KR19980020871A - Calcium supplement containing herbal medicine and its manufacturing method - Google Patents

Calcium supplement containing herbal medicine and its manufacturing method Download PDF

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KR19980020871A
KR19980020871A KR1019960039534A KR19960039534A KR19980020871A KR 19980020871 A KR19980020871 A KR 19980020871A KR 1019960039534 A KR1019960039534 A KR 1019960039534A KR 19960039534 A KR19960039534 A KR 19960039534A KR 19980020871 A KR19980020871 A KR 19980020871A
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safflower
extract
calcium
osteoporosis
pharmaceutically acceptable
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KR100190452B1 (en
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최외순
심성보
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이웅열
주식회사 코오롱
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/286Carthamus (distaff thistle)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/618Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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Abstract

본 발명은 홍화(Carthamus tinctorius)를 추출한 홍화추출엑기스 또는 홍화추출엑기스에 굴껍질 분말을 첨가하고 여기에 통상의 약제학적으로 허용되는 부형제와 통상의 약제학적으로 허용되는 방법으로 제제화하여 제조된 골다공증의 치료와 예방에 사용되는 약학적 제제 및 제조방법에 관한 것이다. 이렇게 제조된 홍화추출엑기스 제제는 칼슘의 공급과 더불어 난소를 보호하여 에스트로겐의 분비를 도울 수 있고 혈장내로 과다한 칼슘의 분비 또한 조절할 수 있다.The present invention adds oyster shell powder to safflower extract extract or safflower extract extract of safflower (Carthamus tinctorius) and is prepared by the conventional pharmaceutically acceptable excipient and formulated in a conventional pharmaceutically acceptable method. It relates to pharmaceutical preparations and methods of preparation for use in the treatment and prophylaxis. The safflower extract extract preparation thus prepared can protect the ovary along with the supply of calcium to help secrete estrogen and can also control the excess calcium secretion into the plasma.

Description

[발명의 명칭][Name of invention]

생약을 함유하는 칼슘 보충제 및 그 제조방법Calcium supplement containing herbal medicine and its manufacturing method

[발명의 상세한 설명]Detailed description of the invention

[발명의 목적][Purpose of invention]

본 발명은 생약을 포함하는 칼슘 보충제 및 그 제조방법에 관한 것이다. 특히 본 발명은 홍화를 활성성분으로 함유하는 칼슘 보충제 및 그 제조방법에 관한 것이다. 인구의 노령화와 더불어 40대 이후의 골밀도의 감소에 의한 골다공증 및 그로인한 골절 등이 증가하고 있다. 폐경기의 1/3 ~ 1/2 여성들과 또한 75세 이상의 거의 50%에 해당하는 여성들이 골다공증을 앓고 있다.The present invention relates to a calcium supplement comprising a herbal medicine and a method for producing the same. In particular, the present invention relates to a calcium supplement containing safflower as an active ingredient and a preparation method thereof. In addition to the aging of the population, osteoporosis and resulting fractures due to a decrease in bone density after the forties are increasing. One third to one half of menopause, and nearly 50% of women over 75, have osteoporosis.

경미한 사고에 의해서도 뼈에 금이 가는 것은 종종 골다공증에 의해 약해진 뼈를 알려주는 첫번째 신호로 X-ray 검사를 통해서는 뼈의 30% 이상이 소모되기까지는 뼈의 중요한 광물인 칼슘의 결핍을 알지 못한다. 또한 손상된 뼈의 해면구조는 한번 소실되면 다시 본래의 형태를 되찾기가 힘들므로 골다공증의 치료에 못지 않게 예방 또한 중요한 문제이다.Cracking bones, even in minor accidents, is often the first sign of bone weakness caused by osteoporosis. X-rays do not reveal the lack of calcium, an important mineral in bone, until more than 30% of the bone is consumed. In addition, once the spongy structure of the damaged bone is lost, it is difficult to regain its original form, so prevention is also an important problem as well as the treatment of osteoporosis.

본 발명은 민방 및 한방에서 사용되어온 생약을 중심으로 하여 골다공증의 예방 및 치료에 유효한 약품을 개발하고자 하는데 그 목적이 있다.An object of the present invention is to develop an effective drug for the prevention and treatment of osteoporosis centered on herbal medicines that have been used in civil and oriental medicine.

