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Preparation method of Huodan dropping pills

A technology for the preparation of dripping pills and Huodan, which is applied in the field of solid dispersion pharmaceutical preparations and Huodan dripping pills. It can solve the problems of drug safety risks and slow addition, and achieve shortening of heating time, halving of heating time, and loss of volatilization Reduced effect

Active Publication Date: 2014-10-01
SHANGHAI LEIYUNSHANG PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] If the "no ethanol" scheme is adopted, that is, hyocholic acid powder is used for feeding, the raw material will float on the polyethylene glycol liquid surface due to the non-water solubility of hyocholic acid, thus forcing the powder feeding process to be slower Add at a faster speed, and at the same time, in order to improve the melting and dispersing effect of hyocholic acid, the polyethylene glycol insulation temperature is often appropriately increased, which will also bring potential danger to the safety of the drug itself, because polyethylene glycol will generate heat when it is above 100 ° C. Oxygen degradation produces formates and esters, and the formate process will be accompanied by the formation of formaldehyde intermediates

Method used

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  • Preparation method of Huodan dropping pills

Examples

Experimental program
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Effect test

Embodiment 1

[0032] Determination of hyodeoxycholic acid in Huodan dripping pills in embodiment 1

[0033] Measured according to high performance liquid chromatography (Appendix VID of Chinese Pharmacopoeia 2010 Edition).

[0034] Chromatographic conditions and system suitability test used octadecylsilane bonded silica gel as filler; acetonitrile-0.1% glacial acetic acid (50:50) as mobile phase; evaporative light scattering detector. The number of theoretical plates calculated based on hyodeoxycholic acid peak should not be less than 3500.

[0035] Preparation of Reference Substance Solution Accurately weigh an appropriate amount of hyodeoxycholic acid reference substance that has been dried under reduced pressure with phosphorus pentoxide for 24 hours, weigh it accurately, add methanol to make a solution containing 0.4mg per 1ml, and obtain it.

[0036] The preparation of the test solution takes an appropriate amount of this product under the weight difference item, grinds finely, takes ...

Embodiment 2

[0038] Determination of patchouli oil in embodiment 2 Huodan dripping pills

[0039] According to gas chromatography (Chinese Pharmacopoeia Appendix VIE) determination.

[0040] Chromatographic conditions and system suitability test A capillary column with 5% phenylmethyl polysiloxane as the stationary phase (column length is 30m, inner diameter is 0.32mm, film thickness is 0.25μm); column temperature is programmed temperature: initial temperature 120°C, hold for 5 minutes, raise the temperature to 170°C at a rate of 10°C per minute, hold for 4 minutes; the detector temperature is 280°C, the inlet temperature is 280°C; split injection, the split ratio is 10:1. The number of theoretical plates should not be less than 5000 based on the peak of patchouli oil.

[0041] Preparation of Reference Substance Solution Use patchouli oil raw material as reference substance, take an appropriate amount, accurately weigh it, add ethyl acetate to make a solution containing 2 mg per 1 ml, and...

Embodiment 3

[0044] Buchuliol content determination in embodiment 3 Huodan dripping pills

[0045] Determination according to gas chromatography (Appendix VIE).

[0046] Chromatographic conditions and system suitability test A capillary column with 5% phenylmethylpolysiloxane as the stationary phase (column length is 30m, inner diameter is 0.32mm, film thickness is 0.25μm); column temperature is programmed temperature: initial temperature 120°C, hold for 5 minutes, raise the temperature to 170°C at a rate of 10°C per minute, hold for 4 minutes; the detector temperature is 280°C, the inlet temperature is 280°C; split injection, the split ratio is 10:1. The number of theoretical plates should not be less than 5000 based on the calculation of the alcohol peak of potion.

[0047] Preparation of Reference Substance Solution: Take an appropriate amount of the reference substance of potcine alcohol, accurately weigh it, add ethyl acetate to make a solution containing 0.6mg per 1ml, and obtain it...

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Abstract

The invention relates to a preparation method of Huodan dropping pills. The method comprises the following steps: respectively putting a raw material hyocholic acid sieved by a 60-mesh sieve and an auxiliary material polyethylene glycol 6000 according to a prescription quantity into a mixer for fully mixing, throwing the mixed material into a melting tank and melting in a heating manner so as to obtain an evenly-dispersed undertint medicine liquid while the medium is molten; adding patchouli oil in a specified prescription quantity in a stirring state; evenly stirring the medicine liquid for forming dropping pills; then, dropping the medicine liquid into cooling oil array pipes with certain temperature gradients in a speed control manner under a certain heat preservation condition; and collecting the formed dropping pills, centrifugally removing the cooling oil and collecting the dropping pills. According to the method, the dropping temperature cannot exceed 85 DEG C, so that the volatilization loss of the patchouli oil taken as an effective medicine is obviously reduced. Compared with a powdery feeding process, according to the method provided by the invention, the heating time of the materials is shorted by half.

Description

technical field [0001] The invention relates to a solid dispersion pharmaceutical preparation, in particular to a preparation method of Huodan dripping pills, which belongs to the technical field of traditional Chinese medicine preparations. Background technique [0002] Dropping pills are a kind of solid dispersion (Soild dispersion). The so-called solid dispersion refers to a mixed substance formed by dispersed phase substances (including various states of matter) dispersed in a solid medium, in which the dispersed phase substances can be dispersed in the state of molecules, ions or particles. Solid dispersion is widely used in modern pharmaceuticals as a drug delivery system. After the solid or liquid drug is heated, melted and mixed with the matrix, it is dropped into the immiscible condensate, and the preparation is made by shrinking and condensing. For oral application. This drop method pill making process is actually to make the solid dispersion into the form of dro...

Claims

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Application Information

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IPC IPC(8): A61K36/532A61K9/20A61K47/34A61P11/02A61J3/06A61K31/575
Inventor 钱湧奚静芳张国明
Owner SHANGHAI LEIYUNSHANG PHARMA
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