CN113456617B - Ferrous succinate oral instant film and preparation method thereof - Google Patents
Ferrous succinate oral instant film and preparation method thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/26—Iron; Compounds thereof
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- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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Abstract
The invention discloses a ferrous succinate oral instant membrane which is prepared by taking ferrous succinate as an active ingredient, a film-forming agent, a plasticizer and a taste masking agent; the weight ratio of the active ingredient to the inactive ingredient is 1-30; the weight ratio of the film forming agent to the plasticizer to the taste masking agent is 8-5. The invention also discloses a preparation method of the ferrous succinate oral instant membrane, which comprises the steps of weighing the ferrous succinate, the film forming agent, the plasticizer and the taste masking agent according to the formula, dispersing the ferrous succinate, the film forming agent, the plasticizer and the taste masking agent into water, stirring and dissolving the mixture to prepare viscous liquid with the mass fraction of the film forming agent being 5-15%, standing the viscous liquid to remove air bubbles, spreading the obtained viscous liquid on a mold or coating the viscous liquid to form a membrane, drying the membrane, forming the membrane and cutting the membrane into a membrane with target specification. The ferrous succinate oral instant membrane has the characteristics of high drug dissolution speed, good absorption, high bioavailability, easy carrying, convenient administration, good patient compliance and the like.
Description
Technical Field
The invention relates to an oral instant membrane and a preparation method thereof, in particular to a ferrous succinate oral instant membrane and a preparation method thereof capable of being industrially implemented.
Background
Imbalance in the body's demand and supply of iron results in depletion of stored iron in the body, followed by iron deficiency in erythrocytes, ultimately leading to iron deficiency anemia.
The incidence of iron deficiency anemia is significantly higher in developing countries, economically undeveloped areas, infants, women of childbearing age. The crowd survey shows that: the annual incidence of iron deficiency anemia is 75.0-82.5% in infants between 6 months and 2 years old, 66.7% in women over 3 months of gestation, 43.3% in women of childbearing age and 13.2% in adolescents between 10 years and 17 years old; the prevalence rates of the iron-deficiency anemia of the people are 33.8-45.7%, 19.3%, 11.4% and 9.8% respectively.
Iron deficiency anemia is mainly associated with the following factors: inadequate supplementary food for infants, menorrhagia/multiple pregnancies/lactation for women, monophagia for teenagers, and some pathological factors such as gastrostaxis, chronic blood loss, chronic diarrhea, atrophic gastritis and hookworm infection.
The treatment principle of the iron deficiency anemia is to supplement iron on the basis of actively correcting the iron deficiency cause.
The development of the iron supplement agent can be roughly divided into four stages: the first generation iron supplement agent is mainly small molecular inorganic iron salt, such as ferrous sulfate; the second generation iron supplement agent mainly comprises organic acid iron salt, such as ferrous succinate; the first and second generation iron supplement agent is mainly oral bivalent iron; the third and fourth generation iron supplement agents mainly comprise ferric iron and are administered intravenously, such as ferric sodium ethylenediamine tetraacetate, ferric sucrose, ferric carboxymaltose, etc.
The ferrous succinate is anhydrous basic salt with iron content of 34-36%, is dark yellow amorphous powder, and has slight odor. According to the BCS classification standard issued by WHO, ferrous succinate is a BCS and 3-class drug, namely a high-solubility and high-permeability drug. Ferrous succinate has many advantages: the iron content is higher, nearly approaches to twice of the iron content in ferrous sulfate under the same dosage; the dissociation rate of the ferrous succinate is slower than that of the ferrous sulfate, the irritation to the gastrointestinal tract is small, and the side effect is little and light; ferrous succinate is absorbed in the duodenum and the proximal jejunum of a human body, and the absorption rate of the ferrous succinate is related to factors such as the dissolution rate of ferrous and the degree of iron deficiency in the body. However, under the damp-heat condition, ferrous succinate is not stable and is easily oxidized into ferric succinate.
An orally fast dissolving film is generally a solid preparation that dissolves rapidly after oral administration and is absorbed through the mucosa of the oral cavity or the gastrointestinal tract. The oral instant film has the advantages that: drinking water is not needed, and the use is convenient; the typical product is designed to be the size of a postage stamp, which dissolves rapidly in the mouth and swallows with normal swallowing; the compliance of patients is good, and the medicine is particularly suitable for children or the old with swallowing inconvenience; the independent single dose package effectively isolates air and moisture to increase the stability of the medicine, and the like.
