TW202023597A - Composition, tablet, and capsule containing ampelopsis grossedentata extract - Google Patents
Composition, tablet, and capsule containing ampelopsis grossedentata extract Download PDFInfo
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- TW202023597A TW202023597A TW108126159A TW108126159A TW202023597A TW 202023597 A TW202023597 A TW 202023597A TW 108126159 A TW108126159 A TW 108126159A TW 108126159 A TW108126159 A TW 108126159A TW 202023597 A TW202023597 A TW 202023597A
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/87—Vitaceae or Ampelidaceae (Vine or Grape family), e.g. wine grapes, muscadine or peppervine
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Abstract
Description
本發明係有關一種抑制了藤茶萃取物的臭味的組成物及含有該組成物的錠劑或膠囊劑。 The present invention relates to a composition that suppresses the odor of a rattan tea extract and a tablet or capsule containing the composition.
藤茶為葡萄科蛇葡萄屬的植物,中國名為顯齒蛇葡萄。學名為Ampelopsis grossedentata。主要分佈於中國的廣西、廣東、雲南、貴州、湖南、湖北、江西及福建等省及自治區。中國的廣西、湖南等省或自治區的壯族或瑤族的人們經常飲用由其莖及葉製成的飲料,還用於感冒、咽喉痛等。 Tengcha is a plant belonging to the genus Snake grape in the grape family, and it is called Xiantooth grape in China. The scientific name is Ampelopsis grossedentata. Mainly distributed in China's Guangxi, Guangdong, Yunnan, Guizhou, Hunan, Hubei, Jiangxi and Fujian provinces and autonomous regions. People of Zhuang or Yao nationality in Guangxi, Hunan and other provinces or autonomous regions in China often drink beverages made from its stems and leaves, and are also used for colds and sore throats.
對於藤茶萃取物已發現有各種各樣的生理活性,已提案有含有藤茶萃取物的醫藥用途或健康食品用途。例如已提案有肝臟疾病的治療用(專利文獻1)、脂肪酶阻礙用(專利文獻2)、基質蛋白酶阻礙用(專利文獻3)、抗菌用(專利文獻4)、防止香料的劣化用(專利文獻5)及防止色素的褪色用(專利文獻6)等用途。 A variety of physiological activities have been found for rattan tea extracts, and medical or health food applications containing rattan tea extracts have been proposed. For example, it has been proposed for the treatment of liver disease (Patent Document 1), lipase inhibition (Patent Document 2), matrix protease inhibition (Patent Document 3), antibacterial use (Patent Document 4), and prevention of perfume deterioration (Patent Document 2). Document 5) and for preventing the fading of pigments (Patent Document 6).
關於藤茶萃取物,黃酮類化合物的白蘞素(ampelopsin)被鑑定作為擔任上述的各種各樣的作用的成分,得到大量含有該物質的萃取物。該物質,由乾燥後的藤茶莖葉經由水或含水酒精等的溶劑進行萃取,進一步市售有濃縮後的膏狀的濃縮物或噴霧乾燥或冷凍乾燥後的粉末。 Regarding the vine tea extract, ampelopsin, a flavonoid compound, was identified as a component for the various functions described above, and a large amount of extracts containing the substance were obtained. This substance is extracted from dried rattan tea stems and leaves through a solvent such as water or hydroalcohol, and is further commercially available as a concentrated paste-like concentrate or spray-dried or freeze-dried powder.
藤茶萃取物,已知在用於含有藤茶萃取物的膠囊劑或錠劑化的製劑化步驟中,會產生藤茶萃取物具有的特有的令人不愉快的臭味(異味)。由於此異味在長期保存時會加重,必然不得不縮短保質期。 Tengcha extracts are known to produce unique unpleasant odors (unpleasant odors) possessed by Tengcha extracts in the preparation step for capsules or tablets containing the Tengcha extracts. Since this peculiar smell will increase during long-term storage, the shelf life must be shortened.
