CN113750260B - Radioactive iodine [ I-131] sodium iodide capsule for treatment and preparation method thereof - Google Patents
Radioactive iodine [ I-131] sodium iodide capsule for treatment and preparation method thereof Download PDFInfo
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- CN113750260B CN113750260B CN202110866474.4A CN202110866474A CN113750260B CN 113750260 B CN113750260 B CN 113750260B CN 202110866474 A CN202110866474 A CN 202110866474A CN 113750260 B CN113750260 B CN 113750260B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/485—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
- A61P5/16—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4 for decreasing, blocking or antagonising the activity of the thyroid hormones
Abstract
The invention provides a radioactive iodine [ I-131] sodium salt capsule for treatment and a preparation method thereof, wherein the radioactive iodine [ I-131] sodium salt capsule for treatment comprises a capsule body and a capsule core, the capsule core comprises a filling agent and a radioactive iodine [ I-131] sodium salt solution, and the filling agent is obtained by uniformly mixing anhydrous disodium hydrogen phosphate and anhydrous sodium sulfite with the granularity range of 60-80 meshes. The capsule medicine prepared by the invention has better performance, the radiochemical purity still meets the requirement after long-time placement, the capsule medicine has good curative effect, hyperthyroidism and cancer can be effectively treated, the medicine can directly reach the stomach, the direct contact with the oral cavity, the esophagus and the wound surface after operation of a patient is avoided, and the occurrence of negative effects such as pollution and damage to the oral cavity and the esophagus of the patient is reduced. The preparation method is simple, can effectively ensure the yield and the drug performance of the product, and has important significance for controlling the quality of the radioactive iodine [ I-131] sodium chemical capsule product for treatment.
Description
Technical Field
The invention relates to the technical field of medicines, in particular to a radioactive iodine [ I-131] sodium chemical capsule for treatment and a preparation method thereof.
Background
The radioactive iodine [ I-131] is a classic specific medicine for treating hyperthyroidism and thyroid cancer, is a well-known classic treatment method in the field of international nuclear medicine, and has the characteristics of good curative effect, low recurrence rate, few complications and the like.
The administration dosage form of the radioactive iodine [ I-131] for the treatment is mainly oral solution. Because of the volatility of iodine, when the solution is taken, the liquid medicine is easy to adhere to the oral cavity and the esophagus of a patient and is easy to be released through ways of cough, spitting and the like, thereby polluting the patient and the external environment; it is also prone to radiation damage to the patient's mouth and esophagus. Compared with a solution dosage form, the capsule has the advantages of simple taking, little pollution to the environment, little non-focus damage to patients and the like because the radioactive iodine [ I-131] is sealed in the capsule, and is increasingly advocated by clinical medication, so the market urgently needs a capsule dosage form for treating the radioactive iodine [ I-131] sodium.
However, unlike the conventional capsule, the chemical content of iodine [ I-131] in the active ingredient, i.e., the radioiodine [ I-131] sodium, of the radioiodine [ I-131] sodium capsule for therapeutic use is only microgram level, and the radioiodine [ I-131] sodium capsule cannot be prepared in a mode in which the active ingredient of the conventional capsule drug is first mixed with a macroscopic amount of a filling base material for refilling. In addition, the radioactive sodium iodide [ I-131] has the characteristics of easy oxidation and easy volatilization to generate radioactive aerosol, so the problem of whether the prepared capsule meets the radiochemical purity index or not needs to be considered. The difficulty in preparing radioactive iodine [ I-131] sodium capsules for therapeutic use is increased by the necessity of radiation protection measures in the preparation of radioactive iodine [ I-131] sodium capsules for therapeutic use from the standpoint of occupational health of the personnel and protection of the environment from radioactive contamination, and the inability of personnel to directly participate in the preparation process.
Disclosure of Invention
Aiming at the problems in the prior art, the invention provides a radioactive iodine [ I-131] sodium chemical capsule for treatment and a preparation method thereof.
The invention adopts the following technical scheme:
the invention provides a radioactive iodine [ I-131] sodium salt capsule for treatment, which comprises a capsule body and a capsule core, wherein the capsule core comprises a filling agent and a radioactive iodine [ I-131] sodium salt solution, and the filling agent is formed by fully and uniformly mixing anhydrous disodium hydrogen phosphate and anhydrous sodium sulfite with the granularity range of 60-80 meshes according to a specific proportion.
