KR100215168B1 - Liquid formulation of herbal composition having no precipitation and improved taste - Google Patents

Abstract

The present invention relates to a herbal liquid with reduced precipitation and improved taste. More specifically, the present invention contains a cyclodextrin solution 0.1-5w / v% and poloxamer 0.05-5w / v% to suppress the sedimentation formation over time to improve the storage stability, masking the bitter taste of the unique herbal medicine The present invention relates to an herbal medicine that is improved pharmaceutical form by making it less objectionable when taking.

Description

Herbal medicine with reduced sedimentation and improved taste

The present invention relates to a herbal liquid with reduced precipitation and improved taste. More specifically, the present invention contains a cyclodextrin liquid 0.1-5 w / v% and poloxamer 0.05-5 w / v% to suppress the sedimentation formation over time to improve the storage stability, and to improve the bitterness and taste of the unique herbal medicine The present invention relates to a pharmaceutical formulation which is improved in a pharmaceutical form by shielding it so that there is no objection when taken.

In general, the following items must be considered in order to manufacture herbal liquids for commercial use.

(1) Uniformity of the active ingredient content-When the herbal extract is concentrated to an appropriate amount, there may be a part with a high concentration, and precipitation may precipitate during cooling, resulting in a lack of uniformity of the active ingredient. There is.

(2) Precipitation Formation-After preparing a liquid and dispensing in each package for commercial use, the components may react with each other to precipitate precipitates, which not only lowers the value of the commodity but may also contain a main component that exhibits efficacy during precipitation. There is a problem that can not sufficiently exhibit the desired pharmacological effect. Therefore, to prevent this, an antisedimentation agent should be used.

(3) Addition of Preservatives-Herbal liquids are liquids of organic substances, so an appropriate amount of preservatives should be used to prevent contamination by bacteria during the storage period.

(4) Use of copulation agent-Herbal medicine is a hot water extract of herbal medicine. In most cases, it is hard to take because of taste, sourness, sourness and unique peculiar taste of herbal medicine. Therefore, a copper should be used to mask the taste or reduce the specific odor.

As mentioned above, in general, herbal medicines are prepared by adding 10-20 times the amount of water to the herbal medicines and then heating them at about 100∵ for 2 to 3 hours. Therefore, herbal medicines are used for the bitterness, sourness, and astringent taste. In addition, since all the components soluble in water are extracted, there are problems such as the formation of precipitates due to the interaction of these components and the change of temperature and other conditions in storage, and the like. There was a difficulty in developing a good quality product.

Among the problems caused by the formulation of herbal medicines, in particular, to increase the value of the product and to facilitate the taking of herbal medicines is the most important and solved. Difficult problems are the prevention of precipitation formation and the improvement of taste.

Conventionally, suspending agents such as celatin, casein, carboxymethylcellulose, polybispyrrolidone, and gum arabic were used for the purpose of preventing precipitation in the preparation of herbal liquids, and honey as a mating agent for improving taste and specific odor. , Flavors such as starch syrup, white sugar, glucose, and orange oil, peppermint oil, rose oil, cinnamon oil, lavender oil, menthol, walnut, ethyl vailla, and the like were used. However, the conventional methods for preventing precipitation and improving taste and specific odor have insufficient effect of preventing precipitation or bitter or irritating odor from the herbal medicine itself during the use and storage period of herbal liquids. Therefore, a method of using various additives has been attempted to improve the above-mentioned disadvantages of herbal liquids, but a method that has not been clearly improved yet has not been developed.

Therefore, the present inventors conducted intensive research to find a component that can improve the disadvantages of the herbal liquids as described above, targeting various additives used in the field of synthetic pharmaceuticals. The study was conducted on cyclodextrins and poloxamers that are used for the purpose and are known to be safe.

Cyclodextrins, ie, cyclodextrins α, β or γ or their complexes, may be used in the field of formulation of synthetic drugs under other names such as Shardinger dextrins, Cycloamylo-ses and Cyclologans. It has been applied to dissolving aids such as pstaglandins, steroids and barbitals, chemical stabilizers such as aspirin, epinephrine and vitamins, and taste and odor improving agents such as prostaglandins and alkyl parabens. Cyclodextrin liquids generally used are complexes of the cyclodextrin α, β and γ types containing starch. It is produced by the action of an enzyme called cyclodextrin transglycosidase in the medium, and has been reported to have a high LD5o value of 10 g / kg or higher upon oral administration to rats, and since only a small amount is absorbed in the gastrointestinal tract, there is little toxicity. It is a secured substance.

