CN115258421B - Packaging method for improving stability of capsules - Google Patents
Packaging method for improving stability of capsules Download PDFInfo
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- CN115258421B CN115258421B CN202211060926.0A CN202211060926A CN115258421B CN 115258421 B CN115258421 B CN 115258421B CN 202211060926 A CN202211060926 A CN 202211060926A CN 115258421 B CN115258421 B CN 115258421B
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
- B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
- B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
- B65D81/266—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
- A61J1/035—Blister-type containers
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02W—CLIMATE CHANGE MITIGATION TECHNOLOGIES RELATED TO WASTEWATER TREATMENT OR WASTE MANAGEMENT
- Y02W90/00—Enabling technologies or technologies with a potential or indirect contribution to greenhouse gas [GHG] emissions mitigation
- Y02W90/10—Bio-packaging, e.g. packing containers made from renewable resources or bio-plastics
Abstract
The application discloses a packaging method for improving the stability of capsules and capsules adopting the packaging method, wherein the active ingredients of the capsules are oxygen-sensitive medicines, the packaging method comprises the steps of packaging the capsules in a medicine packaging container, and a double-absorption deoxidizer is placed in the medicine packaging container. The packaging method can prevent the oxygen-sensitive medicine from being oxidized by contacting oxygen in the air to cause the increase of related substances, and simultaneously maintain proper relative humidity, prevent the capsule shell from losing moisture and becoming brittle, further influence the properties, dissolution and the like of the medicine, and further effectively maintain the quality of the medicine. Compared with the method of directly adding the antioxidant in the prescription, the method can avoid the problem of compatibility of raw materials and auxiliary materials possibly caused by adding new auxiliary materials, and can also avoid reevaluation caused by changing the prescription process of the preparation.
Description
Technical Field
The application belongs to the technical field of pharmaceutical preparations, and particularly relates to a packaging method for improving the stability of capsules, capsules adopting the packaging method, and application of double-absorption deoxidizer in preparation of oxygen-sensitive pharmaceutical capsules.
Background
Stability of drugs is a major and difficult point of drug development. Moisture and oxygen can be introduced into the medicine in the links of production, storage, circulation and the like, so that impurities are increased and exceed the quality standard limit, and the stability problem of the medicine can be solved by controlling the preparation process, packaging, drying agent and the like. Oxygen sensitive drugs often require additional excipients, packaging and/or manufacturing steps to enhance stability. Chemical methods (e.g., pH control, addition of antioxidants and control components) are generally first considered as a means of enhancing the stability of oxygen sensitive drugs. The chemical method has the defect that the compatibility of the raw materials and the auxiliary materials can be caused by adding the auxiliary materials, and the re-evaluation can be caused by changing the prescription process of the preparation.
Oxygen sensitive pharmaceutical formulations also require extra care in storage and circulation to be isolated from air, oxygen. Oxygen sensitive active pharmaceutical ingredients are susceptible to oxidation by oxygen to produce impurities, which can lead to too rapid growth of the relevant substances beyond quality standards. Packaging of pharmaceuticals is an important factor in preventing the above-mentioned changes in the storage and distribution of pharmaceuticals from exceeding limits. Generally, after the medicine is packed in the blister, the medicine is directly packed in the packing box, but the blister still has certain permeability after packing due to the barrier property of the packing material, the packing process and the like, and the medicine can still contact moisture or oxygen, so that the medicine is degraded or deteriorated. Sealing the blister sheet in a composite film pouch can further reduce the degree of contact of the drug with moisture and oxygen, but the risk of degradation or deterioration is still higher for highly active pharmaceutical ingredients. In order to further reduce the risk of the quality of the medicine exceeding the quality standard, for tablets or preparations which are not sensitive enough to moisture, a drying agent and/or a deoxidizing agent can be added into the composite film bag to continuously absorb moisture and/or oxygen, so that the stability of the preparation is improved.
However, for oxygen sensitive drug capsules, conventional deoxidizers still cannot solve the problem of impurity growth during long-term storage. And simultaneously adding the drying agent can cause the characteristic change of the capsule shell, thereby affecting the properties of the capsule, the dissolution of medicines and the like.