Disclosure of Invention
The technical problem to be solved by the invention is to provide the ferrous succinate oral instant membrane, which not only ensures that the ferrous succinate is quickly dissolved out in the oral cavity and has proper taste, is beneficial to the absorption and the bioavailability improvement of effective components at the stomach and duodenum parts, but also ensures that a patient is easy to carry, convenient to take and good in compliance; meanwhile, the preparation is simple, and the process reproducibility is good.
In order to achieve the purpose, the invention provides the following technical scheme:
an oral instant film of ferrous succinate is prepared from ferrous succinate as active component, filming agent, plasticizer and taste-masking agent.
The weight ratio of the active ingredient (ferrous succinate) to the inactive ingredient (film forming agent, plasticizer and taste masking agent) is (1-30) to (99-70), preferably 1; the weight ratio of the film forming agent to the plasticizer to the taste masking agent is (8-5) to (1-3) to (1-2), and preferably is (8-5).
The ferrous succinate oral instant membrane is prepared by the following method: at room temperature, ferrous succinate, a film forming agent, a plasticizer and a taste masking agent are respectively weighed according to the formula, dispersed in water, stirred and dissolved to prepare a viscous liquid with the film forming agent accounting for 5-15% by mass, kept stand to remove air bubbles, and the obtained viscous liquid is laid on a mold or coated to form a film, dried, formed and cut into a film with the target specification.
The ferrous succinate is less than 100 meshes.
The film forming agent is selected from one or more of natural, water-soluble polymer materials or synthetic, water-soluble polymer materials or other pharmaceutically-allowable arbitrary water-soluble film forming materials. The natural and water-soluble high molecular material is selected from dextrin, gelatin, sodium alginate, carrageenan, xanthan gum, guar gum, chitin and the like; the synthetic water-soluble polymer high molecular material is selected from polyvinylpyrrolidone, polyvinyl alcohol, hydroxypropyl methylcellulose, cellulose ether polymers, acrylate polymers and the like.
Preferably, the film forming agent is selected from polyvinylpyrrolidone and hydroxypropyl methylcellulose.
An important feature of the oral fast dissolving film is: the oral fast dissolving film melts in the oral cavity in 30 seconds or less. The inventor finds that: in the ferrous succinate oral instant film agent, if polyvinylpyrrolidone is selected as a film forming material, the dissolution rate is high, and a viscous liquid formed after dissolution is favorable for shielding uncomfortable mouthfeel of taste buds to iron. Therefore, more preferably, the film forming agent is selected from polyvinylpyrrolidone, in particular polyvinylpyrrolidone k30.
The plasticizer is selected from one or more of polyalcohol compounds, organic carboxylic ester compounds or other pharmaceutically-allowable arbitrary water-soluble plasticizers. The polyalcohol compounds are selected from glycerol, propylene glycol, polyethylene glycol and the like. The organic carboxylic ester compound is selected from triethyl citrate, tributyl citrate, dibutyl sebacate, diethyl phthalate and the like.
Preferably, the plasticizer is selected from polyethylene glycol and triethyl citrate.
More preferably, the plasticizer is selected from polyethylene glycol, in particular polyethylene glycol 400.
The taste masking agent is selected from one or more of sweetening agent, aromatic agent, sour agent, amino acid ingredient or other pharmaceutically allowable optional taste masking agents. The sweetener is selected from sucrose, mel, saccharin sodium, aspartame, stevioside, mogroside, etc. The flavoring agent is selected from lemon essence, mint essence, apple essence, banana essence, etc. The sour agent is selected from succinic acid, citric acid, etc. The amino acid compound is selected from arginine, sodium glutamate and the like.
Preferably, the taste-masking agent is selected from succinic acid and citric acid.
Different dispersion media were prepared, and the solubility of ferrous ion in ferrous succinate (mg/ml, 37 ℃) was measured according to the method, and the results are shown in table 1. The inventors found that in the succinic acid/sodium hydroxide buffer, the solubility of ferrous ions was significantly increased, indicating that succinic acid has a significant solubilizing effect on the dissolution of ferrous succinate.