Poloxamer is another name such as P1uronic, Poloxalko1, Monolan and Superonic, and is mainly used for moisturizers, dissolution aids and suspending agents in liquid preparations. have. Poloxamer also showed a high LD5o value of more than 15 g / kg upon oral administration to five animals, and showed no irritation when 5% and 10% solutions were applied to the rabbit's eyes, It is a safe substance that has been reported to have no symptoms of toxicity as the LD5o value is O.lg / kg and 1.Og / kg, respectively.

Through various experiments, the present inventors can add cyclodextrin and poloxamer in specific ratios and add them to herbal liquids, which can prevent the formation of silver precipitates and effectively mask unpleasant tastes. It was confirmed to complete the present invention.

Accordingly, the present invention relates to a herbal medicine containing cyclodextrin liquid and poloxamer, which effectively prevents precipitation and improves taste.

More specifically, an object of the present invention is to improve the effect of preventing the formation of precipitates by adding a cyclodextrin solution 0.1-5w / v% and poloxamer 0.05-5w / v% and preventing unpleasant writing, steaming and sourness peculiar to herbal medicines. It is to provide a herbal medicine. When cyclodextrin solution or poloxamer is added in an amount of less than 0.1w / v% and 0.05w / w%, respectively, the desired effect is not sufficiently exhibited in the present invention, and cyclodextrin solution is a homologue of cyclic oligosaccharide, If the cyclodextrin liquid exceeds 5w / v% because it is a liquid, it may be a cause of a poorly clogged liquid due to the liquid around the bottle cap during preparation, and crystals may precipitate and become cloudy during cooling. When the poloxamer exceeds 5w / v%, the sulphate and bitter taste of the poloxamer itself is unfavorable, which is against the object of the present invention to improve the taste. In particular, it is preferable to contain 1 to 3 w / v% of cyclodextrin liquid and 0.1 to lw / v% of poloxamer.

According to the present invention, the combination of cyclodextrin and poloxamer in the above ratio provides an advantage that the prevention of precipitation formation and the unpleasant taste masking effect are synergistically excellent compared to the case of using each component alone.

Specific examples of the cyclodextrin liquid used in the present invention may be mentioned Serdedix SL-20 (manufactured by 日本 食品 化工 株 式 會 Corporation), poloxamer is a polyoxyethylene-polyoxyceprophyllene copolymer as a representative example thereof And poloxamer 188 (trade name: Lutro1 F68, BASF) or poloxamer 407 (brand name: Root F127, BASF).

There is no particular limitation in the herbal liquids which can achieve the effects as desired in the present invention by adding cyclodextrin and poloxamer, and may be applied to any herbal liquid prepared by hydrothermal leaching. Specific examples of such herbal preparations may include sugar prescriptions described in Dong Bobogam, which is the representative herbal medicine in Korea, and prescription preparations that can be prepared as other types of decoctions. Yeongdang, Mundong umja, Cheon volcano, Okcheon mountain, Hwangnyeon Jihwangdang, Saengji Hwangja, Ginseng paddoksan, Cheong Gantang, Cheong Sinbodang, Odutang, Goyeontang, Gagambaekhodang, Sagunjatang, Bojungikgitang , Samtangtang, Donggui boultang, poppy soup, Sogunjungdang, Galgeumtang, Daegigitang, zonigigitang, rhubarbjajatang, dashhotang, hubakchildang and the like can be mentioned, but are not particularly limited.

The present invention is explained in more detail by the following examples, but the present invention is not limited in any way by these examples.

Example 1

The raw herbal medicines of Hwanggi-tang described in Dongbobom, Saenggunjihwang, Hwanggi, Bokryeong, Chunhwa flour, Macmun-dong, Schisandra chinensis and licorice, respectively, were taken in the amounts shown in Table 1, and then placed in an extraction container. After extracting at 100∵ for 1 hour and 30 minutes, filtered with 75 여과 filter paper and adding 60m ㅛ of extract to the preparation tank, and then 50% of D-sorbitol and Geneva 5 istebioside + 50% of soluble dextrin) After dissolving by adding cyclodextrin solution (complex of cyclodextrin α, β, γ), citric acid, poloxamer 188 and sodium benzoate, sterilize at 95C for at least 10 minutes, and add sterilized purified water so that the total amount is 100 Layered.