The capsule of the invention is different from the conventional common capsule medicine, on one hand, the stabilizing agent in the capsule, namely the antioxidant, can destroy the reducibility by adopting the conventional mixing granulation method, and on the other hand, the sodium iodide [ I-131] has radioactivity and volatility, so that various medicine components cannot be simply mixed uniformly to be used as a capsule core material like the common capsule. The selection of the filling agent is particularly critical, firstly, the complete absorption of the radioactive iodine [ I-131] sodium solution during the preparation of the capsule is ensured, secondly, the content of the stabilizing agent in each capsule is enough to maintain the radiochemical purity index of the radioactive iodine [ I-131] sodium in the effective period to be more than 95 percent, but simultaneously, the content of the stabilizing agent cannot exceed the maximum allowable use amount of pharmaceutical excipients recommended by FDA, and the uniformity index of the stabilizing agent is required to meet the requirements of pharmacopoeia and the like. According to literature research, a patent related to radioactive iodine [ I-131] sodium iodide capsules published abroad is US005314678A. The patent can prepare sodium iodide [ I-131] capsule with activity of 100 × 37MBq by adding at least two of sodium thiosulfate, ascorbic acid, fructose, gentisic acid and the like into anhydrous disodium hydrogen phosphate. However, the patent focuses on the control ability to reduce the amount of radioactive iodine [ I-131] volatilized, and does not describe the drug-related quality properties of the product, such as radiochemical purity and uniformity index of the stabilizer. The granularity of the filler selected by the method is controlled between 50 and 200 meshes, the granularity span is large, and uniform mixing is difficult to achieve; although the reduction force of the used stabilizer sodium thiosulfate is strong and no problem exists in the aspect of ensuring radiochemical purity indexes, the dosage of the stabilizer sodium thiosulfate exceeds the maximum dosage of the pharmaceutical excipients recommended by the FDA, and the stabilizer sodium thiosulfate is not suitable for being used in medicines. In the domestic sodium radioiodinate [ I-131] capsule for diagnosis, disodium hydrogen phosphate hexahydrate is used as a filling agent, but the filling agent has weak liquid adsorption capacity, so that a therapeutic radioactive capsule with high radioactivity cannot be prepared. According to the invention, through research, the small particle sizes of the anhydrous disodium hydrogen phosphate and the anhydrous sodium sulfite are beneficial to improving the uniformity, but the gaps among the filler powder are too small, so that the solution can not be absorbed quickly and stays on the surface of the filler in the capsule body, and the capsule shell is softened; on the contrary, although the increase of the particle size is beneficial to increase of the permeation speed of the solution, the dripped solution is easy to permeate into the capsule shell through larger gaps among the powder, so that the capsule shell is softened, and in addition, the large particle size can also cause the difficulty in uniformly mixing the powder and the powder, so that the uniformity index of the filling agent is reduced. Through research and exploration, the invention determines the formula of the filling agent consisting of anhydrous disodium hydrogen phosphate and anhydrous sodium sulfite with specific granularity combination and proportion, and solves the problem of synergy between the content uniformity of the stabilizing agent and the adsorption capacity of the filling agent. The filling agent and radioactive iodine [ I-131] sodium salt solution form a capsule core material, the obtained capsule medicine has good performance, the radiochemical purity can still meet the requirement after long-time placement, the capsule has good curative effect, and the capsule yield is high.
The capsule is prepared according to the formula, and various indexes such as uniformity and the like meet the control requirements of pharmacopoeia of the people's republic of China on related indexes of capsule dosage forms.
Furthermore, the mass percent of the anhydrous disodium hydrogen phosphate in the filling agent is 97.5-99.1%, and correspondingly, the mass percent of the anhydrous sodium sulfite is 2.5-0.9%.
When the proportion of the anhydrous disodium hydrogen phosphate and the anhydrous sodium sulfite meets the requirements, the quality of the obtained capsule is more reliable.
More preferably, the mass percent of the anhydrous disodium hydrogen phosphate in the filling agent is 98.8%, and the mass percent of the anhydrous sodium sulfite is 1.2%.
Furthermore, the capsule body is a No. 0 capsule shell, and the weight of the filling agent is 0.65-0.75 g.
Further, the volume of the radioiodine [ I-131] sodium salt solution is 5 to 170 μ L.