Disclosure of Invention
One of the purposes of the present application is to provide a packaging method for improving the stability of capsules and capsules using the packaging method, which can prevent or reduce oxidation impurities generated by oxidation of oxygen sensitive drugs in capsules and prevent denaturation of capsule shells to affect the quality of the drugs.
The second object of the application is to provide the application of the double-absorption deoxidizer in the preparation of oxygen-sensitive medicine capsules.
According to one aspect of the present application, there is provided a packaging method for improving stability of a capsule, wherein a pharmaceutically active ingredient of the capsule is an oxygen-sensitive drug, the packaging method is to encapsulate the capsule in a drug packaging container, and a double-absorption deoxidizer is placed in the drug packaging container.
Further, the capsule shell of the capsule contains gelatin. The capsule can be a hard capsule or a soft capsule.
Further, the capsule is one of a gelatin empty capsule, an enteric gelatin empty capsule or a gelatin soft capsule.
Further, the total oxygen absorption amount of the double-absorption deoxidizer is not less than 20% of the packaging container.
Further, the total oxygen absorption amount of the double-absorption deoxidizer is not less than 50% of the packaging container.
Further, the moisture absorption rate of the double-absorption deoxidizer is not higher than 15% in 48 hours under the conditions that the temperature is 25+/-2 ℃ and the relative humidity is 50+/-5%; the moisture absorption rate of the double-absorption deoxidizer is not lower than 20% in 48 hours under the conditions of the temperature of 25+/-2 ℃ and the relative humidity of 90+/-5%.
Further, in one embodiment, the pharmaceutical packaging container is a pharmaceutical packaging bottle.
Further, in another embodiment, the pharmaceutical packaging container is a composite film pouch, the capsule is first enclosed within a blister of a blister sheet, and the blister sheet is then enclosed within the composite film pouch.
Further, the oxygen-sensitive drug is selected from at least one of the following: cetirizine, levocetirizine, acetaminophen, ibuprofen, acetylcysteine, carbamazepine, verapamil, selegiline, ephedrine, oxybutynin, diltiazem, mexiletine, emedastine.
According to another aspect of the present application, there is also provided a capsule packaged by the above-mentioned packaging method for improving stability of the capsule.
According to another aspect of the present application, there is provided the use of a double-suction deoxidizer in the preparation of an oxygen-sensitive pharmaceutical capsule drug product for slowing the growth rate of oxidized impurities of the drug and preventing the denaturation of the capsule shell, thereby improving the stability and safety of the capsule drug product.
The application has the beneficial effects that:
according to the packaging method for improving the stability of the capsule, disclosed by the application, the active pharmaceutical ingredient of the capsule is an oxygen-sensitive drug, the capsule is packaged in the drug packaging container, the double-absorption deoxidizer is placed in the drug packaging container, the drug packaging container has barrier property to air, the double-absorption deoxidizer has strong deoxidizing capability and weak dehydrating capability, the drug is wet-isolated and oxygen-isolated, the active pharmaceutical ingredient in the capsule is inhibited from being contacted with oxygen in the air, oxidized and degraded to generate impurities, the quality of the drug is improved, meanwhile, the moisture of the capsule can be maintained, the capsule shell is prevented from losing moisture and becoming fragile, the properties, the dissolution quality and the like are further influenced, and the shelf life of the drug of the capsule is effectively prolonged. Compared with the direct addition of deoxidizer in the prescription, the method can avoid the compatibility problem of raw materials and auxiliary materials possibly caused by the addition of new auxiliary materials, and can also avoid the reevaluation caused by changing the prescription process of the preparation.
Drawings
FIG. 1 is a graph comparing the magnitude of increase in chlorobenzophenone and total impurities in an X200101 batch of levocetirizine hydrochloride capsule bubble cap sample acceleration test.
Fig. 2 is a graph comparing the increase amplitude of chlorbenzophenone and total impurities in a long-term test of X200101 batches of levocetirizine hydrochloride capsule bubble cap samples.
Fig. 3 is a graph comparing the increase amplitude of chlorobenzophenone and total impurities in an acceleration test of X200101 batches of levocetirizine hydrochloride capsule HDPE bottle packaging samples.
Fig. 4 is a graph comparing the increase amplitude of chlorobenzophenone and total impurities in a long-term test of X200101 batches of levocetirizine hydrochloride capsule HDPE bottle packaging samples.