因此,尋求大量含有藤茶萃取物,長期保存也甚少產生異味,易於飲用的製劑。 Therefore, looking for a preparation that contains a large amount of vine tea extract, and is easy to drink with little odor after long-term storage.
[專利文獻1]日本特開2003-026584號公報 [Patent Document 1] Japanese Patent Application Publication No. 2003-026584
[專利文獻2]日本特開2003-012536號公報 [Patent Document 2] JP 2003-012536 A
[專利文獻3]日本特開2002-173424號公報 [Patent Document 3] JP 2002-173424 A
[專利文獻4]日本特開2002-159566號公報 [Patent Document 4] JP 2002-159566 A
[專利文獻5]日本特開2004-018756號公報 [Patent Document 5] JP 2004-018756 A
[專利文獻6]日本特開2002-065201號公報 [Patent Document 6] JP 2002-065201 A
本發明者們,以上述背景技術為基礎進行研究,在各種各樣的製劑化條件下對藤茶萃取物進行了研究,發現若將含有殼聚糖及藤茶萃 取物的組成物製劑化,則可以抑制藤茶萃取物特有的異味。基於如此的見識,本發明提出一種含有殼聚糖及藤茶萃取物的組成物及含有該組成物的錠劑或膠囊劑。 The inventors of the present invention conducted research on the basis of the above-mentioned background technology, and conducted research on Tengcha extract under various formulation conditions, and found that if chitosan and Tengcha extract are contained Formulation of the composition of the extract can suppress the peculiar smell of Tengcha extract. Based on such insights, the present invention proposes a composition containing chitosan and rattan tea extract and a tablet or capsule containing the composition.
即,本發明的課題在於提供一種大量含有藤茶萃取物,且抑制了藤茶特有的異味(被評價為惡臭的臭味)的組成物及錠劑或膠囊劑。 That is, the subject of the present invention is to provide a composition, a lozenge, or a capsule that contains a large amount of rattan tea extract and suppresses the peculiar smell of rattan tea (an odor evaluated as a bad smell).
本發明的主要構成如下所示。 The main structure of the present invention is as follows.
(1)一種組成物,含有殼聚糖及藤茶萃取物,每份組成物含有10至35質量%的殼聚糖、5至22質量%的白蘞素,且殼聚糖/白蘞素的質量比為0.6至3.5。 (1) A composition containing chitosan and rattan tea extract, each composition containing 10 to 35% by mass of chitosan, 5 to 22% by mass of leucocephaly, and chitosan/leucocephaly The mass ratio is 0.6 to 3.5.
(2)一種錠劑,係含有(1)所述的組成物。 (2) A tablet containing the composition described in (1).
(3)一種膠囊劑,係含有(1)所述的組成物。 (3) A capsule containing the composition described in (1).
根據本發明,提供抑制了藤茶萃取物的異味的組成物及錠劑、膠囊劑。特別根據本發明,長期的保存成為可能,並且由於來自藤茶萃取物的異味的產生得到抑制,從而可以成為即使對於老人或兒童也沒有抗拒感,容易吞嚥的製劑。 According to the present invention, there is provided a composition, lozenges, and capsules in which the peculiar smell of Tengcha extract is suppressed. In particular, according to the present invention, long-term storage is possible, and since the generation of peculiar smell from the vine tea extract is suppressed, it can be a preparation that is easy to swallow even if it is not resistant to the elderly or children.
本發明係有關含有殼聚糖及藤茶萃取物的組成物、含有該組成物的錠劑或膠囊劑。 The present invention relates to a composition containing chitosan and rattan tea extract, and a tablet or capsule containing the composition.
本發明的組成物的主要構成成分之一為殼聚糖。所謂殼聚糖,為主要具有藉由β1,4鍵與葡萄糖胺連接的構造,且有時除葡萄糖胺以外還含有N-乙醯葡糖胺作為構成成分的多糖類。 One of the main constituents of the composition of the present invention is chitosan. The so-called chitosan is a polysaccharide that mainly has a structure connected to glucosamine via a β1,4 bond, and sometimes contains N-acetylglucosamine as a constituent in addition to glucosamine.
