JPS60222412A - Method for separating insoluble component of aqueous solution - Google Patents

Abstract

PURPOSE:To separate components depositing easily precipitating components in a crude drug, by dissolving a polyoxyethylene hardened castor oil derivative in an aqueous solution containing a leachate component of the crude drug, adding polyvinylpyrrolidone thereto, heating the resultant mixture, and rapidly flocculating the above-mentioned easily precipitating components. CONSTITUTION:A polyoxyethylene hardened castor oil derivative within 40- 60mol% content range of ethylene oxide polymer in an amount within 0.1- 5.0%, preferably 0.5-2.0% range based on the final solution is added and dissolved in a leachate solution or aqueous solution containing a crude drug component, and preferably further polyvinylpyrrolidone having 40,000-1,200,000 average molecular weight in an amount within 0.01-1.0%, particularly 0.1-0.6% range is added thereto. The resultant mixture is heated at 30-70 deg.C for a relatively short time (about 30min), and insoluble components in the crude drug are flocculated and cooled to filter the resultant mixture through an ordinary filter paper. Thus, the aimed aqueous solution without causing turbidity nor precipitates during preservation can be rapidly obtained by easy operation without requiring special equipment.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to preventing the precipitation of crude drug components from an aqueous liquid pharmaceutical containing herbal drug leaching components.

In order to effectively demonstrate the unique efficacy and effects of crude drugs,
Furthermore, for the convenience of being easy to drink, it is very common to mix one or more leached components of herbal medicines with other chemicals and use them as aqueous medicines. For example, it has a wide range of uses, including drinks, syrups, oral liquids, and external liquids.

However, liquid preparations containing crude drug leaching components tend to become cloudy or precipitate due to the precipitation of some of the components, which often worsens over time. This not only reduces the product value by impairing the appearance of the liquid preparation and causing psychological aversion to the user, but also may affect the effectiveness of the liquid preparation due to the precipitation of the active ingredients of the herbal medicine, which may cause it to be used as a medicinal product. This phenomenon can be said to be a serious problem. The main countermeasures against this problem include adding alcohol and using it as a dissolving agent. It is true that alcohol is useful for solubilizing some herbal medicine leaching components, but there are various legal conditions for its use, and drinking excessive amounts can affect bodily functions, so the amount used must be carefully controlled. There is a limit. It is also said to be effective to leave the infusion solution of herbal medicine for a long period of time to release the easily precipitated components as N'' and separate it. However, this method is inefficient and cannot be easily applied to industrial production. Although various processing operations have been attempted during the extraction process of other herbal medicines, there seems to be no particularly effective method.

The inventor of the present invention has conducted extensive research into ways to prevent turbidity and precipitation, which are drawbacks of liquid preparations containing crude drug extracts, and has found that by adding and dissolving polyoxyethylene hydrogenated castor oil derivatives, it is extremely effective and also effective over time. It was found to be very stable.

About 10 to 15 times the amount of purified water to be used is added to the herbal medicine extract, and if necessary, it is heated to dissolve, and then filtered. A polyoxyethylene hardened castor derivative is added to the filtrate in an amount ranging from 0.5 to 5.0% based on the final solution intended for preparation, and heated at about 50° C. for 30 minutes to obtain a transparent solution.

The crude drug solution treated above is diluted with purified water to a predetermined amount for the purpose of preparation, or mixed with other substances to produce various liquid preparations. In addition, the prepared herbal medicine solution may be stored as it is for a long period of time and used as needed.

The leached ingredients of crude drugs used here include not only crude drugs listed in official documents such as the Revised Japanese Pharmacopoeia and the Standard Collection of Crude Drugs, but also other widely used crude drugs that have undergone processing. It refers to the extract extracted from

Extract formulations include infusions, liquid extracts, tinctures, concentrated extracts, etc., and these can be used singly or in a mixture of two or more, and also include herbal medicines, which are crude drug preparations.

The polyoxyethylene hydrogenated castor oil derivative used here preferably has an ethylene oxide polymer in the range of 40 to 60 moles. In addition to herbal medicine ingredients, water-soluble drugs, sweeteners (sugars, artificial sweeteners), thickeners, heat-preserving agents, preservatives, etc. are usually combined in the production of aqueous solutions.