Example 2

The solution prepared according to the composition shown in Table 1 in Example 1 was stored in a 40 ton life tester, and after 3 days, 7 days, 14 days, 1 month, 2 months, 4 months and 6 months, Changes in precipitation and taste were visually and taste tested. The measured results are shown in Table 2 below.

In the table,-means no sedimentation, + means that the small amount of sedimentation is observed with the naked eye when observed in detail, ++ means that the sedimentation is easy enough to identify easily , +++ means that a significant amount of precipitation occurs.

As shown in Table 2, the liquid of Composition 1 (the formulation without adding cyclodextrin or poloxamer as the basic prescription of sulfur group described in the agreement) precipitates from 2 weeks after storage, and the taste and taste increase as time passes. I wore it and broke it.

On the other hand, in the compositions 1, 2, 3, or 4 g of the cyclodextrin solution, 4, 5, and 6 were not precipitated at 40 kPa for 2 months, and the taste was slightly masked. In addition, in the compositions 1 and 9, in which 0.5 g or nin of poloxamer was added to the composition 1, no precipitation was observed at 40C for 2 months and the taste was almost masked.

However, in the composition 11 in which 2 g of cyclodextrin liquid and 0.5 g of poloxamer were added to the composition 1, and in the composition 12 in which 2 g of cyclodextrin liquid and 1 g of poloxamer were added together, even after 40 months at 6 months. No sedimentation was observed, and the bitter, sour and astringent tastes were almost masked and remained good to take. From these results, it can be seen that the precipitation inhibiting effect and the taste masking effect is excellent when the two components were mixed and added to the Hwanggi-tang than when the cyclodextrin liquid and poloxamer were used alone, respectively.

According to the results of Example 2, precipitation formation was inhibited by adding 2 g of cyclodextrin liquid (complex of cyclodextrin α, β, and γ) and poloxamer 407 0.5g per 100 ml of various herbal compositions in the following. An herbal liquid according to the present invention was prepared in which an unpleasant taste was masked.

Example 3

According to the prescription of Hwanggi-tang, which is loaded with Dongbobogam, 250g of raw dried turmeric, 125g of Hwanggi, Bokryeong, Cheonhwa-bun, and Mcmun-dong, 63g each of Schisandra chinensis and licorice are weighed and placed in an extraction container. After extracting at 100 t for 1 hour 30 minutes, the mixture was filtered through a 75-p filter paper. 6 ㅛ extract was added to the preparation tank and dissolved by adding 90 g of D-sorbitol, 3 g of Genvia 50, 200 g of cyclodextrin solution (complex of cyclodextrin α, β, and γ), 10 g of citric acid, 50 g of poloxamer 407 and 6 g of sodium benzoate. Then, sterilized for 10 minutes or more in 951 ○ and the stock solution was prepared by aligning the 10 ㅛ mark with sterile purified water, and filled in a transparent glass bottle by 100 ㅛ.

Example 4

According to the prescription of Live Hull-Yunsaeng-Jin-Eum, which is listed in Dongbo-gam, as raw material herbals, Astronomical dong, Mcmun-dong, Ohmi-Ja; 25 g each of fruit fruit, fruit juice, mulberry fruit, mulberry, sorghum, raw sulfur, lichen powder and licorice were weighed and processed in the same manner as in Example 3 to prepare a lively lubricated algae solution.

Example 5

According to the prescription of Sangbaekpitang, which is loaded with Dongbobogam, 250g of Donggeunsangbaekpi, Baekboknyeong, Ginseng, Macmundong, brown root, powder and cinnamon 125g and 63g were weighed and processed in the same manner as in Example 3 to prepare Sangbaekpitang. It was.

Example 6

According to the prescription of Jaumyang Yeongtang, which was loaded with Dongbobogam, weigh 250g of Angelica ginseng, 188g of ginseng and raw green sulfur, 125g each of Macmundong, Baekjak, Jimo and Yellowbaek and 63g of licorice and weigh 500 tablets of Omija as the raw and herbal medicines. It was processed according to the method to prepare a Jjayang Yangtang.

Example 7

According to the prescription of Mundong-mum, registered in Dongbogam, weigh 250g of Macmun-dong, Schisandra chinensis, Ginseng, Gigolpi, Baekbokryeong and Licorice each, and weigh 100g of ginger and process 100 g of ginger to prepare the Mundong-mum solution. It was.

