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A kind of streptomycin calcium sulfate sustained-release preparation and preparation method thereof

A slow-release preparation, calcium sulfate technology, applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, inorganic non-active ingredients, etc., can solve problems such as muscle contracture, concentration reduction, infection, etc., to avoid local intramuscular injection, avoid Toxic and side effects, good biocompatibility effect

Inactive Publication Date: 2021-06-15
中国人民解放军南京军区福州总院四七六医院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The intramuscular injection of streptomycin has the following disadvantages: ①Due to the particularity of anti-tuberculosis, streptomycin often requires continuous intramuscular injection for up to 3 months, which is difficult for many patients; ②Long-term intramuscular injection can easily cause infection at the injection site, Complications such as induration and muscle contracture force the treatment to be interrupted; ③ Long-term application of streptomycin can lead to nephrotoxicity and ototoxicity, which are closely related to the blood concentration of streptomycin
In the event of nephrotoxicity and / or ototoxicity, streptomycin must be suspended, thereby affecting the efficacy of tuberculosis treatment
[0005] At present, in tuberculosis surgery, especially in bone tuberculosis surgery, streptomycin sulfate powder is sprinkled on the wound after the tuberculosis focus is removed, but this method of administration has the following disadvantages: ①The early wound tissue is in the edema and exudation stage after the focus removal and bleeding, most of the streptomycin dissolves with the exudate and blood, and is excreted through the drainage tube. After the drainage tube is pulled out, the lesion wound tissue will enter the absorption period, and then the streptomycin will be absorbed into the blood and distributed throughout the body. The local drug concentration decreases, and the effective drug concentration does not last long enough; ② If an overdose of drug is given to the lesion at one time, although the local concentration and effective action time of the drug can be improved, the high blood drug concentration after the excessive drug is absorbed into the blood will increase its Incidence of Adverse Reactions

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  • A kind of streptomycin calcium sulfate sustained-release preparation and preparation method thereof
  • A kind of streptomycin calcium sulfate sustained-release preparation and preparation method thereof
  • A kind of streptomycin calcium sulfate sustained-release preparation and preparation method thereof

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preparation example Construction

[0062] A kind of preparation method of streptomycin calcium sulfate slow-release preparation of the present invention comprises the following steps,

[0063] S1: put streptomycin sulfate powder and calcium sulfate powder in corresponding weight parts in a sterile environment, and stir evenly;

[0064] S2: Add corresponding parts by weight of sterilized water for injection; fully stir for 20-40 seconds in a low-temperature environment until a uniform paste is formed;

[0065] S3: Spread the paste evenly on the mold of the corresponding shape; pressurize with a pressure of 15-20N to drive out the remaining air;

[0066] S4: The paste is allowed to stand in the mold for more than 10 minutes to solidify;

[0067] S5: The stretching mold releases the particles;

[0068] S6: sterilize the prepared granules, and store them at low temperature for later use;

[0069] The temperature of the low-temperature stirring and mixing is 0-5°C, the preferred temperature of the low-temperature...

Embodiment 1

[0092] A streptomycin calcium sulfate slow-release preparation, mainly prepared from 0.5g streptomycin sulfate, 2.6g calcium sulfate, 1g sterilized water for injection; concrete method is as follows,

[0093] Put the streptomycin sulfate powder and calcium sulfate powder of the above weight in a sterile environment and stir evenly; add the above weight parts of sterile water for injection; fully stir for 20 seconds at 0°C until a uniform paste , spread the paste evenly on the mold with cylindrical holes, and fill the holes; pressurize with 15N to drive off the residual air; let the paste stand in the mold for 10 minutes to solidify; stretch the mold to release the particles; and place it at 2°C Store in ambient conditions.

[0094] The prepared preparation is placed in low-temperature refrigeration, and the preparation and other surgical drugs are placed under ultraviolet light for routine sterilization during surgery, and can be placed in the bone marrow of bone tuberculosis ...

Embodiment 2

[0097] A streptomycin calcium sulfate slow-release preparation, mainly prepared from 3g streptomycin sulfate, 7g calcium sulfate, 3g sterilized water for injection, the specific preparation method is as follows,

[0098]Place the streptomycin sulfate powder and calcium sulfate powder of the above weight in a sterile environment, and stir evenly; add the sterilized water for injection of the above weight; fully stir for 40 seconds in a low temperature environment until a uniform paste, wherein, Stir and mix at low temperature at 5°C; spread the paste evenly on the mold with cylindrical holes and fill the holes; pressurize with 20N to drive out the remaining air; put the paste in the mold for 30 minutes to solidify; stretch the mold release the particles; and store at 3°C ​​for later use.

[0099] The prepared preparation is placed in low-temperature refrigeration, and the preparation and other surgical drugs are placed under ultraviolet light for routine sterilization during su...

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Abstract

The invention belongs to the field of sustained-release drugs, in particular to a sustained-release preparation of streptomycin calcium sulfate, which comprises the following components in parts by weight: 0.5-9 parts of streptomycin sulfate, 2.6-21 parts of calcium sulfate, and 1-9 parts of ammonium sulfate The water for bacterial injection may also include 2.6-5 parts by weight of glycosaminoglycan and 2.6-5 parts by weight of osteopeptide. The preparation is a granule with a diameter less than or equal to 4mm. From the inside to the outside, there are an inner release layer, a middle release layer and an outer release layer closely connected in sequence. The streptomycin calcium sulfate sustained-release preparation of the present invention is prepared at low temperature and has better effect. The present invention combines streptomycin sulfate and calcium sulfate to form a drug delivery system, which replaces the existing intramuscular injection drug delivery method. The multi-layer design, especially in the process of early intensive treatment against bone tuberculosis, releases osteopeptide and glycosamine in sequence Polysaccharides have the beneficial effect of promoting rapid bone repair, and solve the problems of low local drug concentration, bacterial drug resistance, insufficient or too slow dietary nutritional supplementation, or pain and inconvenience caused by intramuscular injection.

Description

technical field [0001] The invention belongs to the field of sustained-release medicines, and in particular relates to a sustained-release preparation of streptomycin calcium sulfate and a preparation method thereof. Background technique [0002] Tuberculosis mostly occurs in the lungs, but it can occur in any organ of the body. About 50% of bone tuberculosis patients are complicated with pulmonary tuberculosis. The sclerotia of tuberculosis first occurs in the lungs. After the lung infection, it can spread to many systems of the body through the blood, which can lead to skeletal system tuberculosis, urinary system tuberculosis, and digestive system tuberculosis. In this case, bone tuberculosis is not a simple lesion, but a local manifestation of a systemic disease. Patients with bone tuberculosis may also have no history of tuberculosis, which is an occult infection of Mycobacterium tuberculosis. Bone and joint tuberculosis is one of the most common extrapulmonary tubercu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K47/02A61K31/7036A61K38/01A61K31/715A61P19/08A61P31/06
CPCA61K9/1611A61K9/167A61K9/1682A61K31/7036A61K31/715A61K38/012A61P19/08A61P31/06A61K2300/00
Inventor 陈勇忠卫秀洋翁少煌
Owner 中国人民解放军南京军区福州总院四七六医院