According to the present invention, it is hardly necessary to mix alcohol to prevent the precipitation of crude drug components, but it can be added as appropriate depending on the purpose. This means that the leached components of herbal medicines, which tend to precipitate, are kept stable by adding alcohol (for example, tinctures, liquid extracts, alcohol-containing liquids, etc.); The above objective can be achieved without using it at all. As a result, it is expected that not only will there be economic benefits due to the omission of alcohol, but also more effective and wide-ranging development of the uses of these herbal medicine components will be achieved. Furthermore, the present invention makes it possible to increase the dosage of crude drug ingredients whose use in liquid preparations has been limited due to instability over time, and it is expected that the effectiveness of the ingredients will be further enhanced accordingly.

As a result of various studies based on the above-mentioned new findings, the present inventor found that by adding a polyoxyethylene hydrogenated castor oil derivative and further adding polyvinyl pyrrolidone, the separation of insoluble particulate components becomes remarkable. We have found that this is effective and have succeeded in completing the present invention.

The present invention is useful for separating insoluble particulate components contained in crude drugs.

The gist of the present invention will be explained in detail below.

Add a polyoxyethylene hardened mustard oil derivative to the infusion solution or aqueous solution containing herbal medicine components and add 0.1 to 5% of the final solution.
．． Polyvinyl pyrrolidone is added in an amount of 0.01 to 1.0%, more preferably 0.0% to the final solution, more preferably 0.5 to 2.0%.
．． Add and dissolve in the range of 1 to 0.6%, at a temperature of about 30 to 70°C, preferably about 50°C, for a relatively short period of time.
Preferably, the mixture is heated for about 30 minutes.

After cooling, it is filtered through a regular filter paper and used in the production of a liquid preparation.

The present invention has a very beneficial effect on the production of aqueous solutions containing herbal medicine ingredients, as will be described in detail below.

That is, although it depends on the type of crude drug component, insoluble particulate components in the exudate are difficult to separate by normal filtration methods, and often cause turbidity and precipitation in the liquid preparation. At this time, in order to separate insoluble components as much as possible, the pore size is 0.1 to 0.5μ.
It may react specifically with other drugs when mixed in solution, resulting in clouding or precipitation. However, according to the present invention, such specifically reactive components cause aggregation in the same manner as described above, and can be easily removed.

As a result of the above, it is now possible to utilize crude drug ingredients that were previously considered contraindicated, making it possible to develop a wide variety of crude drug solutions. This is one of the greatest effects of the present invention.

According to Example 1, which relates to a nourishing and tonic oral liquid containing a concentrated extract of herbal medicine and water-soluble vitamins, the present invention showed excellent effects.

In this Example 1, which will be described later, guarana extract in particular reacts with other crude drug extracts and becomes cloudy in an aqueous solution.
If the process was carried out according to the method of the present invention, the reaction components were removed in advance, so this phenomenon could be prevented. This cloudiness has nothing to do with medicinal efficacy, and the occurrence of this cloudiness significantly reduces the value of the product.

A material manufactured according to Example 1 described below was subjected to a severe test at 40° C. for 6 months. 80% of this with water as a control.
The transmittance at 0 nm was measured, and it was 96%, the same as at the time of manufacture, and was transparent with no precipitate observed.

The excellent effects of the present invention are clear from this.

The polyvinyl pyrrolidone used in the present invention is listed in the Pharmaceutical Component Standards, and can be used in the present invention regardless of the degree of polymerization.

As detailed above, the present invention is simple and quick to operate, and does not require any special equipment, so it can be industrially processed in large quantities and can be expected to produce highly efficiently. can.

The present invention will be described in more detail with reference to Examples, but the present invention is not limited thereto.

Example 1 Eleuthero extract 130 mg (equivalent to 2.0 g of Eleuthero) Epimedium 70 mg (equivalent to 500 mg of Epimedium) Female Sadako extract (equivalent to 500 mg of Eleuthero) 130 mg
Guarana extract (equivalent to 1.0g of guarana) 125mg
Riboflavin phosphate 2mg Pyridoxine hydrochloride 10mg Calcium pantothenate 30mg Nicotinamide 25mg Anhydrous caffeine 30mg White sugar 5,000mg Sorbitol solution 5,000mg Citric acid 140mg Sodium citrate 70mg Flavoring Trace total amount 300ml This is a concentrated extract of herbal medicine and water-soluble vitamins. of This figure shows an example of a formulated nourishing and tonic oral solution.

