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Nasal administration preparation containing bupleurum root volatile oil

A technology of nasal drug delivery preparation and volatile oil, which is applied in the field of nasal drug delivery preparations, can solve the problems of cilia toxicity, nasal cilia toxicity, irritation and toxicity, etc., and achieve the effect of increasing solubility

Active Publication Date: 2005-05-18
FUDAN UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent application (Application No.: 02111558.3) discloses a method for increasing the solubility of Bupleurum volatile oil by using solubilizer Tween 80 and propylene glycol. The disclosed Bupleurum nasal cavity administration preparation (compared with prescription) has the advantage of little toxicity to nasal cilia , but there is still some nasal ciliary toxicity
Tween 80 is a commonly used and effective solubilizer. It is used in some injection prescriptions, but it has certain irritation and toxicity to nasal mucosa and cilia. Usually, more than 2% may cause more obvious Cilia toxicity

Method used

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  • Nasal administration preparation containing bupleurum root volatile oil
  • Nasal administration preparation containing bupleurum root volatile oil
  • Nasal administration preparation containing bupleurum root volatile oil

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] With Tween 80, Propylene Glycol, Transcutol  P and PEG400 are used as solubilizers, the optional dosage of Tween 80 is 0-1.5%, propylene glycol is 0-15%, Transcutol  P is 0-50%, PEG400 is 0-20%. According to the prescription listed in Table 1, these four solubilizers can solubilize Bupleurum volatile oil to 0.044-4.4% within the above range, that is, 0.00044-0.044g of Bupleurum volatile oil is dissolved per 1ml of the preparation, which is equivalent to the crude drug Bupleurum 1- 100g, to prepare clear and uniform solution or solution gel.

[0036] Prescription 1

Prescription 2

Prescription 3

Prescription 4

Prescription 5

Prescription 6

Prescription 7

Bupleurum volatile oil

1.1g

1.1g

4.4g

3.3g

2.2g

0.22g

0.044g

Equivalent to herbal medicine

2500g

2500g

10000g

7500g

5000g

500g

100g

crude drug source

North Bupleurum root

N...

Embodiment 2

[0052] Adopt one or more of Tween 20, Tween 40, Tween 60, Tween 80 and Tween 85, the total dosage is 0-1.5%; adopt one or two of PEG400 and PEG600, the total dosage is 0-20%; the amount of propylene glycol is 0-15%; Transcutol The amount of P used is 0-50%. These four solubilizers can solubilize Bupleurum volatile oil to 0.044-4.4% within the above range, that is, dissolve 0.00044-0.044g of Bupleurum volatile oil per 1ml preparation, which is equivalent to 1-100g of crude drug Bupleuri, and prepare a clear and uniform solution . When the above four solubilizers are selected according to the upper limit of the dosage range, the prepared solution prescription (see Table 4 prescription 14-21) can solubilize 4.4% of Bupleurum volatile oil, that is, every 1ml preparation can dissolve 0.044g of Bupleurum volatile oil , which is equivalent to 100g of the crude drug Bupleuri.

[0053] Prescription 14

Prescription 15

Prescription 16

Prescription 17

Prescr...

Embodiment 3

[0057] Take Transcutol  P and Labrasol  As a solubilizer, Transcutol  The optional content of P is 2.5-35%, Labrasol  2.5-20%. These two solubilizers can solubilize Bupleurum volatile oil to 0.044-4.4% within the above range, that is, dissolve 0.00044-0.044g of Bupleurum volatile oil per 1ml of the preparation, which is equivalent to 1-100g of the crude drug Bupleuri, and prepare a clear and uniform solution . When the above two solubilizers are selected according to the upper limit of the dosage range, the prepared solution prescription can solubilize 4.4% of Bupleurum volatile oil, that is, each 1ml preparation can dissolve 0.044g of Bupleurum volatile oil, which is equivalent to 100g of the crude drug Bupleuri. Polysorbates (including Tween 20, Tween 40, Tween 60, Tween 80 and Tween 85), polyethylene glycols (including PEG400 and PEG600) and propylene glycol solubilizers can also be added simultaneously in the preparation. One or more to further improve the solubil...

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Abstract

The present invention belongs to the field of Chinese medicine preparation, and is a kind of nasal administrated preparation containing volatile bupleurum root oil. Proper pharmaceutical supplementary material in certain proportion is used to increase the dissolving degree of volatile bupleurum root oil in water medium while producing no irritation to nasal mucous membrane and toxicity to nasal cilium. The nasal administrated preparation of volatile bupleurum root oil of the present invention has high dissolving degree of volatile bupleurum root oil and low irritation to nasal mucous membrane and toxicity to nasal cilium.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine preparations, and relates to a nasal administration preparation containing bupleurum volatile oil. Background technique [0002] The traditional Chinese medicine Bupleurum is a pungent and cool-relieving medicine, bitter in nature, slightly cold, and returns to the liver and gallbladder meridian. It has the effects of dispersing and reducing fever, soothing the liver and promoting yang. Especially the volatile oil extracted from Bupleuri herb has the advantages of low toxicity and remarkable antipyretic effect. Clinically, the volatile oil of Bupleurum radix is ​​prepared into injection, and the administration route of intramuscular injection is used to treat fever, and the curative effect is definite. However, since Bupleurum Injection needs to be administered by injection, the route of administration is inconvenient, and at the same time it will cause strong injection pain, which mak...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61P29/00
Inventor 蒋新国陆伟谢月玲李明虎徐广庆左庆友
Owner FUDAN UNIV
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