對於本發明中使用的殼聚糖的來源並無特別限制,例如可使用對藉由將鈣或蛋白質等從蝦、蟹等甲殼類動物的甲殼、墨魚骨等去除而得到的甲殼質進行脫乙醯化而得到的物質。 The source of chitosan used in the present invention is not particularly limited. For example, chitin obtained by removing calcium or protein from crustaceans such as shrimps, crabs, etc., cuttlefish bones, etc. can be used Substances obtained by acylation.
此外,對於本發明中使用的殼聚糖的脫乙醯化度並無特別限制。通常使用脫乙醯化度50至100%的物質即可。另外,殼聚糖的脫乙醯化度為根據膠體滴定法而測定的值。 In addition, the degree of deacetylation of chitosan used in the present invention is not particularly limited. Usually, a substance with a degree of deacetylation of 50 to 100% is sufficient. In addition, the degree of deacetylation of chitosan is a value measured by a colloidal titration method.
此外進一步,對於本發明中使用的殼聚糖的平均分子量並無特別限制。 Furthermore, the average molecular weight of chitosan used in the present invention is not particularly limited.
用於本發明的殼聚糖較佳係使用符合市售的食品原料的規格之粉末。 The chitosan used in the present invention preferably uses powder that meets the specifications of commercially available food materials.
藤茶萃取物可以使用藤茶的葉、莖、花及根中的任意1種或2種以上的萃取物。特佳係利用莖或葉的萃取物。 As the Tengcha extract, any one or more of the leaves, stems, flowers and roots of Tengcha can be used. Particularly good use of stem or leaf extracts.
從藤茶中萃取的方法並無特別限定。實施萃取時可以直接使用藤茶,或者使用其乾燥物,從萃取效率上而言,較佳為乾燥物。此外,粉碎至顆粒狀或粉末狀以供萃取的方式,可以在穩定的條件下短時間內以高萃取效率進行有效成分的萃取。萃取溫度並無特別限定,可以根據藤茶的粉碎物的粒徑或溶劑的種類等適當設定即可。 The method of extraction from Tengcha is not particularly limited. Tengcha can be used directly during extraction, or its dried product can be used. In terms of extraction efficiency, the dried product is preferred. In addition, the method of crushing to granular or powder for extraction can extract the effective ingredients in a short time and with high extraction efficiency under stable conditions. The extraction temperature is not particularly limited, and it can be appropriately set according to the particle size of the pulverized product of Tengcha or the type of solvent.
溶劑的種類並無特別限定。較佳為水、乙醇等低級醇或者此等的混合溶劑。萃取可以在常溫下進行。也可以在加熱的條件下(例如使用溫水或熱水等加熱後的溶劑)進行。 The kind of solvent is not particularly limited. It is preferably a lower alcohol such as water and ethanol, or a mixed solvent thereof. The extraction can be carried out at room temperature. It can also be performed under heating conditions (for example, using a heated solvent such as warm water or hot water).
根據上述萃取操作,可以從藤茶中萃取本發明的有效成分,溶解在溶劑中。可以直接使用含有萃取物的溶劑。較佳係在根據需要實施了滅菌、洗滌、過濾、脫色、脫臭等常用的提純處理後使用。進一步,使溶劑全部揮發製成固體狀(乾燥物)。可以將該乾燥物再度溶解於任意的溶劑中,藉由進行噴霧乾燥等操作予以粉末化而使用。在本發明中,較佳係使用上述粉末。 According to the above extraction operation, the effective ingredients of the present invention can be extracted from Tengcha and dissolved in a solvent. The solvent containing the extract can be used directly. Preferably, it is used after performing common purification treatments such as sterilization, washing, filtration, decolorization, and deodorization as needed. Furthermore, all the solvents were volatilized to obtain a solid state (dried product). The dried product can be re-dissolved in any solvent, and powdered and used by performing operations such as spray drying. In the present invention, it is preferable to use the above-mentioned powder.