Fig. 5 is a graph comparing the increase of impurity C and total impurities in the acceleration test of X201101 lot of acetylcysteine capsule blister samples.
Fig. 6 is a graph comparing the increase of impurity C and total impurities in a long-term test of X201101 lot of acetylcysteine capsule blister samples.
Detailed Description
The application provides a packaging method for improving the stability of a capsule, wherein the active pharmaceutical ingredient of the capsule is an oxygen-sensitive drug, and the oxygen in the oxygen-sensitive drug contacts with air to cause oxidative degradation, so that related impurities and total impurities are increased to influence the quality of the drug. The capsule is packaged in a medicine packaging container, and a double-suction deoxidizer is placed in the medicine packaging container.
The double-absorption deoxidizer is also called as a dry deoxidizer, has strong deoxidizing capability and weak dehydrating capability, is prepared by mixing reduced iron powder, silica gel fine powder, salt, resin and water as main raw materials, and adopts a solid medical polyethylene composite bag for packaging, which can absorb water in the air and oxygen in the air, so that the medicine is moisture-proof and oxygen-proof, and the medicine active ingredients in the capsule are inhibited from being contacted with oxygen in the air to oxidize and degrade to generate impurities, thereby improving the medicine quality.
The packaging method for improving the stability of the capsule can be hard capsules or soft capsules, and is particularly suitable for capsules, wherein the capsule shell of the capsules contains gelatin, such as gelatin empty capsules, enteric gelatin empty capsules, gelatin soft capsules and the like. If a drying agent is added into the capsule, the moisture loss is lower than the lower limit, so that the capsule shell becomes brittle, and even the dissolution speed of the medicine is possibly influenced, so that the quality of the medicine is unqualified.
One embodiment of the application is that the packaging container is a medicine packaging bottle. The capsule is directly packaged in a medicine packaging bottle, and then the double-suction deoxidizer is placed in the medicine packaging bottle. The medicine packaging bottle has a barrier function to air, and the material is not limited herein, and can be used as a glass bottle, a plastic bottle or other materials for medicine packaging in the prior art.
In another embodiment of the application, the capsule is firstly packaged in a bubble cap of a bubble cap plate, the bubble cap plate is hermetically packaged in a composite film bag, the composite film bag has the barrier property to air, and the double-suction deoxidizer is placed in the composite film bag. The composite film bag is preferably in the form of a self-sealing bag so that the package remains intact during administration after the drug has arrived in the hands of the consumer, reducing the level of oxygen exposure to the capsule, but this is not required, and the dosage per bag is sufficient to maintain the relevant substances of the drug in the process without increasing beyond limits. According to the embodiment of the application, the packaging technology of the composite film bag is only added after the original bubble cap procedure, the operation is simple and convenient, and the production efficiency is maintained unchanged.
Preferably, the total oxygen uptake of the double-absorption deoxidizer is not less than 20% of the packaging container loading, more preferably not less than 50% of the packaging container loading. When the medicine packaging container is a medicine packaging bottle, the filling amount of the medicine packaging container refers to the volume of the medicine packaging bottle; when the medicine packaging container is a composite film bag, the loading amount of the medicine packaging container refers to the volume of the composite film bag filled with oxygen (or air).
Preferably, the double-absorption deoxidizer has a moisture absorption rate of not more than 15% in 48 hours at a temperature of 25 ℃ +/-2 ℃ and a relative humidity of 50% +/-5%; the moisture absorption rate of the double-absorption deoxidizer is not lower than 20% in 48 hours under the conditions of the temperature of 25+/-2 ℃ and the relative humidity of 90+/-5%. The double-absorption deoxidizer has the total oxygen absorption and the moisture absorption rate, and can effectively prolong the shelf life of the capsule medicine. The total oxygen uptake and the moisture absorption rate were measured according to the conventional measurement method. Only one method for measuring the moisture absorption rate for reference is provided here: proper amount of sample (2 bags below 3 g/bag, 1 bag above 3 g/bag) is spread on a surface dish (or a proper container), dried for 2 hours at 150+/-5 ℃, cooled to room temperature, quickly and precisely weighed (m 1), and then placed in a constant temperature and humidity box, and two samples are prepared by the same method. The two samples were placed at a temperature of 25.+ -. 2 ℃ and a relative humidity of 50.+ -. 5% and 90.+ -. 5% for 48 hours, respectively, and then taken out for rapid and precise weighing (m 2). Calculated as follows: moisture absorption= (m 2-m 1)/m1×100%.
