Andrographolide soft capsule and preparing method thereof

Abstract

The present invention relates to an andrographolide soft capsule and its production method. Every soft capsule contains 10-300 mg of andrographolide, and contains beeswax and medicinal auxiliary material. Said medicinal auxiliary material includes diluting agent, suspension adjuvant and defoaming agent, and the interior of said capsule shell, contains (by weight ratio) 10 portions of gelatin and 4.0-5.5 portions of glycerine. Its production process includes the following steps: adding water to dissolve gelatin, adding glycerine and proper quantity of preservative, vacuum deaerating, adding suspension adjuvant into vegetable oil, mixing andrographolide, diluting agent and defoaming agent uniformly, die-pressing to obtain said invented soft capsule. Its quality is stable, administration is convenient and its effective components can be quickly resolved out.

Description

technical field [0001] The invention relates to an andrographolide soft capsule and a preparation method thereof. Background technique [0002] Upper respiratory tract infection is one of the most common diseases, among which children and the elderly have a higher incidence rate. According to statistics, in 1999, the sales of medicines used to treat upper respiratory tract infection in the world have reached 94 billion US dollars. Currently, there are such diseases on the market The drugs and their disadvantages are: [0003] (1) Compound preparations for the respiratory system: Since a certain amount of histamine antagonists are generally added to this type of preparations, adverse reactions such as sedation, drowsiness, and fatigue are likely to occur, so the application range of this type of preparations is limited, especially for some Patients who work at heights or drive cars, boats, etc. [0004] (2) Single drug preparations for the respiratory system: most of them a...

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Problems solved by technology

[0003] (1) Compound preparations for the respiratory system: Since a certain amount of histamine antagonists are generally added to this type of preparations, adverse reactions such as sedation, drowsiness, and fatigue are likely to occur, so the application range of this type of preparations is limited, especially for some Patients who work at heights or drive cars, boats, etc.

[0004] (2) Single drug preparations for the respiratory system: most of them are newly marketed varieties such as dioxpromazine (Kekemin), tipepidine (Ansouling), ipratone (Yikezine), phenproperone Phenyl (cough fast and good), etc., have the advantages of strong pertinence and small side effects, but because of their high cost, it is difficult for ordinary patients to accept; in addition, this class of drugs is still in the stage of IV clinical research (after-sales research stage), and its toxicity must be confirmed. further investigation

[0005] (3) Andrographolide Tablets (Ministry of Health Drug Standards Traditional Chinese Medicine Prescriptions Volume 19 Page 128, Standard Number: WS 3 -B-3634-91, 8), the original dosage form is tablet, which is used for upper respiratory tract infection and bacillary dysentery.

However, it is inconvenient to carry and administer injections and freeze-dried powder injections; the active ingredients in tablets are slow to dissolve and cannot take effect in time.

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