[종래 기술 및 그 문제점][Prior Art and Problems]

골다공증의 치료 및 예방을 위하여 의사들은 대개 칼슘이 함유된 식사를 권하고 폐경기의 여성들에게는 에스트로겐을 투여하여 골다공증을 예방하거나 막기 위한 비타민 D를 투여한다. 칼시토닌이나 바이포스포네이트는 새로운 대체 치료제로 주목받고 있으나 어느것도 치료제가 아니며 특히 에스트로겐의 투여는 자궁암의 부작용을 일으킬 수 있다.For the treatment and prevention of osteoporosis, doctors usually recommend a diet containing calcium and vitamin D to prevent or prevent osteoporosis by administering estrogen to postmenopausal women. Calcitonin and biphosphonate are attracting attention as new alternatives, but neither is a treatment and especially estrogen can cause side effects of uterine cancer.

[발명의 구성 작용 및 효과][Composition and Effects of the Invention]

골다공증에 유효한 생약의 선정은 크게 두가지 기준을 만족시키는 것에 중점을 둔다. 첫째는 발암의 위험성이 존재하는 에스트로겐제제의 투여 대신에 난소의 기능을 강화시켜 에스트로겐의 분비를 도울 수 있는 생약의 선정으로 부인병의 치료 특히 통경 폐경 등의 치료에 이용되는 한약재를 중심으로 한 것이다.Selection of herbal medicines that are effective in osteoporosis focuses on satisfying two criteria. First, instead of the administration of estrogen preparations, which present a risk of carcinogenesis, the selection of herbal medicines can enhance the function of the ovary to help estrogen secretion.

그 두번째 기준은 골다공증의 주요원인은 뼈 속의 칼슘이 혈장내로 용출되어 뼈가 약화되는 것인데 이러한 혈장내의 과다한 칼슘의 용출은 신장에 부담을 주고 신장 결석의 원인을 제공하기도 한다. 그러므로, 통경 및 폐경의 치료에도 사용되어오고, 신장결석의 치료에도 이용되었던 생약인 홍화의 추출물을 이용하여 골다공증의 예방 및 치료에 이용될 수 있는 약품을 만들고자 한다.The second criterion is that the major cause of osteoporosis is that the calcium in the bone is eluted into the plasma, resulting in weakening of the bone. The excess calcium in the plasma can burden the kidneys and cause kidney stones. Therefore, it is intended to make a drug that can be used for the prevention and treatment of osteoporosis by using the extract of safflower, which is used in the treatment of pain and menopause, and used in the treatment of kidney stones.

따라서, 본 발명의 목적은 홍화추출물을 활성성분으로 함유하는 골다공증의 예방과 치료제를 제공하는 것이다.Accordingly, it is an object of the present invention to provide an agent for the prevention and treatment of osteoporosis containing safflower extract as an active ingredient.

본 발명의 또다른 목적은 홍화추출물을 활성성분으로 함유하는 골다공증의 예방과 치료제의 제조방법를 제공하는 것이다.It is another object of the present invention to provide a method for the preparation of a preventive and therapeutic agent for osteoporosis containing safflower extract as an active ingredient.

본 발명자들은 또한 홍화추출물에 칼슘성분을 함께 함유하여도 유용한 골다공증의 예방과 치료에 유용한 사실을 발견하였다.The present inventors also found that safflower extracts are useful for the prevention and treatment of osteoporosis, which is also useful with calcium components.

따라서, 본 발명의 또다른 목적은 홍화추출물에 칼슘제를 첨가하여 제조된 골다공증의 예방과 치료제를 제공하는 것이다.Accordingly, another object of the present invention is to provide an agent for the prevention and treatment of osteoporosis prepared by adding calcium to safflower extract.

본 발명의 또다른 목적은 홍화추출물에 칼슘제를 첨가하여 골다공증의 예방과 치료제를 제조하는 방법을 제공하는 것이다.Still another object of the present invention is to provide a method of preparing a preventive and therapeutic agent for osteoporosis by adding calcium to safflower extract.

홍화는 1년생 초목으로서 꽃은 6-7월에 피는데, 황색에서 적홍색으로 변할 때 건조하여 쓰며, 학명은 Carthamus tinctorius이다.Safflower is an annual vegetation. Flowers bloom in June-July. They are dried when they turn yellow to red-red, and the scientific name is Carthamus tinctorius.

골밀도의 측정은 골밀도계(Bone Densitometry)를 사용하여 측정이 가능하며, 골다공증과 가장 관련이 높은 것은 골밀도이다.Bone density can be measured using Bone Densitometry. Bone density is most often associated with osteoporosis.