另外,丸善製藥股份有限公司市售有藤茶萃取物(提取物),此等亦可使用。市售的藤茶萃取物係將藤茶的葉中大量含有的黃酮類化合物的一種之白蘞素作為指標並對萃取率進行管理並規範化的粉末,在本發明中也可以利用此粉末。 In addition, Maruzen Pharmaceutical Co., Ltd. has rattan tea extracts (extracts) commercially available, and these can also be used. The commercially available Tengcha extract is a powder that uses as an index, a kind of flavonoid compound, which is a large amount of flavonoids contained in the leaves of Tengcha, and regulates the extraction rate. This powder can also be used in the present invention.
另外藤茶萃取物,在上述的膠囊劑化、錠劑化的製劑化工序中會產生極其特異的不期望的臭味(異味)。 In addition, the Tengcha extract produces extremely specific and undesirable odors (unpleasant odors) during the above-mentioned encapsulation and tablet formulation steps.
對於含有殼聚糖和藤茶萃取物的組成物,為了抑制藤茶的臭味,將殼聚糖和藤茶萃取物的粉末均勻地混合。殼聚糖和藤茶萃取物的粉末,其調配量和調配比例非常重要。較佳係使每份組成物含有10至35質量%的殼聚糖。此外,較佳係使每份組成物中的白蘞素的濃度成為5至22質量%而含有藤茶萃取物。此外,使殼聚糖/白蘞素的質量比成為0.6至3.5而進行調配。 For the composition containing chitosan and rattan tea extract, in order to suppress the smell of rattan tea, the powder of chitosan and rattan tea extract is uniformly mixed. For the powder of chitosan and rattan tea extract, the blending amount and blending ratio are very important. Preferably, each component contains 10 to 35% by mass of chitosan. In addition, it is preferable that the concentration of leucocephalin in each part of the composition is 5 to 22% by mass and the rattan tea extract is contained. In addition, the mass ratio of chitosan/leucocylin is adjusted to 0.6 to 3.5 and blended.
此外,含有殼聚糖和藤茶萃取物的組成物,為了藉由壓錠法製成錠劑,可以混合各種賦形劑,例如糖類或澱粉等,且可以根據需要實施粒化的操作製成顆粒劑。藉由將該顆粒劑或粉末遵循常規方法壓錠成型,可以得到抑制了藤茶萃取物的異味的錠劑。 In addition, the composition containing chitosan and rattan tea extract can be mixed with various excipients, such as sugar or starch, in order to be made into tablets by the squeezing method, and can be granulated according to needs. Agent. By pressing the granule or powder into a tablet according to a conventional method, a tablet can be obtained that suppresses the peculiar smell of Tengcha extract.
製成膠囊劑時,根據常規方法將組成物填充至硬膠囊中製成膠囊劑。此時,在製成膠囊劑時,可以混合各種賦形劑,例如糖類或澱粉等,且可以根據需要實施粒化的操作製成顆粒劑。藉由將該顆粒劑或粉末組成物遵循常規方法填充至硬膠囊中,可以得到抑制了藤茶萃取物的異味的膠囊劑。 When making a capsule, the composition is filled into a hard capsule according to a conventional method to make a capsule. At this time, when forming a capsule, various excipients such as sugar or starch may be mixed, and granulation may be performed as needed to form a granule. By filling the granule or powder composition into hard capsules in accordance with a conventional method, a capsule with suppressed peculiar smell of Tengcha extract can be obtained.
此外在製劑化中,作為可以作為賦形劑使用的物質為纖維素、澱粉、乳糖、麥芽糖醇、環糊精、半纖維素、瓜爾膠、蒟蒻甘露聚糖、海藻酸、瓊脂、卡拉膠、甲殼質、羧甲基纖維素及聚葡萄糖。特佳為纖維素或澱粉。 In addition, in formulation, the substances that can be used as excipients are cellulose, starch, lactose, maltitol, cyclodextrin, hemicellulose, guar gum, konjak mannan, alginic acid, agar, carrageenan , Chitin, carboxymethyl cellulose and polydextrose. Especially preferred is cellulose or starch.