In the application, the active pharmaceutical ingredient of the capsule is oxygen-sensitive medicine. The oxygen sensitive drug is selected from at least one of the following: cetirizine, levocetirizine, acetaminophen, ibuprofen, acetylcysteine, carbamazepine, verapamil, selegiline, ephedrine, oxybutynin, diltiazem, mexiletine, emedastine. All the above listed are oxygen sensitive drugs, and the existing capsules are marketed, and there is a possibility that impurities are generated by oxidative degradation in circulation.
The application also provides a capsule, and the capsule is packaged by adopting the packaging method for improving the stability of the capsule.
The present application will be described in further detail below with reference to levocetirizine capsules and acetylcysteine capsules. The following examples are merely illustrative of the present application and should not be construed as limiting the application, and the packaging principle of other oxygen sensitive drugs is similar and therefore not described in detail.
Oxidative degradation impurity p-chlorobenzophenone in the levocetirizine capsule preparation is a main growth impurity, and the corresponding total impurity is also increased. The structure of the p-chlorobenzophenone is known to be an oxidative degradation impurity of the levocetirizine, and the p-chlorobenzophenone is mainly obtained by oxidizing the molecular structure of the levocetirizine after being broken.
/>
Levocetirizine hydrochloride of p-chlorobenzophenone.
According to the analysis of acetylcysteine structure, the degradation pathway is as follows:
。
example 1
A batch of levocetirizine hydrochloride capsules were prepared, the batch number was marked as X200101, the capsule shell was a gelatin hollow capsule (Ningbo guangfeng capsules limited company), and after blister packaging, it was placed in a 30ml composite film bag. The composite film bag package is provided with a group of double-suction deoxidizer which is marked as A, a group of common deoxidizer which is marked as B, a group of common deoxidizer and drier which is marked as C, and a group of non-deoxidizer which is marked as D. The total oxygen uptake of the double-suction deoxidizer and the common deoxidizer is 30ml. The moisture absorption rate of the double-absorption deoxidizer is 13.5 percent and 28.1 percent respectively in 48 hours under the conditions of the temperature of 25+/-2 ℃ and the relative humidity of 50+/-5 percent or 90+/-5 percent; the moisture absorption rate of the common deoxidizer in 48 hours is 1.3 percent and 3.9 percent respectively; the moisture absorption rates of the drying agent for 48 hours were 27.6% and 40.1%, respectively.
Stability tests are respectively carried out to examine the quality changes of the finished products under acceleration conditions (40 ℃ +/-2 ℃ and RH75% +/-5 ℃) and long-term conditions (25 ℃ +/-2 ℃ and RH60% +/-10 ℃).
Table 1 is a table of accelerated test results for X200101 batch of blister samples, and table 2 is a table of long-term test results for X200101 batch of blister samples.
Fig. 1 is a graph showing the comparison of the increase of chlorobenzophenone and total impurities in the accelerated test of X200101 batches of bubble cap samples, and fig. 2 is a graph showing the comparison of the increase of chlorobenzophenone and total impurities in the long-term test of X200101 batches of bubble cap samples.
Watch (watch)Test results table of blister packed levocetirizine hydrochloride capsule acceleration test for 6 months
。
Table 2 table of test results of long-term test of blister-packaged levocetirizine hydrochloride capsules for 12 months
。
Example 2
A batch of levocetirizine hydrochloride capsules was prepared, the batch number was marked as X200101, the capsule shell was a gelatin hollow capsule (Ningbo guangfeng capsules limited company), and the capsule was packaged with a 60ml High Density Polyethylene (HDPE) bottle. The HDPE bottle is marked with a group of double-suction deoxidizer added, a group of common deoxidizer added and desiccant added, a group of no deoxidizer added, and a group of no deoxidizer added. The total oxygen uptake of the double-suction deoxidizer and the common deoxidizer is 30ml. The moisture absorption rate of the double-absorption deoxidizer is 8.5 percent and 21.6 percent respectively in 48 hours under the conditions of the temperature of 25+/-2 ℃ and the relative humidity of 50+/-5 percent or 90+/-5 percent; the moisture absorption rate of the common deoxidizer in 48 hours is 2.1 percent and 4.0 percent respectively; the moisture absorption rates of the drying agent for 48 hours were 19.6% and 31.6%, respectively.