사용된 홍화추출물은 다음과 같은 방법에 의하여 제조되어진다.Safflower extract used is prepared by the following method.

홍화 1㎏을 10 ~ 70%의 알콜류 또는 열수를 이용하여 50 - 90℃의 온도에서 3 ~ 8 시간 동안 추출하고 여과한 후 그 여액을 농축 건조시킨다.Safflower 1 kg is extracted with 10-70% alcohols or hot water at a temperature of 50-90 ° C. for 3-8 hours, filtered and the filtrate is concentrated to dryness.

농축 건조된 홍화추출물 또는 굴껍질 가루(Oyster shell powder)과 홍화추출물의 복합제제로 구성된 골다공증의 예방 및 치료제의 혼합물은 칼슘의 공급과 더불어 난소를 보호하여 에스트로겐의 분비를 도울 수 있고, 혈장내로의 과다한 칼슘의 분비 또한 조절할 수 있을 것으로 사려된다.A mixture of concentrated dried safflower extract or oyster shell powder and a combination of safflower extract and osteoporosis prevention and treatment can help secrete ovaries along with calcium supply and help release estrogens, and excess blood into the plasma The release of calcium is also thought to be controlled.

다음에 실시예 및 실험예로서 본 발명을 더욱 상세히 설명한다.Next, the present invention will be described in more detail as Examples and Experimental Examples.

[실시예 1]Example 1

홍화 1㎏을 30% EtOH 5ℓ를 넣고 50℃에서 6시간 동안 추출한다. 여과한 후 여액을 따로 모으고, 잔사를 50% EtOH를 이용하여 1회 추가로 추출한 후 여과하고 두 액을 합하여 농축한다(수율 32%).1 kg safflower is added 5 L of 30% EtOH and extracted for 6 hours at 50 ℃. After filtration, the filtrates are collected separately, the residue is extracted once more with 50% EtOH, filtered and the two are combined and concentrated (yield 32%).

[실시예 2]Example 2

홍화 1㎏을 50% MeOH 5ℓ를 넣고 50℃에서 6시간 동안 추출한다. 여과한 후 여액을 따로 모으고, 잔사를 50% MeOH를 이용하여 1회 추가로 추출한 후 여과하고 두 액을 합하여 농축건조한다(수율 20%).1 kg safflower is added 5 L of 50% MeOH and extracted for 6 hours at 50 ℃. After filtration, the filtrates are collected separately, the residue is further extracted once with 50% MeOH, filtered and the two are combined and concentrated to dryness (yield 20%).

[실험예 1]Experimental Example 1

본 마커(Bone Marker: Deoxypyridinoline)의 측정:Determination of Bone Marker (Deoxypyridinoline):

데옥시피리디놀린(Deoxypyridinoline)은 뼈의 결합조직인 타입 I 코라겐이 분해될 때 생성되는 물질로서 皮骨細胞活性化因子(Osteoclast)의 활성에 대한 지표로 사용된다.Deoxypyridinoline (Deoxypyridinoline) is a substance produced when the connective tissue of bone type I collagen is decomposed and used as an indicator of the activity of Osteoclast.

생후 10주령의 SD 랫트(rat)를 한 마리당 케타민 하이드로클로라이드(ketamine hydrochloride) 0.7㎖를 복강내 주사하여 마취를 유도한 후 양쪽 난소를 적출하고 봉합하였다(대조군).Anesthesia was induced by intraperitoneal injection of 0.7 ml of ketamine hydrochloride per 10-week-old SD rat, and both ovaries were extracted and sutured (control).

가장수술군은 케타민 하이드로클로라이드(ketamine hydrochloride) 0.7㎖를 복강내 주사하여 마취를 유도한 후 수술부위를 절개한 후 난소는 제거하지 않고 다시 봉합하였다(가장수술군). 한군은 10마리로 하고 각군은 가장수술군(일반 사료), 대조군(일반 사료), 홍화(실시예 1에서 제조된 홍화추출물 3%을 함유한 사료), 홍화+칼슘투여군(제조된 실시예 1의 홍화추출물 0.3%와 굴껍질 가루 0.18%를 함유한 사료), 칼슘투여군(굴껍질 가루 0.18%를 함유한 사료)이다.The most surgical group was intraperitoneally injected with 0.7 ml of ketamine hydrochloride to induce anesthesia, and then the surgical site was resected and the ovaries were removed again (most surgical group). One group had 10 rats, and each group was the most surgical group (general feed), the control group (general feed), safflower (feed containing 3% safflower extract prepared in Example 1), safflower + calcium administration group (prepared Example 1 Of safflower extract and feed containing oyster shell powder 0.18%), and calcium administration group (feed containing oyster shell powder 0.18%).