Table 1: solubility of ferrous ion in ferrous succinate (mg/ml, 37 ℃ C.)
| pH1.2 | pH2.0 | pH4.5 | pH6.8 | |
| Hydrochloric acid solution | 3.22 | 0.81 | / | / |
| Succinic acid/sodium hydroxide buffer | 4.1 | 1.85 | 2.11 | 2.31 |
The important characteristics of the oral instant film agent are as follows: the composition should have pleasant taste when taken, so as to increase the compliance of patients in taking medicines. The inventor finds that the proper amount of succinic acid is added into the oral instant film agent of ferrous succinate, so that the solubility of the ferrous succinate can be effectively increased, and the bad taste of the ferrous succinate can be obviously improved.
More preferably, the taste-masking agent is selected from succinic acid.
As the most preferable technical scheme of the ferrous succinate oral instant membrane, the oral instant membrane is prepared by taking ferrous succinate as an active ingredient, polyvinylpyrrolidone as a film-forming agent, polyethylene glycol as a plasticizer and succinic acid as a taste masking agent.
The invention also aims to provide a preparation method of the ferrous succinate oral instant membrane which is suitable for industrial implementation.
A preparation method of ferrous succinate oral instant membrane comprises the following steps:
weighing raw materials according to a formula, and dispersing ferrous succinate, a film-forming agent, a plasticizer and a taste masking agent in water to obtain an aqueous dispersion with the mass fraction of the film-forming agent being 5-15%;
step (2), fully stirring the aqueous dispersion until the aqueous dispersion is dissolved, and standing to remove air bubbles to obtain viscous liquid;
step (3), coating the viscous liquid into a film and drying;
and (4) stripping the dried film, and cutting the film into a film sheet with the target specification.
In the step (2), the standing time is based on that no bubbles exist on the surface of the viscous liquid after standing.
In the step (3), the drying temperature is below 60 ℃.
The preparation method of the ferrous succinate oral instant membrane further comprises the following steps: and (3) correspondingly inspecting and checking the ferrous succinate oral instant membrane to be qualified, and subpackaging the ferrous succinate oral instant membrane into specified packages according to the marked amount of the active ingredients to obtain the independently packaged ferrous succinate oral instant membrane.
Ferrous succinate is less stable under humid conditions. The inventor finds that: the ferrous succinate oral instant film is independently packaged by adopting a polyethylene/aluminum layer composite film bag, so that the ferrous succinate oral instant film can be stored for a long time at room temperature, and the stability is better.
Detailed Description
The ferrous succinate used in the invention is produced by Nanjing Jinling pharmaceutical factory of Jinling pharmaceutical industry GmbH, the used film-forming agent, plasticizer and taste-masking agent are all purchased in the market, and all the materials accord with the 2020 edition standard of Chinese pharmacopoeia.
The most important index for evaluating the quality of the oral instant film is the evaluation of drug-loading performance, such as the disintegration time limit and the content of the oral instant film agent.
The examination method of the oral instant film agent is not loaded in the examination method of disintegration time limit of '2020 edition, four departments and 0921 of Chinese pharmacopoeia'. The inventor sets the test device and the requirement thereof of ' disintegration time limit inspection method ' of ' 2020 edition, four departments, 0921 of ' Chinese pharmacopoeia ' by using a phosphate buffer solution with pH 6.8 simulating oral liquid as a medium for oral instant film disintegration time limit inspection according to American medicine evaluation research center guidelines, and film samples completely pass through a fixed-aperture screen as an index for evaluating drug-loading performance within 30 seconds.
The disintegration time of the following examples was measured with reference to a test apparatus of "examination method of disintegration time" in "Chinese pharmacopoeia 2020 edition, four parts, 0921, and the like, and the medium for disintegration was a phosphate buffer solution having a pH of 6.8, and the disintegration time was 30 seconds.
Example 1
The formula of the ferrous succinate oral instant film comprises the following components:
preparation: weighing ferrous succinate, polyvinylpyrrolidone k30, polyethylene glycol 400, succinic acid and purified water according to a formula, dispersing the ferrous succinate, the polyvinylpyrrolidone k30, the polyethylene glycol 400 and the succinic acid in the purified water, stirring until the mixture is dissolved to prepare a viscous liquid with polyvinylpyrrolidone k30 mass fraction of 10%, and standing until no bubbles exist on the surface of the solution; coating the viscous liquid into a film, and placing the film in a drying oven for heat preservation and drying at 60 ℃; detecting that the moisture content of the coating film is less than 1 percent, meeting relevant regulations, stripping the film, and cutting the film into a film with a target specification; and (3) taking a film agent sample for carrying out disintegration time limit detection.
