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Novel preparation of neuroactive steroids

A neuroactive and steroid technology, applied in the oily preparations of neuroactive steroids, in the field of medicines for the treatment of central nervous system diseases, can solve problems such as the inability to quickly reach effective blood drug concentrations

Pending Publication Date: 2020-06-16
NANJING NORATECH MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is generally believed that oily carriers such as castor oil and sesame oil have the effect of slow release, and the preparations made by them cannot quickly reach the effective blood drug concentration after administration, and exert the drug effect.

Method used

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  • Novel preparation of neuroactive steroids
  • Novel preparation of neuroactive steroids
  • Novel preparation of neuroactive steroids

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0104] Embodiment 1 Solubility of allopregnolone in common non-aqueous solvents

[0105] Test method: Disperse excess porpregnanolone in different solvents, shake at room temperature for 24 hours, filter and measure the content by HPLC.

[0106] The inventor tested the solubility of allopregnolone in common non-aqueous solvents, the results are shown in Table-1,

[0107] Table 1

[0108] solvent Solubility (mg / mL) solvent Solubility (mg / mL) Soybean oil 11.5 Corn oil 12 sesame oil 9.5 Propylene Glycol 9.7 castor oil 35.4 PEG400 9 ethanol 60.7 polyoxyethylene castor oil 29 Benzyl alcohol 120.6 N-Methylpyrrolidone 161.9 Benzyl Benzoate 42.1 ethyl oleate 8.4 Isopropyl myristate 13.2 N,N-Dimethylacetamide 230.5 medium chain fatty acid triglycerides 12

[0109]From the above test results, it can be seen that the solubility of allopregnolone in oily carriers is quite different, and it is obv...

Embodiment 2

[0110] Example 2 Effect of Different Alcohol Excipients on the Solubility of the Allopregnolone Pharmaceutical Composition

[0111] Test method: Weigh pregnanolone, benzyl benzoate, ethanol or benzyl alcohol in a vial according to the prescription in Table-2, heat and stir for 10-30 minutes, then add the prescribed amount of castor oil, stir at 60°C and observe the drug Is it completely dissolved.

[0112] Table 2

[0113]

[0114] " / " means no addition, "×" means it cannot be dissolved, "√" means it can be dissolved

[0115] From the above results, it can be seen that ethanol has an unexpected contribution to the stability of the allopregnolone formulation. As shown in Table-1, the solubility of benzyl alcohol is significantly higher than that of ethanol, which is more than 2 times that of ethanol. According to the common understanding, the formulation with ethanol should be less soluble and less stable than the formulation with benzyl alcohol. But unexpectedly, the pr...

Embodiment 3

[0116] Embodiment 3 Allopregnolone composition of the present invention

[0117] prescription:

[0118] table 3

[0119]

[0120]

[0121] " / " means not added

[0122] Preparation:

[0123] According to the prescription shown in Table-3, weigh other excipients except castor oil, mix them evenly to form a solvent; add the prescribed amount of pregnanolone, heat and stir; then add the prescribed amount of castor oil, and continue stirring until uniformly mixed.

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Abstract

The invention relates to the field of pharmaceutical preparations, and in particular to a novel preparation of neuroactive steroids, a method for preparing the preparation and application of the preparation to preparation of a medicine for treating central nervous system diseases.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an oily preparation of neuroactive steroids, a method for preparing the preparation, and a use of the preparation in preparing medicines for treating central nervous system diseases. Background technique [0002] Neuroactive steroids are steroids that are active in nervous tissue. Neurosteroids that play an important regulatory role in the human body mainly include progesterone, pregnenolone, and pregnanolone. Progesterone, pregnenolone and allopregnolone are all metabolized from cholesterol through different pathways. Cholesterol is transferred from the mitochondrial outer membrane to the inner membrane under the mediation of the 18kDa translocation protein, and passes through the cytochrome P450 cholesterol side chain cleavage enzyme Pregnenolone is metabolized into pregnenolone, which is then metabolized into progesterone by 3β-hydroxysteroid dehydrogenase, and then ...

Claims

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Application Information

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IPC IPC(8): A61K31/57A61K47/44A61K47/14A61K47/22A61K47/10A61P25/14A61P25/08A61P25/24A61P25/00A61P25/18
CPCA61K31/57A61K47/44A61K47/14A61K47/22A61K47/10A61P25/14A61P25/08A61P25/24A61P25/00A61P25/18A61K9/08
Inventor 刘飞吴刚张翠霞林成刚姜伟化刘迪尹德燕王露露
Owner NANJING NORATECH MEDICAL TECH CO LTD
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