CN1090487A

CN1090487A - Shuanghuanglian aerosol, spray (nose kettle), enema and preparation method thereof

Info

Publication number: CN1090487A
Application number: CN 93115315
Authority: CN
Inventors: 丛繁滋
Original assignee: Individual
Current assignee: Individual
Priority date: 1992-12-28
Filing date: 1993-12-28
Publication date: 1994-08-10

Abstract

The present invention is Shuanghuanglian aerosol, spray (nose kettle), enema and preparation method thereof.Abandoned is fallen in the 'Shuang Hualian ' preparation process in the past Flos Lonicerae, Forsythia volatile oil have been added in the 'Shuang Hualian ' of the present invention.In spray, enema, added pH buffer agent, osmotic pressure regulator,, reduced irritating purpose to reach further raising curative effect.

Description

Shuanghuanglian aerosol, spray (nose kettle), enema and preparation method thereof

The invention belongs to pharmaceutical preparation and preparation method thereof.

The present invention is once improving again on the basis of the preparation method patent application characteristics of Shuanghuanglian aerosol, spray and the enema thereof of the application number 92115119.5 of inheriting 1992.12.28 the author's application fully, it is bigger that it has overcome when in former 921228 applications volatile oil of Flos Lonicerae, Fructus Forsythiae being used as hazardous waste and spray nasal-cavity administration zest, deficiency such as defecate feeling slightly during the enema anum administration.

The objective of the invention is to release the Shuanghuanglian aerosol to make full use of the medicine source, spray, enema and preparation method thereof and synergisting method, so that the curative effect height that is more suitable for the patient and uses, the SHUANGHUANLIAN novel form of instant effect to be provided to society to people.

The present invention includes three kinds of Shuanghuanglian aerosols, spray (nose kettle), enema, existing division is as follows:

Shuanghuanglian aerosol is by formations such as medicine (or containing synergist), solvent, propellant.Wherein drug main will be by formations such as Flos Lonicerae, Radix Scutellariae, Fructus Forsythiae (if when needing potentiation, but methylate benzyl Aminometradine), 15～200% of the suitable aerosol content gross weight of its crude drug consumption; The optional water of solvent, ethanol, propylene glycol, dimethyl sulfoxide, Laurel nitrogen

At least a among the ketone, its consumption should account for 20～90% of aerosol content total amount; Propellant can be selected compressed air for use; Nitrous oxide, nitrogen, liquid gas, fluorine alkyl chloride chemical compound, Hydrocarbon etc. are wherein at least a, and its consumption should account for 10～80% of aerosol content gross weight.Its preparation method is: Flos Lonicerae in will writing out a prescription, that Fructus Forsythiae extracts volatile oil with steam distillation is standby, and, each 1.5 hours, be concentrated into relative density 1.20～1.25 with medicine residue water (or ethanol) decoction twice, precipitate with ethanol handles twice, and it is standby that recovery ethanol is evaporated to thick paste.Radix Scutellariae is standby according to well-established law extraction baicalin in the prescription.Thick paste and baicalin with standby Flos Lonicerae, Fructus Forsythiae, add dissolve with ethanol, transfer pH value 6.5, leave standstill, filter (if when needing potentiation, then in filtrate, add Trimethoprim) in filtrate, add decolorizing with activated carbon, leave standstill, filter, add cosolvent and standby Flos Lonicerae, Forsythia volatile oil in the filtrate, standardize solution, mix homogeneously, after the assay was approved, be sub-packed in the bottle with filling machine, charge into a certain amount of dichlorodifluoromethane promptly by covering valve behind the gland.

SHUANGHUANLIAN spray (nose kettle) is by formations such as medicine (or containing synergist), solvent, solubilizing agent, PH buffer agent, osmotic pressure regulator, school flavor agent, if wherein drug main constitutes (if needing potentiation can add synergist) its consumption by Flos Lonicerae, Radix Scutellariae, Fructus Forsythiae etc. and amounts to 10～250% of the suitable spray content of crude drug gross weight; At least a among the optional water of solvent, the ethanol, its consumption should account for 50～98% of spray total amount; Solubilizing agent can be selected tween 80 for use, dimethyl sulfoxide, Laurel nitrogen

Ketone etc., its consumption should account for 0～10% of spray content total amount; The PH buffer agent can be selected the Sha Shi phosphate buffer for use, Palitzsch, lucky Fei Shi buffer etc.; Its consumption should account for 0～5% of spray total amount; Osmotic pressure regulator can be selected sodium chloride boric acid, Borax, glucose, Chile saltpeter etc. for use, and its consumption should account for 0～3% of spray total amount; School flavor agent can be selected stevioside, sweet sugar element, sucrose, Herba Menthae wet goods for use; Its consumption should account for 0～6% of spray total amount.The preparation method of SHUANGHUANLIAN spray (nose kettle) is: it is standby that the preparation method described in the preparation method of aerosol is extracted Flos Lonicerae, Forsythia volatile oil, thick paste and baicalin.Get standby Flos Lonicerae, Fructus Forsythiae thick paste and baicalin, add an amount of water, and transfer pH value to 7 with 10% sodium hydrate aqueous solution, make it dissolving, add decolorizing with activated carbon, filtration, in filtrate, add solubilizing agent (and or adding synergist), PH buffer agent, osmotic pressure regulator, Flos Lonicerae, Forsythia volatile oil and school flavor agent, standardize solution, mix homogeneously is sub-packed in the bottle after the assay was approved, cover have the mechanical spraying valve lid promptly.