Furthermore, the specification range of the iodine [ I-131] sodium iodide capsule for treatment obtained by the invention is 37 MBq-100 multiplied by 37MBq. The minimum activity of the therapeutic radioiodine [ I-131] sodium capsule on the day of production is 37MBq, considering that the activity of the radionuclide decreases exponentially with time. The maximum activity of the therapeutic sodium radioiodinate [ I-131] capsule on the day of production is 614X 37MBq, and the activity of the contained radioiodine [ I-131] is reduced to 100X 37MBq after the radioactive iodine [ I-131] decays after 21 days of validity. The specification range of the radioactive iodine [ I-131] sodium salt capsule for treatment can meet the medication requirements of hyperthyroidism and patients with thyroid cancer, and the radioactive iodine [ I-131] sodium salt capsule for treatment is customized according to the patient's condition in clinical application.
In another aspect, the invention also provides a preparation method of the radioactive iodine [ I-131] sodium iodide capsule for treatment.
The preparation method provided by the invention comprises the step of filling the filling agent into the capsule body and then dropwise adding the radioactive iodine [ I-131] sodium salt solution.
The invention adopts the mode of firstly filling the filling agent and then dripping the radioactive sodium iodide [ I-131] solution, which can effectively ensure the yield and the drug performance of the therapeutic sodium iodide [ I-131] capsule product.
Further, the preparation method also comprises a method for confirming the radioactive concentration of the key raw material radioactive iodine [ I-131] sodium iodide solution. The confirmation method utilizes a capsule preparation instrument to set the dropping liquid volume and the actually measured activity of the radioactive capsule to reversely deduce the radioactive concentration of the key raw material, namely the radioactive iodine [ I-131] sodium solution during actual dropping, thereby eliminating the influence caused by the system error of the capsule preparation instrument and further providing the dropping liquid volume required by radioactive capsules of other specifications. The specific method comprises the following steps: firstly, two radioactive iodine [ I-131] sodium chloride capsules with the same dropping volume are tried, after the radioactive iodine [ I-131] sodium chloride solution is added dropwise, the radioactivity of iodine [ I-131] in the capsules is measured, and the concentration of the radioactive iodine [ I-131] sodium chloride solution used when the medicine is dropped is calculated by dividing the radioactivity by the dropping volume. If the measured radioactive concentration of the liquid medicine meets the requirement, the preparation is continued, and if the measured radioactive concentration of the liquid medicine does not meet the requirement, the radioactive iodine [ I-131] sodium salt solution is prepared again.
Further, after the therapeutic radioiodine [ I-131] sodium capsule is prepared, radioactivity is detected, and the detection value is 90-110% of the target value, so that the product is qualified.
The invention provides a radioactive iodine [ I-131] sodium salt capsule for treatment and a preparation method thereof, the capsule uses anhydrous disodium hydrogen phosphate and anhydrous sodium sulfite as filling agents, and then forms a capsule core object with radioactive iodine [ I-131] sodium salt solution, the obtained capsule has better drug performance, the radiochemical purity still meets the requirement after long-time placement, the capsule has good curative effect, hyperthyroidism and cancer can be effectively treated, the drug can directly reach the stomach, the direct contact with the oral cavity, the esophagus and the postoperative wound surface of a patient can be avoided, the occurrence of negative effects such as pollution and injury to the oral cavity and the esophagus of the patient can be reduced, the process of subpackaging oral solution by medical personnel can be omitted, the unnecessary radiation to the medical personnel and the patient can be reduced, in addition, the capsule dosage form can effectively reduce the open operation time, and avoid the problem of environmental pollution caused by the direct volatilization of iodine [ I-131 ]. The preparation method is simple, can effectively ensure the yield and the drug performance of the product, and has important significance for controlling the quality of the radioactive iodine [ I-131] sodium chemical capsule product for treatment.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention are clearly and completely described below, and it is obvious that the described embodiments are a part of the embodiments of the present invention, but not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The embodiment of the invention provides a radioactive iodine [ I-131] sodium salt capsule for treatment, which comprises a capsule body and a capsule core, wherein the capsule core comprises a filling agent and a radioactive iodine [ I-131] sodium salt solution, and the filling agent consists of anhydrous disodium hydrogen phosphate and anhydrous sodium sulfite. The specification range of the radioactive iodine [ I-131] sodium iodide capsule for treatment is 37 MBq-100 multiplied by 37MBq. The therapeutic radioiodine [ I-131] sodium capsules have a minimum activity of 37MBq on the day of production, considering that the activity of the radionuclide decays exponentially with time. The therapeutic sodium radioiodinate [ I-131] capsule has a maximum activity of 614 x 37MBq on the day of production, and the activity of radioiodine [ I-131] contained in the capsule decreases to 100 x 37MBq after 21 days of decay over the validity period.