Checking disintegration time limit: and 6 parts of film agent samples to be tested are taken and respectively placed in glass tubes of a hanging basket, a disintegration tester is started for inspection, and the samples completely pass through a screen with a fixed aperture within 30 seconds, so that the film agent samples meet the requirements. The results are shown in Table 2.
Table 2: example 1 examination result of disintegration time limit of ferrous succinate oral fast dissolving film
| Film agent sample | 1 | 2 | 3 | 4 | 5 | 6 |
| Disintegration time limit (seconds) | 12 | 9 | 10 | 10 | 11 | 12 |
And (3) hermetically packaging a ferrous succinate oral instant film sample by adopting a polyethylene/aluminum layer composite film.
Example 2
The formula of the ferrous succinate oral instant film comprises the following components:
preparation: weighing ferrous succinate, polyvinylpyrrolidone k30, polyethylene glycol 400, succinic acid and purified water according to a formula, dispersing the ferrous succinate, the polyvinylpyrrolidone k30, the polyethylene glycol 400 and the succinic acid in the purified water, stirring until the mixture is dissolved to prepare a viscous liquid with polyvinylpyrrolidone k30 mass fraction of 10%, and standing until no bubbles exist on the surface of the solution; coating the viscous liquid into a film, and placing the film in a drying oven for heat preservation and drying at 60 ℃; detecting that the water content of the coating film is less than 1 percent and meets related regulations, stripping the film and cutting the film into a film with a target specification; and (3) taking a film agent sample for carrying out disintegration time limit detection.
Checking disintegration time limit: 6 parts of film agent samples to be tested are taken and respectively placed in glass tubes of hanging baskets, a disintegration tester is started for inspection, and the samples completely pass through a screen with a fixed aperture within 30 seconds, so that the film agent samples meet the requirements. The results are shown in Table 3.
Table 3: example 2 examination result of disintegration time limit of ferrous succinate oral fast dissolving film
| Film agent sample | 1 | 2 | 3 | 4 | 5 | 6 |
| Disintegration time limit (seconds) | 14 | 18 | 15 | 17 | 17 | 14 |
Example 3
Samples of ferrous succinate oral fast dissolving film were prepared and packaged as in example 1 and subjected to the "influential factor test".
According to the standard of the stability test of raw material medicines and pharmaceutical preparations in China pharmacopoeia 2020 edition, four parts and 9001, the ferrous succinate oral instant film packaged by a polyethylene/aluminum layer composite film bag (which is easily dissolved into a mass under the high-humidity condition and is easily oxidized under the high-temperature condition, so that an influence factor test is carried out by adopting a completely packaged sample) is respectively placed under the conditions of high temperature (60 ℃), high humidity (25 +/-5 percent, RH92.5 percent) and strong light (4500 Lx +/-500 Lx) for sampling for 0 day, 5 days and 10 days, and the disintegration time limit and content inspection are carried out according to the law. The results are shown in tables 4 and 5.
Table 4: examination result of disintegration time limit of ferrous succinate oral instant film (unit: second) under different influence factors
Table 5: examination result of iron content in ferrous succinate oral instant membrane under different influence factors
| Day 0 | High temperature for 5 days | High humidity for 5 days | Strong light for 5 days |
| 35.0％ | 34.3％ | 34.6％ | 34.5％ |
| Day 0 | High temperature for 10 days | High humidity for 10 days | Illuminating for 10 days |
| 35.0％ | 34.3％ | 34.5％ | 34.7％ |
Note: the iron content is calculated by ferrous iron and is 31.5 to 37.0 percent of the marked amount; the average of 6 samples of ferrous succinate oral fast dissolving film.
Example 4
3 batches of ferrous succinate oral fast dissolving film samples were prepared and packaged as in example 1 for "accelerated stability testing".