Stability tests are respectively carried out to examine the quality changes of the finished products under acceleration conditions (40 ℃ +/-2 ℃ and RH75% +/-5 ℃) and long-term conditions (25 ℃ +/-2 ℃ and RH60% +/-10 ℃).
Table 3 is a table of accelerated test and investigation results for X200101 HDPE bottle packaging samples, and Table 4 is a table of long-term test and investigation results for X200101 HDPE bottle packaging samples.
Fig. 3 is a graph showing the comparison of the increase of chlorobenzophenone and total impurities in the accelerated test of the X200101-batch HDPE bottle packaging samples, and fig. 4 is a graph showing the comparison of the increase of chlorobenzophenone and total impurities in the long-term test of the X200101-batch HDPE bottle packaging samples.
Table 3 table of test results of acceleration test of levocetirizine hydrochloride capsules packaged in HDPE bottles for 6 months
。
Table 4 table of the results of long-term 12 month test of levocetirizine hydrochloride capsules packaged with HDPE bottles
。
The results of example 1 and example 2 show that, for the levocetirizine hydrochloride capsules, after the common deoxidizer is added, the moisture content of the capsule content is obviously increased, the capsules are bonded, and the impurity growth speed is faster. Because the common deoxidizer contains moisture, the moisture can be released while absorbing oxygen, so that the content of the capsule or the capsule shell absorbs moisture, even the phenomenon of capsule bonding occurs, the final finished product has obvious quality change, and the phenomenon of capsule bonding under the bottled condition is more prominent. Simultaneously, deoxidizing agent and drying agent are added, although the impurity growth speed is inhibited, the properties and dissolution of the capsule are problematic, because the levocetirizine hydrochloride capsule uses a gelatin hollow capsule, the requirement on environmental moisture is met, and the excessive high and low are not performed; the desiccant has stronger moisture absorption capacity, so that the capsule shell becomes crisp, the dissolution is slowed down, and the product quality is obviously changed. The double-absorption deoxidizer can absorb oxygen, prevent oxidative degradation of the active ingredients of the oxygen-sensitive medicine, has weaker moisture absorption capacity, solves the problem of the growth of relevant substances of the levocetirizine hydrochloride capsule, does not influence the quality of the capsule, and effectively prolongs the shelf life of the capsule.
Example 3
A batch of acetylcysteine capsules was prepared, the batch number was designated as X201101, the capsule shell was an enteric gelatin hollow capsule (anhuihuangshan capsules inc.) and after blister packaging, it was placed in a 30ml composite film bag. The composite film bag package is provided with a group of double-suction deoxidizer which is marked as A, a group of common deoxidizer which is marked as B, a group of common deoxidizer and drier which is marked as C, and a group of non-deoxidizer which is marked as D. The total oxygen uptake of the double-suction deoxidizer and the common deoxidizer is 30ml. The moisture absorption rate of the double-absorption deoxidizer is 8.9 percent and 22.1 percent respectively in 48 hours under the conditions of the temperature of 25+/-2 ℃ and the relative humidity of 50+/-5 percent or 90+/-5 percent; the moisture absorption rate of the common deoxidizer in 48 hours is 1.9 percent and 3.5 percent respectively; the moisture absorption rates of the drying agent for 48 hours were 22.9% and 34.8%, respectively.
Stability tests are respectively carried out to examine the quality changes of the finished products under acceleration conditions (40 ℃ +/-2 ℃ and RH75% +/-5 ℃) and long-term conditions (25 ℃ +/-2 ℃ and RH60% +/-10 ℃).
Table 5 is a table of accelerated test results for X201101 batch of blister samples, and table 6 is a table of long-term test results for X201101 batch of blister samples.