此外只要不阻礙本發明的目的,可以調配食用油、鈣、鐵、鈉、鋅、銅、鉀、磷、鎂、碘、錳及硒等礦物質,維生素A、維生素C、維生素D、維生素E、維生素K、煙酸、葉酸及泛酸等脂溶性或水溶性維生素群,甘油脂肪酸酯、蔗糖脂肪酸酯、山梨糖醇酐脂肪酸酯、丙二醇脂肪酸酯、磷脂、阿拉伯樹膠、黃原膠、黃蓍膠、槐豆膠、保存劑及抗氧化劑、調味劑或香料,氯化鈉、谷氨酸鈉、甘氨酸、琥珀酸及乳酸鈉等呈味劑,檸檬酸、檸檬酸鈉、乙酸、己二酸、富馬酸及蘋果酸等酸味劑,阿斯巴甜等低熱量甜味劑及著色劑等。 In addition, as long as it does not hinder the purpose of the present invention, edible oil, calcium, iron, sodium, zinc, copper, potassium, phosphorus, magnesium, iodine, manganese, selenium and other minerals, vitamin A, vitamin C, vitamin D, vitamin E can be formulated , Vitamin K, niacin, folic acid and pantothenic acid and other fat-soluble or water-soluble vitamins, glycerin fatty acid ester, sucrose fatty acid ester, sorbitan fatty acid ester, propylene glycol fatty acid ester, phospholipid, gum arabic, xanthan gum , Tragacanth gum, locust bean gum, preservatives and antioxidants, flavoring agents or spices, sodium chloride, sodium glutamate, glycine, succinic acid and sodium lactate and other flavoring agents, citric acid, sodium citrate, acetic acid, hexyl Diacid, fumaric acid and malic acid and other sour agents, aspartame and other low-calorie sweeteners and coloring agents.
<錠劑> <Lozenges>
以下,展示使用實施例、比較例的錠劑實施的試驗例,對本發明的效果進行說明。 Hereinafter, test examples carried out using the lozenges of the examples and comparative examples are shown, and the effects of the present invention are explained.
1.臭味的評估方法 1. Evaluation method of odor
由於目前藤茶萃取物的臭味的本質還不明確,因此決定根據感官評估進行數值化。數值化係由熟練的專業感官評估人員藉由和標準品的2種比較法進行判斷,給出評分。關於標準品,製備以下的表1的組成的錠劑,將其作為標準品。另外,評估標準於表格的欄外進行明示。標準錠劑設置為 8mm、250mg/粒的錠劑,在將原料混合後,使用單沖式壓錠機(岡田精工公司製)以打擊壓1000kgf進行製備。 Since the nature of the odor of Tengcha extract is still unclear, it was decided to quantify it based on sensory evaluation. Numericalization is judged by a skilled professional sensory evaluator by two comparison methods with standard products, and a score is given. Regarding the standard product, a tablet having the composition shown in Table 1 below was prepared and used as a standard product. In addition, the evaluation criteria are clearly indicated in the column of the form. The standard lozenge setting is A tablet of 8 mm and 250 mg/tablet was prepared after mixing the raw materials using a single-punch tablet press (manufactured by Okada Seiko Co., Ltd.) at a shock pressure of 1000 kgf.
[表1]
另外標準5至1的臭味的強度以上述表1中所記載的內容為標準,感官上相當於以下的表述。 In addition, the odor intensity of the criteria 5 to 1 is based on the content described in the above-mentioned Table 1, which corresponds to the following expression in sense.
標準5:幾乎感覺不到臭味。 Criterion 5: There is almost no smell.
標準4:感覺到些許臭味。 Criterion 4: A slight smell is felt.
標準3:感覺到強烈的臭味但是並不影響飲用。 Criterion 3: A strong smell is felt but does not affect drinking.