Wherein the capsule body is 0 # capsule shell, the weight of the filling agent is 0.65-0.75 g, and the volume of the radioactive iodine [ I-131] sodium salt solution is 5-170 mu L. The mass percent of the anhydrous disodium hydrogen phosphate in the filler is 97.5-99.1%, the mass percent of the anhydrous sodium sulfite is correspondingly 2.5-0.9%, the granularity ranges of the anhydrous sodium hydrogen phosphate and the anhydrous sodium sulfite are both 60-80 meshes, and the anhydrous sodium hydrogen phosphate and the anhydrous sodium sulfite are fully and uniformly mixed to form the filler.
The embodiment of the invention also provides a method for preparing the radioactive iodine [ I-131] sodium compound capsule for treatment, which comprises the following steps:
1. preparation of medicinal liquid
According to the required production specification of radioactive sodium iodide [ I-131] capsule for therapeutic use, the proper concentration of sodium iodide [ I-131] oral solution is prepared or purchased for standby.
Wherein, the concentration requirement of the iodine [ I-131] sodium iodide oral solution is as follows:
product target activity a = A0 × e (0.693×t÷T)
In the formula: a0 is the specification of the product to be produced (customized according to the requirement of a customer), T is iodine [ I-131] half life period of 8.021 days, and T is the number of days from the calibration time to the production date.
The dropping volume of the liquid medicine is in the range of 5-170 mu L (namely the maximum allowable dropping volume is 170 mu L, and the minimum allowable dropping volume is 5 mu L).
If it is
The same concentration of radioactive iodine [ I-131] cannot be used]Sodium melting for producing radioactive iodine [ I-131] with all task specifications]And (4) dissolving sodium into capsules. The radioactive iodine [ I-131]]The production task of the sodium dissolving capsule needs to be split into two independent medicine production batches.
The product is produced in an order form mode, and the specification of a product to be produced is customized according to the requirement of a customer. Because the dropping volume of the liquid medicine is in the range of 5-170 muL (namely the maximum allowed dropping volume is 170 muL, and the minimum allowed dropping volume is 5 muL), the product specification span which can be produced in each batch is 170/5=34, namely the maximum specification and the minimum specification of the same batch of products can be different by 34 times, in this range, the production can be completed by using the sodium iodide [ I-131] oral solution with the same concentration, and if the range is exceeded, the batch production can not be completed by using the sodium iodide [ I-131] oral solution with the same concentration, and the order is required to be split, and the batch production is performed.
2. Sieving and mixing the filler
2.1 Filler screening
The anhydrous disodium hydrogen phosphate and the anhydrous sodium sulfite are respectively sieved, and the particle size is controlled to be 60-80 meshes.
2.2 mixing of fillers
And uniformly mixing the screened anhydrous disodium hydrogen phosphate and the screened anhydrous sodium sulfite according to the target mass ratio, and taking out for later use. Wherein the blending operation can be performed by a blender.
3. Body and cap separation
Separating the No. 0 gelatin hollow capsule from the capsule body.
4. Filling with fillers
Filling the uniformly mixed filler into a capsule body. The filling amount of the No. 0 capsule is 0.65-0.75 g/grain.
5. Dropping the medicinal liquid
Firstly, two radioactive iodine [ I-131] sodium chloride capsules with the same dropping volume are tried, after the radioactive iodine [ I-131] sodium chloride solution is added dropwise, the radioactivity of iodine [ I-131] in the capsules is measured, and the concentration of the radioactive iodine [ I-131] sodium chloride solution used when the medicine is dropped is calculated by dividing the radioactivity by the dropping volume. If the measured radioactive concentration of the liquid medicine meets the requirements of the calculation formula in the liquid medicine preparation item 1, the preparation is continued, and if the measured radioactive concentration of the liquid medicine does not meet the requirements, the radioactive iodine [ I-131] sodium solution needs to be prepared again.
The dropping volume is calculated according to the target activity of the radioactive iodine [ I-131] sodium compound capsule for treatment and the concentration of the raw material radioactive iodine [ I-131] sodium compound solution, and the corresponding volume of the radioactive iodine [ I-131] sodium compound medicine is dropped on the filling agent in the capsule body.
6. Capsule combination
After the dropping of the liquid medicine is finished, the capsule body and the cap are buckled to finish the capsule combination.