Fig. 5 is a graph showing the comparison of the increase of impurity C and total impurities in the accelerated test of the X201101 lot of blister samples, and fig. 6 is a graph showing the comparison of the increase of impurity C and total impurities in the long-term test of the X201101 lot of blister samples.
Table 5 table of test results for 6 months of accelerated acetylcysteine capsules in blister packs
。
Table 6 table of test results of blister packed acetylcysteine capsules for long term test for 12 months
。
The result shows that after the common deoxidizer is added into the acetylcysteine capsule, the moisture content of the capsule content is obviously increased, the capsule is bonded, and the impurity growth speed is faster. Because the common deoxidizer contains moisture, the moisture can be released while absorbing oxygen, so that the content of the capsule or the capsule shell absorbs moisture, even the phenomenon of capsule bonding occurs, and the final finished product has obvious quality change. Simultaneously, deoxidizing agent and drying agent are added, although the impurity growth speed is inhibited, the properties and dissolution of the capsule are problematic, because the acetylcysteine capsule uses an enteric gelatin hollow capsule, the requirement on environmental moisture is met, and the overhigh and overlow are not possible; the desiccant has stronger moisture absorption capacity, so that the capsule shell becomes crisp, the dissolution is slowed down, and the product quality is obviously changed. The double-absorption deoxidizer can absorb oxygen, prevent oxidative degradation of the active ingredients of the oxygen-sensitive medicine, has weaker moisture absorption capacity, solves the problem of growth of related substances of the acetylcysteine capsule, does not influence the quality of the capsule, and effectively prolongs the shelf life of the capsule.
The foregoing is a further detailed description of the application in connection with specific embodiments, and it is not intended that the application be limited to such description. It will be apparent to those skilled in the art that several simple deductions or substitutions may be made without departing from the spirit of the application, and these should be considered to be within the scope of the application.
Claims (8)
1. The packaging method for improving the stability of the capsule is characterized in that the capsule is packaged in a medicine packaging container, and a double-absorption deoxidizer is placed in the medicine packaging container;
the capsule shell of the capsule contains gelatin;
the double-absorption deoxidizer is also called a dry deoxidizer, which is prepared by taking reduced iron powder, silica gel fine powder, salt, resin and water as main raw materials, mixing the raw materials, and packaging the raw materials by adopting a solid medicinal polyethylene composite bag;
the total oxygen absorption amount of the double-absorption deoxidizer is not less than 20% of the packaging container;
the moisture absorption rate of the double-absorption deoxidizer is not higher than 15% in 48 hours under the conditions that the temperature is 25+/-2 ℃ and the relative humidity is 50+/-5%;
the moisture absorption rate of the double-absorption deoxidizer is not lower than 20% in 48 hours under the conditions of the temperature of 25+/-2 ℃ and the relative humidity of 90+/-5%.
2. The method of claim 1, wherein the method comprises the steps of,
the capsule is one of a gelatin hollow capsule, an enteric gelatin hollow capsule or a gelatin soft capsule.
3. The method of claim 1, wherein the method comprises the steps of,
the total oxygen absorption amount of the double-absorption deoxidizer is not less than 50% of the packaging container.
4. The method for packaging a capsule according to any one of claims 1 to 3, wherein,
the medicine packaging container is a medicine packaging bottle.
5. The method for packaging a capsule according to any one of claims 1 to 3, wherein,
the medicine packaging container is a composite film bag, the capsule is firstly packaged in a bubble cap of a bubble cap plate, and then the bubble cap plate is packaged in the composite film bag.
6. The method of claim 4, wherein the method of packaging the capsule for improving stability,
the oxygen-sensitive drug is selected from at least one of the following: cetirizine, levocetirizine, acetaminophen, ibuprofen, acetylcysteine, carbamazepine, verapamil, selegiline, ephedrine, oxybutynin, diltiazem, mexiletine, emedastine.
7. The method of claim 5, wherein the method of packaging the capsule for improving stability,
the oxygen-sensitive drug is selected from at least one of the following: cetirizine, levocetirizine, acetaminophen, ibuprofen, acetylcysteine, carbamazepine, verapamil, selegiline, ephedrine, oxybutynin, diltiazem, mexiletine, emedastine.
8. A capsule characterized in that it is packaged by the method for improving the stability of a capsule according to any one of claims 1 to 7.
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