The SHUANGHUANLIAN enema is by medicine (or containing synergist) solvent, solubilizing agent, PH buffer agent, formations such as osmotic pressure regulator, if wherein drug main constitutes (if needing potentiation can add methyl benzyl Aminometradine) by Flos Lonicerae, Radix Scutellariae, Fructus Forsythiae etc., its consumption is amounted to 10～250% of the suitable enema content of crude drug gross weight; At least a among the optional water of solvent, the ethanol, its consumption should account for 50～98% of enema gross weight, and solubilizing agent can be selected tween 80, dimethyl sulfoxide, Laurel nitrogen for use

Ketone etc., its consumption should account for 0～10% of enema content gross weight, and the PH buffer agent can be selected Sha Shi phosphate buffer, Palitzsch, lucky Fei Shi buffer etc. for use, and its consumption should account for 0～5% of enema total amount; Osmotic pressure regulator can be selected sodium chloride, boric acid, Borax, glucose, Chile saltpeter etc. for use, and its consumption should account for 0～3% of enema total amount.The preparation method of SHUANGHUANLIAN enema is: it is standby that method is extracted Flos Lonicerae, Forsythia volatile oil, thick paste and baicalin described in production of aerosol.Get standby Flos Lonicerae, Fructus Forsythiae thick paste and baicalin, add an amount of water, and transfer pH value to 7 with 10% sodium hydrate aqueous solution, make it dissolving, add decolorizing with activated carbon, filter, add solubilizing agent (and or adding synergist), volatile oil, PH buffer agent, osmotic pressure regulator etc. in filtrate, standardize solution, mix homogeneously are sub-packed in after the assay was approved in the plastics peace bottle and seal promptly.

The preparation method that the present invention has inherited 921228 patent applications therefore have following when 1. having avoided preparing a certain dosage form in the past relative insoluble composition be taken as the phenomenon of hazardous waste, saved the medicine source.2. but aerosol, spray are compared patient's self-administration with injection, do not have the hardship of injection, and easy to carry, compare directly focus administration with injection, tablet, oral liquid, and dosage is little, local lesion's drug level height, curative effect height, instant effect; 3. to compare preparation method simple, with low cost for enema and suppository, and the production efficiency height has saved the advantages such as time that suppository dissolves at internal rectum.And compare with the preparation method patent application of Shuanghuanglian aerosol, spray and enema thereof of 921228 applications, on prescription and on the expression method, slightly adjust: 1. directly provide every bottle of crude drug recipe quantity in the embodiment of the invention, so explain more clear; 2. abandoned is fallen in the 'Shuang Hualian ' preparation process in the past Flos Lonicerae, Forsythia volatile oil have been added in the 'Shuang Hualian ' of the present invention; 3. added PH buffer agent, osmotic pressure regulator in spray of the present invention, the enema,, reduced irritating purpose to reach further raising curative effect.

For the present invention is further illustrated, provide following embodiment:

Embodiment 1: the preparation method of Shuanghuanglian aerosol.

Flos Lonicerae in will writing out a prescription, that Fructus Forsythiae extracts volatile oil with steam distillation is standby, and with twice of medicine residue water decoction, each 1.5 hours, filter merging filtrate, be concentrated into relative density 1.2～1.25, precipitate with ethanol handles twice, reclaims ethanol, and it is standby to be evaporated to thick paste, Radix Scutellariae is according to the 226th page of baicalin preparation method of version Heilongjiang Province drug standard in 1986 in will writing out a prescription, and the preparation baicalin is standby.When prescribed dose is chosen to be Radix Scutellariae 375g, Flos Lonicerae 375g is during Fructus Forsythiae 750g, each amounts of components is as follows during adjustment: with above-mentioned standby Flos Lonicerae, the thick paste of Fructus Forsythiae and baicalin, add dissolve with ethanol, transfer PH6.5, and with ethanol dilution to 450ml, left standstill 24 hours, filter, filtrate is transferred PH6.5, adds the 10g activated carbon, reflux decolouring in 15 minutes, left standstill 48 hours, and filtered, add 350ml dimethyl sulfoxide and above-mentioned standby volatile oil (about 5ml) in the filtrate, it is 700ml that reuse ethanol transfers to cumulative volume, mix homogeneously, sampling check is sub-packed in 100 bottles after the assay was approved, gland, every bottle charges into the 5g dichlorodifluoromethane promptly.

