- 239000002994 raw material Substances 0.000 claims abstract description 5
- 239000000725 suspension Substances 0.000 claims description 15
- 238000000034 method Methods 0.000 claims description 11
- 239000007788 liquid Substances 0.000 claims description 9
- 239000000243 solution Substances 0.000 claims description 8
- 229940079593 drug Drugs 0.000 claims description 7
- 238000001816 cooling Methods 0.000 claims description 6
- 238000010438 heat treatment Methods 0.000 claims description 3
- ZCYVEMRRCGMTRW-UHFFFAOYSA-N 7553-56-2 Chemical compound [I] ZCYVEMRRCGMTRW-UHFFFAOYSA-N 0.000 claims description 2
- 229910052740 iodine Inorganic materials 0.000 claims description 2
- 239000011630 iodine Substances 0.000 claims description 2
- 230000004927 fusion Effects 0.000 claims 1
- 230000000052 comparative effect Effects 0.000 description 15
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 4
- 230000000694 effects Effects 0.000 description 3
- 238000009472 formulation Methods 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 239000002511 suppository base Substances 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 229920001030 Polyethylene Glycol 4000 Polymers 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- PNDPGZBMCMUPRI-UHFFFAOYSA-N iodine Chemical compound II PNDPGZBMCMUPRI-UHFFFAOYSA-N 0.000 description 2
- 229920002523 polyethylene Glycol 1000 Polymers 0.000 description 2
- 229920001223 polyethylene glycol Polymers 0.000 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 208000007074 Trichomonas Vaginitis Diseases 0.000 description 1
- 208000025206 Trichomonas vaginitis urogenital infection Diseases 0.000 description 1
- 208000006374 Uterine Cervicitis Diseases 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 206010008323 cervicitis Diseases 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 239000003684 drug solvent Substances 0.000 description 1
- 230000003628 erosive effect Effects 0.000 description 1
- 238000010579 first pass effect Methods 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 229920001519 homopolymer Polymers 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 239000007858 starting material Substances 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/74—Synthetic polymeric materials
- A61K31/785—Polymers containing nitrogen
- A61K31/787—Polymers containing nitrogen containing heterocyclic rings having nitrogen as a ring hetero atom
- A61K31/79—Polymers of vinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
-
- 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
- A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/02—Local antiseptics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/10—Antimycotics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P33/00—Antiparasitic agents
- A61P33/02—Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Reproductive Health (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Gynecology & Obstetrics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Tropical Medicine & Parasitology (AREA)
- Urology & Nephrology (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a povidone iodine suppository, which is prepared by taking povidone iodine as a main medicine, taking 50% PEG-400 aqueous solution as a main medicine solvent and taking PEG-6000 as a suppository matrix, wherein the using amount of each raw material is as follows: 35-40 parts of povidone iodine, 13-16 parts of 50% PEG-400 aqueous solution and 30-33 parts of PEG-6000. The novel povidone iodine suppository is prepared by using the main medicine solvent and the matrix in specific types and proportions, has proper hardness, fine and smooth appearance, proper melting time limit and main medicine content, and accords with the regulations of Chinese pharmacopoeia.
Description
Technical Field
The invention relates to the field of pharmaceutical preparations, and in particular relates to a povidone iodine suppository and a preparation method thereof.
Background
Povidone iodine is an amorphous soluble compound formed by combining polyvinylpyrrolidone homopolymer (PVP) and iodine, can increase the solubility and stability of iodine, has stronger bactericidal action, and has better curative effects on mycotic and trichomonas vaginitis, cervicitis, cervical erosion and other diseases.
The suppository is a common preparation formulation, can overcome the stimulation of an oral preparation formulation to gastrointestinal tracts, can avoid the liver first-pass effect possibly generated by the oral preparation formulation, reduces the generation of adverse reactions, improves the bioavailability and enhances the curative effect. Meanwhile, the suppository is also a very suitable dosage form for gynecological diseases.
Therefore, there is a need to develop new povidone-iodine suppositories.
Disclosure of Invention
The invention mainly aims to provide a novel povidone iodine suppository. Furthermore, the invention also provides a preparation method of the povidone iodine suppository.
The specific technical scheme is as follows:
the invention provides a povidone iodine suppository, which is prepared by taking povidone iodine as a main medicine, taking 50% PEG-400 aqueous solution as a main medicine solvent and taking PEG-6000 as a suppository matrix, wherein the using amount of each raw material is as follows:
35-40 parts by weight of povidone iodine,
13-16 parts of 50% PEG-400 aqueous solution,
and (3) PEG-600030-33 parts by weight.
In some embodiments of the invention, the 50% PEG-400 aqueous solution is used in an amount of 14 parts by weight.
In some embodiments of the present invention, PEG-6000 is used in an amount of 32.2 parts by weight.
