Inhalation solution preparation containing Centella asiatica active ingredients and preparation method of inhalation solution preparation

An active ingredient, the technology of Centella asiatica, applied in the field of pharmacy, can solve the problems of low bioavailability and poor therapeutic effect

Pending Publication Date: 2020-07-07
INCREASEPHARM HENGQIN INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, most of the drugs clinically used to treat pulmonary fibrosis are taken orally, and oral preparations have the disadvantages of low bioavailability and poor therapeutic effect. In order to change this situation, we pioneered the active ingredient in Cent

Method used

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  • Inhalation solution preparation containing Centella asiatica active ingredients and preparation method of inhalation solution preparation
  • Inhalation solution preparation containing Centella asiatica active ingredients and preparation method of inhalation solution preparation
  • Inhalation solution preparation containing Centella asiatica active ingredients and preparation method of inhalation solution preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1 asiaticoside inhalation solution preparation

[0029] prescription:

[0030] Active ingredient: asiaticoside (purchased from the market, the content of asiaticoside, madecassoside and asiaticoside B is not less than 80wt%) 130mg;

[0031] Isotonic agent: sodium chloride (appropriate amount, adjust osmotic pressure (osmolality) to 295mOsmol / kg);

[0032] pH adjuster: 1wt% HCl aqueous solution (adjust pH to 5);

[0033] Water for injection: 1000mL.

[0034] Take the prescription amount of asiaticosides and water for injection, mix them evenly at room temperature, add sodium chloride to adjust the osmotic pressure, add a pH regulator to adjust the pH, and constant volume to obtain the asiaticosides solution for inhalation; The total glucoside solution is filled into the ampoule bottle, and the asiaticoside solution preparation for inhalation of the present invention is obtained.

Embodiment 2

[0035]Example 2 Preparations of asiaticoside inhalation solutions with different pH values

[0036] The physical properties of the inhalation solution will affect the compliance of the patient. For example, the pH value may cause unnecessary mucosal irritation to the patient, and it will also affect the stability of the inhalation solution itself, affecting the quality of the inhalation solution, and ultimately causing unnecessary harm to the patient. risk of use. In order to overcome the influence of pH value, the inventors investigated the stability of asiaticoside inhalation solution formulations under different pH conditions.

[0037] prescription:

[0038] Active ingredient: Asiaticoside 150mg;

[0039] Isotonic agent: sodium chloride (appropriate amount, adjust osmotic pressure (osmolality) to 298mOsmol / kg);

[0040] pH adjuster: 1wt% HCl aqueous solution (adjust pH to 3, 4, 5, 6); 0.2mol / L NaOH aqueous solution (adjust pH to 8);

[0041] Water for injection: 1000mL....

Embodiment 3

[0047] Example 3 Formulations of Madecassoside Inhalation Solution with Different pH Values

[0048] In order to overcome the influence of pH value, the inventors investigated the stability of madecassoside inhalation solution formulations under different pH conditions.

[0049] prescription:

[0050] Active ingredient: Madecassoside 130mg;

[0051] Isotonic agent: sodium chloride (appropriate amount, adjust osmotic pressure (osmolality) to 290-310mOsmol / kg);

[0052] pH adjuster: 1wt% HCl aqueous solution (adjust pH to 3, 4, 5, 6); 0.2mol / L NaOH aqueous solution (adjust pH to 8);

[0053] Water for injection: 1000mL.

[0054] Take the prescribed amount of madecassoside and add them to 6 volumetric flasks, add water for injection to the above volumetric flasks, mix well at room temperature, add sodium chloride to adjust the osmotic pressure, and add pH regulators to adjust the pH value 3, 4, 5, 6, 7 (no pH regulator), 8, constant volume to obtain the madecassoside solution...

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Abstract

The invention belongs to the field of pharmaceutics, and particularly relates to an inhalation solution preparation containing Centella asiatica active ingredients and a preparation method of the inhalation solution preparation. The solution preparation includes 1 [mu]g/mL-30 mg/mL of Centella asiatica active ingredients, an isotonic agent and a solvent, wherein the Centella asiatica active ingredients are one or more selected from Centella asiatica total asiaticosides, asiaticoside, madecassoside, asiaticoside B, asiatic acid, pharmaceutical salts of asiatic acid, madecassic acid, pharmaceutical salts of madecassic acid, asiatic acid B and pharmaceutical salts of asiatic acid B. The solution preparation has clear pharmaceutical effects and low content of impurities, the active ingredientsof Centella asiatica have good stability during long-term storage, and the content of main ingredients reaches 98% or above; the inhalation solution preparation has clear pharmaceutical effects, highstability, reliable quality, high safety and long storage time, and moreover, no preservatives are added to the solution preparation, so that the safety factor of the solution preparation is higher;and the solution preparation has suitable taste, and the taste of the active ingredients of Centella asiatica is covered fully.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a solution preparation of active ingredients of Centella asiatica for inhalation and a preparation method thereof. Background technique [0002] Pulmonary fibrosis is the end-stage change of a large class of lung diseases characterized by fibroblast proliferation and accumulation of a large amount of extracellular matrix, accompanied by inflammatory damage and tissue structure destruction, that is, normal alveolar tissue is damaged and undergoes abnormal repair to lead to structural changes. Abnormal (scarring). Pulmonary fibrosis seriously affects the respiratory function of the human body, manifested as dry cough and progressive dyspnea (perceived insufficient gas), and with the aggravation of the disease and lung damage, the patient's respiratory function continues to deteriorate. The morbidity and mortality of idiopathic pulmonary fibrosis are increasing year by year. The...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/02A61K36/23A61P11/00
CPCA61K9/0078A61K9/08A61K47/02A61K36/23A61P11/00
Inventor 张保献张宏武胡杰薛春美张建平马文转方秘芬宋艳威
Owner INCREASEPHARM HENGQIN INST CO LTD
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