標準2:感覺到非常強烈的臭味,對於飲用感覺到抗拒。 Criterion 2: Feel a very strong smell, and feel resistant to drinking.
標準1:感覺到難以飲用的臭味。 Criterion 1: An unpleasant smell is felt.
2.實施例1至6及比較例1至6的錠劑的製備和評估 2. Preparation and evaluation of tablets of Examples 1 to 6 and Comparative Examples 1 to 6
根據表2的配方,將原料混合後,以單沖式壓錠機(岡田精工公司製)製作 8mm、250mg/粒的錠劑。將該錠劑20粒裝入鋁製袋中,在40℃75%RH的恆溫箱中保存2周後,由3名接受過專業的訓練的感官評估人員對開封時產生的臭味進行了評估。此外,以如上述製備的5種錠剤作為標準品,與此等藉由2種比較法對等同性進行了判斷。 According to the formula in Table 2, after mixing the raw materials, it is produced with a single punch press (manufactured by Okada Seiko Co., Ltd.) 8mm, 250mg/tablet tablets. The 20 tablets of the tablets were put into an aluminum bag and stored in an incubator at 40°C and 75%RH for 2 weeks. Three professionally trained sensory assessors evaluated the odor generated during opening. . In addition, five ingots prepared as described above were used as standard products, and the equivalence was judged by two comparison methods.
評估的判定,例如,若試驗品為與標準3等同的令人不愉快的臭味,則評分為3。另外感官試驗結果,求取了3名的評分的平均值。結果如表2的最後一行所示 For the judgment of the evaluation, for example, if the test product has an unpleasant odor equivalent to standard 3, the score is 3. In addition, as a result of the sensory test, the average of the scores of 3 people was calculated. The results are shown in the last row of Table 2
感官評估平均值4以上判斷為可降低令人不愉快的臭味。 The sensory evaluation average value 4 or more judged that the unpleasant odor can be reduced.
[表2]
由使用了實施例1至6及比較例1至6的錠劑的實驗結果可知,調配殼聚糖對於抑制含有藤茶萃取物的錠劑中的來自藤茶萃取物的特異性臭味有效。此外,在含有殼聚糖和藤茶萃取物的壓錠前的組成物中,若調整成每份組成物含有5至22質量%的白蘞素、10至35質量%的殼聚糖,且殼聚糖/白蘞素的質量比為0.6至3.5,則可以得到感受不到來自藤茶的特異性臭味的錠劑。 From the experimental results using the tablets of Examples 1 to 6 and Comparative Examples 1 to 6, it can be seen that formulating chitosan is effective in suppressing the specific odor derived from the Tengcha extract in the tablets containing the Tengcha extract. In addition, in the composition before pressing the tablet containing chitosan and vine tea extract, if the composition is adjusted to contain 5 to 22% by mass of interleukin, 10 to 35% by mass of chitosan, and If the mass ratio of glycan/leucoside is 0.6 to 3.5, a tablet can be obtained without the specific odor from Tengcha.
<膠囊劑> <Capsules>
以下,展示使用實施例、比較例的膠囊劑實施的試驗例,對本發明的效果進行說明。 Hereinafter, test examples carried out using the capsules of the examples and comparative examples are shown to explain the effects of the present invention.
1.臭味的評估方法 1. Evaluation method of odor
與錠劑的試驗相同,由熟練的專業感官評估人員藉由和標準品的2種比較法進行判斷,給出評分。關於標準品,製備以下的表3的組成的膠囊劑,將此作為標準品。另外,評估標準於表格的欄外進行明示。 Similar to the tablet test, a skilled professional sensory assessor will judge by two comparison methods with the standard product and give a score. Regarding the standard product, a capsule having the composition shown in Table 3 below was prepared, and this was used as a standard product. In addition, the evaluation criteria are clearly indicated in the column of the form.