According to the standard of the stability test of bulk drugs and pharmaceutical preparations in the Chinese pharmacopoeia 2020 edition, the four parts and 9001, the samples of ferrous succinate oral instant films packaged by polyethylene/aluminum layer composite film bags are placed in a constant temperature and humidity box (40 ℃ plus or minus 2 ℃ and RH75 percent plus or minus 5 percent), the samples are respectively sampled in 0, 1, 2, 3 and 6 months, the disintegration time limit and the content of the samples are checked according to the method, and each batch is respectively detected for three times. The results are shown in tables 6 and 7.
Table 6: examination result of disintegration time limit of ferrous succinate oral instant film under accelerated stability test conditions (unit: second)
Table 7: iron content inspection result of ferrous succinate oral instant membrane under accelerated stability test condition
| Batches of | Day 0 | Accelerated for 1 month | Accelerated for 2 months | Accelerated for 3 months | Accelerated for 6 months |
| 1 | 34.6％ | 34.4％ | 34.4％ | 34.4％ | 32.3％ |
| 2 | 34.4％ | 34.4％ | 34.3％ | 34.0％ | 35.0％ |
| 3 | 34.3％ | 34.4％ | 34.4％ | 34.1％ | 34.2％ |
| 1 | 35.2％ | 34.9％ | 35.1％ | 34.4％ | 33.0％ |
| 2 | 34.5％ | 34.4％ | 34.2％ | 34.3％ | 34.2％ |
| 3 | 34.2％ | 34.4％ | 34.3％ | 34.4％ | 34.2％ |
| 1 | 34.6％ | 34.4％ | 34.6％ | 33.8％ | 32.8％ |
| 2 | 34.4％ | 34.4％ | 34.3％ | 34.0％ | 34.9％ |
| 3 | 34.2％ | 35.1％ | 34.8％ | 34.8％ | 35.0％ |
Note: the content of iron is 31.5-37.0% of the marked amount in terms of ferrous iron.
Claims (6)
1. The ferrous succinate oral instant film is characterized in that: the oral instant film is prepared by taking ferrous succinate as an active ingredient, and a film forming agent, a plasticizer and a taste masking agent, wherein the weight ratio of the active ingredient to the inactive ingredient is 1-30; the weight ratio of the film forming agent to the plasticizer to the taste masking agent is 8-5; the film forming agent is selected from polyvinylpyrrolidone; the plasticizer is selected from polyethylene glycol; the taste masking agent is selected from succinic acid.
2. An oral instant film of ferrous succinate, which is characterized in that: the oral instant film is prepared by taking ferrous succinate as an active ingredient, and a film forming agent, a plasticizer and a taste masking agent, wherein the weight ratio of the active ingredient to the inactive ingredient is 1; the weight ratio of the film forming agent to the plasticizer to the taste masking agent is 8-5; the film forming agent is selected from polyvinylpyrrolidone; the plasticizer is selected from polyethylene glycol; the taste masking agent is selected from succinic acid.
3. The ferrous succinate oral fast dissolving film according to claim 1 or 2, characterized in that: the ferrous succinate oral instant membrane is prepared by the following method: the ferrous succinate, the film forming agent, the plasticizer and the taste masking agent are respectively weighed according to the formula, dispersed in water, stirred and dissolved to prepare a viscous liquid with the film forming agent accounting for 5 to 15 percent by mass, kept stand to remove air bubbles, the obtained viscous liquid is spread on a die or coated to form a film, dried, formed and cut into a film with the target specification.
4. The ferrous succinate oral fast dissolving film according to claim 1 or 2, wherein: the ferrous succinate is less than 100 meshes.
5. A method of preparing the ferrous succinate oral fast dissolving film of claim 1 or 2, characterized in that: comprises the following steps:
weighing raw materials according to a formula, and dispersing ferrous succinate, a film-forming agent, a plasticizer and a taste masking agent in water to obtain an aqueous dispersion with the mass fraction of the film-forming agent being 5-15%;
step (2), stirring the aqueous dispersion until the aqueous dispersion is dissolved, and standing to remove air bubbles to obtain viscous liquid;
step (3), coating the viscous liquid to form a film, and drying;
and (4) stripping the dried film, and cutting the film into a film sheet with the target specification.
6. The method of claim 5, wherein the iron succinate oral fast dissolving film comprises: according to the marked amount of the active ingredients, the ferrous succinate oral instant membrane is subpackaged in the specified polyethylene/aluminum layer composite membrane bag for independent packaging to obtain the ferrous succinate oral instant membrane with independent packaging.
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