(Manufacturing method) Dissolve the guarana extract in the above formulation in 2 ml of purified water, and add 100 mg of polyoxyethylene hydrogenated castor oil derivative (Nikkor C0-60 manufactured by Nikko Chemicals Co., Ltd.)
and 30 mg of polyvinyl pyrrolidone were gradually added and dissolved, and heated at about 50° C. for 30 minutes. After cooling, the aggregates formed are filtered through a filter paper (Toyo Roshi Case 2). In addition, Eleuthero, Epimedium, and Female Sadako extracts were blended and dissolved in 3 ml of purified water, 200 mg of HCO-60 was added, and the mixture was heated at about 50° C. for 30 minutes. Meanwhile, 10 components from the above formulation, from riboflavin phosphate to perfume, were dissolved in 20 ml of purified water. Add the treated liquid of guarana, then the treated liquid containing the extract of Eleuthero or other herbal medicines, and add exactly 30 m of purified water.
Set to 1.

After filtration, the mixture was filled into bottles and sterilized by heating at about 80° C. for 1 hour to prepare an oral solution.

Example 2 Ethanol Appropriate amount Epimedium Nikis total amount 1β This is an example of producing Epimedium Nikis that is stable for long-term storage.

(Manufacturing method) 10v/v% ethanol 10 to Ikg of cut epimedium
β was added, extracted by heating at 100℃ for 3 hours, and after cooling, it was sieved (1
00 mesoyu). This operation is repeated once more, and all the filtrates are combined and concentrated under reduced pressure to 41° C. at about 70°C. Add Niracol 11cO-608g and 3g of polyvinyl pyrrolidone to the concentrated solution, heat at 50°C for about 30 minutes, and after cooling,
Perform filter paper filtration (Toyo Roshi Kaisha 2). Approximately 900ml of filtrate
Concentrate under reduced pressure. Add diurnal ethanol to the concentrate to make a total volume of 11.

Applicant Kokando Co., Ltd. Agent Patent attorney Hiroshi Katama Procedural amendment (spontaneous) Commissioner of the Japan Patent Office 1. Case description 1982 Patent Application No. 071187 2. Name of the invention Method for separating insoluble components of aqueous liquids 3 , Relationship with the case of the person making the amendment Patent applicant address 2-9-1 Umezawa-cho, Toyama-shi, 930 Name Kokando Co., Ltd. President and CEO Seiji Sekino 4 Agent residence Address 601 Kisshoin Nishinosho, Minami-ku, Kyoto Kadoguchicho 14l
I! ! 7. Contents of amendment (1) The claims on page 1 of the specification are corrected as shown in the attached sheet.

(2) On page 3, line 5 of the specification, the statement ``By adding and dissolving a polyoxyethylene hydrogenated castor oil derivative'' has been replaced with ``Some crude drug ingredients become cloudy due to polyvinylpyrrolidone. The present inventors have discovered that if a polyoxyethylene hydrogenated castor oil derivative is added in advance, components that tend to precipitate will quickly coagulate, leading to the completion of the present invention.
According to the method of the present invention, components that cause turbidity and precipitation are removed in advance, so precipitation can be prevented.''

(3) From line 13 on page 3 of the specification, the following text has been changed: "Add and heat at approximately 50°C for 30 minutes to obtain a transparent solution." .0
Add and dissolve in the range of 1 to 1.00% and heat at about 50℃ for 30 minutes.
A precipitate is formed by heating for a minute. This is removed by conventional filtration to give a clear solution. ” is corrected.

(4) "...is preferable" on page 4, line 12 of the specification.
"Also, polyvinylpyrrolidone has an average molecular weight of 4.
0,000 and 1,200.000 are used. ” is inserted.

Above 2, Claims In the production of an aqueous solution containing crude drug infusion components, a polyoxyethylene hydrogenated castor oil derivative is added and dissolved in the solution, and polyvinylpyrrolidone is further added. Method for separating insoluble components.

Claims (1)

[Claims] A method for separating insoluble components in a crude drug infusion, which comprises adding and dissolving a polyoxyethylene hydrogenated castor oil derivative to the solution, and further adding polyvinyl pyrrolidone, in the production of an aqueous solution containing a crude drug infusion.