4주 동안 모든 군에 대하여 정상적으로 먹이와 사료를 공급하여 골다공증을 유발시킨 후 10주 동안 약물을 투여하고 DEXA를 사용하여 BMD를 측정하였다.After four weeks, all groups were fed with normal food and feed to induce osteoporosis. Then, the drug was administered for 10 weeks and BMD was measured using DEXA.

그 결과는 다음의 표 1과 같다.The results are shown in Table 1 below.

[표 1]TABLE 1

상기의 실험결과로부터 본 발명의 홍화 및 홍화 + 칼슘이 대조군이나 칼슘만을 단독으로 투여하였을 때보다 월등한 효과를 가지고 있음이 확인된다.From the above experimental results, it is confirmed that safflower and safflower + calcium of the present invention have a superior effect than the control group or calcium alone.

본 발명의 약제는 환자의 나이 및 질병의 정도에 따라서 그 투여량이 달라질 수 있으나, 통상 일일 홍화추출물 10㎎ 내지 5000㎎을 1 내지 3회 분할하여 투여할 수 있다. 투여량은 환자의 질병의 정도에 따라서 증감될 수 있다.The dosage of the drug of the present invention may vary depending on the age of the patient and the degree of the disease, but can usually be administered by dividing the daily safflower extract 10mg to 5000mg 1 to 3 times. The dosage can be increased or decreased depending on the severity of the patient's disease.

본 발명의 약제는 통상으로 약제학적으로 허용되는 부형제와 통상으로 약제학적으로 허용되는 방법으로 통상의 약제학적인 제제형태로 제형화하여 투여할 수 있다.The medicament of the present invention may be administered in a conventionally pharmaceutically acceptable excipient and formulated in a conventional pharmaceutical formulation in a pharmaceutically acceptable manner.

다음에 제제실시예를 예시한다.Next, a formulation example is illustrated.

[제제실시예 1]Preparation Example 1

홍화추출엑기스100㎎Safflower Extract Extract 100mg

유당100㎎Lactose 100mg

전분 50㎎Starch 50mg

탈크 2㎎Talc 2mg

스테아린산 마그네슘 적량Magnesium stearate proper amount

상기의 성분을 통상의 방법으로 혼합하고 통상의 방법으로 타정하여 정제를 제조한다.The above components are mixed by a conventional method and compressed into a conventional method to prepare a tablet.

[제제실시예 2]Preparation Example 2

홍화추출엑기스100㎎Safflower Extract Extract 100mg

굴껍질 분말100㎎Oyster Shell Powder100mg

유당100㎎Lactose 100mg

전분100㎎Starch 100mg

탈크 2㎎Talc 2mg

스테아린산 마그네슘 적량Magnesium stearate proper amount

상기의 성분을 통상의 방법으로 혼합하고 통상의 방법으로 타정하여 정제를 제조한다.The above components are mixed by a conventional method and compressed into a conventional method to prepare a tablet.

[제제실시예 3]Preparation Example 3

홍화추출엑기스100㎎Safflower Extract Extract 100mg

유당100㎎Lactose 100mg

전분 50㎎Starch 50mg

탈크 2㎎Talc 2mg

스테아린산 마그네슘 적량Magnesium stearate proper amount

상기의 성분을 통상의 방법으로 혼합하고 젤라틴 캡슐에 충진하여 캡슐제를 제조한다.The above ingredients are mixed in a conventional manner and filled into gelatin capsules to prepare capsules.

[제제실시예 4]Preparation Example 4

홍화추출엑기스100㎎Safflower Extract Extract 100mg

굴껍질 분말100㎎Oyster Shell Powder100mg

유당100㎎Lactose 100mg

탈크 2㎎Talc 2mg

스테아린산 마그네슘 적량Magnesium stearate proper amount

상기의 성분을 통상의 방법으로 혼합하고 젤라틴 캡슐에 충진하여 캡슐제를 제조한다.The above ingredients are mixed in a conventional manner and filled into gelatin capsules to prepare capsules.