In some embodiments of the invention, the starting materials are used in the following amounts:
3.8 parts by weight of povidone iodine,
14 parts by weight of 50% PEG-400 aqueous solution,
PEG-600032.2 weight portions.
In some embodiments of the invention, the povidone-iodine suppository has a time-to-fusion of 40 to 45 minutes.
In some embodiments of the invention, each povidone-iodine suppository contains povidone iodine in an amount of 0.017 to 0.023g calculated as effective iodine (I).
In a second aspect, the present invention provides a method for preparing the povidone-iodine suppository, which comprises the following steps:
(1) dissolving povidone iodine in 50% of PEG-400 aqueous solution to obtain main drug solution;
(2) heating and melting PEG-6000 to obtain clear liquid to obtain a liquid matrix;
(3) adding the liquid matrix into the main medicine solution to obtain a main medicine suspension;
(4) and cooling the main medicine suspension, filling the main medicine suspension into a suppository mold bag, and cooling to solidify the main medicine suspension to obtain the povidone iodine suppository.
In some embodiments of the second aspect of the invention, the principal drug suspension is cooled to 50 ℃ prior to filling into the suppository mold bag.
Advantageous effects
The novel povidone iodine suppository is prepared by using the main medicine solvent and the matrix in specific types and proportions, has proper hardness, fine and smooth appearance, proper melting time limit and main medicine content, and accords with the regulations of Chinese pharmacopoeia.
Detailed Description
The following description of the embodiments of the present invention is provided for the purpose of making the objects, technical solutions and advantages of the present invention more apparent, and the technical solutions of the present invention will be described in detail and fully with reference to the following embodiments.
In the following examples, those not indicated with specific conditions were performed according to conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.
Preparation of povidone iodine suppository
Example 1
The preparation of 10 granules of povidone iodine suppository according to the following prescription
The preparation steps are as follows:
(1) dissolving povidone iodine in 50% of PEG-400 aqueous solution to obtain main drug solution;
(2) heating and melting PEG-6000 to obtain clear liquid to obtain a liquid matrix;
(3) adding the liquid matrix into the main drug solution under slow stirring to obtain a main drug suspension;
(4) and cooling the main medicine suspension to 50 ℃, filling the main medicine suspension into a suppository mold bag, and cooling to solidify the main medicine suspension to obtain the povidone iodine suppository.
Wherein, the 50% PEG-400 aqueous solution refers to the aqueous solution with the PEG-400 mass fraction of 50%, and the PEG represents the polyethylene glycol.
Example 2
A suppository of 10 povidone-iodine was prepared as follows according to the method of example 1.
Comparative example 1
A suppository of 10 povidone-iodine was prepared as follows according to the method of example 1.
Comparative example 2
A suppository of 10 povidone-iodine was prepared as follows according to the method of example 1.
Comparative example 3
A suppository of 10 povidone-iodine was prepared as follows according to the method of example 1.
Comparative example 4
A suppository of 10 povidone-iodine was prepared as follows according to the method of example 1.
Comparative example 5
A suppository of 10 povidone-iodine was prepared as follows according to the method of example 1.
Comparative example 6
A suppository of 10 povidone-iodine was prepared as follows according to the method of example 1.
Comparative example 7
A suppository of 10 povidone-iodine was prepared as follows according to the method of example 1.
The results of the preparations of examples 1-2 and comparative examples 1-7 and the indices of the povidone-iodine suppositories prepared were examined and the results are reported in table 1 below.
TABLE 1
As can be seen from the above Table 1, the comparative examples 1-2 adopt medicinal ethanol as a main drug solvent, and have the problems that the raw materials are agglomerated and can not be filled. This problem was solved by replacing the solvent with an aqueous solution of PEG-400.
Further, from the results of the preparations of comparative examples 3 to 5, it can be seen that the moldability was not satisfactory when the combination of PEG-1000 and PEG-4000 was used as a suppository base, and that the suspensions of comparative examples 3 to 5 were too thin and did not form.
Comparative example 6 PEG-1000 was removed and PEG-4000 alone as the suppository base, which was soft and rough in appearance, although formable.
Comparative example 7 the appearance was slightly improved by adding PEG-6000 to the suppository base, based on comparative example 6.
The povidone-iodine suppository prepared according to the examples 1-2 of the invention has the advantages of obviously better moldability, appearance and melting time limit than those of the suppository prepared according to the comparative examples 1-7, especially the suppository prepared according to the example 2, and more ideal indexes.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the present invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention.
Claims (8)
1. The povidone-iodine suppository is characterized by being prepared by taking povidone iodine as a main medicine, taking 50% PEG-400 aqueous solution as a main medicine solvent and taking PEG-6000 as a suppository matrix, wherein the using amount of each raw material is as follows:
35-40 parts by weight of povidone iodine,
13-16 parts of 50% PEG-400 aqueous solution,
and (3) PEG-600030-33 parts by weight.