7. Radioactivity measurement and sorting
The prepared sodium iodide [ I-131] capsule for treatment is subjected to radioactivity detection.
The radioactivity exceeds 90-110% of the target value, and the product is judged to be unqualified; and removing unqualified products, and placing and decaying the unqualified products. For example: the target activity of a certain specification is 10 × 37MBq, and if the measured activity is greater than 11 × 37MBq or less than 9 × 37MBq, the product is determined to be a non-defective product.
Example 1
Effect of particle size on the amount of filler adsorbed experiment: 100g of anhydrous disodium hydrogen phosphate powder with the granularity of 10-18 meshes, 18-30 meshes, 30-40 meshes, 40-60 meshes, 60-80 meshes and more than 80 meshes and without sieving is prepared respectively and is filled into capsules. The volume of the dropping liquid for each powder particle size test is respectively 100 mu L, 120 mu L, 140 mu L, 150 mu L, 160 mu L and 170 mu L, 20 capsules are tested, the capsule combination condition is observed and recorded, and the capsule combination success rate is counted. When the volume of the dropping liquid exceeds the maximum adsorption capacity of the powder, the capsule shell can be softened and shrunk, and the capsule can not be normally packed, so that the capsule is regarded as unqualified; otherwise, it is qualified. The results are shown in Table 1.
TABLE 1 Capsule closure success ratio (%) -for capsules prepared with different filler particle sizes, different drop volumes
The adsorption capacity of the filler is mainly determined by the adsorption capacity of anhydrous disodium hydrogen phosphate. From the results, it can be seen that the adsorption capacity of anhydrous disodium hydrogen phosphate powder is closely related to the powder particle size. When the granularity is larger (less than 30 meshes), the dripped solution is easy to permeate into the capsule shell through gaps among the powder, so that the capsule shell is softened to influence capsule combination; when the particle size is smaller (more than 80 meshes), the gaps among the powder are too small, so that the dripping solution can permeate downwards to form a barrier, and the solution can not be adsorbed in time to cause the softening of the capsule shell, thereby influencing the capsule combination. In the experiment, 20 tested capsules are qualified when powder with the granularity of 30-40 meshes, 40-60 meshes and 60-80 meshes is dropped into the volume range of 100-170 mu L; while other particle sizes are rejected. It can be seen that the filler is selected from the range of 30 to 80 mesh size.
Example 2
The mixing experiment is directly carried out by adopting 30-80 meshes of anhydrous disodium hydrogen phosphate and anhydrous sodium sulfite, and the result shows that the mixture cannot be mixed even if various mixing parameters are set, and the mesh range of the filler is properly tightened to achieve the mixing effect. In the comprehensive consideration of raw material utilization rate, quality risk, environmental protection and the like, 60-80 meshes in the interval of 30-80 meshes are taken as the preferable mesh number of the filler, and blending research is further carried out.
230 g of anhydrous disodium hydrogen phosphate of 60-80 meshes and 2.79 g of anhydrous sodium sulfite of 60-80 meshes are uniformly mixed. And splitting the No. 0 capsule shell into a capsule body and a capsule cap for later use. And filling the uniformly mixed filler into a No. 0 capsule body, and directly joining the capsule without dripping the solution. 20 capsules were prepared per batch and 10 capsules were randomly tested for uniformity of the filler filled in the capsules. Three batches were prepared in total.
TABLE 2 mixing uniformity of 60-80 mesh anhydrous disodium hydrogen phosphate and anhydrous sodium sulfite
| Batch number | 20191228-1 | 20191228-2 | 20191228-3 |
| Found Na 2 SO 3 Content (%) | 1.20 | 1.25 | 1.20 |
| A | 5.46 | 5.66 | 7.87 |
| S | 2.04 | 2.12 | 0.98 |
| Results (A + 2.2S) | 9.9 | 10.3 | 10.0 |
| And (3) judging standard: a +2.2S is less than or equal to 15.0 | Qualified | Qualified | Qualified |
Example 3
This example is primarily intended to investigate the efficacy of anhydrous sodium sulfite and sodium thiosulfate as antioxidants.
