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Formulation of a micro drop pill and the preparation method thereof

a micro drop pill and drop pill technology, which is applied in the field of traditional chinese medicine (tcm) micro drop pill and tcm micro drop pill preparation, can solve the problems of inaccurate dosage, inability to meet, and generally unacceptable by international consumers, and achieves high drug loading capacity, small amount of matrix, and simple and high-speed

Inactive Publication Date: 2016-06-02
TIANJIN TASLY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The objective of this patent is to provide a way to make small, high-speed pills that can carry a lot of medication and have very little material in them. The method involves several steps, but it's simple and easy to follow.

Problems solved by technology

This cannot meet the requirement of international market that the maximum daily dosage of polyethylene glycols (PEGs) matrix should not exceed 700 mg.
Moreover, it is difficult to prepare the traditional drop pill with a diameter of less than 2.5 mm, so the patients have to take a lot of hard-to-swallow pills each time, which will not satisfy fast-paced trend of modern life, and be prone to the problem of inaccurate dosage.
Thus, it is generally unacceptable by the international consumers.
Because the coolant has been used for solidifying the drop pills, the necessary step is needed in the subsequent process to remove the coolant, and the irremovable coolant may cause the problem of residual organic solvent.
Besides, drying methods for the traditional drop pill have the defects of prolonged time, uneven drying and easily leading to evaporation of volatile oil-containing products and precipitation of borneol of borneol-containing products during drying.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

trial example 1

Comparative Study on Effects of Two Kinds of CSDPs on Acute Myocardial Infarction in Rats

[0123]1. Animals:

[0124]SD male rats, weighing 340˜360 g, were purchased from Beijing Weitonglihua Experimental Animal Co., Ltd, and certification No.: SCXK (Jing) 2007˜0001.

[0125]2. Drugs, Reagents and Apparatus

[0126]CSMDP of the present invention was prepared by the method of Preparative Example 1 of CSMDP.

[0127]CSDP, used as a comparative drug, was commercially available in China, prepared by Tianjin Tasly Pharmaceutical Co., Ltd.

[0128]Chloral hydrate and triphenyl tetrazolium chloride (TTC) were used for anesthesia. Apparatus: MedLab-U / 8c bio-signals collecting-processing system, purchased from Nanjin Meiyi Inc.

[0129]3. Experimental Methods

[0130]Grouping: the rats were randomly divided into groups according to their body weight: S group (Sham operation group), M group (Model group), Y group (Positive control group, metoprolol tartrate, Lot No. 1201039), F group (CSMDP of the present invention...

example 1

CSMDP Preparative Example 1

[0139]The following materials were prepared: 75 g of Salvia Militiorrhiza and Panax Notoginseng extract, 7.5 g of borneol and 165 g of PEG-6000.

[0140](1) Pre-mixing step: the API of Compound Salvia Militiorrhiza was added with water to pre-mix, stirred in a heat-insulated tank at 40±10° C. for 60 min or longer to make the water content of the API of Compound Salvia Militiorrhiza at 13.0 wt % to give a pre-mixed material of the API of Compound Salvia Militiorrhiza for later use;

[0141](2) Material melting step: the PEG-6000 was firstly added into a melting tank, pre-molten by heating to 90° C., into which the pre-mixed material of the API of Compound Salvia Militiorrhiza was added and the resultant material was mixed by a low-speed homogenization (3200 rpm); after mixing, the homogenization rate was increased to 5000 rpm to melt the material for 6 min; during melting process, the temperature of the material was kept at 80±5° C. to give a molten medicine liqu...

example 9

CSMDP Preparative Example 9

[0188]The following materials were prepared: the API powder of Compound Salvia Militiorrhiza (including 100 g of Salvia Militiorrhiza and Panax Notoginseng extract and 5 g of borneol) and 35 g of a mixture of PEG-4000:PEG-6000 (1:1). CSMDP was prepared by the following steps:

[0189]The API powder of Compound Salvia Militiorrhiza was added with water and stirred at 80° C. for 10 min or longer to obtain a pre-mixed API of Compound Salvia Militiorrhiza.

[0190](1) Material melting step: the mixture of PEG-4000: PEG-6000 (1:1) and the pre-mixed API of Compound Salvia Militiorrhiza were charged into a homogenizer to homogenize at 2500 rpm for 100 min to give a material; the material was molten homogenously at 6000 rpm for 80 min; during the melting process, the temperature of the material was kept at 80° C. to obtain a molten medicine liquid;

[0191](2) Dropping step: the molten medicine liquid was delivered to a dripper and dropped by means of vibration dropping a...

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Abstract

The present invention relates to a preparation method for a traditional Chinese medicine drop pill and a traditional Chinese medicine micro drop pill prepared by using the method, and in particular, the present invention relates to a micro drop pill preparation method with high drug-loading capacity, simple preparation process and high production rate and a micro drop pill prepared by using the method. Specially, The drop pill preparation method used comprises the following steps: (1) material melting step: heat melting a medicine and a drop pill matrix to obtain a molten medicine liquid; (2) dropping step: delivering the molten medicine liquid to a dripper, and acquiring medicine drops of the molten medicine liquid by means of vibration dropping; and, (3) condensation step: cooling the medicine drops with a cooling gas to obtain micro drop pills.

Description

FIELD OF THE INVENTION[0001]The present invention relates to a preparation method of a traditional Chinese medicine (TCM) micro drop pill and TCM micro drop pill prepared by using the method, more particularly, the present invention relates to a micro drop pill preparation method with high drug-loading capacity, simple preparation process and high production rate and a micro drop pill prepared by the method. The method can be used to prepare an uncoated micro drop pill, a coated micro drop pill and a micro drop pill capsule with high drug-loading capacities.BACKGROUND OF THE INVENTION[0002]Drop pill, as an important traditional Chinese medicine preparation, has been used widely. In practice, it has the following merits: shortened production cycle, dust pollution-free, high bioavailability, rapid onset of effect, prolonged action in topical administration, reduced volatility of drug, increased drug stability and being easily carried and stored.[0003]However, the preparation method of...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K36/48A61K36/481A61K36/258A61J3/06A61K36/537
CPCA61K9/2095A61J3/06A61K36/537A61K36/481A61K9/2054A61K36/48A61K9/2027A61K9/2059A61K36/258A61K9/1641A61K9/1694A61K9/2031A61K9/2846A61K9/2866A61K9/288A61K9/5015A61K9/5026A61K9/5042A61K9/5047A61K9/5063A61K9/5089A61K45/06A61P7/02A61P9/00A61P9/10A61K2300/00
Inventor YAN, XIJUNWU, NAIFENGYAN, KAIJINGSUN, XIAOBINGZHANG, SHUNNANYE, ZHENGLIANGDONG, HAI'OUZHANG, HONGBOZHANG, WENSHENGZHOU, LIHONGLI, CHENMINGCHEN, CONGLIU, XIAOFENGWANG, SHIQINGRONG, CHANGSHENGZHENG, YONGFENGFAN, LIJUN
Owner TIANJIN TASLY PHARMA CO LTD