2. The povidone-iodine suppository of claim 1, wherein the 50% PEG-400 aqueous solution is used in an amount of 14 parts by weight.
3. The povidone-iodine suppository of claim 1, wherein PEG-6000 is used in an amount of 32.2 parts by weight.
4. The povidone-iodine suppository of claim 1, wherein the raw materials are used in the following amounts:
3.8 parts by weight of povidone iodine,
14 parts by weight of 50% PEG-400 aqueous solution,
PEG-600032.2 weight portions.
5. A povidone-iodine suppository as claimed in any one of claims 1 to 4, which has a time limit of fusion of 40 to 45 minutes.
6. The povidone-iodine suppository of any one of claims 1 to 4, wherein the povidone-iodine is present in each suppository in an amount of 0.017 to 0.023g, calculated as available iodine (I).
7. A method of preparing a povidone-iodine suppository as claimed in any one of claims 1 to 6 which includes the steps of:
(1) dissolving povidone iodine in 50% of PEG-400 aqueous solution to obtain main drug solution;
(2) heating and melting PEG-6000 to obtain clear liquid to obtain a liquid matrix;
(3) adding the liquid matrix into the main medicine solution to obtain a main medicine suspension;
(4) and cooling the main medicine suspension, filling the main medicine suspension into a suppository mold bag, and cooling to solidify the main medicine suspension to obtain the povidone iodine suppository.
8. The process of claim 7, wherein the suspension of the principal drug is cooled to 50 ℃ prior to filling into the suppository mold pack.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110818972.1A CN113559053A (en) | 2021-07-20 | 2021-07-20 | Povidone-iodine suppository and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110818972.1A CN113559053A (en) | 2021-07-20 | 2021-07-20 | Povidone-iodine suppository and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN113559053A true CN113559053A (en) | 2021-10-29 |
Family
ID=78165779
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110818972.1A Pending CN113559053A (en) | 2021-07-20 | 2021-07-20 | Povidone-iodine suppository and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN113559053A (en) |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4755378A (en) * | 1985-08-17 | 1988-07-05 | Euroceltique, S.A. | Iodophor-containing suppository |
| RU2262344C2 (en) * | 2001-07-25 | 2005-10-20 | Дж.Б.Кемикалс Энд Фармасьютикалс Лтд. | Pharmaceutical composition for treatment of cutaneous infection and method for its preparing |
| CN102846725A (en) * | 2012-03-21 | 2013-01-02 | 华南农业大学 | Compound povidone iodine suppository and preparation method and application thereof |
| CN103720640A (en) * | 2013-12-31 | 2014-04-16 | 哈尔滨欧替药业有限公司 | Povidone-iodine vaginal swelling suppository, as well as preparation method and detection method thereof |
| CN110025632A (en) * | 2019-05-20 | 2019-07-19 | 中山万汉制药有限公司 | A kind of povidone iodine composition and preparation method thereof and external preparation |
| CN110141580A (en) * | 2019-07-03 | 2019-08-20 | 河南大华生物技术有限公司 | A kind of animal povidone iodine and diethylstilbestrol compound suppository and preparation method thereof |
-
2021
- 2021-07-20 CN CN202110818972.1A patent/CN113559053A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4755378A (en) * | 1985-08-17 | 1988-07-05 | Euroceltique, S.A. | Iodophor-containing suppository |
| RU2262344C2 (en) * | 2001-07-25 | 2005-10-20 | Дж.Б.Кемикалс Энд Фармасьютикалс Лтд. | Pharmaceutical composition for treatment of cutaneous infection and method for its preparing |
| CN102846725A (en) * | 2012-03-21 | 2013-01-02 | 华南农业大学 | Compound povidone iodine suppository and preparation method and application thereof |
| CN103720640A (en) * | 2013-12-31 | 2014-04-16 | 哈尔滨欧替药业有限公司 | Povidone-iodine vaginal swelling suppository, as well as preparation method and detection method thereof |
| CN110025632A (en) * | 2019-05-20 | 2019-07-19 | 中山万汉制药有限公司 | A kind of povidone iodine composition and preparation method thereof and external preparation |
| CN110141580A (en) * | 2019-07-03 | 2019-08-20 | 河南大华生物技术有限公司 | A kind of animal povidone iodine and diethylstilbestrol compound suppository and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 潘承法,翁林福: "聚维酮碘栓的制备", 中国药学杂志, no. 12, pages 55 * |
| 袁吉根;: "聚维酮碘栓制备的处方工艺优选", 中国药业, no. 07, pages 43 - 9 * |
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Application publication date: 20211029 |