此外,關於膠囊劑,在將原料混合後,使用硬膠囊填充機(Capsugel公司製“Profill 100”),製備膠囊尺寸2號的硬膠囊(膠囊殼為Capsugel公司製)。 In addition, regarding the capsule, after mixing the raw materials, a hard capsule filling machine ("Profill 100" manufactured by Capsugel) was used to prepare a hard capsule of No. 2 capsule size (capsule shell manufactured by Capsugel).
[表3]
另外標準5至1的臭味的強度以上述表3中所記載的內容為標準,感官上相當於以下的表述。 In addition, the odor intensity of the criteria 5 to 1 is based on the content described in the above Table 3 as a criterion, and sensory corresponds to the following expression.
標準5:幾乎感覺不到臭味。 Criterion 5: There is almost no smell.
標準4:感覺到些許臭味。 Criterion 4: A slight smell is felt.
標準3:感覺到強烈的臭味但是並不影響飲用。 Criterion 3: A strong smell is felt but does not affect drinking.
標準2:感覺到非常強烈的臭味,對於飲用感覺到抗拒。 Criterion 2: Feel a very strong smell, and feel resistant to drinking.
標準1:感覺到難以飲用的臭味。 Criterion 1: An unpleasant smell is felt.
2.實施例7至12及比較例7至12的膠囊劑的製備和評估 2. Preparation and evaluation of capsules of Examples 7 to 12 and Comparative Examples 7 to 12
根據表4的配方,將原料混合後,和標準品同樣地使用硬膠囊填充機(Capsugel公司製“Profill 100”),製備膠囊尺寸2號的硬膠囊(膠囊殼為Capsugel公司製)劑。將該膠囊劑20粒密封入鋁製袋中,在40℃75%RH 的恆溫箱中保存2周後,由3名接受過專業的訓練的感官評估人員對開封時產生的臭味進行了評估。 According to the formula of Table 4, the raw materials were mixed, and a hard capsule filling machine ("Profill 100" manufactured by Capsugel) was used in the same manner as the standard product to prepare a hard capsule (capsule shell manufactured by Capsugel) of No. 2 capsule size. The 20 capsules were sealed in an aluminum bag at 40℃75%RH After being stored in the incubator for 2 weeks, 3 professionally trained sensory evaluators evaluated the odor generated during opening.
另外,與上述製備的5種標準膠囊劑藉由2種比較法對等同性進行了判斷。 In addition, the equivalence with the 5 standard capsules prepared above was judged by 2 comparison methods.
評估的判定,例如,若試驗品為與標準3等同的令人不愉快的臭味,則評分為3。另外感官試驗結果,求取了3名的評分的平均值。結果如表4的最後一行所示。 For the judgment of the evaluation, for example, if the test product has an unpleasant odor equivalent to standard 3, the score is 3. In addition, as a result of the sensory test, the average of the scores of 3 people was calculated. The results are shown in the last row of Table 4.
感官評估平均值4以上判斷為可降低令人不愉快的臭味。 The sensory evaluation average value 4 or more judged that the unpleasant odor can be reduced.
[表4]
由使用了實施例7至12及比較例7至12的膠囊劑的實驗結果可知,調配殼聚糖對於抑制含有藤茶萃取物的膠囊劑中的來自藤茶萃取物的特異性臭味有效。此外,在含有殼聚糖和藤茶萃取物的膠囊填充前的組成物中,若調整成每份組成物含有5至22質量%的白蘞素、10至35 質量%的殼聚糖,且殼聚糖/白蘞素的質量比為0.6至3.5,則可以得到感受不到來自藤茶的特異性臭味的膠囊劑。 From the experimental results using the capsules of Examples 7 to 12 and Comparative Examples 7 to 12, it is known that formulating chitosan is effective in suppressing the specific odor derived from the Tengcha extract in the capsules containing the Tengcha extract. In addition, in the composition before filling the capsules containing chitosan and vine tea extract, if the composition is adjusted to contain 5 to 22% by mass of leucocein, 10 to 35 The mass% of chitosan, and the mass ratio of chitosan/bleachin is 0.6 to 3.5, the capsule can be obtained without the specific odor from Tengcha.
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