The mixture of anhydrous disodium hydrogen phosphate and sodium thiosulfate (the percentage content of the sodium thiosulfate is 0.25%,0.5% and 1%) and the mixture of anhydrous disodium hydrogen phosphate and anhydrous sodium sulfite (the percentage content of the anhydrous sodium sulfite is 0,0.3%,0.6%,0.9%,1.2%,2.5%,5% and 10%) are prepared according to different mass ratios. The sodium iodide [ I-131] capsule for treatment is prepared by the preparation method, the dropping volume is 20 mu L, and the adding amount of the iodine [ I-131] is 37 MBq/capsule. The radiochemical purity of the capsules was checked on days 0, 5, 9, 15 and 21. The results are shown in Table 3.
TABLE 3 Effect of antioxidant type and content on Capsule stability
The standard of the radiochemical purity of the therapeutic sodium radioiodinate (I-131) capsule is more than or equal to 95 percent, and the experimental result shows that the radiochemical purity index of the therapeutic sodium radioiodinate (I-131) capsule can not be ensured when no antioxidant is added and the content of anhydrous sodium sulfite of the antioxidant is 0.3 percent and 0.6 percent, so that the quality risk exists. When the content of the anhydrous sodium sulfite is 0.9%, although the radiochemical purity index is qualified in the effective period of the product, the radiochemical purity index shows an obvious reduction trend, and the anhydrous sodium sulfite is used as the lower limit of the addition of the antioxidant. Meanwhile, when the content of the anhydrous sodium sulfite is 1.2%, the radiochemical purity of the radioactive iodine [ I-131] sodium sulfide capsule for treatment can maintain a preset index.
When the content of sodium thiosulfate is 0.25 percent as a reference, the radiochemical purity of the capsule after 21 days of storage is 97.8 percent, which meets the requirement. However, the content of sodium thiosulfate in the single-particle capsule is 1.6mg, which exceeds the maximum oral dosage of 0.60mg recommended by FDA, and is not suitable for selection.
Finally, it should be noted that: the above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.
Claims (8)
1. A radioactive iodine [ I-131] sodium salt capsule for treatment comprises a capsule body and a capsule core, and is characterized in that the capsule core comprises a filling agent and a radioactive iodine [ I-131] sodium salt solution, wherein the filling agent is obtained by uniformly mixing anhydrous disodium hydrogen phosphate and anhydrous sodium sulfite with the granularity range of 60-80 meshes;
the mass percent of the anhydrous disodium hydrogen phosphate in the filler is 97.5-99.1%, and correspondingly, the mass percent of the anhydrous sodium sulfite is 2.5-0.9%.
2. The therapeutic radioiodine [ I-131] sodium iodide capsule as claimed in claim 1, wherein the filling agent is dosed in a proportion of 98.8% by mass of anhydrous disodium hydrogen phosphate and 1.2% by mass of anhydrous sodium sulfite.
3. The sodium radioiodinated [ I-131] capsule for treatment according to claim 1, wherein the capsule body is a No. 0 capsule shell, and the weight of the filling agent is 0.65-0.75 g.
4. The therapeutic radioiodine [ I-131] sodium capsule as claimed in any one of claims 1 to 3, which has a specification in the range of 37MBq to 100 x 37MBq.
5. The method for producing a therapeutic sodium radioiodine [ I-131] capsule according to any one of claims 1 to 4, comprising a step of adding dropwise the solution of sodium radioiodine [ I-131] after the filling agent is filled in the capsule.
6. The method for preparing a therapeutic sodium radioiodine [ I-131] capsule according to claim 5, wherein the volume of the sodium radioiodine [ I-131] solution is 5 to 170 μ L.
7. The method for preparing a therapeutic radioiodine [ I-131] sodium capsule as claimed in claim 5, further comprising measuring the radioactive concentration of the dropped drug solution after dropping the radioiodine [ I-131] sodium capsule, continuing the preparation if the radioactive concentration of the drug solution meets the requirement, and preparing the radioiodine [ I-131] sodium capsule again if the radioactive concentration of the drug solution does not meet the requirement.
8. Preparation of therapeutic radioiodine [ I-131] sodium capsule according to claim 5
The preparation method is characterized in that after the radioactive iodine [ I-131] sodium iodide capsule for treatment is prepared,
and performing radioactivity detection, wherein the detected value is 90-110% of the target value, and the product is qualified.
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| US4349529A (en) * | 1980-04-14 | 1982-09-14 | E. R. Squibb & Sons, Inc. | Diagnostic and therapeutic capsules and method of producing |
| US5314678A (en) * | 1992-01-28 | 1994-05-24 | Mallinckrodt Medical, Inc. | Sodium iodide 131 I capsules |
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