[제제실시예 5]Preparation Example 5

홍화추출엑기스 2㎎Safflower Extract Extract 2mg

주사용 멸균증류수 적량Appropriate sterile distilled water for injection

pH를 7.4로 조정하고 전체2㎖Adjust pH to 7.4 and total 2 ml

상기의 성분을 잘 혼합하고 미세여과한 후 2㎖의 앰플에 충진하고 밀봉한 후 멸균시켜서 주사제를 제조한다.The above ingredients are mixed well, microfiltered, filled into 2 ml ampoules, sealed and sterilized to prepare an injection.

[제제실시예 7]Preparation Example 7

홍화추출엑기스1,000㎎Safflower Extract Extract1,000mg

이성화당 100g100 g of isomerized sugar

레몬향 적량Lemon flavor

상기의 성분을 통상의 방법으로 잘 혼합한 후 100㎖ 용량의 갈색병에 충진하고 멸균하여 액체를 제조한다.The above components are mixed well by a conventional method, and then filled into a 100 ml brown bottle and sterilized to prepare a liquid.

[제제실시예 8]Preparation Example 8

홍화추출엑기스1,000㎎Safflower Extract Extract1,000mg

굴껍질 분말2,000㎎Oyster Shell Powder2,000mg

이성화당 100g100 g of isomerized sugar

현탁화제(Na-CMC) 적량Suspending Agent (Na-CMC) Correct

레몬향 적량Lemon flavor

상기의 성분을 통상의 방법으로 잘 혼합한 후 갈색병에 충진하고 멸균시켜서 시럽제를 제조한다.The above components are mixed well by a conventional method, and then filled into a brown bottle and sterilized to prepare a syrup.

Claims (2)

홍화(Carthamus tinctorius)를 추출한 홍화추출엑기스 또는 홍화추출엑기스에 굴껍질 분말을 첨가하고 여기에 통상의 약제학적으로 허용되는 부형제와 통상의 약제학적으로 허용되는 방법으로 제제화하여 제조된 골다공증의 치료와 예방에 사용되는 약학적 제제.Treatment and prevention of osteoporosis prepared by adding oyster shell powder to safflower extract or safflower extract extracted safflower (Carthamus tinctorius) and formulated in a conventional pharmaceutically acceptable excipient and a conventional pharmaceutically acceptable method. Pharmaceutical preparations used in. 홍화(Carthamus tinctorius)를 추출한 홍화추출엑기스 또는 홍화추출엑기스에 굴껍질 분말을 첨가하고 여기에 통상의 약제학적으로 허용되는 부형제와 혼합하고 통상의 약제학적으로 허용되는 방법으로 제제화함을 특징으로 하는 골다공증 치료와 예방에 사용되는 약제를 제조하는 방법.Osteoporosis characterized by adding oyster shell powder to safflower extract or safflower extract extract of safflower (Carthamus tinctorius), mixed with conventional pharmaceutically acceptable excipients and formulated in a conventional pharmaceutically acceptable method. Method of manufacturing a medicament used for treatment and prevention.
KR1019960039534A 1996-09-12 1996-09-12 Calcium supplement containing and their preparation process KR100190452B1 (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20000019869A (en) * 1998-09-16 2000-04-15 정세영 Composition comprising extract of seed of carthamus tinctorius l. for promoting regeneration of hard tissues
KR20010067023A (en) * 2000-12-13 2001-07-12 류희영 Curing agents for born porosity symptom, arthralgia and arthritis, and the manufacturing method thereof
CN112919943A (en) * 2021-03-26 2021-06-08 生态环境部华南环境科学研究所 Composting agent for efficiently removing steroid estrogen in livestock and poultry manure and aerobic composting method

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR19980061480A (en) * 1996-12-31 1998-10-07 이웅열 Osteoporosis treatment containing herbal medicine and vitamin K

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20000019869A (en) * 1998-09-16 2000-04-15 정세영 Composition comprising extract of seed of carthamus tinctorius l. for promoting regeneration of hard tissues
KR20010067023A (en) * 2000-12-13 2001-07-12 류희영 Curing agents for born porosity symptom, arthralgia and arthritis, and the manufacturing method thereof
CN112919943A (en) * 2021-03-26 2021-06-08 生态环境部华南环境科学研究所 Composting agent for efficiently removing steroid estrogen in livestock and poultry manure and aerobic composting method

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