Oral solid preparation containing polyene phosphatidylcholine and its preparation process

A polyene phosphatidylcholine content technology, applied in the direction of medical preparations containing active ingredients, medical preparations with non-active ingredients, anti-toxic agents, etc., can solve the problems of expensive special equipment, high energy consumption, and demand, Achieve the effects of facilitating industrial production, saving equipment costs, and improving dissolution performance

Active Publication Date: 2016-12-28
HEFEI BOSIKC PHARMTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The imported polyene phosphatidylcholine capsules are waxy viscous substances that are heated and liquefied, filled into hard capsule shells by special filling equipment, and hard capsule preparations whose contents are waxy viscous substances are formed after cooling. The disadvantage is that it needs expensive special equipment that is not yet domestically produced. The price of a set of imported equipment is not less than 8 million yuan, and the products obtained by this preparation process cannot effectively isolate air and moisture; at the same time, the temperature during storage or transportation is too high. High, its contents will soften, thereby reducing the safety of the drug during storage and transportation
[0006] In the prior art, Chinese patent application 200910079858.0 discloses an oral solid preparation containing polyene phosphatidylcholine and its preparation method, which consists of raw materials polyene phosphatidylcholine, antioxidants and related auxiliary materials necessary for molding the corresponding preparations Composition, the polyene phosphatidylcholine is cryogenically frozen and pulverized to make different dosage forms. The disadvantage is that it requires ultra-low temperature freezing equipment, high energy consumption and is not conducive to industrial operation.
Chinese patent applications 200510037429.9 and 200510094998.7 disclose freeze-dried powder for injection of polyene phosphatidylcholine, which also requires ultra-low temperature freezing equipment, high energy consumption and unfavorable for industrial operation

Method used

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Experimental program
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preparation example Construction

[0032] (1) Preparation of polyene phosphatidylcholine pellets

[0033] A. Solution preparation

[0034] Weigh the prescribed amount of polyene phosphatidylcholine, stir and dissolve it in an appropriate amount of ethanol under vacuum or inert gas protection state, add the prescribed amount of antioxidant, substrate, and absorption promoter in turn and mix evenly, maintain the protected state and stir status, standby;

[0035] B. Preparation of pellets

[0036] Under the state of stirring, the solution obtained in A is vacuum-dried to remove ethanol, heated to a molten state, stirred evenly, left standing, until the bubbles are completely removed, maintained in a vacuum state, kept in a molten state at a constant temperature, and set aside;

[0037] Transfer the above-mentioned polyene phosphatidylcholine mixed molten liquid with no bubbles into the liquid storage cylinder, maintain the protection state, and use the dropping pill machine to drip under the condition of constan...

Embodiment 1

[0052] Preparation formula:

[0053] Polyene Phosphatidylcholine 228g

[0054] Macrogol 4000 260g

[0055] Sodium sulfite 1g

[0056] Sorbitan Ester 40 5g

[0057] Proper amount of ethanol

[0058]

[0059] A total of 1000 capsules were made

[0060] Preparation:

[0061] (1) Preparation of polyene phosphatidylcholine pellets

[0062] A. Solution preparation

[0063] Weigh the polyene phosphatidylcholine of the above prescription amount, stir and dissolve it in an appropriate amount of ethanol in a vacuum state, add the prescription amount of sodium sulfite, polyethylene glycol 4000, and sorbitan ester 40 and mix evenly, maintain the vacuum state and stir status, standby;

[0064] B. Preparation of pellets

[0065] Vacuum-dry the solution obtained in A under stirring to remove ethanol, raise the temperature to 60°C and stir evenly, let stand until the bubbles are completely removed, maintain a vacuum state, keep the temperature at 60°C, and set aside;

[0066] Tra...

Embodiment 2

[0072] Preparation formula:

[0073] Polyene Phosphatidylcholine 228g

[0074] Macrogol 2000 60g

[0075] Macrogol 6000 210g

[0076] tert-butyl-p-hydroxyanisole 0.1g

[0077] Sorbitan Ester 40 5g

[0078] Proper amount of ethanol

[0079]

[0080] A total of 1000 capsules were made

[0081] Preparation:

[0082] (1) Preparation of polyene phosphatidylcholine pellets

[0083] A. Solution preparation

[0084] Weigh the polyene phosphatidylcholine of the above prescription amount, stir and dissolve in an appropriate amount of ethanol in a vacuum state, add the prescription amount of tert-butyl p-hydroxyanisole, polyethylene glycol 2000, polyethylene glycol 6000, Mix the sorbitan ester 40 evenly, maintain the vacuum state and stirring state, and set aside;

[0085] B. Preparation of pellets

[0086] Vacuum-dry the solution obtained in A under stirring to remove ethanol, raise the temperature to 60°C and stir evenly, let stand until the bubbles are completely removed,...

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Abstract

The invention relates to an oral solid preparation containing polyene phosphatidyl choline and a preparation method thereof. The preparation method comprises the following steps: dissolving polyene phosphatidyl choline in ethanol; adequately mixing the polyene phosphatidyl choline with a matrix, an antioxygen and a sorbefacient in a protective state; carrying out vacuum drying and volatilizing to remove ethanol, and preparing pellets by a pill dropping machine; and packaging the pellets coated or packing in hard capsules or tabletting and coating to obtain the oral solid preparation containing polyene phosphatidyl choline. The oral solid preparation containing polyene phosphatidyl choline provided by the invention can enhance the stability of polyene phosphatidyl choline, reduce the gastrointestinal irritation by the medicine and improve the dissolving-out performance of polyene phosphatidyl choline, so that the equipment cost is saved to the benefit of industrialized production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an oral solid preparation containing polyene phosphatidylcholine and a preparation process thereof. Background technique [0002] At present, there are tens of millions of patients with various liver diseases in my country, hundreds of millions of hepatitis virus carriers, and hundreds of thousands of people who die each year due to liver diseases. The task of preventing and treating liver diseases in my country is very arduous. There are few drugs that are good and have low side effects, especially those that are effective for various liver diseases and have a broad spectrum for treating liver diseases. [0003] Polyene phosphatidylcholine is a hepatobiliary disease treatment drug developed by SANOFI AVENTIS. It is mainly used clinically for various types of liver diseases, such as: hepatitis, chronic hepatitis, liver necrosis, cirrhosis, Hepatic coma (including prodro...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K9/20A61K9/16A61K9/48A61K31/685A61K47/44A61K47/34A61K47/20A61K47/22A61P1/16A61P39/02A61P1/08A61P17/06A61P17/00
Inventor 郭辉
Owner HEFEI BOSIKC PHARMTECH CO LTD
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