Example 8

According to the prescription of Tianhua Mountain, which was loaded in Dongbobom, 250g of raw powder, 250g of raw dried sulfur, 250g of brown root, 125g of dried root, 125g of gimmun-dong, 125g of Schisandra chinensis, 63g of licorice and 60g of weighing rice were weighed and processed according to the same method as in Example 3 Was prepared.

Example 9

According to the prescription of Okcheon-san loaded in Dongbobogam, 250g of cheonhwa flour, brown root powder, ganmun-dong, saengjihwang, Schisandra chinensis and licorice were weighed out and processed in the same manner as in Example 3 to prepare Okcheonsan liquid.

Example 10

According to the prescription of Hwangnyeonjihwangtang in Dongbobogam, weigh 25g each of Hwangnyeon, Saengjihwang, Cheonhwabun, Schisandra chinensis, Schisandra chinensis, Angelica, Ginseng, Scallops, Baekbokyeong, Macmundong and Licorice, and take 67 pages of ginger, 33 dates of jujube and 330 leaves of porridge. It was processed in the same manner as in Example 3 to prepare a Hwangyeonjihwangtang.

Example 11

According to the prescription of Saengjihwang Sounded by Donggibogam, 125g and 63g each of ginseng, raw dried sulfur, riped sulfur, huanggi, astronomical dong, mackmun-dong, crust, Seokgok, Sangbaekpi and Taeksa were weighed and processed according to the same method as in Example 3 To prepare a saengjihwangja solution.

12

In accordance with the prescription of ginseng paddoksan stored in Dongbobogam, 125g each of ginseng, Siho, Jehoho, Ganghwa, Dokbok, Cheonung, Perception, Bokryeong, Gilgyeong, and licorice were weighed and processed in the same manner as in Example 3 to prepare ginseng padoxane solution. Was prepared.

Example 13

According to the prescription of Cheongan-tang, which was loaded with Dongbobogam, 188g of Peony, 50g of Peel Bark, 125g of Cheonung and Angelica, 100g of Seahawk and 50g of Sanchi were weighed and processed according to the same method as in Example 3, and 75In ㅛ / bottle was prepared per Example 3. 100 bottles of liquid solution were prepared.

Example l4

Stability was tested in the same manner as in Example 2 with each type of detergent prepared in Examples 3 to 13 being stored at 40 kPa for 6 months. The results are shown in Table 3 below.

In Table 3,-means no occurrence of precipitation, and + means that it is visually identified when observed in detail that a small amount of precipitation has occurred.

As shown in Table 3, the stability test results for herbal medicines prepared by mixing a variety of herbal medicines in synonym with a single dose of 100m or 751n {2g of cyclodextrin solution and 0.5g of poloxamer per Example 1 Example 3 The solutions of, 5,7,8,9 and 13 did not produce precipitate after 6 months of storage at 40 ° C, and only after 4 months or 6 months at 40C in the solutions of Examples 4,6,10 and 11 When observed in detail, it was observed that some precipitation was produced.

On the other hand, the bitter taste of the various liquids tested did not appear in most cases from the start of the test until 40 months to 6 months, but only a slight bitter taste was detected in the case of the liquids of Examples 6 and 10. It can be seen that.

Therefore, according to the present invention, if the cyclodextrin liquid and the poloxamer of the herbal liquid are mixed at a predetermined ratio, it is possible to prevent the precipitation from occurring after the storage period has elapsed, thereby providing an improved effect on the storage stability, as well as the herbal medicine. It provides a pharmaceutical advantage that masks most of the inherent bitterness and taste so that it can be taken without reluctance.

Claims (3)

Hwanggi-tang. Cyclotextins α, β, and γ of the formulations selected from the group consisting of active blood lubricated algae, Sangbaekpitang, Jaumyangyoungtang, Mundongumja, Chunhwasan, Okcheonsan, Hwangryunjihwangtang, Saengjihwangja, Ginseng paddoksan, and Cheonggantang An herbal liquid comprising 0.1 to 5 w / v% of a cyclodextrin liquid as a complex and 0.05 to 5 w / v% of poloxamer selected from the group consisting of poloxamer 407. The herbal solution according to claim 1, which contains 1 to 3 w / v% of cyclodextrin liquid and 0.1 to 1 w / v% of poloxamer. The herbal medicine according to claim 1, wherein the cyclodextrin solution and poloxamer are included in the prescription of Hwanggi-tang.