Embodiment 2: the preparation method of SHUANGHUANLIAN spray (nose kettle)

Method described in the preparation method of aerosol is extracted Flos Lonicerae, Forsythia volatile oil, thick paste and baicalin are standby, when the prescription inventory is chosen to be Flos Lonicerae 500g, Radix Scutellariae 500g, during Fructus Forsythiae 1000g, each amounts of components of following adjustment is as follows: get standby Flos Lonicerae, Fructus Forsythiae thick paste and baicalin, add 1000ml water, and transfer pH value to 7 with 10% sodium hydrate aqueous solution, make it dissolving, add activated carbon 15g, little boiling 15 minutes left standstill 24 hours, filtered, in filtrate, add 160ml ethanol respectively, the 30ml tween 80, Borax 2.85g, boric acid 16.8g, standby Flos Lonicerae, Forsythia volatile oil (about 7.5ml), stevioside 4g, the plain 15g of sweet sugar, and add water to 1500ml, mix homogeneously, after the assay was approved, be sub-packed in 100 bottles, cover have the mechanical spraying valve lid promptly.

Embodiment 3: the preparation method of SHUANGHUANLIAN enema

Method described in the preparation method of aerosol is extracted Flos Lonicerae, Forsythia volatile oil, thick paste and baicalin are standby, putting forward the material amount when prescription is Flos Lonicerae 100g, Radix Scutellariae 100g, during Fructus Forsythiae 200g, the consumption of each component is as follows during adjustment: get standby Flos Lonicerae, Fructus Forsythiae thick paste and baicalin, add 200ml water, and transfer pH value to 7 with 10% sodium hydrate aqueous solution, make it dissolving, add activated carbon 3g, heat little boiling 15 minutes, left standstill 24 hours, filter, in filtrate, add the 6ml tween 80 respectively, Borax 0.57g, boric acid 3.36g and standby Flos Lonicerae and Fructus Forsythiae volatile oil add water to 300ml then, mix homogeneously is sub-packed in after the assay was approved in 100 plastics peace bottles and seals promptly.

Claims

1, Shuanghuanglian aerosol is characterized in that this aerosol is to be made of medicine, solvent, propellant etc., and wherein drug main will be by formations such as Flos Loniceraes, Fructus Forsythiae, Radix Scutellariae when needing potentiation (if, methylate benzyl Aminometradine); At least a among the optional water of solvent, ethanol, propylene glycol, dimethyl sulfoxide, the laurocapram; Propellant can be selected compressed air for use: nitrogen, nitrous oxide, liquid gas; Fluorine alkyl chloride chemical compound, Hydrocarbon etc. are wherein at least a.

2, Shuanghuanglian aerosol as claimed in claim 1, the percentage ratio that it is characterized in that constituting each ingredients constitute aerosol content gross weight of aerosol content is: medicine is amounted to crude drug and is accounted for 15%～200%; Solvent accounts for 20%～90%; Propellant accounts for 10%～80%.

3, Shuanghuanglian aerosol is characterized in that this aerosol is by dosing, transfers PH, filtration, hydrotropy, adds Flos Lonicerae, Forsythia volatile oil, standardize solution, fill, gland, charges into operation such as propellant and finishes, and wherein the PH range of accommodation is 4.5～8.

4, SHUANGHUANLIAN spray (nose kettle), enema, it is characterized in that these two kinds of preparations are by medicine, solvent, solubilizing agent, PH buffer agent, osmotic pressure regulator, school flavor agent formations such as (enema do not contain school flavor agent), wherein drug main will be by formations such as Flos Loniceraes, Fructus Forsythiae, Radix Scutellariae (if need potentiation, but methylate benzyl Aminometradine); At least a among the optional water of solvent, the ethanol; Solubilizing agent can be selected tween 80, dimethyl sulfoxide, Laurel nitrogen for use

Ketone etc.; The PH buffer agent can be selected the Sha Shi phosphate buffer for use, Palitzsch, lucky Fei Shi buffer etc.; Osmotic pressure regulator can be selected sodium chloride, boric acid, Borax, glucose, Chile saltpeter etc. for use; School flavor agent can be selected stevioside, sweet sugar element, sucrose, Herba Menthae wet goods for use.

5, SHUANGHUANLIAN spray as claimed in claim 4 (nose kettle), enema, the percentage ratio that it is characterized in that constituting each ingredients constitute preparation content gross weight of these two kinds of preparation contents is: medicine is amounted to crude drug and is accounted for 10%～250%; Solvent accounts for 50%～98%; Solubilizing agent accounts for 0～10%; The PH buffer agent accounts for 0～5%; Osmotic pressure regulator accounts for 0～3%; School flavor agent accounts for 0～6%.

6, SHUANGHUANLIAN spray (nose kettle), enema, it is characterized in that these two kinds of preparations are by dosing, transfer PH, decolouring, filtration, (potentiation), operation is finished to add PH buffer agent, osmotic pressure regulator, Flos Lonicerae and Fructus Forsythiae volatile oil, (school flavor agent) etc., standardize solution, fill respectively, seal etc., and wherein the PH range of accommodation is: 4.5～9.